- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05003466
Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years(COVID-19)
11. august 2021 opdateret af: Shenzhen Kangtai Biological Products Co., LTD
A Randomized, Double-blind, Placebo-controlled Phase Ⅱ Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years
This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
480
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Guifan Li, M.S
- Telefonnummer: +861059613591
- E-mail: liguifan@biominhai.com
Studiesteder
-
-
Hunan
-
Changsha, Hunan, Kina, 410005
- Hunan Provincial Center for Diseases Control and Prevention
-
Kontakt:
- Tao Huang
- Telefonnummer: +8673184305935
- E-mail: ymlc01@hncdc.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
3 år til 17 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy residents aged 3 to 17 years at the time of consent
- Subjects and/or their guardian agree to sign the informed consent forms voluntarily.
- Be able to comply with study requirements/procedures.
- Axillary temperature ≤ 37.0℃
Exclusion Criteria:
- Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;
- Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
- Subjects with history of SARS virus infection by self-reported;
- Positive in throat swab through RT-PCR;
- History of vaccination of various COVID-19 vaccines or positive in SARS-CoV-2 antibody test;
- Positive urine pregnancy test for females with menarche
- History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine;
- History or family history of convulsion, epilepsy, encephalopathy or mental illness;
- Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, drug-uncontrollable hypertension, diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases;
- Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
- Subjects receiving anti-TB treatment;
- Subjects receiving other research drugs within 6 months before vaccination;
- Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);
- Subjects receiving blood products within 3 months before administration;
- Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
- Subjects vaccinated with other vaccine within 7 days before vaccination;
- The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
2 doser placebo bør indgives som en intramuskulær injektion i den laterale deltoideus af overarmen med et 28-dages interval.
|
|
Eksperimentel: kandidatvaccine
|
2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated with a 28-day interval constitute a primary immunization course. The third dose on 6 months after primary course is the booster dose. Administer as an intramuscular injection into the lateral deltoid of the upper arm. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Tidsramme: 28 days post full primary immunization course
|
28 days post full primary immunization course
|
|
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Tidsramme: 28 days post full primary immunization course
|
28 days post full primary immunization course
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Forekomst af bivirkninger/hændelser
Tidsramme: 0-28 dage efter hver vaccination
|
0-28 dage efter hver vaccination
|
|
Serious Adverse Events (SAE)
Tidsramme: within 12 months post full primary immunization course and the booster dose respectively
|
within 12 months post full primary immunization course and the booster dose respectively
|
|
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Tidsramme: 28 days post full primary immunization course
|
28 days post full primary immunization course
|
|
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Tidsramme: 28 days, 3 months, 6 months and 12 months post full primary immunization course
|
28 days, 3 months, 6 months and 12 months post full primary immunization course
|
|
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Tidsramme: 28 days, 3 months, 6 months and 12 months after the booster dose
|
28 days, 3 months, 6 months and 12 months after the booster dose
|
|
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Tidsramme: 3 months, 6 months and 12 months post full primary immunization course
|
3 months, 6 months and 12 months post full primary immunization course
|
|
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Tidsramme: 28 days, 3 months, 6 months and 12 months after the booster dose
|
28 days, 3 months, 6 months and 12 months after the booster dose
|
|
Seropositive rate of SARS-CoV-2 neutralizing antibody
Tidsramme: 3 months, 6 months and 12 months post full primary immunization course
|
3 months, 6 months and 12 months post full primary immunization course
|
|
Seropositive rate of SARS-CoV-2 neutralizing antibody
Tidsramme: 28 days, 3 months, 6 months and 12 months after the booster dose
|
28 days, 3 months, 6 months and 12 months after the booster dose
|
|
Seropositive rate of SARS-CoV-2 IgG binding antibody
Tidsramme: 3 months, 6 months and 12 months post full primary immunization course
|
3 months, 6 months and 12 months post full primary immunization course
|
|
Seropositive rate of SARS-CoV-2 IgG binding antibody
Tidsramme: 28 days, 3 months, 6 months and 12 months after the booster dose
|
28 days, 3 months, 6 months and 12 months after the booster dose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. september 2021
Primær færdiggørelse (Forventet)
1. marts 2023
Studieafslutning (Forventet)
1. april 2023
Datoer for studieregistrering
Først indsendt
10. august 2021
Først indsendt, der opfyldte QC-kriterier
10. august 2021
Først opslået (Faktiske)
12. august 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2020L001-2B
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