Guidance

Hexavalent DTaP/IPV/Hib/HepB combination vaccine: information for healthcare practitioners

Updated 2 June 2025

Applies to England

Background

From 2004, the UK used a pentavalent (5 in 1) infant vaccine in the routine childhood vaccination schedule to protect against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib). Two vaccines were supplied: lnfanrix®-IPV+Hib and Pediacel®. Three primary doses were scheduled, due at 8, 12 and 16 weeks of age.

In 2006, following studies that showed that protection against (Hib) waned during the second year of life, a fourth (booster) dose of Hib antigen (combined with capsular group C meningococcal (MenC) antigen as Hib/MenC, brand name Menitorix®) was introduced into the routine childhood schedule at 12 months of age.

From autumn 2017, a hexavalent (6 in 1) vaccine (initially lnfanrix hexa® but later Vaxelis® was also supplied), protecting against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B replaced the pentavalent infant vaccines in the UK. All babies born on or after 1 August 2017 became eligible for this hexavalent vaccine for their primary vaccinations, which included hepatitis B (HepB) in addition to the other antigens or toxoids previously included in the pentavalent vaccines. The hexavalent vaccine is abbreviated to DTaP/IPV/Hib/HepB.

Following notification from the manufacturer in 2022 of discontinuation of the Hib/MenC vaccine (Menitorix®), which was given at 12 months of age, a review of the UK routine infant schedule was undertaken by the JCVI. Options for the necessary changes were considered and in November 2022 the JCVI issued a statement on changes to the childhood immunisation schedule. JCVI advised that a dose of meningococcal C containing vaccine was no longer recommended in the childhood schedule at age 12 months but there was still a continued need for a Hib booster during the second year of life. As there is no Hib monovalent vaccine licensed in the UK, from 1st July 2025 a 4th dose of the hexavalent (DTaP/IPV/Hib/HepB vaccine) has been introduced into the UK schedule (replacing the previous 12 month dose of Hib/MenC). This is to be given at age 18 months of age to children with a date of birth on or after 01 July 2024.

As a result of the introduction of a fourth hexavalent hepatitis B containing vaccine at 18 months, the JCVI also recommended a change to the selective neonatal hepatitis B programme, as children on this pathway would otherwise be offered an unnecessary seventh hepatitis B containing vaccine. Children on the selective neonatal hepatitis B programme turning 12 months of age on or after 1 July 2025 (born on or after 1 July 2024) are no longer offered a 12 month dose of monovalent HepB vaccine as they will receive their sixth dose as part of the routine hexavalent vaccine at their 18 month appointment.

Further changes to the childhood vaccination schedule were also recommended and separate overarching 2025 childhood changes information for healthcare practitioner guidance is available.

The purpose of this hexavalent and selective neonatal hepatitis B information for healthcare practitioner guidance is to provide information about the hexavalent vaccine to healthcare practitioners who are involved in delivering or advising on the routine childhood vaccination schedule. This guidance also contains information for healthcare practitioners about the use of the hexavalent vaccine as part of the selective neonatal hepatitis B vaccination programme.

The selective neonatal hepatitis B immunisation programme

All pregnant women should be offered antenatal screening for hepatitis B infection in every pregnancy.

Babies born to pregnant women who are living with^{[footnote 1]} chronic hepatitis B or who had acute hepatitis B during pregnancy are at risk of acquiring hepatitis B infection. Hepatitis B virus (HBV) can be transmitted from women living with hepatitis B to their babies at or around the time of birth (perinatal transmission). Babies acquiring infection at this time have a high risk of developing chronic hepatitis B.

The development of chronic infection after perinatal transmission can be prevented in over 90% of cases by appropriate vaccination, starting within 24 hours of birth. The objective of the selective neonatal hepatitis B vaccination programme is to provide post exposure immunisation to prevent perinatal transmission at or around the time of birth. To fulfil this objective, pregnant women living with hepatitis B need to be identified through antenatal screening and immunisation of the infant needs to start with a dose of monovalent hepatitis B vaccine as soon as possible after birth (ideally within 24 hours), followed by a second monovalent dose at 4 weeks of age. The child requires further doses of hepatitis B vaccine, contained in the hexavalent vaccine given as part of the routine childhood vaccination schedule at 8, 12 and 16 weeks.

Children born on or before 30th June 2024 should continue to be offered of monovalent hepatitis B vaccine with their other one year vaccinations (Hib/MenC, MenB, MMR and PCV13) as per the previous schedule. If Hib/MenC vaccine is no longer available, they should be given the hexavalent DTaP/IPV/Hib/HepB vaccine at one year and a monovalent HepB vaccine would not be necessary. They should be tested for infection from 12 months of age using the dried blood spot (DBS) test.

Children born on or after 1 July 2024 who are on the selective hepatitis B vaccination programme will no longer be offered a monovalent vaccine at 12 months of age as they will now receive a further dose of hepatitis B vaccine as part of the hexavalent vaccine being offered at 18 months from 1 January 2026. These children should however, continue to receive their MenB, PCV13 and 1st MMR vaccines at one year of age.

It is important that these children are tested for infection using the dried blood spot  (DBS) test. DBS testing can be performed at any time between one year and 18 months, for example at an opportunistic healthcare attendance or at a routine appointment. This change to the timing of the test for hepatitis B surface antigen has been carefully considered and is not thought to present a clinical risk for any children who acquired infection at or around the time of birth through perinatal transmission.

As chronic infection in an infant is asymptomatic, testing for infection between 12 and 18 months of age is strongly recommended. It is important that timely vaccination and testing of children on the selective neonatal hepatitis B programme are not overlooked now that HepB is part of the routine infant vaccination programme.

An aide memoire and other resources are available to support staff with management of a child on the selective neonatal hepatitis B programme.  

Infanrix hexa® and Vaxelis® vaccines

Infanrix hexa® and Vaxelis® are combination vaccines used for primary vaccination of infants at 8, 12 and 16 weeks of age to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib). For children born on or after 1 July 2024, a 4th hexavalent dose is also given at 18 months of age to boost protection against Hib (replacing the Hib/MenC vaccine previously given at 12 months of age).

Multiple studies have shown that Infanrix hexa® and Vaxelis®  are safe and highly immunogenic for all their component toxoids/antigens.

Further details can be found in the Summary of Product Characteristics (SPC) for Infanrix hexa® and Vaxelis®

It is important to note that Infanrix hexa® requires reconstitution before being administered whilst Vaxelis® is presented in a pre-filled syringe.

Hexavalent vaccines for use in the routine childhood primary vaccination schedule are available to order online through the ImmForm website and are distributed by Movianto UK.

