NCT02111135

Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life

Phase II, Observer-blind, Randomized Study on the Safety, Reactogenicity, Immunogenicity and Impact on Intestinal Shedding of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) or a Single Dose of Standard Trivalent Inactivated Poliovirus Vaccine (t-IPV) When Given Concomitantly With the Third Dose of Bivalent Oral Poliovirus Vaccine (b-OPV) to Infants Early in Life

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Vaxtrials S.A. · Academic / Other
• Sex: All
• Age: 6 Weeks – 6 Weeks
• Healthy volunteers: Accepted

Summary

Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus vaccine (b-OPV) to infants early in life

Conditions

• Polio

Interventions

Type	Name	Description
BIOLOGICAL	b-OPV
BIOLOGICAL	m-OPV2
BIOLOGICAL	m-IPV HD
BIOLOGICAL	t-IPV

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-09-01
• Completion: 2015-03-01
• First posted: 2014-04-10
• Last updated: 2015-07-20

Locations

1 site across 1 country: Panama