Clinical trial

Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine…

NCT00345878 · GlaxoSmithKline, Industry · Completed

Key facts

NCT number NCT00345878
Title Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years
Official title Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up
Lead sponsor GlaxoSmithKline, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Infections, Papillomavirus
Intervention type Biological
Interventions Placebo, HPV-16/18 L1 VLP AS04 (Cervarix TM)
Enrollment 271
Start date Sep 25, 2006
Primary completion Dec 21, 2007
Completion Dec 21, 2007
First posted Jun 29, 2006
Last update posted Jul 20, 2018
Countries Malaysia

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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