Interchangeability of Infanrix hexa and Vaxelis

Vaxelis® and Infanrix hexa® vaccines are considered interchangeable, but where possible and if local stock allows, it is preferable that the same DTaP/IPV/Hib/HepB vaccine be used for all 3 doses of the primary course. However, vaccination should never be delayed because the vaccine used for previous doses is not known or unavailable.

Why a hexavalent vaccine was introduced into the infant schedule

Hepatitis B is an infection of the liver caused by the hepatitis B virus (HBV). Most new hepatitis B infections are sub-clinical or may only cause a flu-like illness. However, acute infection occasionally leads to sudden and severe liver damage which can be fatal. Chronic hepatitis B infection can result in progressive liver disease, leading to cirrhosis (development of scar tissue) in some patients and an increased risk of developing liver cancer. In 1992, the World Health Assembly recommended that every country should have a universal hepatitis B vaccination programme by 1997.

As the UK is a low prevalence and low incidence country for hepatitis B, introducing a universal hepatitis B programme using a monovalent hepatitis B vaccine would not have been cost-effective. Since then, infant combination hepatitis B vaccines (which also protect against diphtheria, tetanus, polio, pertussis and Hib) have become available in the UK. As a result, in 2014 the Joint Committee of Vaccination and Immunisation (JCVI) re-evaluated the benefits and cost-effectiveness of a universal hepatitis B infant vaccination programme in the UK and subsequently recommended the use of the hexavalent DTaP/IPV/Hib/HepB combination vaccine for all infants subject to securing the vaccine at a cost-effective price.

By vaccinating against hepatitis B as part of the hexavalent vaccine, as well as being protected against diphtheria, tetanus, pertussis, polio and Hib, all infants now have the benefit of protection against hepatitis B virus as part of the UK routine vaccination schedule.

Babies born to women living with hepatitis B also require additional monovalent HepB vaccine doses, at birth and 4 weeks of age (as per the Green Book, chapter 18).

Children born on or before 30 June 2024 require a 3rd dose of monovalent hepatitis B vaccine with their other one year vaccinations (Hib/MenC, MenB, MMR and PCV13) as per the previous schedule.

Why a fourth hexavalent dose was introduced into the routine childhood vaccination schedule at 18 months of age

Following notification of a commercial decision to discontinue production of the Hib/MenC vaccine (Menitorix®) by the manufacturer, a review of the UK routine childhood vaccination schedule was undertaken by the JCVI. As this is the only Hib/MenC vaccine available, changes to the routine infant schedule were therefore required. The UKHSA estimated that the central stock of this vaccine would be depleted by mid-2025. As there is no other Hib/MenC vaccine available on the UK market, the JCVI discussed options for the necessary changes to the schedule, publishing an interim statement in August 2022 and a full statement ‘Changes to the childhood immunisation schedule’ in November 2022.

Following introduction of an infant MenC vaccination programme in 1999, meningococcal C disease decreased significantly in the UK. Since 2015, teenagers in the UK have been vaccinated against four strains of meningococcal disease (strains A, C, W and Y), usually around 14 years of age (in school year 9). JCVI advised that as the UK has a successful adolescent MenACWY programme through which excellent control of meningococcal C disease across the whole population could be maintained; a dose of meningococcal C containing vaccine was no longer recommended in the childhood schedule at age 12 months.

There is no Hib monovalent vaccine licensed in the UK so JCVI advised that an additional dose of a Hib-containing multivalent vaccine (such as the hexavalent DTaP/IPV/Hib/HepB vaccine) should be administered at age 18 months to replace the Hib component of the Hib/MenC (Menitorix®) previously given at 12 months. This required the introduction of a new routine appointment at 18 months of age. Although the hexavalent dose given at 18 months will also boost protection against the other components in those children who have previously completed their primary course of vaccination with sufficient intervals between doses, the aim of this 4th dose at 18 months of age is specifically to boost the immune response to the Hib component. JCVI advised that as Hib transmission is primarily driven by children aged 2 to 4 years, this dose during the second year of life was still required to provide protection against Hib during this period, reducing carriage and interrupting transmission.

The HepB component of the hexavalent vaccine dose given to children born on or after 1 July 2024 at 18 months of age also completes the course of additional vaccination required for children born to women living with hepatitis B (known as the selective neonatal hepatitis B vaccination programme). This has removed the need for a separate additional monovalent HepB dose which was previously given at 12 months of age.

Safety and efficacy of the hexavalent vaccines

The safety profile of both hexavalent vaccines is excellent, and any adverse events experienced are generally mild to moderate in severity. These may include redness, swelling and tenderness at the injection site, fever, sleepiness, irritability, loss of appetite, diarrhoea and vomiting.

Results from clinical trials show that nearly all infants given the 3-dose primary vaccination course of Infanrix hexa® at 8, 12 and 16 weeks of age develop protective levels of antibodies against diphtheria (100%), tetanus (100%), pertussis (100%), hepatitis B (99.5%), polio (97.8% to 100%) and Hib (96.4%). Studies also show that when a further (fourth) dose is given during the second year of life, protective levels of antibodies against all components were seen one month after receiving the dose in at least 98.4% of cases.

Similar levels of protection were seen with Vaxelis® where protective levels of antibodies against diphtheria (99.8%), tetanus (100%), pertussis (varies by component), hepatitis B (97.8%), polio (99.8% to 100%) and Hib (98%) were seen one month after completing the 3-dose primary vaccination schedule.

Vaccine dosage and schedule

The number of hexavalent doses that a child receives will depend on whether they are born on/before 30 June 2024 or on or after 1 July 2024. Additional monovalent hepatitis B vaccine doses will also be required if the child is born to a woman living with hepatitis B and should also be offered before discharge from hospital if there is anyone else in the household living with hepatitis B (see Appendix A).

The routine schedule for the hexavalent vaccines

The primary infant vaccination schedule includes a hexavalent vaccine at  8, 12 and 16 weeks of age. From 1 January 2026, children with a date of birth on or after 1 July 2024 will be offered a fourth hexavalent dose at a new 18-month routine vaccination appointment (primarily to replace the Hib component of Menitorix® which was a Hib/MenC vaccine previously given at 12 months of age).  

The first dose of the hexavalent vaccine can be given from 6 weeks if required in certain circumstances, for example travel to an endemic country. Rotavirus and MenB vaccines should also be given at the same time. The schedule should then be completed with a minimum of 4 weeks between subsequent doses of the hexavalent vaccine. Vaccine providers may decide to return a child who received the first set of primary vaccinations early back to the routine schedule and give the second set at 12 weeks. An individual decision should be made depending on the circumstances. Doses of HepB-containing vaccine should not be delayed if the infant is on the selective neonatal hepatitis B programme.

Note: MenB administration before 8 weeks of age is off-label and will require a patient specific direction (PSD) or prescription for its supply and administration during this period.

