Clinical trial NCT06690502: Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination
Official title: Safety Profile of Booster IndoVac COVID-19 Vaccination in Healthy Populations Aged 18 Years and Above
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
IndoVac
Safety Vaccine
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2024-11-15
Enrollment: 1208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults aged 18 years and above

Brief summary: This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination

Detailed description: This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with IndoVac using retrospective cohort study trial design to assess safety profile following IndoVac booster vaccine in healthy populations aged 18 years and above.

Eligibility criteria: Inclusion Criteria:

1. Clinically healthy subjects aged 18 years and above
2. Subjects have been injected with IndoVac booster.
3. Minimum 6-month interval from primary or booster COVID-19 vaccination.
4. Subjects have been informed properly regarding the study and signed the informed consent form.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got IndoVac booster vaccination.
2. Subject's telephone number is invalid or cannot be contacted.

Primary outcomes:
measure: Serious adverse event following IndoVac booster vaccination
timeFrame: until 30 minutes after each dose
Secondary outcomes:
measure: 0-7 Days Reactions
timeFrame: Within 0-7 Days after each dose
measure: 8-28 Days Reactions
timeFrame: Within 8-28 Days after each dose
measure: 28 Days Reactions
timeFrame: 28 Days after each dose
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Gambir Public Health Center
state: Center Jakarta
city: Jakarta
country: Indonesia
facility: Kemayoran Public Health Center
state: Center Jakarta
city: Jakarta
country: Indonesia
facility: Menteng Public Health Center
state: Center Jakarta
city: Jakarta
country: Indonesia
facility: Sawah Besar Public Health Center
state: Center Jakarta
city: Jakarta
country: Indonesia
facility: Tanah Abang Public Health Center
state: Center Jakarta
city: Jakarta
country: Indonesia
facility: Cakung Public Health Center
state: East Jakarta
city: Jakarta
country: Indonesia
facility: Cipayung Public Health Center
state: East Jakarta
city: Jakarta
country: Indonesia
facility: Ciracas Public Health Center
state: East Jakarta
city: Jakarta
country: Indonesia
facility: Makasar Public Health Center
state: East Jakarta
city: Jakarta
country: Indonesia
facility: Matraman Public Health Center
state: East Jakarta
city: Jakarta
country: Indonesia
facility: Pulogadung Public Health Center
state: East Jakarta
city: Jakarta
country: Indonesia
facility: Cilincing Public Health Center
state: North Jakarta
city: Jakarta
country: Indonesia
facility: Kelapa Gading Public Health Center
state: North Jakarta
city: Jakarta
country: Indonesia
facility: Koja Public Health Center
state: North Jakarta
city: Jakarta
country: Indonesia
facility: Pademangan Public Health Center
state: North Jakarta
city: Jakarta
country: Indonesia
facility: Cilandak Public Health Center
state: South Jakarta
city: Jakarta
country: Indonesia
facility: Jagakarsa Public Health Center
state: South Jakarta
city: Jakarta
country: Indonesia
facility: Kebayoran Baru Public Health Center
state: South Jakarta
city: Jakarta
country: Indonesia
facility: Mampang Public Health Center
state: South Jakarta
city: Jakarta
country: Indonesia
facility: Pancoran Public Health Center
state: South Jakarta
city: Jakarta
country: Indonesia
facility: Pesanggrahan Public Health Center
state: South Jakarta
city: Jakarta
country: Indonesia
facility: Cengkareng Public Health Center
state: West Jakarta
city: Jakarta
country: Indonesia
facility: Grogol Petamburan Public Health Center
state: West Jakarta
city: Jakarta
country: Indonesia
facility: Kalideres Public Health Center
state: West Jakarta
city: Jakarta
country: Indonesia
facility: Kebon Jeruk Public Health Center
state: West Jakarta
city: Jakarta
country: Indonesia
facility: Kembangan Public Health Center
state: West Jakarta
city: Jakarta
country: Indonesia
facility: Palmerah Public Health Center
state: West Jakarta
city: Bandung
country: Indonesia
facility: Imunicare Bio Farma
state: West Java
Study officials:
affiliation: National Committee of Adverse Events Following Immunization / NC Indonesia
name: Hindra Irawan Satari, Prof., Dr., dr., SpA(K), M. Trop. Paed
role: PRINCIPAL_INVESTIGATOR
References: