Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants

Shantha Biotechnics

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Rotavirus Infections

Treatments

Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00757926

SBL/BRV-TV/PhI/2008/0100

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

6 to 8 weeks old

Volunteers

Accepts Healthy Volunteers

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.