EUCTR2017-000110-35-Outside-EU/EEA进行中（未招募）1 期
Evaluation of Safety and Immunogenicity of GARDASIL™ in Healthy Females Between 9 and 26 Years of Age in SubSaharan Africa. - Safety and Immunogenicity of GARDASIL™ in Healthy Females Between 9 and 26 Years of Age
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- Female
入选标准
- •Phase A-Primary Phase
- •1. Healthy female subjects aged 9 to 26 years old who are native to and living in a participating SubSaharan African country.
- •2. Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes. If a potential subject does not have a telephone number, the subject must provide an address at which he or she may be contacted.
- •3. For post-pubertal female subjects, no evidence of current pregnancy, as demonstrated by a negative urine ?-hCG test.
- •4. For subjects who are sexually active, must agree to use effective contraception or remain abstinent through Month 7 of the study. Effective contraception will be considered to include oral birth control pills or at least single-barrier contraception (males using condom or females using diaphragm, contraceptive sponge, or IUD and etc.)
- •5. For subjects who have not yet had sexual intercourse, must either agree to remain abstinent through Month 7 of the study, or if they become sexually active during the vaccination phase of the study, to use effective contraception through Month 7. Effective contraception will be considered to include oral birth control pills or at least single-barrier contraception (males using condom or females using diaphragm, contraceptive sponge, or IUD and etc.)
- •6. Subject is judged to be in good physical health on the basis of medical history, physical examination and laboratory testing.
- •7. Subjects who have had sexual intercourse in the two weeks prior to enrollment must have been using effective contraception as defined above. (Emergency contraception is not considered effective contraception for enrollment in the study.)
- •Phase B-Vaccination of Placebo Subjects
- •To be eligible to receive vaccination with GARDASIL in this phase of the study, subjects must have received placebo during the Primary Phase of the study. In addition, subjects must meet inclusion criteria 4-7 above.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Phase A-Primary Phase
- •1. Subject is pregnant as determined by a positive urine ?-hCG test.
- •2. Subject has had a temperature =?37.8ºC or =?100ºF (oral or oral equivalent) within 24 hours prior to the first injection.
- •3. Subject is currently enrolled in another clinical study of an investigational agent or agents.
- •4. Subject has a history of known prior vaccination with a HPV vaccine, or was previously enrolled in an HPV vaccine study and received either active agent or placebo.
- •5. Subject has received any inactivated vaccine within 14 days prior to enrollment or any live vaccine within 21 days prior to enrollment.
- •6. Subject has a history of severe allergic reaction to any agent (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
- •7. 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]).
- •8. Subject has received any immune globulin preparation or blood-derived products within the 6 months prior to the first injection, or plans to receive any such products during the course of the study.
- •9. Subject has a history of splenectomy, known autoimmune disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis), or is receiving immunosuppressives (e.g., substances or treatments known to diminish 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 systemic 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) will be eligible for vaccination.
- •10. Subject is immunocompromised or has been diagnosed as having HIV infection (either through prior diagnosis or by the rapid HIV test at study screening).
- •11. Subject has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- •12. Subject has known sickle cell anemia disease (sickle cell trait is not an exclusion), active malaria or active tuberculosis.
- •13. Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
- •14. Subject has a history of recent or ongoing alcohol or other drug abuse.
- •15. Subject is unable to give consent/assent.
- •16. Subject has a prior history of an abnormal Pap test showing squamous intraepithelial lesion (SIL) or ASC-US, ASC-H, or biopsy showing cervical intraepithelial neoplasia (CIN) or worse.
- •17. Subject has any prior history (or at Day 1) of genital warts or treatment for genital warts.
- •18. Subject has >4 lifetime sexual partners.
- •19. Subject has undergone hysterectomy with removal of the cervix.
- •20. Subject 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.
- •Phase B-Vaccination of Placebo Subjects
- •Subjects must not have had a temperature =?37.8ºC or =?100ºF (oral or oral equivalent) within the 24 hours prior to the first injection.
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