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NCT06006858 Clinical Trial

Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

COVID-19 Clinical Trial

Official title:
Safety Profile Following Moderna COVID-19 Primary Vaccine in Healthy Adults Aged ≥ 18 Years in Indonesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06006858
Other study ID # COV19M-0422
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 3, 2022
Est. completion date March 31, 2023

Study information
Verified date November 2023
Source PT Bio Farma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine

Description:

This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with Moderna COVID-19 vaccine using retrospective cohort study trial design to assess safety profile following Moderna COVID-19 primary vaccine in healthy adults aged ≥ 18 years in Indonesia.

Recruitment information / eligibility
Status Completed
Enrollment 1284
Est. completion date March 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinically healthy adults aged = 18 years. - Subjects have been informed properly regarding the study and accepted to be enrolled in this study. Exclusion Criteria: - Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Moderna COVID-19 Vaccine
Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.

Locations
Country Name City State
Indonesia Cengkareng Public Health Center Jakarta
Indonesia Cilincing Public Health Center Jakarta
Indonesia Duren Sawit Public Health Center Jakarta
Indonesia Kebayoran Lama Public Health Center Jakarta
Indonesia Kebon Jeruk Public Health Center Jakarta
Indonesia Koja Public Health Center Jakarta
Indonesia Kramat Jati Public Health Center Jakarta
Indonesia Pademangan Public Health Center Jakarta
Indonesia Palmerah Public Health Center Jakarta
Indonesia Pulo Gadung Public Health Center Jakarta
Indonesia Regional Hospital Duren Sawit Jakarta
Indonesia Setiabudi Public Health Center Jakarta
Indonesia Tanjung Priok Public Health Center Jakarta
Indonesia Tebet Public Health Center Jakarta
Indonesia Cempaka Putih Public Health Center Jakarta Pusat Jakarta
Indonesia Gambir Public Health Center Jakarta Pusat Jakarta
Indonesia Johar Baru Public Health Center Jakarta Pusat Jakarta
Indonesia Kemayoran Public Health Center Jakarta Pusat Jakarta

Sponsors (2)
Lead Sponsor Collaborator
PT Bio Farma National Advisory Immunization Committee Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local Reactions Following Moderna COVID-19 Vaccine Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine. 28 Days after each dose
Primary Systemic Reactions Following Moderna COVID-19 Vaccine Percentage of subject with systemic reactions following immunization with Moderna COVID-19 28 Days after each dose
Secondary Immediate Reactions percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine. 30 minutes after each dose
Secondary 1-3 Days Reactions percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine. 1-3 minutes after each dose
Secondary 4-7 Days Reactions percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine. 4-7 Days after each dose
Secondary 8-28 Days Reactions percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine. 8-28 Days after each dose
Secondary Serious Reactions Any serious adverse events following immunization with Moderna COVID-19 vaccine 28 Days after each dose
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