A clinical Trial to study the safety, immunogenicity and tolerability of a tetravalent rotavirus vaccine in Indian infants.
- Registration Number
- CTRI/2009/091/001080
- Lead Sponsor
- Shantha Biotechnics Limited, Hyderabad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 90
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 more than equal to 2 kgs
- 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.
- 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 more than or equal to 38.1oC (more than or equall to 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);
- Infants suspected to be HIV, HBV or HCV positive from the available clinical history or born to mothers known to be HIV, HBV or HCV positive.
- Prior receipt of a blood transfusion or blood products, including immunoglobulins;
- Any infants who cannot be adequately followed for safety by a home visit;
- Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- Parent/s or guardian of subject unable to maintain diary card
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method