Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2–10 years: A Phase II/III double-blind randomized controlled trial

Abstract

This study compares the immunogenicity and safety of a single dose of a new meningococcal A conjugate vaccine (PsA-TT, MenAfriVac™, Serum Institute of India Ltd., Pune) against the meningococcal group A component of a licensed quadrivalent meningococcal polysaccharide vaccine (PsACWY, Mencevax ACWY®, GSK, Belgium) 28 days after vaccination in Indian children. This double-blind, randomized, controlled study included 340 Indian children aged 2–10 years enrolled from August to October 2007; 169 children received a dose of PsA-TT while 171 children received a dose of PsACWY. Intention-to-treat analysis showed that 95.2% of children in PsA-TT group had a ≥4-fold response in serum bactericidal titers (rSBA) 28 days post vaccination as compared to 78.2% in the PsACWY group. A significantly higher rSBA GMT (11,209, 95%CI 9708–12,942) was noted in the PsA-TT group when compared to PsACWY group (2838, 95%CI 2368–3401). Almost all children in both vaccine groups had a ≥4-fold response in group A-specific IgG concentration but the IgG GMC was significantly greater in the PsA-TT group (89.1 μg/ml, 95%CI 75.5–105.0) when compared to the PsACWY group (15.3 μg/ml, 95%CI 12.3–19.2). Local and systemic reactions during the 4 days after immunization were similar for both vaccine groups except for tenderness (30.2% in PsA-TT group vs 12.3% in PsACWY group). None of the adverse events or serious adverse events was related to the study vaccines. We conclude that MenAfriVac™ is well tolerated and significantly more immunogenic when compared to a licensed polysaccharide vaccine, in 2- to-10-year-old Indian children.

Citation

Siddhivinayak Hirve; Ashish Bavdekar; Anand Pandit; Juvekar, S.; Malini Patil; Preziosi, M.P.; Tang YuXiao; Marchetti, E.; Martellet, L.; Findlow, H.; Elie, C.; Parulekar, V.; Plikaytis, B.; Borrow, R.; Carlone, G.; Kulkarni, P.S.; Goel, A.; Karupothula Suresh; Suresh Beri; Subhash Kapre; Suresh Jadhav; Preaud, J.M.; Viviani, S.; LaForce, F.M. Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2–10 years: A Phase II/III double-blind randomized controlled trial. Vaccine (2012) 30 (45) 6456-6460. [DOI: 10.1016/j.vaccine.2012.08.004]

Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2–10 years: A Phase II/III double-blind randomized controlled trial

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