NCT01391546已完成3 期
An Open-label, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ZOSTAVAX When Administered by Intramuscular Route or Subcutaneous Route to Subjects of 50 Years of Age and Older
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 354
- 主要终点
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route
研究概览
简要总结
PRIMARY OBJECTIVES
Two co-primary objectives are:
- To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC)
- To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination
SECONDARY OBJECTIVES
Immunogenicity objectives
- To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following ZOSTAVAX administered by IM or SC route
- To evaluate the immune response as measured by a second assay, the VZV Interferon gamma Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route
Safety objective
- To describe the safety profile of ZOSTAVAX administered by IM or SC route
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged >=50 years
- •Varicella history-positive or residence for >30 years in a country with endemic VZV infection
排除标准
- •Febrile illness
- •History of hypersensitivity or anaphylactoid reaction to any of the vaccine components
- •Prior herpes zoster episode clinically diagnosed or exposure to varicella or herpes zoster within the 4 weeks prior to vaccination
- •Prior receipt of varicella or zoster vaccine
- •Active untreated tuberculosis
- •Thrombocytopenia, any other coagulation disorder contraindicating intramuscular injection
- •Receipt of medication / vaccine that may interfere with study assessments
- •Known or suspected immune dysfunction
- •User of recreational / illicit drugs or subject with alcohol abuse or dependence within the last year
- •Any condition that might interfere with the interpretation of the study,
研究组 & 干预措施
ZOSTAVAX intramuscular (IM) route
Experimental
Single dose of 0.65 mL via IM injection
干预措施: ZOSTAVAX (Biological)
ZOSTAVAX subcutaneous (SC) route
Active Comparator
Single dose of 0.65 mL via SC injection
干预措施: ZOSTAVAX (Biological)
结局指标
主要结局
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route
时间窗: Pre-vaccination (Day 0) and 4 week post-vaccination
Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination
时间窗: 4 week post-vaccination
Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).
次要结局
- Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies(Pre-vaccination (Day 0) and 4 week post-vaccination)
- Percentage of Participants Who Report at Least 1 Systemic Adverse Event(up to Day 28 after vaccination)
- Percentage of Participants Who Report at Least 1 Serious Adverse Event(up to 35 days after vaccination)
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route(Pre-vaccination (Day 0) and 4 week post-vaccination)
- Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies(4 week post-vaccination)
- Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction(up to 28 days after vaccination)
研究者
相似试验
终止
1 期
ZN-c3 in Adult Participants With Metastatic Colorectal CancerMetastatic Colorectal CancerNCT05743036K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc44
终止
1 期
Study of Vorinostat Plus Melphalan and Prednisone (Zmp) in Advanced, Refractory Multiple Myeloma PatientsMultiple MyelomaNCT00857324Tiziana Marangon18
进行中（未招募）
3 期
Efficacy, Safety and Immunogenicity Study of Recombinant Zoster Vaccine(CHO Cell) in Adults Aged 40 Years and OlderHerpes ZosterNCT06447779MAXVAX Biotechnology Limited Liability Company25,000
已完成
3 期
A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)Herpes ZosterNCT00231816Merck Sharp & Dohme LLC763
撤回
2 期
Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition to Standard Treatment in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19).COVID-19NCT04452474R-Pharm