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 enrollmentSeptember 2009

ConditionsRotavirus Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Rotavirus Infections
Sponsor: Shantha Biotechnics Limited
Enrollment: 240
Locations: 1
Primary Endpoint: Safety and tolerability
Status: Withdrawn
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

September 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shantha Biotechnics Limited

Eligibility Criteria

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);