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Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520598
First Posted: August 24, 2007
Last Update Posted: November 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

Condition Intervention Phase
Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection Biological: Comparator: V505 formulation 1 Drug: Comparator: V505 formulation 2 Biological: Comparator: V505 formulation 3 Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Biological: Comparator: Placebo (unspecified) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen [ Time Frame: 4 weeks post dose 2 ]

Enrollment: 511
Study Start Date: October 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.
Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 2
Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.
Biological: Comparator: V505 formulation 1
0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 3
Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen
Drug: Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 4
Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection
Drug: Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
Biological: Comparator: Placebo (unspecified)
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
Experimental: 5
Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection
Biological: Comparator: V505 formulation 3
0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
Biological: Comparator: Placebo (unspecified)
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

  Eligibility

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:

  • Female between 16 to 26 years old
  • Has never had Pap testing or have 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 any 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 time of consent)
  Contacts and Locations
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): NCT00520598


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00520598     History of Changes
Other Study ID Numbers: V505-001
2007_567
First Submitted: August 22, 2007
First Posted: August 24, 2007
Last Update Posted: November 26, 2015
Last Verified: November 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