A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

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

924 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-24

Study Completion Date

2015-11-28

Brief Summary

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This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.

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Detailed Description

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Conditions

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Cervical Cancers Vulvar Cancers Vaginal Cancers Genital Warts

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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9vHPV Vaccine

Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.

Group Type EXPERIMENTAL

V503

Intervention Type BIOLOGICAL

V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension

Placebo

Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.

Group Type PLACEBO_COMPARATOR

V503

Intervention Type BIOLOGICAL

V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension

Placebo to V503

Intervention Type BIOLOGICAL

Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study

Interventions

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V503

V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension

Intervention Type BIOLOGICAL

Placebo to V503

Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Participants Age 12 to 15 Years:

* Participant is in good health
* Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up
* Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
* Participant has not received any other HPV vaccine
* Participant is not yet sexually active

Participants Age 16 to 26 Years:

* Participant is in good health
* Participant agrees to provide a primary telephone number for follow-up
* Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
* Participant has not received any other HPV vaccine
* Participant has never had Papanicolaou (Pap) testing or has only had normal results
* Participant has a history of 0 to 4 lifetime sexual partners at enrollment

Exclusion Criteria

All participants:

* Participant has a history of severe allergic reaction that required medical intervention
* Participant has any disorder that would contraindicate intramuscular injections
* Participant is pregnant
* Participant is immunocompromised or has an autoimmune condition
* Participant has had a splenectomy
* Participant has received any immune globulin product or blood-derived product
* Participant has participated in a HPV vaccine clinical trial

Participants Age 16 to 26 Only:

* Participant expects to donate eggs during the study
* Participant has a history of abnormal cervical biopsy result
* Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer

Minimum Eligible Age

12 Years

Maximum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes