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Completed

NCT Number: NCT00092495

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

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.

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Key information

Conditions

Cervical Cancer Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Genital Warts Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases Warts

Age range

10 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

Biological

qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.

Other names: V501, Gardasil

Primary outcomes

  1. Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3

    Time frame: Week 4 Postdose 3 (Month 7)

    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).

  2. Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3

    Time frame: Week 4 Postdose 3 (Month 7)

  3. Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3

    Time frame: Week 4 Postdose 3 (Month 7)

    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).

  4. Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3

    Time frame: Week 4 Postdose 3 (Month 7)

  5. Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3

    Time frame: Week 4 Postdose 3 (Month 7)

    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.

  6. Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3

    Time frame: Week 4 Postdose 3 (Month 7)

  7. Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3

    Time frame: Week 4 Postdose 3 (Month 7)

    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).

  8. Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3

    Time frame: Week 4 Postdose 3 (Month 7)

    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).

  9. Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3

    Time frame: Week 4 Postdose 3 (Month 7)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2009
First posted
Sep 27, 2004
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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