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

Primary Purpose

Rotavirus Gastroenteritis

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)
Placebo
Sponsored by
Shantha Biotechnics Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus Gastroenteritis focused on measuring Safety of vaccine

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Christian Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Outcomes

Primary Outcome Measures

Severity and causality of all Adverse Events following the dose of vaccine/placebo
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
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

Full Information

First Posted
March 17, 2010
Last Updated
June 7, 2011
Sponsor
Shantha Biotechnics Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01091298
Brief Title
A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shantha Biotechnics Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Gastroenteritis
Keywords
Safety of vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)
Intervention Description
Single dose (0.5 mL) of the vaccine administered orally
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Single dose (0.5 mL) of the placebo administered orally
Primary Outcome Measure Information:
Title
Severity and causality of all Adverse Events following the dose of vaccine/placebo
Description
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
Time Frame
upto 10 days following administration of vaccine/placebo
Secondary Outcome Measure Information:
Title
The frequency and the percentage change, as compared to baseline, in the protocol defined laboratory parameters following the single dose of Vaccine/placebo
Description
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
Time Frame
Upto 10 days following administration of vaccine/placebo

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raman Rao, MD
Organizational Affiliation
Shantha Biotechnics Limited
Official's Role
Study Director
Facility Information:
Facility Name
Christian Medical College
City
Vellore
State/Province
TamilNadu
ZIP/Postal Code
632002
Country
India

12. IPD Sharing Statement

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

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