Poliomyelitis Clinical Trial
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 Vaccine (bOPV) in Comparison to a WHO Prequalified Comparator bOPV
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.
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
;
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