A Clinical Trial to evaluate the safety of a Tetravalent Rotavirus Vaccine in healthy adult male volunteers
- Registration Number
- CTRI/2010/091/000260
- Lead Sponsor
- Shantha Biotechnics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Healthy Indian adult male volunteers aged between 18 to 55 years.
- No apparent signs or symptoms of ill health.
- Properly informed about the study and having signed the informed consent form (ICF). In case of the volunteer being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF;
- Subject available for the entire period of the study and reachable by study staff for post-vaccination follow-up.
- Known or suspected impairment of immunological function;
- Known hypersensitivity to any component of the rotavirus vaccine;
- Fever, with axillary temperature >38.1oC (>100.5oF); measured by study staff.
- History of chronic diarrhea;
- Clinical evidence of active gastrointestinal illness;
- Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days
- Subjects suspected to be HIV, HBV or HCV positive from the available clinical history
- Prior receipt of a blood transfusion or blood products, including immunoglobulins;
- Any subject who cannot be adequately followed for safety;
- Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- Subject unable to maintain diary card
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The frequency, severity, and causality of Reactogenicity Events and other Adverse EventsTimepoint: Upto 10 days following administration of the dose of vaccine/placebo
- Secondary Outcome Measures
Name Time Method The frequency and the percentage change in the laboratory parameters following the single dose of BRV-TV/placeboTimepoint: Upto 10 days after administration of vaccine/placebo