This is a randomized, double-blind, active-controlled Phase I clinical trial to evaluate the safety and immunogenicity of Influenza Vaccine (Split Virion), Inactivated (High Dose) developed by Sinovac.
Who can participate
Age range
60 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
. Participants aged 60 years and older who are in stable health condition.
. Participants who are fully informed and voluntarily sign the informed consent form.
. Participants who are willing and able to comply with all study procedures and remain contactable throughout the study.
. Participants who are able to provide valid legal identification.
Exclusion criteria
. Participants who have received a seasonal influenza vaccine within 6 months before enrollment, have received a seasonal influenza vaccine for the current influenza season, or plan to receive a seasonal influenza vaccine during the study.
. Participants who have had seasonal influenza within 6 months before enrollment.
. Participants with known severe allergy to any vaccine or vaccine component, such as urticaria, dyspnea, angioedema, or anaphylactic shock.
. Participants with poorly controlled chronic diseases or a history of serious diseases, including but not limited to cardiovascular diseases, such as hypertension not controlled by medication (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg measured at the study site) or coronary heart disease; metabolic diseases, such as poorly controlled diabetes; hematologic diseases; hepatic or renal diseases; digestive system diseases; respiratory system diseases; malignant tumors; a history of major organ transplantation; or any other disease or physiological condition that, in the investigator's opinion, may interfere with the study results.
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.
. Participants with autoimmune diseases or immunodeficiency diseases, including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, or HIV infection.
. Participants with coagulation disorders, such as coagulation factor deficiency or platelet abnormalities.
. Participants with current or previous severe neurological disease or psychiatric disease, or a family history of psychiatric disease.
. Participants with a history of long-term alcohol abuse or drug abuse.