CTRI/2022/12/048070进行中（未招募）4 期
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
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Deviations from inclusion criteria are not allowed because they can potentially jeopardize the
- •scientific integrity of the trial. Therefore, adherence to the criteria as specified in the protocol is
- •The following criteria must be met in order to be enrolled in the trial:
- •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
- •Deviations from the exclusion criteria are not allowed because they can potentially jeopardize the
- •scientific integrity of the trial. Therefore, adherence to the criteria as specified in the protocol is
- •Participants meeting ANY of the following criteria are not eligible for participation:
- •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 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 6 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 judgment.
- •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°C (100.4°F) by any route. The preferred location for measuring temperature will be oral
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional
- •abnormality, as determined by medical history, physical examination, or laboratory screening
- •Any other clinical condition that, in the opinion of the Investigator, might pose additional risk
- •to the participant due to participation in the trial.
研究者
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