- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03369808
A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine
Immunogenicity And Safety Of An Alum-Adjuvanted Inactivated H7N9 Influenza Vaccine
The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults.
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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Henan
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Zhumadian, Henan, Kina, 463100
- Suiping Center for Disease Control and Prevention
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Over the age of 12 years,healthy population
- 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:
- A history of influenza A (H7N9) virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 7.5μg H7N9 Vaccine
Participants will receive 2 doses of 7.5μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
|
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.
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Eksperimentel: 15μg H7N9 Vaccine
Participants will receive 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
|
Vaccinen var et inaktiveret, hel virionpræparat af influenza A/Shanghai/2/2013(H7N9) virus, opformeret i embryonerede hønseæg, blandet med aluminiumhydroxidadjuvans.
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Eksperimentel: 30μg H7N9 vaccine
Participants will receive 2 doses of 30μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
|
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.
|
Placebo komparator: Aluminum hydroxide adjuvant
Participants will receive 2 doses of aluminum hydroxide adjuvant at 21-day intervals.
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0.5ml aluminum hydroxide adjuvant
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Placebo komparator: Phosphate buffer solution
Participants will receive 2 doses of phosphate buffer solution at 21-day intervals.
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0.5ml phosphate buffer solution
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Reactogenicity Events
Tidsramme: Continuous observation for 30 days after two inoculations
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Continuous observation for 30 days after two inoculations
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of participants that presented seroconversion post injection
Tidsramme: 21 days after two inoculations
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21 days after two inoculations
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Number of participants that presented seroprotection post injection
Tidsramme: 21 days after two inoculations
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21 days after two inoculations
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Geometrisk middelværdi af hæmagglutinationshæmningstiter efter første undersøgelsesinjektion
Tidsramme: 21 dage efter to podninger
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21 dage efter to podninger
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ze Chen, PhD, Shanghai Institute Of Biological Products
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Luftvejsinfektioner
- Luftvejssygdomme
- Orthomyxoviridae infektioner
- Influenza, menneske
- Influenza hos fugle
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Immunologiske faktorer
- Gastrointestinale midler
- Adjuvanser, immunologiske
- Antacida
- Vacciner
- Aluminiumhydroxid
Andre undersøgelses-id-numre
- 2016L09902
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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