NCT00365443

Brief Summary

This study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by the HPV types in the study vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate vaccine immune responses in women. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

First QC Date

August 16, 2006

Last Update Submit

June 18, 2015

Conditions

Cervical CancerCondylomata Acuminata

Keywords

anogenital wartspremalignancyHPVHuman papillomavirus

Outcome Measures

Primary Outcomes (1)

  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcomes (1)

  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Interventions

V502BIOLOGICAL

Eligibility Criteria

Age16 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female, between the ages of 16 and 26

You may not qualify if:

  • History of an abnormal PAP test or abnormal cervical biopsy result
  • History of external genital/vaginal warts
  • History of positive HPV test
  • Currently a user of any illegal drugs or an alcohol abuser
  • Are pregnant
  • Currently enrolled in another 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical NeoplasmsCondylomata Acuminata

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPapillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

October 1, 2006

Last Updated

June 19, 2015

Record last verified: 2015-06