Clinical trial

Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in…

NCT00480324 · GlaxoSmithKline, Industry · Completed

Key facts

NCT number NCT00480324
Title Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
Official title Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants
Lead sponsor GlaxoSmithKline, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Infections, Rotavirus, Rotavirus Vaccines
Intervention type Biological
Interventions Rotarix, Placebo
Enrollment 765
Start date Jun 19, 2007
Primary completion Mar 31, 2009
Completion Nov 21, 2009
First posted May 30, 2007
Last update posted Jan 2, 2020
Countries Japan

At a glance

  • 10–99 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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