COVID-19NCT06690502
Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination
An observational study of COVID-19, run by PT Bio Farma at 28 sites in Indonesia.
Trial summary
This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults aged 18 years and above
Who may be able to join
- Clinically healthy subjects aged 18 years and above
- Subjects have been injected with IndoVac booster.
- Minimum 6-month interval from primary or booster COVID-19 vaccination.
- Subjects have been informed properly regarding the study and signed the informed consent form.
Who cannot join
- Subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got IndoVac booster vaccination.
- Subject's telephone number is invalid or cannot be contacted.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Indonesia28 sites
Imunicare Bio Farma
Bandung, West Java
Gambir Public Health Center
Jakarta, Center Jakarta
Kemayoran Public Health Center
Jakarta, Center Jakarta
Menteng Public Health Center
Jakarta, Center Jakarta
Sawah Besar Public Health Center
Jakarta, Center Jakarta
Tanah Abang Public Health Center
Jakarta, Center Jakarta
Cakung Public Health Center
Jakarta, East Jakarta
Cipayung Public Health Center
Jakarta, East Jakarta
Ciracas Public Health Center
Jakarta, East Jakarta
Makasar Public Health Center
Jakarta, East Jakarta
Matraman Public Health Center
Jakarta, East Jakarta
Pulogadung Public Health Center
Jakarta, East Jakarta
Cilincing Public Health Center
Jakarta, North Jakarta
Kelapa Gading Public Health Center
Jakarta, North Jakarta
Koja Public Health Center
Jakarta, North Jakarta
Pademangan Public Health Center
Jakarta, North Jakarta
Cilandak Public Health Center
Jakarta, South Jakarta
Jagakarsa Public Health Center
Jakarta, South Jakarta
Kebayoran Baru Public Health Center
Jakarta, South Jakarta
Mampang Public Health Center
Jakarta, South Jakarta
Pancoran Public Health Center
Jakarta, South Jakarta
Pesanggrahan Public Health Center
Jakarta, South Jakarta
Cengkareng Public Health Center
Jakarta, West Jakarta
Grogol Petamburan Public Health Center
Jakarta, West Jakarta
Kalideres Public Health Center
Jakarta, West Jakarta
Kebon Jeruk Public Health Center
Jakarta, West Jakarta
Kembangan Public Health Center
Jakarta, West Jakarta
Palmerah Public Health Center
Jakarta, West Jakarta
About this study
Official title: Safety Profile of Booster IndoVac COVID-19 Vaccination in Healthy Populations Aged 18 Years and Above
This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination
Read the 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.
- Conditions
- COVID-19
- Keywords
- COVID-19, IndoVac, Safety Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IndoVac COVID-19 Vaccine | Clinically healthy adults aged 18 years and above who received Booster IndoVac COVID-19 Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse event following IndoVac booster vaccination
Any serious adverse event occurring from inclusion until 30 minutes after IndoVac booster vaccination
Measured: until 30 minutes after each dose
Secondary outcomes (3)
0-7 Days Reactions
Number and percentage of any solicited and unsolicited local reaction and systemic events within 0-7 days after IndoVac booster vaccination.
Measured: Within 0-7 Days after each dose
8-28 Days Reactions
Number and percentage of any solicited and unsolicited local reaction and systemic events within 8-28 days after IndoVac booster vaccination.
Measured: Within 8-28 Days after each dose
28 Days Reactions
Number and percentage of any serious adverse event after IndoVac booster vaccination
Measured: 28 Days after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start18 Dec 2023
- Primary completion3 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,208 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hindra Irawan Satari, Prof., Dr., dr., SpA(K), M. Trop. Paed, Principal investigator, National Committee of Adverse Events Following Immunization / NC Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690502
- Sponsor's protocol ID
- COV19REC-0423
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile of Booster IndoVac COVID-19 Vaccination in Healthy Populations Aged 18 Years and Above
- ClinicalTrials.gov ID
- NCT06690502
- Acronym / sponsor ID
- COV19REC-0423
- Conditions
- COVID-19
- Keywords
- COVID-19, IndoVac, Safety Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,208 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IndoVac COVID-19 Vaccine | – | –Clinically healthy adults aged 18 years and above who received Booster IndoVac COVID-19 Vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults aged 18 years and above
Key inclusion criteria (4 listed)
- Clinically healthy subjects aged 18 years and above
- Subjects have been injected with IndoVac booster.
- Minimum 6-month interval from primary or booster COVID-19 vaccination.
- Subjects have been informed properly regarding the study and signed the informed consent form.
Key exclusion criteria (2 listed)
- Subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got IndoVac booster vaccination.
- Subject's telephone number is invalid or cannot be contacted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serious adverse event following IndoVac booster vaccination
Time frame: until 30 minutes after each dose
Any serious adverse event occurring from inclusion until 30 minutes after IndoVac booster vaccination
3 secondary outcomes
0-7 Days Reactions
Time frame: Within 0-7 Days after each dose
8-28 Days Reactions
Time frame: Within 8-28 Days after each dose
28 Days Reactions
Time frame: 28 Days after each dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hindra Irawan Satari, Prof., Dr., dr., SpA(K), M. Trop. Paed principal investigator
National Committee of Adverse Events Following Immunization / NC Indonesia
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by PT Bio Farma at 28 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse event following IndoVac booster vaccination (time frame: until 30 minutes after each dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.