Clinical trial

A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV…

NCT00263666 · GlaxoSmithKline, Industry · Completed

Key facts

NCT number NCT00263666
Title A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
Official title A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Reactogenicity and Immunogenicity of Three Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine
Lead sponsor GlaxoSmithKline, Industry
Status Completed
Phase Phase 2
Study type Interventional
Conditions Infections, Rotavirus
Intervention type Biological
Interventions Rotarix, Placebo, Tritanrix-HB+Hib, Polio Sabin
Enrollment 100
Start date Mar 16, 2005
Primary completion Feb 7, 2008
Completion Feb 13, 2008
First posted Dec 9, 2005
Last update posted Nov 23, 2020
Countries South Africa

At a glance

  • 1–9 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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