A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women
Phase 2
16 Years
26 Years
16 Years
26 Years
Not Enrolling
Female
Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
Female
Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
Trial Information
A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women
Inclusion Criteria:
- Female between 16 to 26 years old
- Has never had Pap testing or have only had normal Pap test results
- Lifetime history of 0 to 4 sexual partners
Exclusion Criteria:
- History of an abnormal cervical biopsy result; History of a positive test for HPV;
History of external genital/vaginal warts; Currently a user of any illegal drugs or
an alcohol abuser
- History of severe allergic reaction that required medical attention
- Are pregnant
- Received a marketed HPV vaccine
- Currently enrolled in a 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 time of consent)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
Outcome Time Frame:
4 weeks post dose 3
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Australia: National Health and Medical Research Council
Study ID:
2007_567
NCT ID:
NCT00520598
Start Date:
October 2007
Completion Date:
May 2011
Related Keywords:
- Cervical Cancer
- Vulvar Cancer
- Vaginal Cancer
- Genital Warts
- Human Papillomavirus Infection
- Uterine Cervical Neoplasms
- Condylomata Acuminata
- Vaginal Neoplasms
- Vulvar Neoplasms
- Warts
- Papillomavirus Infections
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