Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China (NCT07710586) | Clinical Trial Compass
CompletedPhase 4
Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China
China3,105 participantsStarted 2024-11-15
Plain-language summary
This study evaluates the safety of the quadrivalent subunit influenza vaccine in individuals aged 3 years and older in Jiangsu Province, China. The primary objectives are to assess the occurrence of very rare adverse reactions (incidence \<0.01%), investigate the incidence of cerebral infarction following vaccination, and evaluate the incidence of systemic adverse events among participants aged 9 to 17 years.
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy individuals aged 3 years or above.
. The participant (and/or their guardian/legal representative) has provided informed consent, voluntarily agreed to participate, signed the Informed Consent Form, and is able to comply with the requirements of this study protocol.
Exclusion criteria
. Individuals with a known allergy to any component of the vaccine, including eggs, excipients, formaldehyde, or Triton N-101.
. Individuals suffering from an acute illness, severe chronic disease, an acute exacerbation of a chronic disease, common cold, or fever.
. Individuals with uncontrolled epilepsy or other progressive neurological disorders, or a history of Guillain-Barré syndrome.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events (AEs)
Timeframe: 30 minutes, 7 days, and 28 days after vaccination
2
Adverse Drug Reactions（ADR）
Timeframe: 30 minutes, 7 days, and 28 days after vaccination