A Single-arm, Open-label, Multi-center, Phase IV Trial to Evaluate the Reactogenicity, Safety, and Immunogenicity of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting Any Solicited Administration Site Adverse Event
研究概览
简要总结
The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter [mL]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Male or female participants aged >= 65 years of age
- •Participants and/or legally acceptable representative (s) (LAR) who in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits
- •Written or witnessed/thumb printed informed consent obtained from the participant and/or participant's LAR(s) after the study has been explained according to the local authority requirements and prior to performance of any study-specific procedure
排除标准
- •History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine.
- •Receipt of licensed vaccine, immune sera and/or any blood products, or an investigational trial agent within previous 30 days or planned during their participation in the trial.
- •Receipt of any flu vaccine within 6 months before trial start or any other vaccine within 30 days before the trial.
- •Receipt of any dose of a Coronavirus Disease 2019 (COVID-19) vaccine within 15 days of trial start.
- •History of Guillain-Barré Syndrome.
- •Altered immune status or chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within six months prior to administration of trial vaccine.
- •History of acute infectious disease or acute respiratory illness needing antibiotics or antivirals in the previous 7 days, based on investigator's judgement.
- •If a participant candidate has fever, the trial vaccination should be postponed to when the fever has resolved for at least 2 days (temporary exclusion criterion). Fever is defined as temperature >=38.0 degree Celsius (°C) (100.4 degrees Fahrenheit [°F]) by any route. The preferred location for measuring temperature will be oral route.
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination, or laboratory screening tests.
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the trial.
研究组 & 干预措施
Quadrivalent seasonal influenza (FLU D-QIV) vaccine group
Participants received 1 dose of seasonal FLU vaccine at Day 1.
干预措施: Fluarix Tetra Vaccine (Biological)
结局指标
主要结局
Number of Participants Reporting Any Solicited Administration Site Adverse Event
时间窗: Day 1 to Day 7
The solicited administration site adverse events included pain, redness and swelling.
Number of Participants Reporting Any Solicited Systemic Events
时间窗: Day 1 to Day 7
The solicited systemic events included fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), sweating and shivering.
Number of Participants Reporting Unsolicited Adverse Events (AEs)
时间窗: Day 1 to Day 21
An unsolicited AE is defined as an event reported in addition to the solicited AEs during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Number of Participants Reporting Serious Adverse Events (SAEs)
时间窗: Day 1 to Day 21
A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
次要结局
- Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies(At Baseline (Day 1) and Day 22)
- Mean Geometric Increase (MGI) of Serum HI Antibodies(At Day 22 (compared with Baseline [Day 1]))
- Number of Participants With Seroconversion Rate (SCR)(At Day 22)
- Number of Participants With Seroprotection Rate (SPR)(At Day 1 and Day 22)