Post-marketing study of safety and efficacy of GARDASIL in young Japanese women.

Phase 1

• Conditions: Human Papillomavirus infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-002932-42-Outside-EU/EEA
• Lead Sponsor: MSD K.K., a subsidiary of Merck & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-14
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: A
• Sex: Female
• Target Recruitment: 1000

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
any genital contact) for 2 calendar days prior to any scheduled visit that includes a
pelvic exam, in an attempt to avoid detection of viral DNA which has been deposited in the vagina or on the perineal/perianal area during sexual intercourse and is not the
result of ongoing infection.
6) Not pregnant now (as determined by a urine pregnancy test sensitive to 25 IU hCG),
and must agree to use effective contraception through Month 7 of the study. Effective
contraception will be considered: oral contraceptives or injection contraception IUD,
sterilization, abstinence, condom (male), diaphragm, cervical cap.
7) *Individuals who have had sexual intercourse in the 2 weeks prior to enrollment must
have been using effective contraception as defined above. (Emergency contraception is
not considered effective contraception for enrollment into the study.)
8) Individuals with a lifetime history of 0 to 4 male or female sexual partners. Women
with 0 lifetime male or female sexual partners must be at least 18 years of age and, if
heterosexual or bisexual, they plan to become sexually active within the first 3 months
of the study.
9) Must agree to provide study personnel with a primary telephone number as well as an
alternate telephone number for follow-up purposes.
10) *No temperature =37.5°C (oral) within 24 hours prior to injection.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1030
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1028
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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
corticosteroids). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of oral corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Subjects using topical steroids (i.e., inhaled, or nasal, or topical) will be eligible for vaccination.
11) Individuals who are immunocompromised or have been diagnosed as having HIV infection.
12) Individuals with known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
13) History of recent (within 1 year from the date of enrollment) or ongoing alcohol abuse
or other drug abuse.
14) Any condition which in the opinion of the investigator might interfere with the
evaluation of the study objectives.
15) Any plans to permanently relocate from the area prior to the completion of the study or
to leave for an extended period of time when study visits would need to be scheduled.
16) Individuals with >4 lifetime male or female sexual partners.
17) *Subject is having menses.
18) Subject does not have an intact cervix uteri or has more than one cervix uteri

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified