A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092547
First received: September 23, 2004
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).


Condition Intervention Phase
Healthy Papillomavirus Infections
Biological: V501
Biological: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Safety and Immunogenicity Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents (Base Study). A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age (Extension Study).

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

Primary Outcome Measures:
  • Number of Participants Reporting Serious Adverse Experiences (SAE) in the Vaccination and Follow-up Phases [ Time Frame: Day 1 through Month 18 ] [ Designated as safety issue: Yes ]

    Tolerability as assessed by the number of participants with clinical adverse experiences in the Vaccination and Follow-up Phases.

    A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.


  • Number of Participants Reporting Serious Adverse Experiences (SAE) in the Extension Phases [ Time Frame: Month 18 to Month 37 ] [ Designated as safety issue: Yes ]
    Tolerability as assessed by the number of participants with clinical adverse experiences in the Extension Phases

  • Number of Participants Reporting Other (Non-serious) Adverse Experiences in the Vaccination and Follow-up Phases [ Time Frame: Injection site AE are collected from Days 1-5 and non-serious AE from Days 1-15, including the day of vaccination. Other AE (Not Including Serious AE) were not collected in the Extension Phases ] [ Designated as safety issue: Yes ]
    Tolerability as assessed by the number of participants with clinical adverse experiences in the Vaccination and Follow-up Phases

  • Percentage of Participants Who Are Seropositive for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 72 [ Time Frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) ] [ Designated as safety issue: No ]
    A subject is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. (For HPV 6, the serostatus cutoff is ≥ 20 mMU/mL).

  • Percentage of Participants Who Are Seropositive for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 72 [ Time Frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) ] [ Designated as safety issue: No ]
    A subject is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. (For HPV 11, the serostatus cutoff is ≥ 16 mMU/mL).

  • Percentage of Participants Who Are Seropositive for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 72 [ Time Frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) ] [ Designated as safety issue: No ]
    A subject is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. (For HPV 16, the serostatus cutoff is ≥ 20 mMU/mL).

  • Percentage of Participants Who Are Seropositive for HPV Type 18 (HPV 18 ≥ 24 mMU/mL) at Month 72 [ Time Frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) ] [ Designated as safety issue: No ]
    A subject is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. (For HPV 18, the serostatus cutoff is ≥ 24 mMU/mL).

  • Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 72 [ Time Frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 72 [ Time Frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 72 [ Time Frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 72 [ Time Frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Original Quadrivalent Human Papillomavirus (qHPV) Vaccine Cohort Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 1 Postdose 3 (Month 7) [ Time Frame: Month 7 (1 Month Postdose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 1 Postdose 3 (Month 7) [ Time Frame: Month 7 (1 Month Postdose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 1 Postdose 3 (Month 7) [ Time Frame: Month 7 (1 Month Postdose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 18 (HPV 18 ≥ 24 mMU/mL) at Month 1 Postdose 3 (Month 7) [ Time Frame: Month 7 (1 Month Postdose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 12 Postdose 3 (Month 18). [ Time Frame: Month 18 (12 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 12 Postdose 3 (Month 18) [ Time Frame: Month 18 (12 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 12 Postdose 3 (Month 18) [ Time Frame: Month 18 (12 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 18 (HPV 18 ≥ 24 mMU/mL) at Month 12 Postdose 3 (Month 18) [ Time Frame: Month 18 (12 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 18 Postdose 3 (Month 24) [ Time Frame: Month 24 (18 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 18 Postdose 3 (Month 24) [ Time Frame: Month 24 (18 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 18 Postdose 3 (Month 24) [ Time Frame: Month 24 (18 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) at Month 18 Postdose 3 (Month 24) [ Time Frame: Month 24 (18 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 24 Postdose 3 (Month 30) [ Time Frame: Month 30 (24 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 24 Postdose 3 (Month 30) [ Time Frame: Month 30 (24 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 24 Postdose 3 (Month 30) [ Time Frame: Month 30 (24 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) at Month 24 Postdose 3 (Month 30) [ Time Frame: Month 30 (24 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 31 Postdose 3 (Month 37). [ Time Frame: Month 37 (31 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 31 Postdose 3 (Month 37) [ Time Frame: Month 37 (31 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 31 Postdose 3 (Month 37) [ Time Frame: Month 37 (31 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) at Month 31 Postdose 3 (Month 37) [ Time Frame: Month 37 (31 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Number of Subjects in the Extension Group Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 1 Postdose 3 of qHPV (Month 37) [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ] [ Designated as safety issue: No ]
  • Number of Subjects in the Extension Group Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 1 Postdose 3 of qHPV (Month 37) [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ] [ Designated as safety issue: No ]
  • Number of Subjects in the Extension Group Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 1 Postdose 3 of qHPV (Month 37) [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ] [ Designated as safety issue: No ]
  • Number of Subjects in the Extension Group Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) at Month 1 Postdose 3 of qHPV (Month 37) [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 6 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) [ Time Frame: Month 7 (1 Month Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 11 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) [ Time Frame: Month 7 (1 Month Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 16 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) [ Time Frame: Month 7 (1 Month Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) [ Time Frame: Month 7 (1 Month Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 6 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) [ Time Frame: Month 18 (Month 12 Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 11 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) [ Time Frame: Month 18 (12 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 16 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) [ Time Frame: Month 18 (12 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18). [ Time Frame: Month 18 (12 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 6 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) [ Time Frame: Month 24 (18 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 11 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) [ Time Frame: Month 24 (18 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 16 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) [ Time Frame: Month 24 (18 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) [ Time Frame: Month 24 (18 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 6 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) [ Time Frame: Month 30 (24 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 11 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) [ Time Frame: Month 30 (24 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 16 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) [ Time Frame: Month 30 (24 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) [ Time Frame: Month 30 (24 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 6 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) [ Time Frame: Month 37 (31 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 11 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) [ Time Frame: Month 37 (31 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 16 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) [ Time Frame: Month 37 (31 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) [ Time Frame: Month 37 (31 Months Post-dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 6 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 11 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 16 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ] [ Designated as safety issue: No ]

Enrollment: 1781
Study Start Date: October 2003
Estimated Study Completion Date: February 2015
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: qHPV
Subjects randomized to receive V501, the Quadrivalent Human Papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
Biological: V501
0.5 mL intramuscular injection of V501 given at Day 1, Month 2, and Month 6.
Other Name: GARDASIL™
Placebo Comparator: Placebo
Subjects randomized to receive Placebo at Day 1, Month 2, and Month 6.
Biological: Comparator: Placebo
0.5 mL intramuscular placebo injection given at Day 1, Month 2, and Month 6.
Experimental: Extension Group
Subjects who were originally enrolled into the Placebo Group who received three 0.5 mL intramuscular injections of V501 (qHPV) given at Month 30, Month 32, and Month 36.
Biological: V501
0.5 mL intramuscular injections of V501 given at Month 30, Month 32, and Month 36.
Other Name: GARDASIL™

Detailed Description:

The original base protocol (V501-018)(NCT00092547) was extended in amendments 05 and 06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the base study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36.

The study was extended again in amendment V501-018-10(NCT00092547), titled "A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age" to allow a follow-up period to Month 126.

  Eligibility

Ages Eligible for Study:   9 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adolescents and preadolescents with no prior sexual history

Exclusion Criteria:

  • Subjects with compromised immune system or have a history of severe allergic reaction
  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: NCT00092547

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092547     History of Changes
Other Study ID Numbers: V501-018, 2004_084
Study First Received: September 23, 2004
Results First Received: November 3, 2009
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014