A Phase III, Double-Blind, Randomized, Multicenter Study to Evaluate the Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 882
- 主要终点
- Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody
研究概览
简要总结
The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211) administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific GMT antibody responses.
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
- Double (Participant, Investigator)
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
- •Has history of varicella or residence in a VZV-endemic area for ≥30 years
- •Is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study
排除标准
- •Has history of hypersensitivity to any vaccine component
- •Has previously received any varicella or zoster vaccine
- •Has received an influenza vaccine for the 2015-16 season
- •Has history of Herpes zoster
- •Has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination
- •Is pregnant or breastfeeding, or expecting to conceive during the study
- •Has used immunosuppressant therapy
- •Has known or suspected immune dysfunction
- •Has experienced Guillain-Barré syndrome within 6 weeks
- •Has severe thrombocytopenia or any other coagulation disorder
研究组 & 干预措施
Concomitant Vaccination
ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
干预措施: Influenza Vaccine (Biological)
Concomitant Vaccination
ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
干预措施: ZOSTAVAX™ (Biological)
Concomitant Vaccination
ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
干预措施: Placebo to ZOSTAVAX™ (Biological)
Nonconcomitant Vaccination
Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
干预措施: ZOSTAVAX™ (Biological)
Nonconcomitant Vaccination
Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
干预措施: Placebo to ZOSTAVAX™ (Biological)
Nonconcomitant Vaccination
Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
干预措施: Influenza Vaccine (Biological)
结局指标
主要结局
Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody
时间窗: Baseline and 4 weeks after Influenza vaccination (Week 4)
Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody
时间窗: Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)
Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.
Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers
时间窗: Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)
Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.
Geometric Mean Titers of H1N1-specific Influenza Virus Antibody
时间窗: Baseline and 4 weeks after Influenza vaccination (Week 4)
Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
Geometric Mean Titers of H3N2-specific Influenza Virus Antibody
时间窗: Baseline and 4 weeks after Influenza vaccination (Week 4)
Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody
时间窗: Baseline and 4 weeks after Influenza vaccination (Week 4)
Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
次要结局
未报告次要终点