NCT05126550

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 435 (actual)
• Sponsor: PT. Kimia Farma (Persero) Tbk · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

• COVID-19

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-11-13
• Primary completion: 2022-11-13
• Completion: 2022-11-30
• First posted: 2021-11-19
• Last updated: 2022-09-08

Locations

4 sites across 1 country: Indonesia