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

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ClinicalTrials.gov Identifier: NCT00260039
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 680 participants
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
Study Start Date : December 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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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

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.

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00260039     History of Changes
Other Study ID Numbers: V502-001
2005_086
First Posted: December 1, 2005    Key Record Dates
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