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

Phase 1

Completed

• Conditions: Rotavirus Gastroenteritis
• Interventions: Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV); Other: Placebo

• Registration Number: NCT01091298
• Lead Sponsor: Shantha Biotechnics Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-20
• Study First Posted: 2010-03-24
• Study Start: 2010-04
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)	-
Group 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Severity and causality of all Adverse Events following the dose of vaccine/placebo	upto 10 days following administration 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

Name	Time	Method
The frequency and the percentage change, as compared to baseline, in the protocol defined laboratory parameters following the single dose of Vaccine/placebo	Upto 10 days following administration 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

Trial Locations

Locations (1)

Christian Medical College; 🇮🇳 Vellore, TamilNadu, India