The neonatal selective schedule for the hexavalent vaccine

Which vaccine schedule to use for high risk infants

Babies born to mothers who received a positive hepatitis B screen in pregnancy, or babies whose mothers had acute hepatitis B in pregnancy, should receive an accelerated course of hepatitis B immunisation, starting with a monovalent HepB dose at birth and 4 weeks before continuing the course with hexavalent vaccines as part of the routine childhood vaccination programme. Six doses of hepatitis B containing vaccine are offered to children on the selective neonatal hepatitis B programme.

As the hexavalent vaccine is given at 8, 12 and 16 weeks of age, babies born to mothers living with hepatitis B still need to have urgent post exposure vaccination with hepatitis B monovalent vaccine at birth and 4 weeks old. This is then followed by the hexavalent vaccine doses given as part of the routine programme.

Children who turn 12 months of age on or before 30 June 2025 (DOB on or before 30 June 2024) who are on the selective hepatitis B vaccination programme should continue to be offered their 6th dose of hepatitis B vaccine as a monovalent HepB vaccine with their other 12-month vaccinations (Hib/MenC, MenB, MMR and PCV13) as per the previous schedule. They should be tested for infection around 12 months of age.

If Hib/MenC vaccine is no longer available, children in this birth cohort should be given the hexavalent DTaP/IPV/Hib/HepB vaccine at 12 months of age (alongside their PCV13, MenB and first MMR). A separate monovalent HepB vaccine would not be necessary.

Children born on or after 1 July 2024 who are on the selective hepatitis B vaccination programme will no longer be offered a monovalent vaccine at 12 months of age as they will now receive a further dose of hepatitis B as part of the hexavalent vaccine being offered at 18 months from 1 January 2026. It is important that these children are tested for infection, ideally using the dried blood spot (DBS) test. The DBS test should continue to be performed but can be undertaken at any time between one year and 18 months of age, for example at an opportunistic healthcare attendance or at a routine appointment. If this test has already been undertaken prior to the 18-month appointment and a negative hepatitis B surface antigen (HBsAg) result returned, the fourth dose of hexavalent vaccine is still required at this point to ensure long-term protection against Hib and HepB. This change to the timing of the test for hepatitis B surface antigen has been carefully considered and is not thought to present a clinical risk for any children who acquired infection at or around the time of birth through perinatal transmission.

Table 1: Hepatitis B immunisation schedule for routine childhood and selective neonatal immunisation programmes following the introduction of hexavalent hepatitis B-containing vaccine at 18 months of age for children born on or after 1 July 2024

Age	Routine childhood programme	Babies born to mothers living with hepatitis B infection
Birth	note 1	Monovalent HepB (with HBIG if indicated)
4 weeks	Not applicable	Monovalent HepB
8 weeks	DTaP/IPV/Hib/HepB	DTaP/IPV/Hib/HepB
12 weeks	DTaP/IPV/Hib/HepB	DTaP/IPV/Hib/HepB
16 weeks	DTaP/IPV/Hib/HepB	DTaP/IPV/Hib/HepB
12-18 months note 2	Not applicable	Dried Blood Spot (DBS) screening test for HBsAg (infection) Can be undertaken anytime between 12 and 18 months of age
18 months	DTaP/IPV/Hib/HepB	DTaP/IPV/Hib/HepB

Note 1: Newborn infants born to a woman without hepatitis B infection but known to be going home to a household where there is a person living with hepatitis B infection may be at risk of hepatitis B exposure. In these situations, a dose of monovalent hepatitis B vaccine should be offered to the newborn before discharge from hospital if there are concerns about immediate risk of exposure and/or risk of delay in receiving the hexavalent doses of the routine childhood schedule commencing at 8 weeks old.

Note 2: Children born on or before 30 June 2024 should continue to be offered a dose of monovalent HepB vaccine and a test for HBsAg on or after their first birthday (alongside Hib/MenC and the other vaccines offered at this age. An 18-month DTaP/IPV/Hib/HepB vaccine is not required in addition. If Hib/MenC vaccine is no longer available, they should be given the hexavalent DTaP/IPV/Hib/HepB vaccine at one year and a monovalent HepB vaccine would not be necessary.

This schedule was agreed at the JCVI October 2024 meeting. The Committee previously considered various schedule options and determined there was no evidence of increased reactogenicity or adverse events associated with multiple doses of hepatitis B-containing vaccine. JCVI also determined that the schedule chosen for babies born to mothers living with hepatitis B (Table 1) reduced the risk of missed doses.

Vaccine dose

Infanrix Hexa should be administered as a 0.5mL dose after reconstitution.

Vaxelis is supplied as a pre-filled 0.5mL dose.

Giving the hexavalent vaccine to premature infants

Clinical data indicate that Infanrix hexa® and Vaxelis® can be given to premature infants and it is important that premature infants receive their vaccinations at the appropriate chronological age (that is age since birth, not corrected), according to the schedule. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. The immune responses seen in premature infants to these vaccines in clinical trials were generally similar to that of those of the overall study population.

In comparative clinical studies, similar rates of adverse reactions were observed in pre-term and full-term infants. However, the occurrence of apnoea following vaccination is increased in infants who were born very prematurely. Very premature infants (born less than or equal to 28 weeks of gestation) who are in hospital should have respiratory monitoring for 48 to 72 hours when given their first vaccination, particularly those with a previous history of respiratory immaturity. If the infant has apnoea, bradycardia or desaturations after the first vaccination, the second vaccination should also be given in hospital, with respiratory monitoring for 48 to 72 hours.

Infants stable at discharge without a history of apnoea and/or respiratory compromise may be vaccinated in the community setting.

As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

Actions required if the vaccine course is interrupted, or an infant misses a scheduled dose

If the primary course of the DTaP/IPV/Hib/HepB-containing vaccine is interrupted, it should be resumed but not repeated, allowing an interval of 4 weeks between the remaining doses.

Infants and children with an uncertain or incomplete immunisation history

Where a child has an uncertain or incomplete immunisation history (for example they have recently moved and are being transferred onto the UK schedule), they should be vaccinated as appropriate for their age in line with the vaccination of individuals with uncertain or incomplete immunisation algorithm.  

Infants and children under 10 years of age who have not completed a primary course of three doses of diphtheria, tetanus, pertussis and polio-containing vaccine should complete their primary course with a DTaP/IPV/Hib/HepB-containing vaccine. Children born on or after 1 August 2017 who received primary vaccines without HepB (for example if given a quadrivalent or pentavalent priming vaccine), should be opportunistically offered three HepB-containing vaccines at least one month apart .

If they are at increased risk of acquisition of hepatitis B (for example, behavioural risk factors, co-existing medical conditions or individual’s with learning disabilities in settings where behaviours such as biting occur) or are exposed to hepatitis B, they should be proactively offered a hepatitis B vaccine course (see the Green Book chapter 18 for further information on vaccine courses and high-risk groups). 

