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CompletedNCT00799825

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
346 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 580299/008 and received the control vaccine (Hepatitis A vaccine).

Conditions

Interventions

TypeNameDescription
BIOLOGICALGSK Biological's HPV vaccine GSK580299 (Cervarix™)All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.

Timeline

Start date
2009-01-01
Primary completion
2012-08-02
Completion
2012-08-02
First posted
2008-12-01
Last updated
2018-07-12
Results posted
2013-09-20

Locations

48 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT00799825. Inclusion in this directory is not an endorsement.

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US (NCT00799825) · Clinical Trials Directory