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Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

Primary Purpose

Neoplasms, Glandular and Epithelial, Diphtheria, Tetanus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine
Comparator: Menactra™ (Concomitant)
Comparator: Adacel™ (Concomitant)
Comparator: Menactra™ (Non-concomitant)
Comparator: Adacel™
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neoplasms, Glandular and Epithelial

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Must be healthy boys or girls, 11-17 years of age Must be a virgin with no intention of becoming sexually active during the study period Must have been properly vaccinated against diphtheria, tetanus and pertussis Exclusion Criteria: Must not have received a vaccine against diphtheria, tetanus and pertussis in the past 5 years Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group 1

    Group 2

    Arm Description

    Concomitant Administration

    Non-concomitant administration

    Outcomes

    Primary Outcome Measures

    Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)
    Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months)
    Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)
    Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months)
    Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™
    Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™
    Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™
    Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™
    Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™
    Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™
    Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™
    Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™
    Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™

    Secondary Outcome Measures

    Acceptable Safety Profile

    Full Information

    First Posted
    May 11, 2006
    Last Updated
    February 23, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00325130
    Brief Title
    Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)
    Official Title
    An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V501 Given Concomitantly With Menactra™ and ADACEL™ in Healthy Adolescents 11-17 Years of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    April 2007 (Actual)
    Study Completion Date
    April 2007 (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
    Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types 6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoplasms, Glandular and Epithelial, Diphtheria, Tetanus, Whooping Cough, Meningitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1042 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Concomitant Administration
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    Non-concomitant administration
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine
    Other Intervention Name(s)
    Gardasil
    Intervention Description
    Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Menactra™ (Concomitant)
    Intervention Description
    A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Adacel™ (Concomitant)
    Intervention Description
    a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Menactra™ (Non-concomitant)
    Intervention Description
    A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Adacel™
    Intervention Description
    A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
    Primary Outcome Measure Information:
    Title
    Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)
    Time Frame
    7 Months
    Title
    Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months)
    Time Frame
    7 Months
    Title
    Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)
    Time Frame
    7 Months
    Title
    Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months)
    Time Frame
    7 Months
    Title
    Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™
    Time Frame
    7 Months
    Title
    Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™
    Time Frame
    7 Months
    Title
    Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™
    Time Frame
    7 Months
    Title
    Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™
    Time Frame
    7 Months
    Title
    Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Time Frame
    7 Months
    Title
    Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Time Frame
    7 Months
    Title
    Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™
    Time Frame
    7 Months
    Title
    Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™
    Time Frame
    7 Months
    Title
    Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™
    Time Frame
    7 Months
    Title
    Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™
    Time Frame
    7 Months
    Title
    Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Time Frame
    7 Months
    Title
    Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Time Frame
    7 Months
    Title
    Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Time Frame
    7 Months
    Title
    Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
    Time Frame
    7 Months
    Secondary Outcome Measure Information:
    Title
    Acceptable Safety Profile
    Time Frame
    15 days post injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Must be healthy boys or girls, 11-17 years of age Must be a virgin with no intention of becoming sexually active during the study period Must have been properly vaccinated against diphtheria, tetanus and pertussis Exclusion Criteria: Must not have received a vaccine against diphtheria, tetanus and pertussis in the past 5 years Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20439595
    Citation
    Reisinger KS, Block SL, Collins-Ogle M, Marchant C, Catlett M, Radley D, Sings HL, Haupt RM, Garner EI; Protocol 025 Investigators. Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. Pediatrics. 2010 Jun;125(6):1142-51. doi: 10.1542/peds.2009-2336. Epub 2010 May 3.
    Results Reference
    result

    Learn more about this trial

    Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

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