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A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
Shantha Biotechnics Limited
ClinicalTrials.gov Identifier:
NCT01091298
First received: March 17, 2010
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at the highest possible viral concentration in 0.5 mL of vaccine.


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

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 Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Tolerability of a Single Administration (10e6.25 FFU of Each Constituent Serotype Per 0.5 ml) of Live Attenuated Tetravalent (G1-G4) Bovine-human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Adult Males

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis
Drug Information available for: Rotarix
U.S. FDA Resources

Further study details as provided by Shantha Biotechnics Limited:

Primary Outcome Measures:
  • Severity and causality of all Adverse Events following the dose of vaccine/placebo [ Time Frame: upto 10 days following administration of vaccine/placebo ] [ Designated as safety issue: Yes ]
    The frequency, severity and causality of all solicited and unsolicited adverse events following administration of a single dose of the vaccine as compared to placebo


Secondary Outcome Measures:
  • The frequency and the percentage change, as compared to baseline, in the protocol defined laboratory parameters following the single dose of Vaccine/placebo [ Time Frame: Upto 10 days following administration of vaccine/placebo ] [ Designated as safety issue: Yes ]
    The frequency, percentage change, as compared to baseline, and causality of all the defined laboratory parameters following administration of a single dose of the vaccine as compared to placebo


Estimated Enrollment: 20
Study Start Date: April 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)
Single dose (0.5 mL) of the vaccine administered orally
Placebo Comparator: Group 2 Other: Placebo
Single dose (0.5 mL) of the placebo administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Indian adult male volunteers.
  • No apparent signs or symptoms of ill health.
  • Properly informed about the study and having signed the informed consent form (ICF). In case of the volunteer 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;
  • Subject available for the entire period of the study and reachable by study staff for post-vaccination follow-up.

Exclusion Criteria:

  • Known or suspected impairment of immunological function;
  • Known hypersensitivity to any component of the rotavirus vaccine;
  • Fever, with axillary temperature ≥38.1oC (≥100.5oF); measured by study staff.
  • History of chronic diarrhea;
  • Clinical evidence of active gastrointestinal illness;
  • Receipt of any intramuscular (IM), oral, or intravenous (IV) corticosteroid treatment in the past 30 days
  • Subjects suspected to be HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) positive from the available clinical history
  • Prior receipt of a blood transfusion or blood products, including immunoglobulins;
  • Any subject who cannot be adequately followed for safety;
  • Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
  • Subject unable to maintain diary card
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091298

Locations
India
Christian Medical College
Vellore, TamilNadu, India, 632002
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
ClinicalTrials.gov Identifier: NCT01091298     History of Changes
Other Study ID Numbers: SBL/BRVTV/Form1/Adlts/PhI/2010
Study First Received: March 17, 2010
Last Updated: June 7, 2011
Health Authority: India: Drugs Controller General of India

Keywords provided by Shantha Biotechnics Limited:
Safety of vaccine

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013