A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis Vaccine in Healthy Infants

Summary

The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.

Timeline

Start

2017-05-31

Primary completion

2019-01-18

Completion

2019-06-14

Publications

• Capeding MR, Gomez-Go GD, Oberdorfer P, Borja-Tabora C, Bravo L, Carlos J, Tangsathapornpong A, Uppala R, Laoprasopwattana K, Yang Y, Han S, Wittawatmongkol O. Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study. J Infect Dis. 2022 Aug 24;226(2):308-318. doi: 10.1093/infdis/jiaa770.

Drugs

Indications