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Completed

NCT Number: NCT00411749

V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females

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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

9 year–17 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

  • Virginal Female Subject Aged 9 To 17 Years

Exclusion criteria

  • Male Subject

Treatment and study plan

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)

Biological

V501; Gardasil, 0.5 ml injection in 3 dosing regimen

Other names: V501, Gardasil

Comparator: placebo (unspecified)

Biological

Placebo 0.5 ml injection in 3 dosing regimen

Primary outcomes

  1. Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series

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

    Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) 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. Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series

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

    Month 7 HPV Competitive Luminex immunoassay (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. Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series

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

    Month 7 HPV Competitive Luminex immunoassay (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. Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series

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

    Month 7 HPV Competitive Luminex immunoassay (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".

Secondary outcomes

  1. HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series

    Time frame: 24 month after completed vaccination series (Month 30)

    Month 30 HPV cLIA Geometric Mean Titers by vaccine group.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 15, 2006
Registry last updated
Apr 21, 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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