- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05104216
Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in Elderly People With Chronic Bronchitis and COPD
Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in Elderly People With Chronic Bronchitis and Chronic Obstructive Pulmonary Disease
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease recruited to receive a third dose of inactivated COVID-19 vaccine.
Blood samples will be collected 3 times: before the third dose of vaccinatioin,28 days and 6 months after the third dose of vaccination.
Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310051
- Zhejiang Provincial 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:
- Subjects aged 60 and above with full capacity for civil conduct;
- Chronic bronchitis (or chronic obstructive pulmonary disease) diagnosed by a medical institution at level I or above;
- Body temperature < 37.3 ° C confirmed by clinical examination before enrollment ;
- Able and willing to complete the entire study plan during the study follow-up period;
- Have the ability to understand the study procedures, voluntarily sign informed consent, and comply with the requirements of the clinical study protocol;
- Subjects participating in the past clinical trial have completed two doses of COVID-19 vaccine and blood collection before and after immunization;
Exclusion Criteria:
- Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons;
- Being allergic to any component of vaccines (including excipients) ;
- Injection of non-specific immunoglobulin within 1 month before enrollment;
- Injection of live attenuated vaccines within 1 month and injection of other vaccines within 14 days before enrollment;
- Subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angioneurotic edema, dyspnea, etc.);
- Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome;
- Having severe liver and kidney diseases, malignant tumors, acute diseases or acute episodes of chronic diseases;
- Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia or other autoimmune diseases;
- Have been diagnosed with thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection;
- During an acute episode of chronic bronchitis/chronic obstructive pulmonary disease;
- Subjects who had vaccine-related adverse reactions after the second dose;
- Having high fever (axillary temperature ≥39.0℃) for three days after the second dose of inoculation, or severe allergic reaction;
- Having any adverse nervous system reaction after the second dose;
- During the acute onset of a chronic disease, or the recovery of acute complications less than two weeks;
- Other reasons for exclusion considered by the investigator.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Experimental Group
Subjects receive a third dose of inactivated COVID-19 vaccine
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modtage en tredje dosis inaktiveret COVID-19-vaccine
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Serokonverteringsrate
Tidsramme: 28 dage efter den 3. dosis (dag 28)
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Hastigheden af serokonversion mod coronavirus
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28 dage efter den 3. dosis (dag 28)
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Neutraliserende antistofniveau
Tidsramme: Før den 3. dosis (dag 0)
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Neutraliserende antistof GMT mod coronavirus før 3. dosis
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Før den 3. dosis (dag 0)
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Neutraliserende antistofniveau
Tidsramme: 28 dage efter den 3. dosis (dag 28)
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Neutraliserende antistof GMT mod coronavirus efter 3. dosis
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28 dage efter den 3. dosis (dag 28)
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Neutraliserende antistofniveau
Tidsramme: 6 måneder efter 3. dosis
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Neutraliserende antistof GMT mod coronavirus efter 3. dosis
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6 måneder efter 3. dosis
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Frekvens for alvorlige bivirkninger
Tidsramme: 0-6 måneder
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Rapporter og analyser alvorlige uønskede hændelser
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0-6 måneder
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Uønskede hændelser rate
Tidsramme: 0-21 dage efter vaccination
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Analyser forekomsten af uønskede hændelser efter vaccination, både opfordret og uopfordret
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0-21 dage efter vaccination
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BIBP2021COPD-third dose
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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