NCT03169725

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

A Prospective, Multi-national, Multi-center, Double-blind, Randomized, Active Controlled, Parallel-group, Seamless Phase II/III Clinical Study to Evaluate the Safety and Immunogenicity of 'LBVC (Sabin Poliomyelitis Vaccine (Inactivated))' Compared With 'Imovax® Polio (Poliomyelitis Vaccine (Inactivated))' in Healthy Infants

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,417 (actual)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 6 Weeks – 8 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Poliomyelitis Vaccine (Sabin strain)	Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
BIOLOGICAL	Inactivated Poliomyelitis Vaccine (Salk strain)	Commercialized IPV based on Salk strain (Imovax Polio). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.

Timeline

• Start date: 2017-05-31
• Primary completion: 2019-01-18
• Completion: 2019-06-14
• First posted: 2017-05-30
• Last updated: 2019-08-29

Locations

3 sites across 2 countries: Philippines, Thailand