Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
NCT ID: NCT04363359
Last Updated: 2023-12-26
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
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COMPLETED
PHASE2
1980 participants
INTERVENTIONAL
2020-01-15
2021-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Quadrivalent influenza vaccine HD
Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28.
0.5ml Quadrivalent influenza vaccine
The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
Quadrivalent influenza vaccine LD
Participants randomized to receive two injections of 0.25 mL quadrivalent influenza vaccine at Day 0 and 28.
0.25ml Quadrivalent influenza vaccine
The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
Trivalent influenza vaccine Victoria
Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Victoria strain at Day 0 and 28.
0.25ml Trivalent influenza vaccine(B/V)
The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains
Trivalent influenza vaccine Yamagata
Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Yamagata strain at Day 0 and 28.
0.25ml Trivalent influenza vaccine(B/Y)
The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains
Interventions
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0.5ml Quadrivalent influenza vaccine
The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
0.25ml Quadrivalent influenza vaccine
The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
0.25ml Trivalent influenza vaccine(B/V)
The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains
0.25ml Trivalent influenza vaccine(B/Y)
The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains
Eligibility Criteria
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Inclusion Criteria
* Volunteer legal guardian or client informed consent, voluntarily participate in and sign informed consent.
* The volunteer legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.
Exclusion Criteria
* Have been suffering from influenza within the previous 3 months (confirmed by either clinical, serological or microbiological methods).
* Any previous influenza vaccination (registered or experimental) within 6 months or any planned influenza vaccination during the study period.
* Allergic to any component of the vaccine, a history of allergic reactions to eggs or gentamicin sulfate.
* A history of severe allergy to any vaccine or drug.
* Preterm birth (delivered before 37 weeks of gestation), low birth weight baby (birth weight \< 2300g for girls, \<2500g for boys).
* Dystocia, asphyxia rescue, nervous system damage history;
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
* Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;
* A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;
* Patients who received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);
* Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
* History of asthma, past two years of instability requiring emergency treatment, hospitalization, intubation, oral or intravenous administration of corticosteroids;
* Have received blood or blood-related products;
* A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or a family history;
* A history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
* Planning to relocate before the end of the study or to leave for an extended -period during the scheduled study visit;
* Participating in or planning to participate in other clinical trials in the near future;
* The investigators determined that any conditions were inappropriate to participate in the clinical trial.
6 Months
35 Months
ALL
Yes
Sponsors
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Shanghai Institute Of Biological Products
INDUSTRY
Responsible Party
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Principal Investigators
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Shilei Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Institute Of Biological Products
Locations
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Henan Provincial Center for Disease Control and Prevention
Shangqiu, Henan, China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CXSL1900048-Ⅰ+Ⅱ
Identifier Type: -
Identifier Source: org_study_id