Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)
Papillomavirus Infections, Genital Diseases, Female
About this trial
This is an interventional prevention trial for Papillomavirus Infections focused on measuring HPV 6/11/16/18 infection and related genital disease
Eligibility Criteria
Inclusion Criteria: Healthy females 16 to 23 years of age Not pregnant at enrollment and must have agreed to use effective contraception through Month 7 of the study Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred) Exclusion Criteria: No prior receipt of an Human Papillomavirus (HPV) vaccine No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment or receipt of live vaccines within 21 days prior to enrollment No prior abnormal Pap test showing squamous intraepithelial lesion (SIL) or biopsy showing cervical intraepithelial neoplasia (CIN) No prior history of genital warts or treatment for genital warts
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
Placebo (mcg) (Aluminum Adjuvant) 225
Placebo (mcg) (Aluminum Adjuvant) 450
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.