Vaccinators should ensure that children on the selective neonatal hepatitis B programme receive all doses of a hepatitis B-containing vaccine (either monovalent or as part of a combined DTaP/IPV/Hib/HepB vaccine) in line with their vaccination schedule. Testing these children for infection is also extremely important to enable a timely assessment of their infection status. Please see later sections of this guidance for management of children on the selective neonatal hepatitis B programme who miss doses or attend late). If any children on the selective neonatal hepatitis B pathway have not been tested for hepatitis B surface antigen (HBsAg) when due, the test (ideally using the free DBS service), should be carried out as soon as possible as advised in the Green Book chapter 18.

Where the child has received a course of pentavalent (5 in 1) vaccines, it cannot be assumed that this is the same as the pentavalent vaccine previously used in the UK (for example, DTaP/IPV/Hib). The composition of the vaccine received should be checked where possible to ascertain which components from the UK schedule are missing (for example, polio (IPV) or HepB), in order to identify what needs to be caught up. Where it is not possible to reliably confirm what the components of the pentavalent vaccine were, it is better to assume the child is unvaccinated and a full course of relevant vaccinations planned.

Polio vaccination

There are three types of poliovirus (types 1, 2 and 3). Children coming to the UK may have received oral polio vaccine (OPV) which is given in many countries. The trivalent OPV was withdrawn in April 2016 and replaced with the bivalent oral poliovirus vaccine, which contains only attenuated virus of types 1 and 3. Inactivated polio vaccine (IPV) protects against all three types of poliovirus. If a child received any OPV in another country since April 2016, these doses should be discounted as they do not protect against type 2 poliovirus.

Most countries have a mixed OPV and IPV schedule and so if sufficient IPV doses have been received for their age, then no additional IPV doses are needed.

Fractional IPV (fIPV) is offered in some countries as part of the routine schedule. fIPV is one fifth of the IPV dose. Overall, a single dose of fIPV leads to lower levels of immune response than the equivalent full dose (although this difference does narrow after multiple doses). A child newly arrived in the UK who has received fIPV doses instead of full doses has not therefore had ‘sufficient doses’ of polio antigen. They should receive any outstanding vaccines using the full dose vaccine to catch-up with the UK schedule. If all of their polio doses were given as fIPV, an additional full dose of the combined IPV-containing vaccine (as appropriate for their age) should be given, at least 4 weeks after their previous dose.

There is no requirement to look back and catch-up individuals who received fIPV and are now established on the UK schedule but should an individual present then opportunistic catch up or boosting should be considered.

Children born on or after 1 July 2024 who have received at least one of their primary DTaP/IPV/Hib/HepB hexavalent vaccines from one year of age

Children less than 10 years of age need to receive at least one dose of Hib-containing vaccine over the age of one year when they make a better and longer lasting response. If they have received this Hib dose through receiving one or more of their primary doses of hexavalent vaccine over one year of age (for example because they are behind with the schedule or have received vaccines overseas), an additional fourth dose of hexavalent vaccine at 18 months is not needed (as long as the vaccine given overseas over one year contained a Hib component).

They should still receive their second dose of MMR from 18 months of age however (provided there have been at least 4 weeks since the previous MMR dose was given). They should also still receive the dTaP/IPV pre-school booster vaccine from 3 years 4 months of age (a minimum of one year should be left between completing the primary immunisation course and the first booster). 

If a fourth dose of hexavalent vaccine has been given to a child who has received at least one of their 3 primary doses of hexavalent vaccine over one year of age however, it does not matter, this will provide additional boosting to their primary course. If the child is under 3 years of age, they should still receive their dTaP/IPV booster vaccine at 3 years 4 months (or once there has been a minimum interval of 1 year between the last dose of hexavalent vaccine and the dTaP/IPV booster). If they were over 3 years of age when it was given, this hexavalent vaccine dose can count as their pre-school booster vaccine.

Contraindications for receiving hexavalent vaccines

There are very few individuals who cannot receive the hexavalent vaccines. Where there is doubt, instead of withholding vaccination, appropriate advice should be sought from a consultant with immunisation expertise, a member of the screening and immunisation team or from the local health protection team.

Hexavalent vaccines should not be administered to those who have had:

• a confirmed anaphylactic reaction to a previous dose of the vaccine or
• a confirmed anaphylactic reaction to any component of the vaccine (this includes formaldehyde, neomycin and polymyxin)

The vaccine-specific SPC should be checked for further information.

Precautions for hexavalent vaccines

If an infant has a minor illness without fever or systemic upset, vaccinations can still be given. If the infant is acutely unwell (for example with a fever above 38.5⁰C), vaccination may be postponed until they have fully recovered. This is to avoid wrongly attributing any new symptom or the progression of symptoms to the vaccine.

The presence of a neurological condition is not a contraindication to vaccination but if there is evidence of current neurological deterioration, deferral of the DTaP/IPV/Hib/HepB vaccine may be considered to avoid incorrect attribution of any change in the underlying condition. The risk of such deferral should be balanced against the risk of the preventable infection and vaccination should be promptly given once the diagnosis and/or the expected course of the condition becomes clear.

Children who have had a systemic or local reaction following a previous vaccination with DTaP/IPV/Hib/HepB or DTaP/IPV/Hib including:

• fever, irrespective of its severity
• hypotonic-hyporesponsive episodes (HHE)
• persistent crying or screaming for more than 3 hours, or
• severe local reaction, irrespective of extent

can continue to receive subsequent doses of DTaP/IPV/Hib/HepB vaccine. Seek further advice if required.

Very premature infants (born less than or equal to 28 weeks of gestation) who are in hospital should have respiratory monitoring for 48 to 72 hrs when given their first vaccination (see section on premature infants).

Vaccine composition

Composition of Infanrix hexa® vaccine

As well as the diphtheria, tetanus, pertussis, polio, Hib and hepatitis B antigens, Infanrix hexa® vaccine also contains the following:

The vial containing Hib powder  contains:

• Lactose anhydrous

The pre-filled syringe containing the DTaP/IPV/HepB suspension  contains:

• Sodium chloride
• Medium 199 containing principally amino acids, mineral salts, vitamins
• water for injections

The vaccine contains the following adjuvants (substances added to enhance the immune response to the antigens):

• Aluminium hydroxide, hydrated
• Aluminium phosphate

The hepatitis B surface antigen component of the vaccine is produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.

The vaccine may also contain traces of formaldehyde, neomycin and polymyxin which are used during the manufacturing process for inactivation and prevention of bacterial growth.

Infanrix hexa® does not contain any thiomersal or porcine gelatine.

A full list of vaccine excipients can be found in the Infanrix hexa vaccine SPC.

