Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Genital Warts; Cervical Cancer

Treatments: Biological: V501; Biological: Human Papillomavirus (HPV) 16 Monovalent; Biological: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092521

V501-013

2004_081

Details and patient eligibility

About

The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.

Enrollment: 5,759 patients

Sex: Female

Ages: 16 to 23 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion criteria

• Prior Human Papillomavirus (HPV) vaccination
• Prior abnormal paps
• History of genital warts

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5,759 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

V501

Treatment:

Biological: V501

2

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Comparator: Placebo

3

Experimental group

Description:

HPV 16 Monovalent Vaccine

Treatment:

Biological: Human Papillomavirus (HPV) 16 Monovalent