Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants
Phase 1
Withdrawn
- Conditions
- Rotavirus Infections
- Interventions
- Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]Other: Placebo
- Registration Number
- NCT00757926
- Lead Sponsor
- Shantha Biotechnics Limited
- Brief Summary
A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine \[BRV-TV\] administered to healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard EPI vaccines would be generally well tolerated and immunogenic.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
- Healthy infants 6-8 weeks of age of either sex;
- Born after a gestational period of 36-42 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);
- Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.
Exclusion Criteria
- History of congenital abdominal disorders, intussusception, or abdominal surgery;
- Known or suspected impairment of immunological function;
- Known hypersensitivity to any component of the rotavirus vaccine;
- Prior receipt of any rotavirus vaccine;
- Fever, with an oral temperature ≥38.1oC (≥100.5oF); presumably measured by study staff?
- History of known rotavirus disease, chronic diarrhea, or failure to thrive;
- Baseline level of ALT or AST >2.5 times the upper limit of normal;
- Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);
- Receipt of any IM, oral, or IV corticosteroid treatment (infants on inhaled steroids may be permitted to participate in the study);
- Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids);
- Infants testing positive for HBV, HCV, or HIV infection;
- Prior receipt of a blood transfusion or blood products, including immunoglobulins;
- Any infants who can not be adequately followed for safety by telephone and/or a home visit;
- Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] - 2 Placebo -
- Primary Outcome Measures
Name Time Method Safety and tolerability Upto one month after each of the three doses of vaccine/ placebo
- Secondary Outcome Measures
Name Time Method Immunogenicity At one month after each of the three doses of vaccine/ placebo Viral Shedding After each of the three doses of the vaccine/placebo
Trial Locations
- Locations (1)
Christian Medical College
🇮🇳Vellore, Tamil Nadu, India