Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older in Taiwan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 4
- 主要终点
- Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
研究概览
简要总结
Primary Objective:
Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants.
Safety: To describe the safety profile of all participants in each study groups.
详细描述
The duration of each participant's participation was approximately 28 days (Day 0 through Day 28 [+ 7 days]).
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
The study was modified double-blind. The designated vaccine prepare(s)/administrator(s) would be unblinded given that the QIV-HD and QIV-SD vaccines had different dose volumes. Neither the participant nor the investigator nor the study staff in charge of vaccination was aware of which vaccine was administered (the syringes was masked to maintained the blinding of the participants and other members of the clinical site). The unblinded designated vaccine preparer(s)/administrator(s) was not involved in any of the blinded study assessments (eg, immunogenicity, safety).
入排标准
- 年龄范围
- 65 Years 至 —（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: High-Dose Quadrivalent Influenza Vaccine (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 Quadrivalent Influenza Vaccine (Biological)
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
干预措施: Standard-Dose Quadrivalent Influenza Vaccine (Biological)
结局指标
主要结局
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
时间窗: Day 0 (pre-vaccination)
Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28
时间窗: Day 28 (post-vaccination)
GMTs of anti-influenza antibodies were measured using 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.
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
时间窗: Day 28 (post-vaccination)
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (\>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer \>=10 (1/dilution) at Day 0 and a \>= four-fold increase in post-vaccination titer at Day 28.
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28
时间窗: Day 28 (post-vaccination)
Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Number of Participants With Solicited Injection Site and Systemic Reactions
时间窗: Within 7 days post-vaccination
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
时间窗: From Day 0 up to 28 days post-vaccination
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0
时间窗: Day 0 (pre-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.
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
时间窗: Within 30 minutes post-vaccination
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Number of Participants With Unsolicited Adverse Events
时间窗: Within 28 days post-vaccination
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
时间窗: Day 0 (pre-vaccination), Day 28 (post-vaccination)
GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
次要结局
未报告次要终点