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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2409 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2009-07-31

Brief Summary

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

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Detailed Description

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Conditions

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HPV 16 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

HPV 16 L1 VLP vaccine

Group Type EXPERIMENTAL

Comparator: HPV 16 L1 Vaccine

Intervention Type BIOLOGICAL

A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6

2

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type BIOLOGICAL

A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6

Interventions

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Comparator: HPV 16 L1 Vaccine

A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6

Intervention Type BIOLOGICAL

Comparator: Placebo

A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6

Intervention Type BIOLOGICAL

Other Intervention Names

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V501

Eligibility Criteria

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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)

Minimum Eligible Age

16 Years

Maximum Eligible Age

23 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes