Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (NCT06800950) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
China4,400 participantsStarted 2025-02-08
Plain-language summary
This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization, and primary safety endpoints are the occurrence of safety events after vaccination including the incidence of adverse events/adverse reactions within 30 minutes/7 days/30 days after immunization, as well as the incidence of serious adverse events/adverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary endpoints are to evaluate the same index above in different administration programs in children aged 3-8 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:
* Age Requirement: volunteers aged 3 years and above at the time of enrollment.
* Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
* Informed Consent: Volutters, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
* Requirements for contraception: agree to take contraception actions in 6 months.
* Temperature Requirement: Axillary body temperature is less than 37.3°C.
* Previous Vaccination Requirements: (a) Received at least 1 dose of influenza vaccine within 1 year before screening in children aged 3-8 years; (b) Never received any influenza vaccine 1 year before screening in children aged over 3 years.
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria will be not eligible for enrollment.
* Subjects with a history of severe allergy to egg or egg protein, such as those who have had symptoms such as angioedema, dyspnea, chest distress, or repeated vomiting due to eating eggs, and even those who have used epinephrine or other emergency medical treatment, especially those who have symptoms immediately or within a short period (minutes to hours).
* Subjects with influenza …
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
Immunogenicity index - seroconversion rates of HI antibody against all types
Timeframe: Between baseline and Day 30 after full vaccination
2
Immunogenicity index - Seropositive rates of HI antibody against all types
Timeframe: Day 30 after full vaccination
3
Immunogenicity index - geometric mean titer (GMT) of HI antibody against all types
Timeframe: Day 30 after full vaccination
4
Safety index - incidence of adverse events/adverse reactions
Timeframe: Day 0 to 7 after the first dose vaccination
5
Safety index - incidence of adverse events/adverse reactions
Timeframe: Day 0 to 7 after the second dose vaccination
6
Safety index - incidence of adverse events/adverse reactions
Timeframe: From Day 0 to Day 30 after full vaccination
Trial details
NCT IDNCT06800950
SponsorInstitute of Medical Biology, Chinese Academy of Medical Sciences