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OpenTrials
Completed

NCT Number: NCT00383903

Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.

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Key information

Conditions

Infections, Rotavirus Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

5 week–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Brits, South Africa

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy infants born after a normal gestation period (>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject's mother.
  • Written informed consent was obtained from the parent/guardian of the subject before study entry.

Exclusion criteria

  • History of allergic disease/polio disease,
  • Confirmed or suspected immunosuppressive or immunodeficient condition,
  • Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator,
  • Received treatment prohibited by the protocol.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

Treatment and study plan

HRV vaccine

Biological

Two or three oral doses

Primary outcomes

  1. Seroconversion after HRV vaccination

Secondary outcomes

  1. shedding, serum anti-rota IgA antibody concentrations, anti-polio 1, 2 and 3 seroprotection rates, reactogenicity, safety

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase II, Randomized, Double-blind, Placebo-controlled Study of Safety, Reactogenicity and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at 10E6.5 CCID50 Viral Concentration in Healthy Infants (Approximately 5-10 Weeks Old) in the Republic of South Africa

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Oct 4, 2006
Registry last updated
Sep 15, 2016

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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