Background: Data on the immunogenicity and safety of acellular pertussis-based combination vaccines when given in the WHO recommended EPI schedule (6, 10 and 14 weeks of age) are needed for making individual clinical practice and public policy decisions in India.Methods: This study assessed the immunogenicity and safety of primary vaccination at 6, 10 and 14 weeks of age with Pentaxim TM (sanofi pasteur, AcXim family vaccine) including diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate (PRP-T)antigens in 226 infants in India. Antibody titers were measured immediately before, and one month after, primary vaccination. Immunogenicity data from French infants vaccinated at 2, 3 and 4 months was used as a reference. Reactogenicity and safety were evaluated from parental reports.Results: One month after the third dose, 90.0% of subjects had anti-PRP ≥ 1.0 g/mL, and the GMT increased from 0.11 g/mL to 4.17 g/mL. Anti-Polio GMTs (1/dil U) increased from 18.1 to 441, from 20.4 to 459, and from 9.9 to 1511 for types 1, 2 and 3, respectively. Two-fold increase in PT and FHA antibody concentration occurred in 97.1% and 92.4% of subjects, and anti-PT and anti-FHA antibody titers ≥ 25 EU/mL were observed in 100% and 97.6% of children, respectively. The vaccine was well-tolerated, with low reactogenicity. Severe solicited reactions were documented in < 0.5% of subjects after any dose. No drop outs occurred because of adverse events.Conclusion: Pentaxim given at 6, 10 and 14 weeks of age was well tolerated and induced large immune responses in Indian infants, similar to those observed in French infants vaccinated at 2, 3, 4 months of age in an earlier trial.[NCT00259337].
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.