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Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine

NCT02434770 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2020-03-10

Study results available
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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.

Conditions

  • Poliomyelitis

Interventions

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.

Sponsors & Collaborators

  • Beijing Bio-Institute Biological Products Co., Ltd., formerly Beijing TiantanBio

    collaborator UNKNOWN

  • PATH

    lead OTHER

Principal Investigators

  • Jessica Cowden, MD, MSPH · US Army Medical Research Unit-Kenya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-06-17
Completion
2016-06-17

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02434770 on ClinicalTrials.gov