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Completed

NCT Number: NCT01091298

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

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.

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Key information

Conditions

Rotavirus Gastroenteritis

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Christian Medical College

Vellore, Tamil Nadu, 632002, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

Single dose (0.5 mL) of the vaccine administered orally

Placebo

Other

Single dose (0.5 mL) of the placebo administered orally

Primary outcomes

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

    Time frame: 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 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Shantha Biotechnics Limited

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2010
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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