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

Rotavirus Gastroenteritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091298
• Other study ID #: SBL/BRVTV/Form1/Adlts/PhI/2010
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2010
• Last updated: June 7, 2011
• Start date: April 2010
• Est. completion date: May 2010

Study information

• Verified date: June 2011
• Source: Shantha Biotechnics Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

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

Locations

Country	Name	City	State
India	Christian Medical College	Vellore	TamilNadu

Sponsors (1)

Lead Sponsor	Collaborator
Shantha Biotechnics Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Upto 10 days following administration of vaccine/placebo	Yes