Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations. (NCT06334510) | Clinical Trial Compass
CompletedNot Applicable
Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations.
China4,900 participantsStarted 2021-11-17
Plain-language summary
To evaluate the inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split virion) in the expanded population aged 3 years and above, in order to observe the rare adverse reaction of 1‰.
Who can participate
Age range
3 Years – 74 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 people aged 3 years and above;
* I (or/and his/her legal guardian/authorized representative) can comply with the requirements of the clinical trial protocol after informed consent and voluntary signed informed consent;
* No contraindications of quadrivalent influenza vaccine in the package insert and meet the vaccination requirements after medical history inquiry.
Exclusion Criteria:
* Allergy to any component of the quadrivalent influenza vaccine, including egg, excipients, formaldehyde, or Triton X-100;
* people with a history of anaphylaxis after vaccination (allergy to any previous vaccination);
* Acute disease, severe chronic disease, acute onset of chronic disease, cold and fever;
* Axillary body temperature ≥37.3℃ (\> 14 years old) and ≥37.5℃ (≤14 years old) before vaccination;
* Uncontrolled epilepsy;
* patients with progressive neurological disease or a history of Guillain-Barre syndrome;
* receiving immunoglobulin injection for less than one month;
* vaccination with live attenuated vaccine within 14 days before and other vaccines within 7 days before vaccination;
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
To evaluate the safety and immunogenicity of Hualan Biovar quadrivalent influenza vaccine in a larger population in the real world, and to observe rare adverse drug reaction (ADR) of 1‰.
Timeframe: The safety was observed until 6 months after the full course of immunization