NCT01462357 - Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females | Biotech Hunter

Enrollment

1,079

Participants

Timeline

Start Date

November 21, 2011

Primary Completion Date

October 27, 2015

Study Completion Date

October 27, 2015

Conditions

Infections, Papillomavirus

Interventions

BIOLOGICAL

Cervarix

2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6.

BIOLOGICAL

Gardasil

2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gardasil 2 dose Group) or at Day 0, Month 2 and Month 6 (Gardasil 3 dose Group), respectively.

DRUG

Placebo

2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 2 to maintain blinding.

Trial Locations (21)

19300

GSK Investigational Site, Rosiers-d'Égletons

31600

GSK Investigational Site, Seysses

37100

GSK Investigational Site, Tours

37540

GSK Investigational Site, Saint Cyr Sur Loir

40100

GSK Investigational Site, Dax

54270

GSK Investigational Site, Essey-lès-Nancy

75970

GSK Investigational Site, Paris

76620

GSK Investigational Site, Le Havre