Clinical trial NCT00757926: Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Rotavirus Infections
Lead sponsor: Shantha Biotechnics Limited
Sponsor class: INDUSTRY
Collaborators: name: PATH
First posted: 2008-09-23
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability
timeFrame: Upto one month after each of the three doses of vaccine/ placebo
Secondary outcomes:
measure: Immunogenicity
timeFrame: At one month after each of the three doses of vaccine/ placebo
measure: Viral Shedding
timeFrame: After each of the three doses of the vaccine/placebo
Other outcomes:
Locations:
city: Vellore
country: India
facility: Christian Medical College
state: Tamil Nadu
Study officials:
affiliation: Shantha Biotechnics Limited
name: Raman Rao, MD
role: STUDY_DIRECTOR
References: