Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

Official Title
-----------------
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

Conditions
-----------------
Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection

Intervention / Treatment
-----------------
* Biological: Comparator: V505 formulation 1
* Drug: Comparator: V505 formulation 2
* Drug: Comparator: V505 formulation 2
* Biological: Comparator: V505 formulation 3
* Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
* Biological: Comparator: Placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 26 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen. | Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant<br>* 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.<br>|
| Experimental: 2<br>Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen. | Biological: Comparator: V505 formulation 1<br>* 0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.<br>|
| Experimental: 3<br>Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen | Drug: Comparator: V505 formulation 2<br>* 0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.<br>|
| Experimental: 4<br>Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection | Drug: Comparator: V505 formulation 2<br>* 0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.<br>Biological: Comparator: Placebo (unspecified)<br>* 0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.<br>|
| Experimental: 5<br>Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection | Biological: Comparator: V505 formulation 3<br>* 0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.<br>Biological: Comparator: Placebo (unspecified)<br>* 0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen |  | 4 weeks post dose 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen |  | 4 weeks post dose 2 |