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

NCT01091298 | Completed Phase 1

• 1 other identifier: SBL/BRVTV/Form1/Adlts/PhI/2010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Safety of vaccine

Outcome Measures

Primary Outcomes (1)

• 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

  upto 10 days following administration of vaccine/placebo

Secondary Outcomes (1)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

PLACEBO COMPARATOR

Other: Placebo

Interventions

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

Single dose (0.5 mL) of the vaccine administered orally

Group 1

Placebo OTHER

Single dose (0.5 mL) of the placebo administered orally

Group 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shantha Biotechnics Limited: lead

Study Sites (1)

Christian Medical College

Vellore, Tamil Nadu, 632002, India

Location

Study Officials

• Raman Rao, MD

  Shantha Biotechnics Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 24, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

IN (1)