Immunogenicity and Safety of High-Dose Quadrivalent Influenza Vaccine (SP0178) Administered by Intramuscular Route Versus Standard-Dose Quadrivalent Influenza Vaccine by Subcutaneous Route in Subjects 60 Years of Age and Older in Japan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,100
- 试验地点
- 10
- 主要终点
- Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28
研究概览
简要总结
Primary Objective:
To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition [HAI] geometric mean titers [GMTs] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants.
Secondary Objective:
- To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants.
- To describe the safety profile of all participants in each study group.
详细描述
Study duration per participant was approximately 28 days including: 1 day of screening and vaccination, a safety follow-up telephone call and an end of study visit approximately at Day 8 and 28 after vaccination, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Modified double-blind: the participant and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1: QIV-HD
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
干预措施: High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD) (Biological)
Group 2: QIV-SD
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
干预措施: Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD) (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28
时间窗: Day 28 (post-vaccination)
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis
时间窗: Day 28 (post-vaccination)
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28.
次要结局
- Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens(Day 28 (post-vaccination))
- GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28(Day 0 (pre-vaccination) and Day 28 (post-vaccination))
- Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens(Day 0 (pre-vaccination), Day 28 (post-vaccination))
- Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies(Day 0 (pre-vaccination), Day 28 (post-vaccination))
- Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)(Within 30 minutes post-vaccination)
- Number of Participants Reporting Unsolicited Adverse Events (AEs)(Within 28 days post-vaccination)
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions(Within 7 days post-vaccination)
- Number of Participants Reporting Serious Adverse Events (SAEs)(From Day 0 up to Day 28 post-vaccination)