9vHPV Vaccine for HPV-Related Oral Infections in Men

Recruiting in Palo Alto (17 mi)

+102 other locations

Age: 18 - 65

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9-valent human papillomavirus (9vHPV) vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of HPV 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.

Eligibility Criteria

Men aged 20-45 who are generally healthy, have had at least one sexual partner, and can complete an electronic vaccination report card. They must not have a history of HPV-related cancers or lesions, severe allergies to vaccine components, immune system problems, or be taking certain medications that affect the immune response.

Inclusion Criteria

I am healthy and in good physical condition as confirmed by a doctor.

I can read, understand, and complete the electronic vaccination report card (eVRC).

I can join the extended study if I was in the placebo or vaccine group but didn't finish all shots.

+8 more

Exclusion Criteria

You have allergies to any ingredients in the vaccine, like aluminum, yeast, or BENZONASE®.

I have received an HPV vaccine or participated in an HPV vaccine trial.

I have had or currently have HPV-related lesions on my genitals.

+17 more

Participant Groups

The trial is testing the effectiveness of the 9-valent human papillomavirus (9vHPV) vaccine in preventing persistent oral HPV infections compared to a saline placebo. Participants will receive three doses and those initially given a placebo may later receive the actual vaccine.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 9vHPV vaccineExperimental Treatment1 Intervention

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6

Group II: PlaceboPlacebo Group1 Intervention

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6