A Phase IV Open-label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women. - V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years

MSD K.K., a subsidiary of Merck & Co., Inc0 sites1,000 target enrollmentDecember 14, 2016

ConditionsHuman Papillomavirus infection Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsGARDASIL

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Human Papillomavirus infection
Sponsor: MSD K.K., a subsidiary of Merck & Co., Inc
Enrollment: 1000
Status: Active, Not Recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 14, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

MSD K.K., a subsidiary of Merck & Co., Inc

Eligibility Criteria

Inclusion Criteria

•1\) Healthy Japanese females age 16 to 26 years.
•2\) Subject (or, for minor subjects, parent/legal guardian and subject) fully understands
•study procedures, alternative treatments available, the risks involved with the study
•and voluntarily agrees to participate by giving written informed consent.
•3\) No clinical evidence of gross purulent cervicitis (otherwise postpone until after
•treatment or lack of laboratory confirmation of treatable cause).
•4\) \*Must agree to refrain from douching/vaginal cleansing or using vaginal medication or
•preparation for 2 calendar days prior to any scheduled visit that includes a pelvic
•examination.
•5\) \*Must agree to refrain from sexual activity (including vaginal and anal penetration and

Exclusion Criteria

•1\) Individuals concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens.
•2\) Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received active agent.
•3\) \*Receipt of inactivated vaccines within 14 days prior to enrollment or receipt of live virus vaccines within 28 days prior to enrollment.
•4\) Individuals with any prior abnormal Pap test showing squamous intraepithelial lesion (SIL), ASC\-US, ASC\-H, Class III or worse (Papanicolaou's classification), or biopsy showing cervical intraepithelial neoplasia (CIN).
•5\) Subject has a history of a positive test for HPV.
•6\) Individuals with genital warts or any prior history of, or treatment for genital warts.
•7\) History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
•8\) Individuals allergic to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed \[used to remove residual nucleic acids from this and other vaccines]). For the purpose of this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for serious adverse experiences defined in Section 3\.4\.
•9\) Individuals who have received any immune globulin or blood derived products within the 6 months prior to the first injection, or plan to receive any through Month 7 of the study.
•10\) Individuals with history of splenectomy, known immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis), or receiving immunosuppressives (e.g., substances or treatments known to diminish the immune response such as radiation therapy, administration of antimetabolites, antilymphocytic sera, systemic