Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)

Summary

This study will evaluate the immunogenicity and safety of concomitant administration of RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2, and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.

Timeline

Start

2020-08-25

Primary completion

2021-05-08

Completion

2021-05-08

Publications

• Results Chen S, Ying Z, Liu Y, Li Y, Yu Y, Huang M, Huang Z, Ou Z, Liao Y, Zhang Y, Liu G, Zhao W, Fu R, Shou Q, Zheng M, Liao X, Tu Y, Stek J, Hartzel J, Li C, Zhang J. A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China. Hum Vaccin Immunother. 2024 Dec 31;20(1):2324538. doi: 10.1080/21645515.2024.2324538. Epub 2024 Mar 20.

Drugs

Indications