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

NCT ID: NCT01091298

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-05-31

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.

Conditions

Rotavirus Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group 1

Group Type: EXPERIMENTAL

Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)

Intervention Type: BIOLOGICAL

Single dose (0.5 mL) of the vaccine administered orally

Group 2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Single dose (0.5 mL) of the placebo administered orally

Interventions

Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)

Single dose (0.5 mL) of the vaccine administered orally

Intervention Type: BIOLOGICAL

Placebo

Single dose (0.5 mL) of the placebo administered orally

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shantha Biotechnics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Shantha Biotechnics Limited

Principal Investigators

Raman Rao, MD

Role: STUDY_DIRECTOR

Shantha Biotechnics Limited

Locations

Christian Medical College

Vellore, Tamil Nadu, India

Countries

India

Other Identifiers

SBL/BRVTV/Form1/Adlts/PhI/2010

Identifier Type: -

Identifier Source: org_study_id