Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003)

Cervical Cancer Clinical Trial

Official title:

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00365443
• Other study ID #: V502-003
• Secondary ID: 2006_503
• Status: Withdrawn
• Phase: Phase 2
• First received: August 16, 2006
• Last updated: June 18, 2015
• Start date: October 2006

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 26 Years

Eligibility

Inclusion Criteria:

• Female, between the ages of 16 and 26

Exclusion Criteria:

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Condylomata Acuminata
• Uterine Cervical Neoplasms

Intervention

Biological:
• V502

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary	Proprietary Information - Exploratory (Non-Confirmatory) Trial