Rotavirus Infections
Conditions
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.
Interventions
BIOLOGICALLive Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]
Three oral doses of the vaccine (0.5 ml each) following oral administration of antacid.
OTHERPlacebo
Three oral doses of the placebo (0.5 ml each)following oral administration of antacid.
Sponsors
PATH
Shantha Biotechnics Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | Upto one month after each of the three doses of vaccine/ placebo |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
India
Outcome results
None listed