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: April 26, 2016
Last verified: April 2016
  Purpose
This study is a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 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 young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).

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:
  • Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

  • Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

  • Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

  • Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

  • Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

  • Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

  • Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

  • Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

  • Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).


Secondary Outcome Measures:
  • Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.

  • Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.

  • Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.

  • Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.

  • Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.

  • Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.

  • Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.

  • Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.

  • Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 [ Time Frame: 4 weeks after the last dose of V503 (Month 7 or Month 13) ] [ Designated as safety issue: No ]
    Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.


Enrollment: 1518
Study Start Date: December 2013
Estimated Study Completion Date: June 2017
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Girls 9 to 14 Years V503 at Months 0 and 6
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
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: Boys 9 to 14 Years V503 at Months 0 and 6
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
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: Girls and Boys 9 to 14 Years V503 at Months 0 and 12
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
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: Girls 9 to 14 Years V503 at Months 0, 2, and 6
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
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: Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
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   (Child, Adult)
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 Papanicolaou (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 vaccine 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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984697

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

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
Results First Received: March 23, 2016
Last Updated: April 26, 2016
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 24, 2016