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Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants

This study has been withdrawn prior to enrollment.
(Replaced with an alternate study)
Sponsor:
Collaborator:
PATH
Information provided by:
Shantha Biotechnics Limited
ClinicalTrials.gov Identifier:
NCT00757926
First received: September 22, 2008
Last updated: February 2, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Rotavirus Infections
Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]
Other: Placebo
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Shantha Biotechnics Limited:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Upto one month after each of the three doses of vaccine/ placebo ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: At one month after each of the three doses of vaccine/ placebo ] [ Designated as safety issue: No ]
  • Viral Shedding [ Time Frame: After each of the three doses of the vaccine/placebo ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: September 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Placebo Comparator: 2 Other: Placebo
Three oral doses of the placebo (0.5 ml each)following oral administration of antacid.

  Eligibility

Ages Eligible for Study:   6 Weeks to 8 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757926

Locations
India
Christian Medical College
Vellore, Tamil Nadu, India, 632004
Sponsors and Collaborators
Shantha Biotechnics Limited
PATH
Investigators
Study Director: Raman Rao, MD Shantha Biotechnics Limited
  More Information

No publications provided

Responsible Party: Dr. Raman Rao, Head clinical Research and Medical Affairs, Shantha Biotechnics Limited, Hyderabad
ClinicalTrials.gov Identifier: NCT00757926     History of Changes
Other Study ID Numbers: SBL/BRV-TV/PhI/2008/0100
Study First Received: September 22, 2008
Last Updated: February 2, 2010
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Rotavirus Infections
RNA Virus Infections
Reoviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014