Clinical trial

Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies…

NCT00329745 · GlaxoSmithKline, Industry · Completed

Key facts

NCT number NCT00329745
Title Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
Official title A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants.
Lead sponsor GlaxoSmithKline, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Infections, Rotavirus
Intervention type Biological
Interventions Rotarix™, Placebo
Enrollment 8,687
Start date Jan 1, 2007
Primary completion Jul 1, 2008
Completion Jul 1, 2008
First posted May 25, 2006
Last update posted Dec 9, 2016
Countries Singapore

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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