Clinical trial NCT01651949: Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
Official title: A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genital Warts
Anal Cancer
Anal Intraepithelial Neoplasia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 2520
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine
timeFrame: Four weeks post vaccination 3 (Month 7)
measure: Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card
timeFrame: Up to 5 days after any vaccination
measure: Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)
timeFrame: Up to 5 days after any vaccination
measure: Percentage of Participants With an Adverse Event
timeFrame: Up to Month 12
measure: Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event
timeFrame: Up to Month 12
Secondary outcomes:
measure: Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine
timeFrame: Four weeks post vaccination 3 (Month 7)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Castellsague X, Giuliano AR, Goldstone S, Guevara A, Mogensen O, Palefsky JM, Group T, Shields C, Liu K, Maansson R, Luxembourg A, Kaplan SS. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015 Nov 27;33(48):6892-901. doi: 10.1016/j.vaccine.2015.06.088. Epub 2015 Jul 2.
citation: Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.