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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Genital Warts; Vulvar Cancer; Vaginal Cancer; Human Papillomavirus Infection; Cervical Cancer

Treatments: Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant; Biological: Comparator: V505 formulation 1; Biological: Comparator: Placebo (unspecified); Drug: Comparator: V505 formulation 2; Biological: Comparator: V505 formulation 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520598

2007_567

V505-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

Enrollment: 511 patients

Sex: Female

Ages: 16 to 26 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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511 participants in 5 patient groups

1

Active Comparator group

Description:

Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.

Treatment:

Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant

2

Experimental group

Description:

Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.

Treatment:

Biological: Comparator: V505 formulation 1

3

Experimental group

Description:

Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen

Treatment:

Drug: Comparator: V505 formulation 2

Drug: Comparator: V505 formulation 2

4

Experimental group

Description:

Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection

Treatment:

Drug: Comparator: V505 formulation 2

Biological: Comparator: Placebo (unspecified)

Drug: Comparator: V505 formulation 2

5

Experimental group

Description:

Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection

Treatment:

Biological: Comparator: V505 formulation 3

Biological: Comparator: Placebo (unspecified)