drugset / Trial / NCT01249365

The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

NCT01249365

Phase 3 Completed 199 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelPrevention

Summary

This extension study is designed to assess the safety of GSK Biological's HPV vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

Timeline

Start
2011-01-24
Primary completion
2017-01-10
Completion
2017-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cervarix Vaccine Intramuscular