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Completed

NCT Number: NCT00378560

V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women

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Key information

Conditions

HPV Infections Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female Subject Aged 18 To 26 Years
  • With 1-4 Lifetime Sexual Partners

Exclusion criteria

  • Male Subject

Treatment and study plan

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Biological

V501; Gardasil, 0.5 ml injection in 3 dosing regimen

Other names: V501, Gardasil

Comparator: Placebo

Biological

Placebo 0.5 ml injection in 3 dosing regimen

Primary outcomes

  1. Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype

    Time frame: Over 30 months

    Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.

Secondary outcomes

  1. Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)

    Time frame: At one month after completed vaccination series (Month 7)

    Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.

    The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".

  2. Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)

    Time frame: At one month after completed vaccination series (Month 7)

    Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

    The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".

  3. Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)

    Time frame: At one month after completed vaccination series (Month 7)

    Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

    The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".

  4. Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)

    Time frame: At one month after completed vaccination series (Month 7)

    Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

    The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

V501 Phase II Efficacy Study in Women Aged 18 to 26

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2006
Registry last updated
Apr 17, 2017

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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