Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
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
2 other identifiers
interventional
2,520
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2012
CompletedFirst Posted
Study publicly available on registry
July 27, 2012
CompletedStudy Start
First participant enrolled
October 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2014
CompletedResults Posted
Study results publicly available
March 9, 2015
CompletedNovember 27, 2018
October 1, 2018
1.8 years
July 25, 2012
February 24, 2015
October 30, 2018
Conditions
Outcome Measures
Primary Outcomes (5)
Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL
Four weeks post vaccination 3 (Month 7)
Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.
Up to 5 days after any vaccination
Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)
Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
Up to 5 days after any vaccination
Percentage of Participants With an Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
Up to Month 12
Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
Up to Month 12
Secondary Outcomes (1)
Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine
Four weeks post vaccination 3 (Month 7)
Study Arms (3)
Females
ACTIVE COMPARATORHealthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Heterosexual Males
EXPERIMENTALHealthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Men who have Sex with Men
EXPERIMENTALHealthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Interventions
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
Eligibility Criteria
You may qualify if:
- Good physical health
- Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 26144901BACKGROUNDMoreira 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.
PMID: 27422279DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2012
First Posted
July 27, 2012
Study Start
October 29, 2012
Primary Completion
August 4, 2014
Study Completion
August 4, 2014
Last Updated
November 27, 2018
Results First Posted
March 9, 2015
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf