Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study

PHASE3CompletedINTERVENTIONAL
Enrollment

752

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

February 28, 2011

Study Completion Date

February 28, 2011

Conditions
Infections, Papillomavirus
Interventions
PROCEDURE

Liquid-based cytology (LBC) sampling

LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)

PROCEDURE

Blood sampling

Blood samples will be collected at Months 36 and 48 for antibody determination

Trial Locations (13)

036-8003

GSK Investigational Site, Aomori

910-0858

GSK Investigational Site, Fukui

733-0813

GSK Investigational Site, Hiroshima

734-0036

GSK Investigational Site, Hiroshima

890-0055

GSK Investigational Site, Kagoshima

892-0824

GSK Investigational Site, Kagoshima

889-1692

GSK Investigational Site, Miyazaki

530-0013

GSK Investigational Site, Osaka

102-0083

GSK Investigational Site, Tokyo

160-0017

GSK Investigational Site, Tokyo

173-0005

GSK Investigational Site, Tokyo

183-0056

GSK Investigational Site, Tokyo

189-0014

GSK Investigational Site, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY