Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)

This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.

The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.

Inclusion Criteria:

• Participant is in good physical health
• Participant has had a lifetime history of 0 to 4 sexual partners
• Females between 18-to-24 years

Exclusion Criteria:

• Participant has a history of abnormal Pap test
• Participant has a history of positive test for HPV
• Participant has a history of recent or ongoing alcohol or drug abuse
• Participant is immunocompromised or has an autoimmune condition
• Participant has received immunosuppressive therapy within a year of screening
• Participant has previously received an HPV vaccine
• Participant is pregnant
• Participant has a history of external genital/vaginal warts
• Participant is currently enrolled in a clinical trial
• Participant has a history of a severe allergic reaction that required medical attention