Brief Title
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)
Official Title
A Phase III, Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™
Brief Summary
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study
Secondary Outcome
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Condition
Cervical Cancers
Intervention
V503
Study Arms / Comparison Groups
9vHPV Vaccine
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
924
Start Date
February 24, 2010
Completion Date
November 28, 2015
Primary Completion Date
June 10, 2011
Eligibility Criteria
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
Gender
Female
Ages
12 Years - 26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Administrative Informations
NCT ID
NCT01047345
Organization ID
V503-006
Secondary IDs
2010_504
Responsible Party
Sponsor
Study Sponsor
Merck Sharp & Dohme Corp.
Study Sponsor
Medical Director, Study Director, Merck Sharp & Dohme Corp.
Verification Date
October 2018