Clinical trial NCT06006858: Post Authorization Safety Study Moderna COVID-19 Primary Vaccine
Official title: Safety Profile Following Moderna COVID-19 Primary Vaccine in Healthy Adults Aged ≥ 18 Years in Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Moderna Vaccine
Safety Vaccine
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: National Advisory Immunization Committee Indonesia
First posted: 2023-08-23
Enrollment: 1284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults aged ≥ 18 years

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Local Reactions Following Moderna COVID-19 Vaccine
timeFrame: 28 Days after each dose
measure: Systemic Reactions Following Moderna COVID-19 Vaccine
timeFrame: 28 Days after each dose
Secondary outcomes:
measure: Immediate Reactions
timeFrame: 30 minutes after each dose
measure: 1-3 Days Reactions
timeFrame: 1-3 minutes after each dose
measure: 4-7 Days Reactions
timeFrame: 4-7 Days after each dose
measure: 8-28 Days Reactions
timeFrame: 8-28 Days after each dose
measure: Serious Reactions
timeFrame: 28 Days after each dose
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Gambir Public Health Center
state: Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Johar Baru Public Health Center
state: Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Cempaka Putih Public Health Center
state: Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Kemayoran Public Health Center
state: Jakarta
city: Jakarta
country: Indonesia
facility: Palmerah Public Health Center
city: Jakarta
country: Indonesia
facility: Kebon Jeruk Public Health Center
city: Jakarta
country: Indonesia
facility: Cengkareng Public Health Center
city: Jakarta
country: Indonesia
facility: Kebayoran Lama Public Health Center
city: Jakarta
country: Indonesia
facility: Tebet Public Health Center
city: Jakarta
country: Indonesia
facility: Setiabudi Public Health Center
city: Jakarta
country: Indonesia
facility: Pulo Gadung Public Health Center
city: Jakarta
country: Indonesia
facility: Duren Sawit Public Health Center
city: Jakarta
country: Indonesia
facility: Regional Hospital Duren Sawit
city: Jakarta
country: Indonesia
facility: Kramat Jati Public Health Center
city: Jakarta
country: Indonesia
facility: Cilincing Public Health Center
city: Jakarta
country: Indonesia
facility: Koja Public Health Center
city: Jakarta
country: Indonesia
facility: Tanjung Priok Public Health Center
city: Jakarta
country: Indonesia
facility: Pademangan Public Health Center
Study officials:
affiliation: National Advisory Immunization Committee
name: Julitasari Sundoro, MD
role: PRINCIPAL_INVESTIGATOR
References: