Phase I/II, Randomized, Double-blind, Placebo-controlled, Dosage Selection (10e5.5 or 10e6.25 FFU of Each Constituent Serotype Per 0.5 mL) 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

Shantha Biotechnics Limited1 site in 1 country90 target enrollmentJuly 2010

ConditionsRotavirus Gastroenteritis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Rotavirus Gastroenteritis
Sponsor: Shantha Biotechnics Limited
Enrollment: 90
Locations: 1
Primary Endpoint: The frequency, severity, and causality of Reactogenicity Events and other Adverse Events.
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]in Indian infants. The study would be carried out in 90 healthy infants. Three doses of the rotavirus vaccine or placebo would be administered orally to each infant at 6-8, 10-12 and 14-16 weeks of age. The rotavirus vaccine would be administered at one of the two planned virus concentrations (10e5.5 or 10e6.25 FFU of each constituent serotype per 0.5 ml). Each administration of the vaccine/placebo would be preceded by oral administration of 2.0 mL of antacid.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

December 2010

Last Updated

15 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 at time of enrollment 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). In case of father, mother or other legally acceptable representative (guardian) 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;
•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 axillary temperature ≥38.1oC (≥100.5oF); 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 in the past 30 days (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);

Outcomes

Primary Outcomes

The frequency, severity, and causality of Reactogenicity Events and other Adverse Events.

Time Frame: After each dose and upto 28 days after third dose

Secondary Outcomes

The Seroconversion rate, Sero-response rate and the GMT of serum IgA antibody against rotavirus.(After each dose and upto 28 days after third dose)
The frequency and duration of post-vaccination shedding of vaccine rotavirus in stool samples(After each dose and upto 7 days after third dose)