EUCTR2009-011617-25-Outside-EU/EEA进行中（未招募）1 期
A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 year olds) with a Comparison to Young Women (16 to 26 year olds)
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Boys and Girls Age 9 to 15 Years:
- •1. Subject is male or female, between the ages of 9 years and 0 days and 15 years and 364 days 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 agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
- •5. Subject must not yet have had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7 period.
- •Inclusion Criteria: Women Age 16 to 26 Years:
- •6. Subject is female, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrollment.
- •7. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
- •8. 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.
- •9. Subject is able to read, understand, and complete the vaccination report card.
- •10. Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
- •11. Subject has never had Pap testing or has only had normal Pap test results.
- •12. Subject has a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment. 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.
- •13. 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 or Pap test).
- •14. 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 or Pap test).
- •15. 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 protoco
排除标准
- •Exclusion Criteria: Boys and Girls Age 9 to 15 Years
- •1. Subject has a known allergy to any vaccine component.
- •2. Subject has a history of severe allergic reaction 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. (Girls 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. 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.
- •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 rheumatoidarthritis (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 immunosuppressive therapies prohibited by the protocol
- •10. Subject has received any immune globulin product or blood-derived product within the 3 months prior to the Day1 vaccination, or plans to receive any such product during Day 1 through Month 7 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 within the 24-hour period prior to the Day 1 vaccination.
- •14. Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
- •15. Subject is unable to give consent/assent.
- •16. Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- •17. 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 abuse or dependence.
- •18. Subject has a history of a positive test for HPV.
- •Exclusion Criteria: Women Age 16 to 26 Years
- •19-21. As 1, 2, 3 above
- •22. Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens.
- •23.- Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG).
- •24. Subject is expecting to donate eggs during Day 1 through Month 7 of the study.
- •25-37. As 6-18 above
- •38. Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse).
- •39. Subject has a history of or clinical evidence at the Day 1 pelvic examination of HPVrelated external genital lesions (e.g., condyloma acuminata or vulvar intraepithelial neoplasia [VIN]) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata or vaginal intraepithelial neoplasia [VaIN]) or vaginal cancer.
- •40. Subject has clinical evidence of gross purulent cervicitis.
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