Immunogenicity of full and fractional dose of inactivated poliovirus vaccine for use in routine immunization and outbreak response: An open-label, randomised controlled trial
The Lancet Jul 05, 2019
Snider CJ, et al. - Through an open-label, randomized, controlled, inequality, non-inferiority trial in two clinics in Dhaka, Bangladesh with 1,076 participants, researchers assessed the immunogenicity of two fractional inactivated poliovirus vaccine (fIPV, a dose-sparing alternative to the intramuscular full dose) doses vs one inactivated poliovirus vaccine (IPV) dose for routine immunization and the immunogenicity of an fIPV booster dose for outbreak response. Patients were randomized into four groups, A (n=271), B (n=267), C (n=268) & D (n=270). A significantly greater vaccine response at 22 weeks to two doses of fIPV (group D) was observed vs one dose of IPV (groups A and B) for all three poliovirus serotypes. For serotype 1, serotype 2, and serotype 3, the fIPV booster was recognized as non-inferior to IPV (group B vs group A), at 26 weeks. One hundred and twenty-nine adverse events were seen, out of which, 21 were categorized as serious including one death, however, none were due to IPV or fIPV. For routine immunization and outbreak responses, fIPV seemed to be an efficacious dose-sparing strategy.
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