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Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)

Primary Purpose

Cervical Cancer, Genital Warts

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

10 Years - 23 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adolescents and pre-adolescents with no prior sexual history Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners Exclusion Criteria: Prior Human Papillomavirus (HPV) vaccination Prior abnormal Paps Prior history of genital warts

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    4

    Arm Description

    100% Formulation qHPV Vaccine

    60% Formulation qHPV Vaccine

    40% Formulation qHPV Vaccine

    20% Formulation qHPV Vaccine

    Outcomes

    Primary Outcome Measures

    Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
    Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
    Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
    Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
    Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).
    Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
    Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
    Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.
    Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
    Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
    Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
    Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
    Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).
    Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3

    Secondary Outcome Measures

    Full Information

    First Posted
    September 22, 2004
    Last Updated
    December 29, 2014
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092495
    Brief Title
    Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
    Official Title
    A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    September 2004 (Actual)
    Study Completion Date
    February 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Genital Warts

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    3055 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    100% Formulation qHPV Vaccine
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    60% Formulation qHPV Vaccine
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    40% Formulation qHPV Vaccine
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    20% Formulation qHPV Vaccine
    Intervention Type
    Biological
    Intervention Name(s)
    V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
    Other Intervention Name(s)
    V501, Gardasil
    Intervention Description
    qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
    Primary Outcome Measure Information:
    Title
    Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
    Description
    Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
    Time Frame
    Week 4 Postdose 3 (Month 7)
    Title
    Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
    Time Frame
    Week 4 Postdose 3 (Month 7)
    Title
    Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
    Description
    Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).
    Time Frame
    Week 4 Postdose 3 (Month 7)
    Title
    Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
    Time Frame
    Week 4 Postdose 3 (Month 7)
    Title
    Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
    Description
    Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.
    Time Frame
    Week 4 Postdose 3 (Month 7)
    Title
    Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
    Time Frame
    Week 4 Postdose 3 (Month 7)
    Title
    Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
    Description
    Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
    Time Frame
    Week 4 Postdose 3 (Month 7)
    Title
    Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
    Description
    Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).
    Time Frame
    Week 4 Postdose 3 (Month 7)
    Title
    Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
    Time Frame
    Week 4 Postdose 3 (Month 7)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    23 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy adolescents and pre-adolescents with no prior sexual history Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners Exclusion Criteria: Prior Human Papillomavirus (HPV) vaccination Prior abnormal Paps Prior history of genital warts
    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
    17079588
    Citation
    Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461.
    Results Reference
    background
    PubMed Identifier
    18313445
    Citation
    Barr E, Gause CK, Bautista OM, Railkar RA, Lupinacci LC, Insinga RP, Sings HL, Haupt RM. Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women. Am J Obstet Gynecol. 2008 Mar;198(3):261.e1-11. doi: 10.1016/j.ajog.2007.09.001.
    Results Reference
    background
    PubMed Identifier
    18000825
    Citation
    Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. doi: 10.1002/ijc.23260.
    Results Reference
    background
    PubMed Identifier
    17955433
    Citation
    Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17.
    Results Reference
    background
    PubMed Identifier
    19935017
    Citation
    Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21.
    Results Reference
    derived
    PubMed Identifier
    19453788
    Citation
    Majewski S, Bosch FX, Dillner J, Iversen OE, Kjaer SK, Munoz N, Olsson SE, Paavonen J, Sigurdsson K, Bryan J, Esser MT, Giacoletti K, James M, Taddeo F, Vuocolo S, Barr E. The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24. J Eur Acad Dermatol Venereol. 2009 Oct;23(10):1147-55. doi: 10.1111/j.1468-3083.2009.03266.x. Epub 2009 Apr 23.
    Results Reference
    derived

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    Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)

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