Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine

Summary

The purpose of this study is to generate data to support the registration extension of IMOVAX Polio to be used in a sequential vaccination. Primary objective: * To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2) poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of seroprotection rate 28 to 42 days after the third dose of the primary vaccination series. Secondary objectives: * To evaluate the safety profile of the investigational vaccines after each administration in each group. * To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3) before the first dose and 28 to 42 days after the third primary series dose of vaccine in each group. * To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and 3) after the third primary series dose administration, at 18 months of age in each group.

Timeline

Start

2011-11

Primary completion

2013-05

Completion

2013-11

Outcome

Met primary endpoint

paper Group A and Group B were noninferior to Group C at 1-month post-Dose 3 as assessed by Sabin strain-based assay (SSBA). PMID 26407255 ↗

Publications

• Li RC, Li CG, Wang HB, Luo HM, Li YP, Wang JF, Ying ZF, Yu WZ, Shu JD, Wen N, Vidor E. Immunogenicity of Two Different Sequential Schedules of Inactivated Polio Vaccine Followed by Oral Polio Vaccine Versus Oral Polio Vaccine Alone in Healthy Infants in China. J Pediatric Infect Dis Soc. 2016 Sep;5(3):287-96. doi: 10.1093/jpids/piv017. Epub 2015 Apr 16.

Drugs

Indications