Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: HPV; Premalignancy Anogenital Warts; Cervical Cancer

Treatments: Biological: Comparator: octavalent HPV Vaccine - dose formulation 2; Biological: Comparator: octavalent HPV Vaccine - dose formulation 1; Biological: Comparator: Gardasil; Biological: Comparator: octavalent HPV Vaccine - dose formulation 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00260039

2005_086

V502-001

Details and patient eligibility

About

This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.

Enrollment: 680 patients

Sex: Female

Ages: 16 to 23 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Lifetime history of 0-4 sexual partners

Exclusion criteria

• History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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680 participants in 4 patient groups

1

Active Comparator group

Description:

Gardasil

Treatment:

Biological: Comparator: Gardasil

2

Experimental group

Description:

HPV VLP vaccine -Dose regimen 1

Treatment:

Biological: Comparator: octavalent HPV Vaccine - dose formulation 1

3

Experimental group

Description:

HPV VLP vaccine -Dose regimen 2

Treatment:

Biological: Comparator: octavalent HPV Vaccine - dose formulation 2

4

Experimental group

Description:

HPV VLP vaccine -Dose regimen 3

Treatment:

Biological: Comparator: octavalent HPV Vaccine - dose formulation 3