A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers

Phase I Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Tolerability of a Single Administration (10e6.25 FFU of Each Constituent Serotype Per 0.5 ml) of Live Attenuated Tetravalent (G1-G4) Bovine-human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Adult Males

This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at the highest possible viral concentration in 0.5 mL of vaccine.

Inclusion Criteria:

• Healthy Indian adult male volunteers.
• 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.

Exclusion Criteria:

• 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 intramuscular (IM), oral, or intravenous (IV) corticosteroid treatment in the past 30 days
• Subjects suspected to be HIV, hepatitis B virus (HBV) or hepatitis C virus (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