EUCTR2006-003651-20-GB进行中（未招募）1 期
A Phase III Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids - Study of Zoster vaccine in subjects on chronic steroid maintenance
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
- 300
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
入选标准
- •1. Age=60 years.
- •2. A history of varicella or long-term residence in a country with endemic VZV infection.
- •3. Receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone or equivalent for at least 2 weeks immediately prior to enrolment.
- •4. Expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week duration of the study (dose may vary within this range during the 6-week postvaccination period).
- •5. All females mst be postmenopausal or have a negative serum or urine pregnancy test. A patient who is reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, oral contraceptive pills, condom, tubal ligation and vasectomy.
- •6. Signed consent form prior to any study procedure.
- •7. Any underlying chronic illness, including the condition for which the patient is receiving corticosteroids, must be in stable condition.
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A histroy of allergic reaction to any vaccine component (including gelatin), or an anaphylactic/anaphylactoid reaction to neomycin (note that patients with history of contact dermatitis from neomycin may receive the vaccine.)
- •2. Prior history of HZ
- •3. Prior receipt of any varicella or zoster vaccine.
- •4. Women who are pregnant or breast feeding or planning to conceive within projected duration of the study.
- •5. Any use in the 8 weeks prior to vaccination or expected for 6 weeks postvaccination of concomitant immunosuppressive medications (e.g. corticosteroids >20 mg daily, chemotherapeutic agents, immunomodulating drugs, immunosuppressive treatments associated with solid organ or bone marrow transplantation.
- •6. Known or suspected immune dysfunction that is casued by a medical condition (other than that for which patient is receiving corticosteroid therapy), or any cause.
- •7. Immunoglobulin or any blood products, other than autologous blood tranfusion, given during the 5 months prior to vaccination or expected during the 6-week postvaccination period.
- •8. Any other live virus vaccine administered or scheduled from 4 weeks prior to vaccination or expected during the 6 week primary safety follow-up period.
- •9. Any inactivated vaccine adminsitered or scheduled in the period from 7 days prior to vaccination or expected during the 6-week primary safety follow-up period.
- •10. participation in an investigational drug or vaccine study within the last 30 days prior to enrollment and for 6-month safety follow-up period.
- •11. Any acute intercurrent illness that might interfere with the study such as unstable systemic lupus ewrythmetosus or unstable multiple sclerosis.
- •12. Significant underlying illness preventing completion of the study.
- •13. Any concomitatn use of nontopical antiviral therapy with activity against herpesviruses, including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscaernet and cidofovir.
- •14. a history of alcohol abuse or recreational drug use, which, in the opinion of the investigator, will interfere with study participation.
研究者
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