Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

PHASE2CompletedINTERVENTIONAL
Enrollment

383

Participants

Timeline

Start Date

March 4, 2005

Primary Completion Date

March 27, 2006

Study Completion Date

March 27, 2006

Conditions
Infections, Papillomavirus
Interventions
BIOLOGICAL

HPV 16/18 L1 AS04

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

BIOLOGICAL

HPV-16/18/31/45 L1 AS04 Formulation 1

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

BIOLOGICAL

HPV-16/18/31/45 L1 AS04 Formulation 2

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

BIOLOGICAL

HPV-16/18/31/45 L1 AS04 Formulation 3

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

BIOLOGICAL

HPV-16/18/31/45 L1 AS04 Formulation 4

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

BIOLOGICAL

HPV-16/18/31/45 L1 AS04 Formulation 5

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

BIOLOGICAL

HPV-16/18/31/45 L1 AS04 Formulation 6

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

Trial Locations (11)

1070

GSK Investigational Site, Brussels

2610

GSK Investigational Site, Wilrijk

3000

GSK Investigational Site, Leuven

4000

GSK Investigational Site, Liège

8800

GSK Investigational Site, Roeselare

9000

GSK Investigational Site, Ghent

80045

GSK Investigational Site, Aurora

80401

GSK Investigational Site, Golden

84109

GSK Investigational Site, Salt Lake City

84121

GSK Investigational Site, Salt Lake City

02881

GSK Investigational Site, Kingston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY