Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2688 participants
INTERVENTIONAL
2018-10-11
2019-10-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)
NCT03859141
Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)
NCT03853993
Clinical Trial of Quadrivalent Influenza Virus Split Vaccine in Population Aged 3-8 Years
NCT05138705
Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
NCT04363359
Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60
NCT02806804
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Quadrivalent influenza vaccine
Quadrivalent influenza vaccine(containing 2 subtypes of B lineage)
Quadrivalent influenza vaccine
0.5 mL, intramuscular, one dose
Trivalent influenza vaccine A
Trivalent influenza vaccine (containing B/Victoria lineage)
Trivalent influenza vaccine A
0.5 mL, intramuscular, one dose
Trivalent influenza vaccine B
Trivalent influenza vaccine (containing B/Yamagata lineage)
Trivalent influenza vaccine B
0.5 mL, intramuscular, one dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Quadrivalent influenza vaccine
0.5 mL, intramuscular, one dose
Trivalent influenza vaccine A
0.5 mL, intramuscular, one dose
Trivalent influenza vaccine B
0.5 mL, intramuscular, one dose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
* To comply with the requirements of clinical trial program
* Temperature≤37.0℃ on day of enrollment
Exclusion Criteria
* Any prior administration of influenza vaccine in last six months
* Allergy to any component in the vaccine, especially for egg allergy
* Allergy history of any previous vaccination or drug
* Acute episodes of chronic illness or acute illness on the day of vaccination
* Received a live vaccine within fourteen days prior to receiving the vaccine, or received a subunit or inactivated vaccine within seven days
* Congenital or acquired immune deficiencies, or treatment with immunosuppressive agents, such as long-term treatment with systemic corticosteroids
* Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
* Asthma, required urgent treatment in last two years
* The blood products were received prior to the acceptance of the vaccine
* Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases
* History of epilepsy, convulsions, or a family history of psychosis
* Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy
* Plan to move or leave the area for an extended period of time before the end of the study
* Under anti-tb treatment
* Any prior administration of other research medicine/vaccine in last one month
* Women are pregnant or in the near future planned pregnancy or pregnancy test positive
3 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Institute Of Biological Products
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hu Yuemei, PhD
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Province Centers for Disease Control and Prevention
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Xinyi County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JSVCT060
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.