CTRI/2014/08/004893
Completed
Phase 3
A phase III study to evaluate immune non inferiority and safety of the All in One liquid formulation of a live attenuated tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV) to a licensed vaccine RotaTeq when administered as three dose series to Indian infants concomitantly with other routinely recommended vaccines for the age.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shantha Biotechnics Limited
- Enrollment
- 1182
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All infants must fulfill all of the following criteria in order to be eligible for the trial enrollment
- •Healthy infants, of either sex, 6\-8 weeks of age at time of enrollment;
- •Born after a gestational period of \>\=36 weeks with birth weight \>\= 2 kg;
- •Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF). In case of father, mother or other legally acceptable representative (guardian) being unable to read or write, having the ICF explained to them in the presence of an impartial witness and the witness having signed the ICF.
- •Infant, parent or guardian available for the entire period of the study and reachable by study staff for post\-vaccination follow\-up.
Exclusion Criteria
- •Any infant fulfilling any of the following criteria is to be excluded from the trial enrollment
- •History of congenital abdominal disorders, intussusception, or abdominal surgery;
- •Infants exhibiting signs of severe malnutrition;
- •Known or suspected impairment of immunological function in subject or immediate family;
- •Developmental delay or Neurological disorder;
- •Known hypersensitivity to any component of the study vaccines or any history of allergic reaction in past;
- •Prior receipt of any rotavirus vaccine;
- •Prior receipt of any dose of Diphtheria, Tetanus, Pertussis, Hepatitis B, Hib or polio virus containing vaccine(s). Birth dose of Hepatitis B,BCG and Oral Polio Vaccine is allowed to be administered to the infants as per the local immunization practices. Oral Polio Vaccines administered as a part of the National Pulse Polio Program are allowed to be administered to the infants.
- •History of known rotavirus disease, chronic diarrhea, or failure to thrive;
- •Clinical evidence of active gastrointestinal illness including ongoing diarrheal episode (infants with GERD can participate in the study as long as the condition is well controlled with or without medication);
Outcomes
Primary Outcomes
Not specified
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