Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,539
- 试验地点
- 17
- 主要终点
- Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years
研究概览
简要总结
Primary Objective:
To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older.
Secondary Objective:
- Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).
- Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).
详细描述
Study duration per participant was approximately 6 months including: 1 day of screening and vaccination, an end of study visit and safety follow-up telephone call approximately at Day 28 and Day 180 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
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Modified double-blind: the participant and the Investigators remained unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member administered the appropriate vaccine but were not 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) QIV-HD, intramuscularly (IM) at Day 0.
干预措施: High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation (Biological)
Group 2: QIV-SD
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
干预措施: Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD) (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years
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, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.
次要结局
- Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants(Day 0 (pre-vaccination), Day 28 (post-vaccination))
- Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years(Day 0 (pre-vaccination), Day 28 (post-vaccination))
- Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants(Day 0 (pre-vaccination), Day 28 (post-vaccination))
- Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years(Day 0 (pre-vaccination), Day 28 (post-vaccination))
- Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution)(Day 28 post-vaccination)
- Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution)(Day 28 post-vaccination)
- Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)(Within 30 minutes post-vaccination)
- Number of Participants Reporting Solicited Injection Site Reactions(Within 7 days post-vaccination)
- Number of Participants Reporting Solicited Systemic Reactions(Within 7 days post-vaccination)
- Number of Participants Reporting Unsolicited Adverse Events (AEs)(Within 28 days post-vaccination)
- Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)(From Day 0 up to 6 months post-vaccination)
- Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens(Day 28 post-vaccination)
- Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens(Day 28 post-vaccination)