Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: HPV 16 Infection

Treatments: Biological: Comparator: Placebo; Biological: Comparator: HPV 16 L1 Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00365378

2006_515

V501-005

Details and patient eligibility

About

Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.

Enrollment: 2,409 patients

Sex: Female

Ages: 16 to 23 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, unmarried females age 16 to 23 years with intact uteri
• Not pregnant at enrollment
• Agreed to use effective contraception through Month 7 of the study
• A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse

Exclusion criteria

• No prior history of Human Papillomavirus (HPV) vaccination
• No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
• No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,409 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

HPV 16 L1 VLP vaccine

Treatment:

Biological: Comparator: HPV 16 L1 Vaccine

2

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Comparator: Placebo