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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-29

Study Completion Date

2014-08-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Genital Warts Anal Cancer Anal Intraepithelial Neoplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Females

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

Group Type ACTIVE_COMPARATOR

9vHPV Vaccine

Intervention Type BIOLOGICAL

9vHPV, V503 (9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen

Heterosexual Males

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

Group Type EXPERIMENTAL

9vHPV Vaccine

Intervention Type BIOLOGICAL

9vHPV, V503 (9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen

Men who have Sex with Men

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

Group Type EXPERIMENTAL

9vHPV Vaccine

Intervention Type BIOLOGICAL

9vHPV, V503 (9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen

Interventions

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9vHPV Vaccine

9vHPV, V503 (9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Good physical health
* Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes