A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01984697
First received: November 8, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

This study is a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in females 16 to 26 years of age. From this study, the goal is to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in females 16 to 26 years of age (the core efficacy population, assessed concurrently in this study) who received the standard 3-dose regimen of V503.


Condition Intervention Phase
Human Papillomavirus Infection
Biological: V503 (9-valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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 a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HPV-9 Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) to HPV types at 4 weeks post last dose [ Time Frame: 4 weeks following the last dose of vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants with HPV-9 cLIA seroconversion to HPV types at 4 weeks post last dose [ Time Frame: 4 weeks following the last dose of vaccine ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: December 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 9-14 year old girls, 2-dose (0, 6 months)
V503 administered at 0 and 6 months
Biological: V503 (9-valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine)
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Experimental: 9-14 year old boys, 2-dose (0, 6 months)
V503 administered at 0 and 6 months
Biological: V503 (9-valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine)
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Experimental: 9-14 year old girls + boys, 2-dose (0, 12 months)
V503 administered at 0 and 12 months
Biological: V503 (9-valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine)
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Active Comparator: 16-26 year old women, 3-dose (0, 2, 6 months)
V503 administered at 0, 2 and 6 months
Biological: V503 (9-valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine)
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Experimental: 9-14 year old girls, 3-dose (0, 2, 6 months)
V503 administered at 0, 2 and 6 months
Biological: V503 (9-valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine)
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

  Eligibility

Ages Eligible for Study:   9 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All Participants:

-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results

Boys and Girls 9 to 14 Years:

-Must not have had coitarche and does not plan on becoming sexually active during the vaccination period

Women 16 to 26 Years:

  • Has never had a Pap test or only had normal Pap test results
  • A lifetime history of 0 to 4 male and/or female sexual partners

Exclusion Criteria:

All Participants:

  • Known allergy to any vaccine component
  • History of severe allergic reaction that required medical intervention
  • Thrombocytopenia or any coagulation disorder
  • Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
  • Currently immunocompromised, or been diagnosed with immunodeficiency
  • Had a splenectomy
  • Receiving or has received immunosuppressive therapies within the last year
  • Received any immunoglobulin product or blood-derived product within 3 months
  • Received a marketed HPV vaccine or has participated in an HPV clinical trial
  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: NCT01984697     History of Changes
Other Study ID Numbers: V503-010, 2013-001314-15
Study First Received: November 8, 2013
Last Updated: May 8, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014