NCT00757926WithdrawnPhase 1
Phase I/II, 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
Shantha Biotechnics Limited1 site in 1 country240 target enrollmentStarted: September 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Shantha Biotechnics Limited
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Safety and tolerability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 6 Weeks to 8 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
1
Experimental
Intervention: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] (Biological)
2
Placebo Comparator
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Safety and tolerability
Time Frame: Upto one month after each of the three doses of vaccine/ placebo
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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