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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Vulvar Cancers; Genital Warts; Cervical Cancers; Vaginal Cancers

Treatments: Biological: Placebo to V503; Biological: V503

Study type: Interventional

Funder types: Industry

Identifiers

NCT01047345

V503-006

2010_504 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 924 patients

Sex: Female

Ages: 12 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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924 participants in 2 patient groups, including a placebo group

9vHPV Vaccine

Experimental group

Description:

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.

Treatment:

Biological: V503

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Biological: Placebo to V503

Biological: V503