Composition of Vaxelis® vaccine

The prefilled syringe contains diphtheria, tetanus, pertussis, polio, Hib and hepatitis B antigens. The vaccine also contains the following:

• Sodium phosphate
• water for injections

The Vaxelis® vaccine contains the following adjuvants (substances added to enhance the immune response to the antigens):

• Amorphous aluminium hydroxyphosphate sulfate
• Aluminium phosphate

The hepatitis B surface antigen component of the vaccine is produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.

The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B, and bovine serum albumin which are used during the manufacturing process.

 Vaxelis® does not contain any thiomersal or porcine gelatine.

A full list of vaccine excipients can be found in the Vaxelis®  SPC.

Vaccine ordering

Infanrix hexa® and Vaxelis® should be ordered via the Immform website. Healthcare practitioners should refer to this website and vaccine update (the vaccination newsletter for healthcare practitioners) for up to date information on vaccine availability. As the programme is a year-round programme and not a seasonal programme, vaccines should be ordered regularly throughout the year.

Healthcare practitioners are reminded to only order what they need for a 2 to 4 week period rather than over-ordering or stockpiling vaccines. Vaccines should be ordered, stored and monitored as described in the Green Book, chapter 3 (storage, distribution and disposal of vaccines).

Vaccine storage and administration

Storage of hexavalent vaccines

Infanrix hexa® and Vaxelis® should be stored in a vaccine refrigerator between +2°C and +8°C. The vaccines should be stored in the original packaging to protect them from light, to ensure that the component parts are kept together and in order to retain the batch number and expiry date for the entire product which is printed on the outer vaccine carton. The vaccines should not be frozen.

Further information on vaccine storage is available in the Infanrix hexa® SPC, Vaxelis® SPC, the Patient Group Direction (PGD) and from the manufacturer.

Effectiveness cannot be guaranteed for vaccines unless they have been stored at the correct temperature and in the correct conditions. Those responsible for the ordering, storage and use of vaccines should be familiar with the recommendations in the Green Book, chapter 3. Vaccines should not be over-ordered or stockpiled.

Stability of Infanrix hexa®

In the event of an inadvertent or temporary temperature excursion outside of the recommended +2°C to +8°C range, stability data detailed in the SPC indicate that the vaccine components are stable at temperatures up to 25°C for 72 hours. At the end of this period Infanrix hexa® should be used or discarded. If further information regarding stability data is required, the manufacturer should be contacted.

Stability of Vaxelis®

In the event of an inadvertent or temporary temperature excursion outside of the recommended +2°C to +8°C range, stability data detailed in the SPC indicate that the vaccine is stable at temperatures up to 25°C for 228 hours. At the end of this period Vaxelis® should be used or discarded. If further information regarding stability data is required, the manufacturer should be contacted. 

For both vaccines, breaches in the cold chain should be reported to the Screening and Immunisation Team in line with local arrangements. Vaccines should not routinely be stored outside of the manufacturer’s recommended temperature parameters so the data above is intended to guide healthcare professionals in case of a temporary temperature excursion only.

Infanrix hexa® presentation

The vaccine is presented in 2 parts: a vial containing the freeze dried Hib component and a pre-filled syringe containing the DTaP/IPV/HepB components in a suspension.

It is very important that the freeze-dried Hib component is reconstituted correctly before administration or the child will not receive protection against this disease.

The DTaP/IPV/HepB components are presented in a cloudy white suspension in a pre-filled glass syringe. Upon storage, a clear liquid and a white deposit may be observed. This is a normal observation.

The freeze dried (lyophilised) Hib vaccine is presented as a white powder in a glass vial.

The Infanrix hexa® vaccine is supplied in single dose packs containing the syringe and vial.

When required for use, the pre-filled syringe should be shaken well in order to obtain a homogeneous turbid white suspension.

The vaccine is reconstituted by adding the entire contents of the pre-filled syringe to the vial containing the powder. The mixture should be well shaken until the powder is completely dissolved prior to administration.

The reconstituted vaccine appears as a slightly cloudier suspension than the liquid component alone. This is a normal observation.

After reconstitution, it is recommended that the vaccine is used immediately.

Full instructions for vaccine preparation are available in the SPC.

Vaxelis® presentation

The DTaP/IPV/HepB/Hib component is presented as a uniform, cloudy, white to off-white suspension in a pre-filled glass syringe.

Prior to administration, the pre-filled syringe should be shaken gently in order to obtain a homogeneous, whitish, cloudy suspension.

The suspension should be visually inspected, prior to administration, for foreign particulate matter and/or variation of physical appearance. If either is observed, discard the pre-filled syringe.

Administration

Infanrix hexa® and Vaxelis® should be administered intramuscularly.

The preferred site of injection for infants under one year of age is the anterolateral aspect of the thigh. The current UK schedule means that only 2 injections need to be given at each primary vaccine appointment so one injection can be given into each thigh. Should it be necessary to give more than one vaccine into the same limb, they should be given at least 2.5cm apart and the site at which each vaccine was given should be noted in the infant’s records.

Vaccination for individuals with bleeding disorders

Individuals with bleeding disorders may be vaccinated intramuscularly if, in the opinion of a doctor familiar with the individual’s bleeding risk, vaccines or similar small volume intramuscular injections can be administered with reasonable safety by this route. If the individual receives medication or treatment to reduce bleeding, for example treatment for haemophilia, intramuscular vaccination can be scheduled shortly after such medication or treatment is administered.

Individuals on stable anticoagulation therapy, including individuals on warfarin who are up to date with their scheduled INR testing and whose latest INR was below the upper threshold of their therapeutic range, can receive intramuscular vaccination. A fine needle (equal to 23 gauge or finer calibre such as 25 gauge) should be used for the vaccination, followed by firm pressure applied to the site (without rubbing) for at least 2 minutes.

If in any doubt, consult with the clinician responsible for prescribing or monitoring the individual’s anticoagulant therapy. On occasion the treating clinician may conclude, in discussion with the child’s parents or carers, that the benefit of protection against disease could outweigh the increased risk of a transient local reaction with intramuscular vaccination. Subcutaneous administration is off-label.

The parents or carer should be informed about the risk of haematoma from the injection.

Post-immunisation care recommendations

When MenB is given alongside infant DTaP-containing combination vaccines, the rate of fever is higher than when either vaccine is administered alone. Vaccinators should recommend that prophylactic paracetamol is given when MenB vaccine is given at the same appointment as the DTaP/IPV/Hib/HepB vaccine. Further information is available in the MenB information for healthcare practitioner guidance.

For further information about administration of paracetamol, please see MenB vaccine and paracetamol webpage and the ‘What to expect after vaccinations’ leaflet.

