Rotavirus Infections Clinical Trial
Official title:
Phase I/II, 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
Verified date | February 2010 |
Source | Shantha Biotechnics Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Drugs Controller General of India |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 240 |
Est. completion date | September 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Weeks to 8 Weeks |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
India | Christian Medical College | Vellore | Tamil Nadu |
Lead Sponsor | Collaborator |
---|---|
Shantha Biotechnics Limited | PATH |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability | Upto one month after each of the three doses of vaccine/ placebo | Yes | |
Secondary | Immunogenicity | At one month after each of the three doses of vaccine/ placebo | No | |
Secondary | Viral Shedding | After each of the three doses of the vaccine/placebo | No |
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