Clinical trial

To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV…

NCT00363545 · GlaxoSmithKline, Industry · Completed

Key facts

NCT number NCT00363545
Title To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
Official title A Study to Assess the Immunogenicity, Reactogenicity and Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated HRV Vaccine, Given as a Two-dose Primary Vaccination, in Healthy Infants Previously Uninfected With HRV
Lead sponsor GlaxoSmithKline, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Infections, Rotavirus
Intervention type Biological
Interventions Lyophilized formulation of HRV vaccine, Liquid formulation of HRV vaccine
Enrollment 1,274
Start date Sep 1, 2006
Primary completion Apr 12, 2007
Completion Apr 12, 2007
First posted Aug 15, 2006
Last update posted Jun 8, 2018
Countries Panama

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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