Selective neonatal immunisation programme for babies at risk of hepatitis B

Why the selective neonatal immunisation programme is continuing now all infants receive hepatitis B vaccine as part of the routine childhood programme

The aim of the selective neonatal hepatitis B immunisation programme is to prevent babies acquiring hepatitis B following exposure to their mothers’ blood and body fluids, especially around the time of birth (perinatal transmission). This occurs mainly because blood containing the hepatitis B virus passes through the placenta from the mother to the baby during delivery. Babies acquiring infection at this time have a high risk of developing chronic hepatitis B. The development of chronic infection in infants born to mothers living with hepatitis B after perinatal transmission can be prevented in over 90% of cases by appropriate post-exposure prophylactic vaccination starting at birth. Timely vaccination at birth and at 4 weeks of age is critical for full protection and to prevent the infant developing infection. Health professionals should be aware of the importance of ensuring that babies born to women with living with hepatitis B require an accelerated course of hepatitis B immunisation starting at birth. This vaccine course is urgent targeted treatment for babies that have been significantly exposed to hepatitis B virus around the time of birth.

The universal infant programme provides pre-exposure protection against hepatitis B virus which will benefit those who may have future risk of exposure to the virus. The dose given to all babies at 8 weeks of age (as part of the routine programme) would be too late to prevent infection in those born to women living with hepatitis B following exposure to the hepatitis B virus at or around birth.

Why Hepatitis B immunoglobulin (HBIG) is still required

Babies born to women considered at a higher risk of passing on hepatitis B onto their child (as defined by maternal blood test results for viral load and hepatitis B e markers) should continue to receive HBIG as well as monovalent HepB vaccine at birth (see Green Book hepatitis B chapter). HBIG provides ready-made hepatitis B-specific antibodies and gives some immediate protection until the hepatitis B vaccine, which should be given at the same time, becomes effective. Giving HBIG concurrently with hepatitis B vaccine does not affect the development of active immunity to the vaccine. HBIG should be given in a different site to the vaccine.

HBIG should be given as soon as possible, preferably within 48 hours of delivery (and within 24 hours of birth dose of vaccine), although it should still be considered up to seven days after exposure.

What the newborn infant should receive if the mother is hepatitis B negative, but there is another person living in the household who is infected with hepatitis B

Newborn infants born to a hepatitis B negative woman but known to be going to a home where another household member is living with hepatitis B may be at immediate risk of hepatitis B infection. In these situations, a monovalent dose of hepatitis B vaccine should be offered before discharge from hospital. The infant should then continue on the routine childhood schedule commencing at 8 weeks old.

Explaining the reason for giving 6 doses of hepatitis B vaccine to high risk infants

Following the introduction of the hexavalent hepatitis B-containing vaccine into the routine vaccination schedule for all infants in 2017, the JCVI considered the various options for vaccinating infants on the selective neonatal hepatitis B programme. It was agreed at that time that having 2 different vaccines being used in the infant programme, (a pentavalent without HepB for infants on the selective neonatal hepatitis B programme for use alongside a separate monovalent hep B schedule and a hexavalent vaccine for all other infants) would be confusing and securing a continuous supply of the small amount of pentavalent vaccine would be difficult. Therefore, JCVI concluded that it was better to recommend that all infants on the selective neonatal hepatitis B programme receive additional doses of HepB vaccine in the hexavalent vaccine. Hepatitis B vaccine is well tolerated and additional doses should not be harmful.

All children born on or after 1 July 2024 receive a fourth dose of hexavalent vaccine at 18 months of age as part of the routine childhood vaccination schedule. As the hexavalent vaccine includes a dose of HepB, for children who are on the selective neonatal hepatitis B vaccination programme this has replaced the monovalent HepB dose previously given at 12 months of age. These children still receive a total of 6 doses of HepB-containing vaccine so the introduction of the 18-month dose of hexavalent vaccine has not increased the number of doses of HepB vaccine that a child on the selective neonatal hepatitis B programme receives.

An infant on the selective neonatal hepatitis B programme misses their 4 weeks of age dose of hepatitis B vaccine and then receives hexavalent vaccine at 8, 12 and 16 weeks

The key to giving optimal protection is the timing of the early doses. The doses given at birth, 4 and 8 weeks old should stimulate immunity in time to prevent the hepatitis B virus replicating to high levels. The doses normally given at 12 and 16 weeks, followed by the hepatitis B monovalent dose at 12 months (for children born on or before 30 June 2024) or hexavalent vaccine at 18 months (for children born on or after 1 July 2024) will help to provide longer term protection and boosting. Where an early dose (for example at 4 weeks) is missed or delayed, this may increase the risk of the child acquiring infection but cannot be reversed by adding additional doses later.

In the situation described above where they missed an early dose of vaccine, it is especially important that the child is tested when they become eligible. For children born on or before 30 June 2024, their test for HBsAg (ideally performed as a DBS), is due on or after their first birthday. Children born on or after 1 July 2024 should be tested when they attend for their vaccination appointment or any opportunistic healthcare appointment between one year and 18 months of age. This is to check whether the infection was acquired early in life. The best approach to preventing these infants acquiring hepatitis B is to ensure all scheduled doses of a hepatitis B-containing vaccine are given on time.

An infant on the selective neonatal hepatitis B programme attends late for their first or second dose of monovalent hepatitis B vaccine but before 6 weeks of age

The infant should receive a dose of monovalent hepatitis B vaccine as soon as possible as early doses of vaccine are of critical importance in preventing infection after perinatal transmission. The first primary dose of hexavalent DTaP/IPV/Hib/HepB vaccine, rotavirus vaccine and MenB vaccine should then be scheduled routinely at 8 weeks of age, irrespective of the timing of the late monovalent hepatitis B vaccine dose, in order not to delay protection against the other diseases. A shorter interval between doses of hepatitis B vaccine in this situation is unlikely to be detrimental to the infant’s overall protection against hepatitis B infection.

In the situation described above where a delayed or missed dose of hepatitis B vaccine means the child may be at a greater risk of becoming infected, it is very important that the child is tested when eligible. For children born on or before 30 June 2024, their test for HBsAg (ideally performed as a DBS), is due on or after their first birthday. Children born on or after 1 July 2024 should be tested when they attend for their vaccination appointment or any opportunistic healthcare appointment between one year and 18 months of age.

An infant on the selective neonatal hepatitis B programme attends late for their first or second dose of monovalent hepatitis B vaccine but on or after 6 weeks of age

Infanrix hexa® and Vaxelis® are approved for use from 6 weeks of age and studies have shown that infants respond effectively to diphtheria, tetanus and pertussis (DTP)-containing vaccines at this age. The first dose of hexavalent vaccine should therefore be given to infants in this situation to provide rapid protection against hepatitis B. Rotavirus and MenB vaccines should also be given at the same time. The second and third doses of the hexavalent vaccines should then be given at 4-week intervals. The remaining dose (a hepatitis B monovalent dose at 12 months for children born on or before 30 June 2024 or hexavalent vaccine at 18 months for children born on or after 1 July 2024) should be given as scheduled to provide longer term protection and boosting.

