Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Shantha Biotechnics Limited.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shantha Biotechnics Limited
ClinicalTrials.gov Identifier:
NCT01061658
First received: February 2, 2010
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

A double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]in Indian infants. The study would be carried out in 90 healthy infants. Three doses of the rotavirus vaccine or placebo would be administered orally to each infant at 6-8, 10-12 and 14-16 weeks of age. The rotavirus vaccine would be administered at one of the two planned virus concentrations (10e5.5 or 10e6.25 FFU of each constituent serotype per 0.5 ml). Each administration of the vaccine/placebo would be preceded by oral administration of 2.0 mL of antacid.


Condition Intervention Phase
Rotavirus Gastroenteritis
Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine
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, Dosage Selection (10e5.5 or 10e6.25 FFU of Each Constituent Serotype Per 0.5 mL) 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

Resource links provided by NLM:


Further study details as provided by Shantha Biotechnics Limited:

Primary Outcome Measures:
  • The frequency, severity, and causality of Reactogenicity Events and other Adverse Events. [ Time Frame: After each dose and upto 28 days after third dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The Seroconversion rate, Sero-response rate and the GMT of serum IgA antibody against rotavirus. [ Time Frame: After each dose and upto 28 days after third dose ] [ Designated as safety issue: No ]
  • The frequency and duration of post-vaccination shedding of vaccine rotavirus in stool samples [ Time Frame: After each dose and upto 7 days after third dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine - High dosage Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine
Higher dosage of vaccine
Experimental: Vaccine - Lower dosage Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine
Lower dosage of vaccine
Placebo Comparator: Placebo Other: Placebo
Placebo

  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 at time of enrollment 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). 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.

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 axillary temperature ≥38.1oC (≥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
  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: NCT01061658

Contacts
Contact: Mandeep S Dhingra, MD +914066301000 ext 1801 drmandeep@shanthabiotech.co.in

Locations
India
Christian Medical College Recruiting
Vellore, Tamilnadu, India, 632002
Contact: Gagandeep Kang, MD PhD    +914162282052    gkang@cmcvellore.ac.in   
Principal Investigator: Gagandeep Kang, MD PhD         
Sponsors and Collaborators
Shantha Biotechnics Limited
Investigators
Study Director: Raman Rao, MD Shantha Biotechnics Limited
  More Information

No publications provided

Responsible Party: Head, Research and Development, Shantha Biotechnics Limited, Hyderabad, India
ClinicalTrials.gov Identifier: NCT01061658     History of Changes
Other Study ID Numbers: SBL/BRV-TV/Form1/PhI/2009/0100
Study First Received: February 2, 2010
Last Updated: October 1, 2010
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Gastroenteritis
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014