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)

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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 LLC

Study Sponsor

Medical Director, Study Director, Merck Sharp & Dohme LLC

Verification Date

October 2018