Status:
WITHDRAWN
Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants
Lead Sponsor:
Shantha Biotechnics Limited
Collaborating Sponsors:
PATH
Conditions:
Rotavirus Infections
Eligibility:
All Genders
6-8 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00757926
Start Date
September 1 2009
End Date
September 1 2010
Last Update
February 3 2010
Active Locations (1)
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1
Christian Medical College
Vellore, Tamil Nadu, India, 632004