Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01651949
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : March 9, 2015
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE July 25, 2012
First Posted Date  ICMJE July 27, 2012
Results First Submitted Date  ICMJE February 24, 2015
Results First Posted Date  ICMJE March 9, 2015
Last Update Posted Date November 27, 2018
Actual Study Start Date  ICMJE October 29, 2012
Actual Primary Completion Date August 4, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine [ Time Frame: Four weeks post vaccination 3 (Month 7) ]
    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 [ Time Frame: Up to 5 days after any vaccination ]
    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) [ Time Frame: Up to 5 days after any vaccination ]
    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 [ Time Frame: Up to Month 12 ]
    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 [ Time Frame: Up to Month 12 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
  • Geometric mean titers (GMTs) to the HPV types contained in the V503 vaccine [ Time Frame: Four weeks post vaccination 3 ]
  • Number of participants with injection-site adverse experiences of erythema, pain, and swelling [ Time Frame: Day 1 through Day 5 following any vaccination ]
  • Number of participants with elevated body temperature (≥100° F) [ Time Frame: Day 1 through Day 5 following any vaccination ]
Change History Complete list of historical versions of study NCT01651949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine [ Time Frame: Four weeks post vaccination 3 (Month 7) ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
Number of participants with seroconversion to the HPV types in the V503 vaccine [ Time Frame: Four weeks post vaccination 3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Genital Warts
  • Anal Cancer
  • Anal Intraepithelial Neoplasia
Intervention  ICMJE Biological: 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
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Biological: 9vHPV Vaccine
  • Experimental: 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
    Intervention: Biological: 9vHPV Vaccine
  • Experimental: 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
    Intervention: Biological: 9vHPV Vaccine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2014)
2520
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2012)
2500
Actual Study Completion Date  ICMJE August 4, 2014
Actual Primary Completion Date August 4, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 26 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Colombia,   Denmark,   Germany,   Israel,   Malaysia,   Mexico,   Norway,   Peru,   Philippines,   Poland,   South Africa,   Spain,   Sweden,   Thailand,   Turkey,   United States
 
Administrative Information
NCT Number  ICMJE NCT01651949
Other Study ID Numbers  ICMJE V503-003
2012-002758-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP