A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine
NCT ID: NCT03369808
Last Updated: 2024-10-15
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
PHASE1/PHASE2
360 participants
INTERVENTIONAL
2017-12-29
2019-11-15
Brief Summary
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The investigators will test the vaccine in participants aged 12-60 years, for a randomized, blind, placebo-controlled, age-stratified clinical study. The investigators designed three dosage groups: 7.5 μg,15 μg and 30 μg of hemagglutinin antigen. According to the age of the subjects, Each group was divided into different age subgroups. Phosphate buffer solution and Aluminum hydroxide adjuvant as placebo controls were both set up in the subgroups.Participants will receive 2 doses of vaccine at 21-day intervals.Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination were determined.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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7.5μg H7N9 Vaccine
Participants will receive 2 doses of 7.5μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
7.5μg H7N9 Vaccine
The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
15μg H7N9 Vaccine
Participants will receive 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
15μg H7N9 Vaccine
The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
30μg H7N9 vaccine
Participants will receive 2 doses of 30μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
30μg H7N9 Vaccine
The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
Aluminum hydroxide adjuvant
Participants will receive 2 doses of aluminum hydroxide adjuvant at 21-day intervals.
Aluminum Hydroxide Adjuvant
0.5ml aluminum hydroxide adjuvant
Phosphate buffer solution
Participants will receive 2 doses of phosphate buffer solution at 21-day intervals.
Phosphate Buffer Solution
0.5ml phosphate buffer solution
Interventions
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7.5μg H7N9 Vaccine
The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
Phosphate Buffer Solution
0.5ml phosphate buffer solution
Aluminum Hydroxide Adjuvant
0.5ml aluminum hydroxide adjuvant
15μg H7N9 Vaccine
The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
30μg H7N9 Vaccine
The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
Eligibility Criteria
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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, receive blood test before and after immunization and cooperate with follow-up
Exclusion Criteria
* Allergy to any component in the vaccine (allergy history of any previous vaccination), especially for egg allergy
* History of asthma, history of thyroid resection, vascular nerve edema, diabetes mellitus, hypertension can not be controlled by medicine, liver and kidney diseases or malignant tumor history
* Suffered from any serious illness, such as cancer, autoimmune disease, progressive atherosclerotic disease or complications of diabetes, chronic obstructive pulmonary disease, need oxygen therapy for acute or progressive liver or kidney disease, congestive heart-failure etc.
* History of signs disease or symptoms of neurological symptoms
* Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
* Acute attacks of various acute or chronic diseases in the past 7 days
* 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
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition etc
* No spleen, functional absence of spleen, and splenectomy or splenectomy without any condition
* Autoimmune diseases or immunodeficiency have been treated with immunosuppressive agents in the past 6 months
* 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
* The blood products were received within 3 months prior to the acceptance of the vaccine
* Received a live vaccine within 14 days prior to receiving the vaccine, or received a subunit or inactivated vaccine within 7 days
* Fever within 3 days prior to vaccination, axillary temperature ≥38 ℃
* Being febrile When inoculating vaccine, axillary temperature \>37.0 ℃
* Women are pregnant or in the near future planned pregnancy or pregnancy test positive
* Participants in another clinical trial
12 Years
ALL
Yes
Sponsors
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Henan Center for Disease Control and Prevention
OTHER_GOV
Shanghai Institute Of Biological Products
INDUSTRY
Responsible Party
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Principal Investigators
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Ze Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Institute Of Biological Products
Locations
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Suiping Center for Disease Control and Prevention
Zhumadian, 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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2016L09902
Identifier Type: -
Identifier Source: org_study_id
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