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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05126550
Other study ID # Sinopharm21
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 13, 2021
Est. completion date November 30, 2022

Study information

Verified date September 2022
Source PT. Kimia Farma (Persero) Tbk
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 435
Est. completion date November 30, 2022
Est. primary completion date November 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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)

Locations

Country Name City State
Indonesia Laboratorium Klinik Kimia Farma Diponegoro Bandung Bandung
Indonesia Laboratorium Klinik Kimia Farma Cikini Jakarta
Indonesia Laboratorium Klinik Kimia Farma Medan Medan
Indonesia Laboratorium Klinik Kimia Farma Sutomo Semarang Semarang

Sponsors (1)

Lead Sponsor Collaborator
PT. Kimia Farma (Persero) Tbk

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percent inhibition of SARS-CoV-2 surrogate Virus Neutralization Test neutralizing antibody (sVNT NAb) 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
Secondary 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 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
Secondary The proportion of adverse event following immunization 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
Secondary The proportion of serious adverse event 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
Secondary The proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection 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
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