CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 750 enrolled
Drug / intervention
BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1 +2 morebiological
Likely dose
BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1 0.1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02434770
NCT02434770Phase 3Completed
CompareCT.gov

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

PATH·interventional·Posted May 5, 2015·Updated Mar 10, 2020

In Brief

A Phase 3 clinical trial evaluating BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1, BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2, and 1 other intervention for Poliomyelitis. Completed, enrolled 750 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis
CountriesKenya
CollaboratorsBeijing Bio-Institute Biological Products Co., Ltd., formerly Beijing TiantanBio

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 5, 2015
Enrollment StartAug 1, 2015
Primary CompletionJun 17, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.2 years ago

Interventions

BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1biological

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.

BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2biological

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.

BioFarma Bivalent Oral Poliomyelitis Vaccinebiological

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.