Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anal Cancer; Genital Warts; Anal Intraepithelial Neoplasia

Treatments: Biological: 9vHPV Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651949

2012-002758-22 (EudraCT Number)

V503-003

Details and patient eligibility

About

This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.

Full description

Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.

Enrollment: 2,520 patients

Sex: All

Ages: 16 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Good physical health
• Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
• Other inclusion criteria will be discussed with the investigator

Exclusion criteria

• History of severe allergic reaction that required medical intervention
• Currently enrolled in a clinical trial
• If participant is female, pregnant
• Currently immunocompromised or having received immunosuppressive therapy in the last year
• Positive test for HPV
• History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
• If participant is female, history of abnormal cervical biopsy results
• Other exclusion criteria will be discussed with the investigator

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,520 participants in 3 patient groups

Females

Active Comparator group

Description:

Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Treatment:

Biological: 9vHPV Vaccine

Heterosexual Males

Experimental group

Description:

Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Treatment:

Biological: 9vHPV Vaccine

Men who have Sex with Men

Experimental group

Description:

Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Treatment:

Biological: 9vHPV Vaccine