EUCTR2013-001314-15-CZActive, not recruitingPhase 1
A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, administered in Preadolescents and Adolescents (9 to 14 year olds) with a Comparison to Young Women (16 to 26 year olds) - 2 doses of V503 in 9 to 14 year-olds.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites1,500 target enrollmentStarted: November 18, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 1,500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Boys and Girls Age 9 to 14 Years
- •1. Subject is male or female, between the ages of 9 years and 14 years on the day of enrollment.
- •2. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
- •3. 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.
- •4. Subject must not yet have had coitarche and does not plan on becoming sexually active during the vaccination period (Day 1 through Month 7 or Day 1 through Month 13).
- •5.1.2.2 Inclusion Criteria: Women Age 16 to 26 Years
- •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.
- •5. Subject is female, between the ages of 16 and 26 years on the day of enrollment.
- •6. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
- •7. 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.
- •8. Subject has never had Pap testing or has only had normal Pap test results.
- •9. Subject has a lifetime history of 0 to 4 male and/or female sexual partners at the time
- •of enrollment.
- •10. *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).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1260
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Subject has a 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 tovaccine components is defined as an allergic reaction that met the criteria for serious adverse experiences.
- •2. 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.
- •3. Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- •4. Subject is concurrently enrolled in clinical studies of investigational agents.
- •5. (Females only) - Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG).
- •6. (Young Adult Women only - 16 to 26 years of age) - Subject is expecting to donate eggs during Day 1 through Month 7 of the study.
- •7. 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.
- •8. Subject has had a splenectomy.
- •9. Subject is receiving or has received in the year prior to enrollment certain immunosuppressive therapies.
- •10. 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 or Day 1 through Month 13 of the study.
- •11. *Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
- •12. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
- •13. *Subject has had a fever (defined as an oral temperature of =100°F or =37.8°C) within the 24-hour period prior to the Day 1 vaccination.
- •14. Subject is unable to give consent/assent.
- •15. Subject has a history of a positive test for HPV.
Investigators
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