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The Immunogenicity, Safety, and Effectiveness of the COVID-19 Inactivated Vaccine

4. september 2022 opdateret af: Prenali Dwisthi Sattwika, PT. Kimia Farma (Persero) Tbk

The Immunogenicity, Safety, and Effectiveness of the SARS-CoV-2 Vaccine (Vero Cell) Inactivated in Adult Population Aged 18 Years Old and Above in Indonesia

To fast respond the coronavirus disease of 2019 (COVID-19) pandemic, the Indonesian government has launched "Vaksinasi Gotong Royong" (a mutual cooperation vaccination program) in which any company/legal entity/business entity may purchase vaccines to be given free of charge to their employees and families of employees (The Indonesian Ministry of Health, 2021). Vaccines provided for this program include the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inactivated vaccines produced by Sinopharm.

The Indonesian National Agency of Drug and Food Control (NADFC) has issued an Emergency Use Authorization (EUA) for several COVID-19 vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (NADFC, 2021). Following EUA, Kimia Farma Indonesia as the holder of EUA has the obligation to monitor the safety and effectiveness in Indonesian population.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

435

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Indonesien
      • Bandung, Indonesien
        • Laboratorium Klinik Kimia Farma Diponegoro Bandung
      • Jakarta, Indonesien
        • Laboratorium Klinik Kimia Farma Cikini
      • Medan, Indonesien
        • Laboratorium Klinik Kimia Farma Medan
      • Semarang, Indonesien
        • Laboratorium Klinik Kimia Farma Sutomo Semarang

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The recruitment will target potential participants via local company/legal entity/business entity registering for "Vaksinasi Gotong Royong"

Beskrivelse

Inclusion Criteria:

Male or female subjects aged 18 years old and above; Will receive the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm; Obtain informed consent to participate this study

Exclusion Criteria:

Previous SARS-CoV-2 vaccination, except for drop out after the first vaccine dose of more than 6 months ago; History of SARS-CoV-2 infection within the last 3 months

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Immunogenicity
Group 1 constitutes the immunogenicity group which will be evaluated regarding immunogenicity, safety, and effectiveness of the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm
Biologisk: SARS-CoV-2 vaccine (Vero cell) inactivated
Two doses of 0.5 mL intramuscular injection containing 4 mcg (6.5 Unit) antigens with an interval of 21-28 days in accordance with "Vaksinasi Gotong Royong" (mutual cooperation vaccination program)
Non-Immunogenicity
Group 2 that constitutes the non-immunogenicity group which will be evaluated regarding only safety and effectiveness of the aforementioned vaccine
Biologisk: SARS-CoV-2 vaccine (Vero cell) inactivated
Two doses of 0.5 mL intramuscular injection containing 4 mcg (6.5 Unit) antigens with an interval of 21-28 days in accordance with "Vaksinasi Gotong Royong" (mutual cooperation vaccination program)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The percent inhibition of SARS-CoV-2 surrogate Virus Neutralization Test neutralizing antibody (sVNT NAb)
Tidsramme: At 14 days, 3 months, and 6 months after 2 doses of vaccination
To evaluate the percent inhibition of SARS-CoV-2 sVNT NAb following the SARS-CoV-2 vaccine (Vero cell) inactivated administration at 14 days, 3 months, and 6 months after 2 doses of vaccination
At 14 days, 3 months, and 6 months after 2 doses of vaccination

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody and the proportion of seropositivity of anti-nucleocapsid antibody
Tidsramme: At 14 days, 3 months, and 6 months after 2 doses of vaccination
To evaluate the GMT of anti-sRBD IgG antibody and the proportion of seropositivity of anti-nucleocapsid antibody following the SARS-CoV-2 vaccine (Vero cell) inactivated administration at 14 days, 3 months, and 6 months after 2 doses of vaccination
At 14 days, 3 months, and 6 months after 2 doses of vaccination
The proportion of adverse event following immunization
Tidsramme: Within 28 days after 2 doses of vaccination
To evaluate the proportion of adverse event following immunization (AEFI) following the SARS-CoV-2 vaccine (Vero cell) inactivated administration after the first dose until 28 days after the second dose of vaccination
Within 28 days after 2 doses of vaccination
The proportion of serious adverse event
Tidsramme: Within 6 months after 2 doses of vaccination
To evaluate the proportion of serious adverse event following the SARS-CoV-2 vaccine (Vero cell) inactivated administration after the first dose until 6 months after the second dose of vaccination
Within 6 months after 2 doses of vaccination
The proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection
Tidsramme: Within 6 months after 2 doses of vaccination
To evaluate the proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection following the SARS-CoV-2 vaccine (Vero cell) inactivated administration within 6 months after second dose of vaccination
Within 6 months after 2 doses of vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

PT. Kimia Farma (Persero) Tbk

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 (Faktiske)

13. november 2021

Primær færdiggørelse (Forventet)

13. november 2022

Studieafslutning (Forventet)

30. november 2022

Datoer for studieregistrering

Først indsendt

12. november 2021

Først indsendt, der opfyldte QC-kriterier

17. november 2021

Først opslået (Faktiske)

19. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2022

Sidst verificeret

1. september 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Sinopharm21

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med COVID-19

Kliniske forsøg med SARS-CoV-2 vaccine (Vero cell) inactivated

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner