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

March 17, 2010
June 7, 2011
April 2010
May 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01091298 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Rotavirus Gastroenteritis
  • Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)
    Single dose (0.5 mL) of the vaccine administered orally
  • Other: Placebo
    Single dose (0.5 mL) of the placebo administered orally
  • Experimental: Group 1
    Intervention: Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)
  • Placebo Comparator: Group 2
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01091298
SBL/BRVTV/Form1/Adlts/PhI/2010
No
Head- Research and Development, Shantha Biotechnics Limited
Shantha Biotechnics Limited
Not Provided
Study Director: Raman Rao, MD Shantha Biotechnics Limited
Shantha Biotechnics Limited
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP