A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3819 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-16

Study Completion Date

2015-11-12

Brief Summary

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This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.

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Detailed Description

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The Base study vaccination period (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned, blinded Gardasil™ (V501, qHPV vaccine) or placebo at Day 1, Month 2 and Month 6. The Base study follow-up period continued through approximately Month 48.

The base study was extended in protocol V501-019-10 (EXT1). Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete, open-label, 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

A Long Term Follow-Up (LTFU) extension study V501-019-21 (EXT2) was added to observe the long term safety, effectiveness, and immunogenicity of qHPV vaccine in approximately 1,600 women who participated in the Base Study at sites in Colombia. Data were collected over a period of 6-10 years following participant's enrollment in the original Base Study.

Conditions

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Healthy Adult Female Participants Prevention Papillomavirus Infection Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

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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qHPV Vaccine in Base Study

Participants received blinded qHPV vaccination at Day 1, Month 2, and Month 6 of the Base Study

Group Type EXPERIMENTAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Intervention Type BIOLOGICAL

qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1

Placebo in Base Study

Participants received blinded placebo at Day 1, Month 2, and Month 6 in the Base Study. They were eligible to receive open-label qHPV vaccine in Extension 1

Group Type PLACEBO_COMPARATOR

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Intervention Type BIOLOGICAL

qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1

Comparator: Placebo

Intervention Type BIOLOGICAL

Placebo intramuscular injection in three 0.5 mL doses over 6 months.

Interventions

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Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1

Intervention Type BIOLOGICAL

Comparator: Placebo

Placebo intramuscular injection in three 0.5 mL doses over 6 months.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN)
* Not pregnant and agrees to use effective contraception through Month 7 of the study
* Additional criteria applied

Exclusion Criteria

* Pregnant
* Concurrently enrolled in a clinical study involving collection of cervical specimens
* Previously received any HPV vaccine
* History of severe allergic reaction that required medical intervention
* Received any immune globulin or blood-derived products within 3 months prior to the first study injection
* History of splenectomy, known immune disorders, or receiving immunosuppressives
* Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection
* Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections
* History of recent or ongoing alcohol or drug abuse
* Prior treatment for genital warts, VIN, or VaIN
* History of cervical disease (ie, surgical treatment for cervical lesions)
* Hysterectomy

Minimum Eligible Age

24 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes