Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
Primary Purpose
Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
9vHPV Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Genital Warts
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Females
Heterosexual Males
Men who have Sex with Men
Arm 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
Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Outcomes
Primary Outcome Measures
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
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.
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
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.
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.
Secondary Outcome Measures
Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine
Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.
Full Information
NCT ID
NCT01651949
First Posted
July 25, 2012
Last Updated
October 30, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01651949
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 29, 2012 (Actual)
Primary Completion Date
August 4, 2014 (Actual)
Study Completion Date
August 4, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2520 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Females
Arm Type
Active Comparator
Arm 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
Arm Title
Heterosexual Males
Arm Type
Experimental
Arm 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
Arm Title
Men who have Sex with Men
Arm Type
Experimental
Arm Description
Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Intervention Type
Biological
Intervention Name(s)
9vHPV Vaccine
Intervention Description
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
Primary Outcome Measure Information:
Title
Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine
Description
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
Time Frame
Four weeks post vaccination 3 (Month 7)
Title
Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card
Description
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.
Time Frame
Up to 5 days after any vaccination
Title
Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)
Description
Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
Time Frame
Up to 5 days after any vaccination
Title
Percentage of Participants With an Adverse Event
Description
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.
Time Frame
Up to Month 12
Title
Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event
Description
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.
Time Frame
Up to Month 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine
Description
Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.
Time Frame
Four weeks post vaccination 3 (Month 7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
26144901
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.
Results Reference
background
PubMed Identifier
27422279
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=V503-003&kw=V503-003&tab=access
Learn more about this trial
Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
We'll reach out to this number within 24 hrs