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

NCT00799825 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2018-07-12

Study results available
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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

  • Infections, Papillomavirus

Interventions

BIOLOGICAL

GSK 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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-01
Primary Completion
2012-08-02
Completion
2012-08-02

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00799825 on ClinicalTrials.gov