The second dose of rotavirus and MenB vaccines should be given 4 weeks after the first (with the second dose of hexavalent vaccine). A single priming dose of PCV should be given from 16 weeks of age. All further doses of any vaccine should be given as per the schedule.

In the situation described above where a delayed or missed dose of hepatitis B vaccine means the child may be at a greater risk of becoming infected, it is very important that the child is tested when eligible. For children born on or before 30 June 2024, their test for HBsAg (ideally performed as a DBS), is due on or after their first birthday. Children born on or after 1 July 2024 should be tested when they attend for their vaccination appointment or any opportunistic healthcare appointment between one year and 18 months of age.

Note: MenB administration before 8 weeks of age is off label. Patient Group Directions (PGDs) should be checked as to whether they cover administration of routine vaccinations before 8 weeks of age – a Patient Specific Direction (PSD) may be required.

Routine infant immunisation programme – booster and catch-up doses

HepB catch up programme for children

The incidence of hepatitis B is currently low in children and by vaccinating all children born on or after 1 August 2017, this will ultimately help to keep the incidence of hepatitis B low in the population as a whole. Individuals born before 1 August 2017 are not eligible for hepatitis B catch up, but will, as always, be eligible for hepatitis B vaccine if they are identified as being at increased risk of hepatitis B infection. As DTaP/IPV/Hib/HepB is the only suitable vaccine containing high dose tetanus, diphtheria and pertussis for children up to their tenth birthday however, those who have not completed a primary course of vaccination should receive three doses of hexavalent with a 4-week interval as per the uncertain or incomplete immunisation status algorithm.

Hepatitis B vaccine booster doses

For infants who have completed a primary course of hexavalent vaccination, a routine booster dose of HepB vaccine is not required. For children on the selective neonatal hepatitis B vaccination programme, the fourth dose of hexavalent vaccine given at 18 months for children born on or after 1 July 2024 has replaced the monovalent Hep B dose previously given at 12 months of age.

The full duration of protection afforded by hepatitis B vaccine is expected to be greater than 20 years. Even though levels of vaccine-induced antibody to hepatitis B decline over time, there is evidence that immune memory persists in those successfully immunised. If they are exposed later in life, this immune memory will help to protect them against serious disease and chronic infection. If there is a significant exposure to an unknown or known hepatitis B surface antigen (HBsAg) positive source however, a booster dose of vaccine may be indicated. See the Green Book hepatitis B chapter for more information.

For those who may become at risk of infection later in life, for example if they become health care workers, additional doses of vaccine and/or antibody testing may be required. Check the Green Book hepatitis B chapter for more information.

The selective neonatal hepatitis B immunisation programme – booster doses and blood tests

Why children on the selective neonatal hepatitis B programme require a blood test between 12 and 18 months of age

Although the hepatitis B vaccine is highly effective at preventing infection if given at birth, a few infants may still acquire infection despite vaccination and HBIG.

Children with hepatitis B infection are usually asymptomatic and do not display any signs of infection. This means testing children for infection is extremely important to enable a timely assessment of their infection status. The change to testing time (from 12 months previously, to between one year and 18 months now) has been carefully considered and is not considered to present a clinical risk for any children who have acquired infection at or around the time of birth through perinatal transmission.

Children born on/before 30 June 2024 who are on the selective hepatitis B vaccination programme should be tested for infection around 12 months of age alongside their sixth dose of hepatitis B (either given as a monovalent HepB vaccine or as part of a hexavalent vaccine if supplies of Hib/MenC are no longer available).

Children born on or after 1 July 2024 who are on the selective hepatitis B vaccination programme should receive their sixth dose of hepatitis B as part of the hexavalent vaccine at 18 months of age but can be tested at any time between one year and 18 months of age, (for example at an opportunistic healthcare attendance or at a routine appointment).

Finding out if the child has acquired infection at this point allows for prompt referral to specialist care to reduce the risk of long-term complications in later life. Additionally, if the child’s blood test is negative, parents can be reassured that transmission has been avoided. Where testing has already been undertaken prior to the 18-month appointment and a negative hepatitis B surface antigen (HBsAg) result returned, the fourth dose of hexavalent vaccine is still required at this point to ensure long-term protection against Hib and hepatitis B.

The purpose of the blood test in the selective neonatal hepatitis B programme is to check for infection, not to check or measure response to the vaccine (that is, immunity) in the way that a healthcare worker’s response is checked.

Numerous studies have already demonstrated that the vast majority of infants who do not become infected make a protective response to a course of hepatitis B vaccine given in the first year of life. See the publication ‘Rationale for not requiring high anti-HBs levels in infants born to HBsAg positive mothers’ for further information.

Why some babies acquire hepatitis B infection despite vaccination and HBIG

If infection has already become established before the full response to immunisation is made, virus replication may not be inhibited completely by HBIG or vaccine. This is why it is important that the child is tested when eligible (between one year and 18 months of age – see the selective neonatal hepatitis B vaccination programme and the hexavalent vaccine section for more information).

However, severe illness and, most importantly, development of the chronic, persistently infected state which can lead to serious liver disease and liver cancer, may still be prevented by immunisation.

Potential vaccine errors

Separate overarching 2025 childhood changes information for healthcare practitioner guidance is available. Guidance on management of potential vaccine errors in relation to the 2025 childhood changes can be found in that publication.

A dose of the hexavalent vaccine given at an interval of less than 4 weeks in error

A minimum 4-week interval is recommended between each of the 3 doses of hexavalent vaccine in the primary schedule. If one of these doses is given up to a week early, either inadvertently or deliberately, for example for travel reasons, then this can be counted as a valid dose and does not need to be repeated. However, no more than one dose should be given early in the 3-dose schedule and any doses given at less than a 3-week interval should be repeated 4 weeks after the final dose.

Infanrix hexa® reconstituted incorrectly and Hib component not added, meaning the child only received the DTaP/IPV/HepB component

As there is no other Hib-containing vaccine licensed in the UK, this dose will need to be discounted, and the vaccine repeated (with the Hib component correctly prepared and administered). This repeat dose should be given either at the same visit or as soon as possible after the error is realised in order to provide protection against Hib.

The incidence of local reaction to DTaP-containing vaccines may increase with additional doses.

All vaccine errors should be reported to the local screening and immunisation team. It is important to establish if the error was a one-off occurrence or a systematic error that might require a look back exercise.

Inadvertent administration of DTaP/IPV/Hib/HepB at one year of age

If the hexavalent vaccine is inadvertently given to a one year old child who is eligible for the 18-month appointment, this will count as a valid dose of Hib-containing vaccine and does not need to be repeated at 18 months of age. However, the child should still attend their 18-month appointment in order to receive their second dose of MMR vaccine.

