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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01651949
First received: July 25, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

This study is designed to evaluate the immunogenicity and tolerability of V503 in 16- to 26-year old men and women. The overall goal is to bridge V503 efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles.


Condition Intervention Phase
Genital Warts
Anal Cancer
Anal Intraepithelial Neoplasia
Biological: V503 Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric mean titers (GMTs) to the HPV types contained in the V503 vaccine [ Time Frame: Four weeks post vaccination 3 ] [ Designated as safety issue: No ]
  • Number of participants with injection-site adverse experiences of erythema, pain, and swelling [ Time Frame: Day 1 through Day 5 following any vaccination ] [ Designated as safety issue: Yes ]
  • Number of participants with elevated body temperature (≥100° F) [ Time Frame: Day 1 through Day 5 following any vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with seroconversion to the HPV types in the V503 vaccine [ Time Frame: Four weeks post vaccination 3 ] [ Designated as safety issue: No ]

Enrollment: 2520
Study Start Date: October 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Women 16 to 26 years of age Biological: V503 Vaccine
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Experimental: Heterosexual men 16 to 26 years of age Biological: V503 Vaccine
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Experimental: Men 16 to 26 years of age who have sex with men Biological: V503 Vaccine
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

Detailed Description:

Study participants will be administered a 3-dose regimen of V503. 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

Ages Eligible for Study:   16 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good physical health
  • Has never had Pap testing (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01651949     History of Changes
Other Study ID Numbers: V503-003, 2012-002758-22
Study First Received: July 25, 2012
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma in Situ
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 24, 2014