NCT02434770

Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine

A Phase III Single-blind, Randomized, Controlled Study in Healthy Kenyan Infants to Assess the Immunogenicity and Safety of Beijing TiantanBio Liquid Bivalent Oral Poliomyelitis Vaccine (bOPV) in Comparison to a WHO Prequalified Comparator bOPV

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV) manufactured by Beijing Bio-Institute Biological Products Co., Ltd (BBIBP) has a similar immunogenicity profile to a WHO prequalified bOPV.

Detailed description

BBIBP has been one of the two suppliers of trivalent oral polio vaccine (tOPV) in China since 1985, with control of polio in China evidence of the effectiveness of its vaccine. The company plans to introduce a liquid formulation of bOPV (types 1 and 3) to meet increasing global demand with the phasing-out of tOPV. The proposed study is intended to provide data sufficient to obtain World Heath Organization (WHO) prequalification for the BBIBP bOPV, thus making the vaccine available to help meet global demand. Infants were enrolled and randomized prior to the birth dose of bOPV. The first dose of study vaccine was administered during the first two weeks of life and then co-administered with the primary Expanded Programme on Immunization (EPI) series vaccines in Kenya at 6, 10 and 14 weeks of age. The Kenya EPI schedule includes the following additional vaccines: * Bacille Calmette-Guérin Vaccine (BCG) at birth * Diphtheria and Tetanus Toxoid with Whole Cell Pertussis, Haemophilus influenzae Type V vaccine (Hib), and Hepatitis B Vaccine (DTwPHibHep) at 6, 10, 14 weeks; * Pneumococcal Conjugate vaccine (PCV) at 6, 10, 14 weeks * Rotavirus vaccine (Rotarix) at 6, 10 weeks

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1	Each dose of bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10\^6 cell culture infectious dose 50% (CCID50)/dose and 10\^5.8 CCID50/dose, respectively.
BIOLOGICAL	BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2	Each dose of bOPV (2 drops, 0.1 ml) contains types 1 and 3 attenuated polioviruses (Sabin), with at least 10\^6 CCID50/dose and 10\^5.8 CCID50/dose, respectively.
BIOLOGICAL	BioFarma Bivalent Oral Poliomyelitis Vaccine	Each dose of the WHO prequalified Bio Farma bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10\^6 and 10\^5.8 infective units per dose, respectively.

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-06-17
• Completion: 2016-06-17
• First posted: 2015-05-05
• Last updated: 2020-03-10
• Results posted: 2020-03-10

Locations

2 sites across 1 country: Kenya