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Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00260039
First Posted: December 1, 2005
Last Update Posted: June 8, 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
This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.

Condition Intervention Phase
HPV Cervical Cancer Premalignancy Anogenital Warts Biological: Comparator: Gardasil Biological: Comparator: octavalent HPV Vaccine - dose formulation 1 Biological: Comparator: octavalent HPV Vaccine - dose formulation 2 Biological: Comparator: octavalent HPV Vaccine - dose formulation 3 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women

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

Primary Outcome Measures:
  • The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay. [ Time Frame: 4 weeks post dose 3 injection ]

Enrollment: 680
Study Start Date: December 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Gardasil
Biological: Comparator: Gardasil
0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6
Experimental: 2
HPV VLP vaccine -Dose regimen 1
Biological: Comparator: octavalent HPV Vaccine - dose formulation 1
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
Experimental: 3
HPV VLP vaccine -Dose regimen 2
Biological: Comparator: octavalent HPV Vaccine - dose formulation 2
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
Experimental: 4
HPV VLP vaccine -Dose regimen 3
Biological: Comparator: octavalent HPV Vaccine - dose formulation 3
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Lifetime history of 0-4 sexual partners

Exclusion Criteria:

  • History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test
  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): NCT00260039


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00260039     History of Changes
Other Study ID Numbers: V502-001
2005_086
First Submitted: November 28, 2005
First Posted: December 1, 2005
Last Update Posted: June 8, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaccines
Immunologic Factors
Physiological Effects of Drugs