Broad Spectrum HPV Vaccine Dose Ranging Study - Full Text View

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 Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Genital Warts Warts

U.S. FDA Resources

Further study details as provided by Merck:

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 ] [ Designated as safety issue: No ]

Enrollment:	680
Study Start Date:	December 2005
Study Completion Date:	February 2008
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

Ages Eligible for Study:	16 Years to 23 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260039

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00260039 History of Changes
Other Study ID Numbers:	2005_086, V502-001
Study First Received:	November 28, 2005
Last Updated:	November 19, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Condylomata Acuminata
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013