NCT00561080已完成3 期
An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of a 1-dose Regimen and Different 2-dose Regimens of a Zoster Vaccine (Live), ZOSTAVAX ®, in Subjects ≥ 70 Years of Age
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 759
- 主要终点
- Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3
研究概览
简要总结
Primary objective:
Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination
Secondary objectives Immunogenicity
- To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®.
- To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX®
- To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 70 years
- •Varicella history-positive or residence for > 30 years in a country with endemic VZV infection
- •Signed informed consent form prior to any study procedure
排除标准
- •Febrile illness within the last 72 hours before the first vaccination
- •Prior herpes-zoster episode clinically diagnosed by a physician
- •Prior receipt of varicella or zoster vaccine
- •Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
- •Significant underlying illness preventing completion of the study vaccination schedules,
- •Known active tuberculosis,
- •Immune deficiency disorder, including active neoplastic disease within the prior 5 years,
- •Immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause,
- •Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination,
- •Receipt of any other live vaccine within the 4 weeks prior to the first vaccination,
- •Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination,
- •Concomitant use of non-topical antiviral therapy
研究组 & 干预措施
Zostavax - Day 0 and Month 3
Experimental
Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 3
干预措施: Zostavax (Biological)
Single Dose of Zostavax
Experimental
Zostavax 0.65mL intramuscular injection administered on Day 0
干预措施: Zostavax (Biological)
Zostavax - Day 0 and Month 1
Experimental
Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 1
干预措施: Zostavax (Biological)
结局指标
主要结局
Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3
时间窗: 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)
Blood samples taken at 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).
次要结局
- Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1(4 weeks post-dose (Month 1))
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 12 Months Post-dose 1 in Group 1 And From Pre-Vaccination To 12 Months Post-dose 2 in Groups 2 and 3(predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15))
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 24 And 36 Months Post-dose 1 in Group 1 and From Pre-vaccination To 24 And 36 Months Post-dose 2 in Groups 2 and 3(Predose 1 and 24 and 36 months post-last dose)
- Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2(up to 4 days after 2nd vaccination)
- Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2(up to 28 days post-dose 2)
- Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1(up to 28 days post-dose 1)
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3(Predose and 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))
- Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose(1 year post final dose for Groups 1, 2, and 3 (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15))
- Geometric Mean Titre (GMT) of VZV Antibodies 24 and 36 Months Post-dose 1 in Group 1 and the 24 and 36 Months Post-dose 2 in Groups 2 and 3(24 and 36 months post-last dose)
- Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1(up to 4 days after 1st vaccination)
- Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1(up to 28 days after 1st of study drug)
- Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2(up to 28 days post-dose 2)
- Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1(up to 28 days post-dose 1)
- Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2(up to 28 days post-dose 2)
- Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1(up to 28 days after 1st vaccination)
- Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2(up to 28 days after 2nd vaccination)
- Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1(up to 28 days after 1st vaccination)
- Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2(up to 28 days after 2nd vaccination)
- Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2(up to 28 days after 2nd vaccination)
- Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1(up to 28 days after 1st vaccination)
- Percentage of Participants Who Reported a Vaccine-related Serious Adverse Event(up to end of study (approximately 15 months))
- Percentage of Participants Who Died During the Study(up to end of study (approximately 15 months))
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