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

NCT05126550 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 435

Last updated 2022-09-08

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • PT. Kimia Farma (Persero) Tbk

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-13
Primary Completion
2022-11-13
Completion
2022-11-30

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05126550 on ClinicalTrials.gov