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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00757926
Other study ID # SBL/BRV-TV/PhI/2008/0100
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received September 22, 2008
Last updated February 2, 2010
Start date September 2009
Est. completion date September 2010

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Live 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.
Other:
Placebo
Three oral doses of the placebo (0.5 ml each)following oral administration of antacid.

Locations

Country Name City State
India Christian Medical College Vellore Tamil Nadu

Sponsors (2)

Lead Sponsor Collaborator
Shantha Biotechnics Limited PATH

Country where clinical trial is conducted

India, 

Outcome

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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