NCT03566940

A Study to Assess the Safety, Reactogenicity and Immunogenicity of a Trivalent Inactivated Poliovirus Vaccine (IPV) Based on Sabin Strains Compared to Conventional Salk IPV in a 6, 10 and 14 Weeks of Age Immunization Schedule

A Phase 2, Observer-blind, Active-controlled, Randomized Dose-finding Study in Healthy Infants to Assess the Safety, Reactogenicity and Immunogenicity of 3 Dose Levels of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains Compared to Conventional Salk IPV, in a 6, 10 and 14 Weeks of Age Immunization Schedule, and Co-administered With Diphtheria, Tetanus, Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Pneumococcal Conjugate and Rotavirus Vaccines

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 39 Days – 59 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an active control.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	sIPV	Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.
BIOLOGICAL	cIPV	Participants will receive 0.5 mL of cIPV as a suspension for IM injection.

Timeline

• Start date: 2018-07-31
• Primary completion: 2019-08-07
• Completion: 2019-10-17
• First posted: 2018-06-25
• Last updated: 2025-02-03

Locations

3 sites across 1 country: Philippines