Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Genital Warts; Cervical Cancer

Treatments: Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092495

2004_083

V501-016

Details and patient eligibility

About

The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.

Enrollment: 3,055 patients

Sex: All

Ages: 10 to 23 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adolescents and pre-adolescents with no prior sexual history
• Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners

Exclusion criteria

• Prior Human Papillomavirus (HPV) vaccination
• Prior abnormal Paps
• Prior history of genital warts

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,055 participants in 4 patient groups

1

Experimental group

Description:

100% Formulation qHPV Vaccine

Treatment:

Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

2

Experimental group

Description:

60% Formulation qHPV Vaccine

Treatment:

Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

3

Experimental group

Description:

40% Formulation qHPV Vaccine

Treatment:

Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

4

Experimental group

Description:

20% Formulation qHPV Vaccine

Treatment:

Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine