Evaluation of Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine

Summary

This Phase III study has been designed to compare the SII Inactivated Salk Polio Vaccine (Adsorbed) with Sii licensed IPV by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific poliovirus neutralizing antibody (PVNA) to poliovirus type 1, type 2 and type 3 by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of SII Inactivated Salk Polio Vaccine (Adsorbed) by demonstrating equivalence in the induction of PVNA across three production lots.

Timeline

Start

2022-01-09

Primary completion

2023-04-29

Completion

2023-04-29

Publications

• Kulkarni PS, Zaman K, Desai SA, Bharati S, Goswami DR, Sharmeen AT, Rana S, Haque W, Khandelwal A, Manney S, Tyagi P, Gairola S, Zade JK, Pisal SS, Dhere RM, Poonawalla CS, Lamberigts C, Parulekar V, Potey AV. Safety and immunogenicity of a reduced-dose inactivated poliovirus vaccine versus a full-dose inactivated poliovirus vaccine in infants in Bangladesh: a double-blind, non-inferiority, randomised, controlled, phase 3 trial. Lancet Infect Dis. 2025 Oct;25(10):1128-1137. doi: 10.1016/S1473-3099(25)00215-4. Epub 2025 Jun 9.

Drugs

Indications