Clinical Trial: Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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<
Brief Summary: The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV) manufactured by Beijing TiantanBio has a similar immunogenicity profile to a WHO pre-qualified bOPV.
Detailed Summary: Beijing TiantanBio has been one of the two suppliers of 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 WHO prequalification for the TiantanBio bOPV, thus making the vaccine available to help meet global demand.
Sponsor: PATH
Current Primary Outcome:
- Number of serious adverse events [ Time Frame: 154 days ]
- anti-polio neutralizing antibody GMTs after last dose [ Time Frame: 28 days ]
- Proportion of infants with serotype-specific anti-polio neutralizing antibody seroconversion after last dose [ Time Frame: 28 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Proportion of infants with protective responses or GMTs to other concomitantly administered EPI vaccines [ Time Frame: 28 days ]
Original Secondary Outcome: Same as current
Information By: PATH
Dates:
Date Received: April 30, 2015
Date Started: August 2015
Date Completion:
Last Updated: August 30, 2016
Last Verified: March 2016
