Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women

PHASE3CompletedINTERVENTIONAL
Enrollment

354

Participants

Timeline

Start Date

July 28, 2006

Primary Completion Date

December 1, 2007

Study Completion Date

December 4, 2007

Conditions
Infections, Papillomavirus
Interventions
BIOLOGICAL

Placebo

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

BIOLOGICAL

HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Trial Locations (4)

110029

GSK Investigational Site, New Delhi

160012

GSK Investigational Site, Chandigarh

700026

GSK Investigational Site, Kolkata

400 012

GSK Investigational Site, Mumbai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00344032 - Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women | Biotech Hunter | Biotech Hunter