A Randomized, International, Double-Blinded (With In-House Blinding), ControlledWith GARDASIL™, Tolerability, Immunogenicity, and Efficacy Study of a SecondGeneration Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) VaccineAdministered to 16- to 26-Year-Old Wome
- Conditions
- Prevention of cervical, vulvar, and vaginal cancers and related precancers, externalgenital lesions, and persistent infection caused by Human Papillomavirus (HPV) 6, 11,16, 18, 31, 45, 52, and 58.MedDRA version: 8.1Level: LLTClassification code 10063001Term: Human papilloma virus infection
- Registration Number
- EUCTR2006-004933-14-DK
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 4000
To be randomized and receive the first study vaccination, subjects should meet all
inclusion criteria. For items with an asterisk (*), if the subject does not meet these
inclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria
can be met.
1. Subject is female, between the ages of 16 years and 0 days and 26 years and 364 days on the day of randomization.
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. Subject is able to read, understand, and complete the vaccination report card.
4. Subject is judged to be in good physical health on the basis of medical history,
physical examination, and laboratory results.
5. The subject has the following lifetime sexual history at the time of enrollment:
a) Subject has had 1 to 4 male and/or female sexual partners; or
b) Subject has had 0 male and/or female sexual partners, is 18 years of age or older,
and plans to become sexually active within the first 3 months of the study.
Male partner is defined as someone with whom the subject has penile penetrative
sexual intercourse. Female partner is defined as someone who has contacted,
either by penetrative (with fingers or other objects) or non-penetrative means, the
subject’s genitalia during sexual activity.
6. *Subject has refrained from douching/vaginal cleansing and using vaginal
medications or preparations for 2 calendar days prior to the Day 1 visit. Subject
agrees to refrain from these activities for 2 calendar days prior to any future visit that
includes collection of study specimens (cervical/genital swabs, Pap test, or
biopsy/definitive therapy tissue).
7. *Subject has refrained from sexual activity (including anal, vaginal, or genital/genital contact whether same sex or opposite sex) for 2 calendar days prior to the Day 1 visit. Subject agrees to refrain from these sexual activities for 2 calendar days prior to any future visit that includes collection of study specimens (cervical/genital swabs, Pap test, or biopsy/definitive therapy tissue).
8. *Since the first day of the subject’s last menstrual period through Day 1, the subject has not had sex with males or has had sex with males and used effective
contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse). Effective contraception is defined as a marketed,
approved contraceptive product that the subject has used per the manufacturer’s
instructions with every act of sexual intercourse. The subject understands and agrees that during the Day 1 through Month 7 period, she should not have sexual intercourse with males without effective contraception, and the uses of the rhythm method alone, withdrawal alone, and emergency contraception, are not acceptable methods per the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
To be randomized and receive the first study vaccination, subjects should not have any exclusion criteria. For items with an asterisk (*), if the subject meets these exclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria are not met.
1. Subject has a history of an abnormal Pap test (showing ASC-US or worse) or an
abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or
worse).
2. Subject has never had a history of an abnormal Pap test, but has a history of a positive test for HPV.
3. Subject is, at the time of signing informed consent, a user of recreational or illicit
drugs or has had a recent history (within the last year) of drug or alcohol abuse or
dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
4. Subject has a history of severe allergic reaction (e.g., swelling of the mouth and
throat, difficulty breathing, hypotension or shock) that required medical intervention.
5. Subject has known allergy 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.
6. Subject is currently immunocompromised or has been diagnosed as having a
congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia,
systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid
arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
7. Subject has had a splenectomy.
8. Subject is receiving or has received in the year prior to enrollment the following
immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine,
methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), TNF-a
antagonists, monocolonal antibody therapies (including rituximab [Rituxan™]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to
interfere with the immune response. With regard to systemic corticosteroids, a
subject will be excluded if she is currently receiving steroid therapy, has recently
(defined as within 2 weeks of enrollment) received such therapy, or has received 2 or
more courses of high dose corticosteroids (orally or parenterally) lasting at least 1
week in duration in the year prior to enrollment. Subjects using inhaled, nasal, or
topical corticosteroids are considered eligible for the study.
9. Subject has received any immune globulin product (including RhoGAM™ [Ortho-
Clinical Diagnostics]) or blood-derived product within the 3 months prior to the Day
1 vaccination, or plans to receive any such product during Day 1 through Month 7 of
the study.
10. *Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live virus) vaccines within 21 days prior to the Day 1 vaccination.
11. Subject has thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injections.
12. *Subject has donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study.
13. Subject is expecting to donate eggs during Day 1 through Month 7 of the study.
14. Subject is concurrently enrolled in clinical
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method