NCT03310073

Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV

Immunogenicity and Safety Profile of Primary Dose of Bivalent OPV (bOPV Bio Farma) Given Simultaneously With Pentabio® And Inactivated Poliovirus Vaccine (IPV) at the 4th Visit in Indonesian Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 1 Minute – 1 Day
• Healthy volunteers: Accepted

Summary

This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit

Detailed description

To describe serological response after four doses of bOPV with 1 dose of IPV. To describe the antibody status to polio 60 days after birth dose of bOPV To assess the safety of bOPV which given simultaneously with Pentabio® and 1 dose 1 dosde of IPV at the 4th visit

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	bOPV	Batch Number: 2042015
BIOLOGICAL	Pentabio	Batch number: 5050115 The vaccine shall be given intramuscularly.
BIOLOGICAL	IPV	The vaccine shall be given intramuscularly.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2017-10-16
• Last updated: 2017-11-08

Locations

1 site across 1 country: Indonesia