The hexavalent vaccine inadvertently given early at the 12-month appointment but then given again at the 18 months appointment

If the hexavalent vaccine is inadvertently given at the 12-month of age appointment, but then given again at 18 months of age, the parents should be advised that this was repeated in error and increased localised adverse reactions (for example, a lump or redness at the site) may be experienced. The child should still receive their second dose of MMR vaccine at 18 months of age. They should continue with the routine scheduled and receive their dTaP/IPV booster vaccine at 3 years, 4 months as usual.

The hexavalent vaccine inadvertently given at 3 years and 4 months of age

If the hexavalent vaccine is inadvertently given to children at their 3 years and 4 months of age appointment (also known as the pre-school booster) instead of the recommended dTaP/IPV vaccine, they will not require a dose of the correct vaccine to be given afterwards. This is because the hexavalent vaccine will still boost their antibodies against diphtheria, tetanus, pertussis and polio as the recommended dTaP/IPV vaccine would have done. They may be at increased risk from an adverse reaction since the antigen dose is higher in the hexavalent vaccines than in the quadrivalent pre-school vaccine.

dTaP/IPV (or other diphtheria and tetanus-containing vaccine) inadvertently given at 18 months of age

If the dTaP/IPV vaccine (usually given at 3 years and 4 months of age), Tdap or Td/IPV vaccine is inadvertently given at 18 months of age, then because these do not protect against Hib, (or hepatitis B for babies on the selective pathway) this should be discounted and a dose of hexavalent DTaP/IPV/Hib/HepB given as soon as the error is realised. dTaP/IPV will still be required at 3 years and 4 months of age.

Monovalent hepatitis B vaccine inadvertently given at 12 months of age to a child born on or after 1 July 2024 who is on the selective neonatal hepatitis B programme

Children born on or after 1 July 2024 who are on the selective neonatal hepatitis B vaccination programme receive their final dose of hepatitis B vaccine as part of the DTaP/IPV/Hib/HepB hexavalent vaccine offered at 18 months. This means they are no longer offered a monovalent vaccine at 12 months of age.

If a child born on or after 1 July 2024 on the selective neonatal hepatitis B programme is given a monovalent dose of hepatitis B at 12 months in error, but did not receive a Hib-containing vaccine (Hib/MenC or DTaP/IPV/Hib/HepB) at this appointment then the hexavalent vaccine should be given at the 18-month appointment as scheduled. There are no safety concerns with giving additional doses of Hepatitis B vaccine.

If a child born on or after 1 July 2024 on the selective neonatal hepatitis B programme is given a monovalent dose of hepatitis B at 12 months and a Hib-containing vaccine (Hib/MenC or DTaP/IPV/Hib/HepB) then these will count as valid doses and will not need to be repeated. However, the child should still attend their 18-month appointment in order to receive their second dose of MMR vaccine. The DBS test should be performed at any time between one year and 18 months of age.

Monovalent hepatitis B vaccine inadvertently given alongside hexavalent vaccine to a child on the selective neonatal hepatitis B programme

If a child inadvertently receives a dose monovalent hepatitis B vaccine alongside a dose of DTaP/IPV/Hib/HepB hexavalent vaccine at one year or at 18 months of age, their parent/carer should be informed of the error but should be reassured that there are no safety concerns with giving additional doses of Hepatitis B vaccine. The DBS test should be performed as scheduled (from one year of age for children born on/before 30 June 2024, or at any time between one year and 18 months of age for children born on or after 1 July 2024).

Addressing parental concerns

Parent or carer concerned about their child receiving a vaccine containing 6 components

It is acknowledged that some parents or carers may be concerned that their child is receiving a 6 component combination vaccine. Whilst these concerns are understandable, parents or carers should be reassured that there is no evidence to support arguments of ‘overloading’ the immune system. From the moment a child is born, they are continually being exposed to a huge number of bacteria and viruses on a daily basis. From birth, their immune system is able to respond to both the many antigens in the environment and the relatively small number of selected antigens in vaccines.

Additionally, before a combined vaccine is licensed for use, it must have demonstrated in pre-licensure studies that a satisfactory immune response is made to each of the combined antigens and that the rates of adverse reactions are lower or the same as they would be if the vaccines were administered separately.

Parent or carer does not want their child to receive a vaccine containing hepatitis B

Healthcare professionals should ascertain what the parent or carer’s specific concerns about the hepatitis B vaccine are and address these. They should also provide them with information as to the benefits of receiving it, including information about the other diseases against which the DTaP/IPV/Hib/HepB hexavalent vaccine protects.  

There is no alternative vaccine with which to adequately protect infants and young children against diphtheria, tetanus, polio, pertussis and Hib disease. The vaccines that are licensed for continuing the vaccination course at 3 years and 4 months contain lower levels of antigens and are therefore only suitable for boosting children who have already received infant priming vaccinations.

Parent or carer does not want their child to receive a hexavalent vaccine at 18 months to primarily protect against Hib

Healthcare professionals should ascertain what the parent or carer’s specific concerns about the hexavalent vaccine are or the timing of this dose and address these. They should also provide them with information as to the benefits of receiving it.

Studies have shown that protection against Hib from the primary vaccines given at 8, 12 and 16 weeks of age wanes during the second year of life so a fourth dose of Hib antigen, given during the second year of life (the 18-month appointment) is required to boost and lengthen protection. As there is no other Hib-containing vaccine available on the UK market, the hexavalent vaccine is the only way of ensuring this protection. For children on the selective neonatal hepatitis B programme, this will also contain their final dose of HepB vaccine. In both cases, this dose is required to complete the course of vaccination and provide optimal protection at the right time of life.

Other issues

Protection against whooping cough from 3 component acellular pertussis (3aP) vaccines compared to 5 component (5aP) vaccines

Between 2004 and 2008, the UK only used infant acellular pertussis vaccines that contained 5 components to ensure optimal protection against whooping cough. UK follow up of children who had received a 3aP vaccine suggested, however, that protection was equivalent to 5aP vaccines to pre-school age.

In 2008, JCVI advised that a 3aP combination vaccine could be used for primary vaccinations. In 2010, the WHO also reviewed all the global data on pertussis control in countries using acellular vaccines. They concluded that acellular pertussis vaccines with 3 or more components have higher protective efficacy than vaccines with fewer components and did not find consistent evidence of a difference between 3 and 5 components. A 3aP component vaccine (Infanrix®-IPV+Hib), similar to Infanrix hexa®, has now been used widely in the UK since 2014.

1. Using person-centred language is increasingly important to avoid stigma. Standardised language used when talking about viral hepatitis takes this approach and therefore ‘living with’ hepatitis in the context of this guidance will always refer to an individual who has current hepatitis infection. This is not to be confused with a household contact, who will be an individual living in a household where someone else is living with hepatitis B. ↩