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A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00551187
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.

Condition or disease Intervention/treatment Phase
Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection Biological: V504 Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Biological: Comparator: Placebo (unspecified) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women
Study Start Date : October 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Biological: V504
V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.
Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.
Placebo Comparator: 2
Placebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.
Biological: Comparator: Placebo (unspecified)
V504 Placebo in 3 dose regimen for 6 month treatment period.



Primary Outcome Measures :
  1. Geometric mean titers (GMTs) to HPV types contained in the administered vaccines [ Time Frame: 4 weeks post dose 3 ]

Secondary Outcome Measures :
  1. Seroconversion percentages to HPV types contained in the administered vaccines [ Time Frame: 4 weeks post dose 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females between 16- to 26-years-old
  • Has never had Pap testing or has only had normal Pap test results.
  • Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

  • History of an abnormal cervical biopsy result
  • History of a positive test for HPV; History of external genital/vaginal warts
  • Currently a user of illegal drugs or an alcohol abuser
  • History of severe allergic reaction that required medical attention
  • Are pregnant
  • Received a marketed HPV vaccine
  • Currently enrolled in a clinical trial
  • Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551187


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00551187     History of Changes
Other Study ID Numbers: V504-001
2007_566
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Papillomavirus Infections
Condylomata Acuminata
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vulvar Diseases
Vaginal Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Warts
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs