Safety IssuesNCT05037227
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
An observational study of Safety Issues, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged >18 years in Indonesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- How many people
- 1,100 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Sep 2021to 27 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study is involving healthy adults aged > 18 years.
Who may be able to join
- Clinically healthy adults aged > 18 years.
- Subjects have been informed properly regarding the study and signed the informed consent form.
- Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
Who cannot join
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with thermometer).
- Women who are lactating, pregnant or planning to become pregnant during the study period.
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
- Subjects receive any vaccination within 1 month before and after IP immunization.
- Subjects plan to move from the study area before the end of study period.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged >18 years in Indonesia.
Read the detailed description
To assess any serious systemic reaction within 30 minutes after COVID-19 vaccine immunization.
To assess systemic reaction after COVID-19 Vaccine immunization. To assess local reaction after COVID-19 Vaccine immunization. To assess any serious adverse event after COVID-19 Vaccine immunization.
- Conditions
- Safety Issues
What is being measured
The primary outcome is the main question the study is designed to answer.
Any serious adverse event occurring from inclusion until 30 minutes after the injection
Number and percentage of subjects with serious systemic reactions 30 minutes after immunization.
Measured: Within 30 minutes after vaccination
Secondary outcomes (3)
Local reaction and systemic events occurring within 30 minutes after each immunization.
Number and percentage of subjects with at least one of these adverse events, solicited or not, within 30 minutes after vaccination.
Measured: Within 30 minutes after vaccination
Local reaction and systemic events occurring within 28 days after immunization
Number and percentage of subjects with at least one of these adverse events, solicited or not, within 28 days after vaccination.
Measured: 28 days
Any serious adverse event during observation period.
Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start2 Sep 2021
- Primary completion17 Oct 2021
- Study completion27 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Prospective
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julitasari Sundoro, MD, Principal investigator, Indonesian Vaccine Safety Advisory Commitee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037227
- Sponsor's protocol ID
- COVID19-0421
- Status last verified
- Jul 2022
- First submitted
- 6 Sep 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
- ClinicalTrials.gov ID
- NCT05037227
- Acronym / sponsor ID
- COVID19-0421
- Conditions
- Safety Issues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 8 Sep 2021 (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.
The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged >18 years in Indonesia.
Detailed description
To assess any serious systemic reaction within 30 minutes after COVID-19 vaccine immunization.
To assess systemic reaction after COVID-19 Vaccine immunization. To assess local reaction after COVID-19 Vaccine immunization. To assess any serious adverse event after COVID-19 Vaccine immunization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is involving healthy adults aged > 18 years.
Key inclusion criteria (3 listed)
- Clinically healthy adults aged > 18 years.
- Subjects have been informed properly regarding the study and signed the informed consent form.
- Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
Key exclusion criteria (7 listed)
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with thermometer).
- Women who are lactating, pregnant or planning to become pregnant during the study period.
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
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
Any serious adverse event occurring from inclusion until 30 minutes after the injection
Time frame: Within 30 minutes after vaccination
Number and percentage of subjects with serious systemic reactions 30 minutes after immunization.
3 secondary outcomes
Local reaction and systemic events occurring within 30 minutes after each immunization.
Time frame: Within 30 minutes after vaccination
Local reaction and systemic events occurring within 28 days after immunization
Time frame: 28 days
Any serious adverse event during observation period.
Time frame: 28 days
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 27 Jul 2022.
Related trials for Safety Issues
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruitingPhase 1
Phase 1 Study to Evaluate RG002C0106 Injection in Healthy Participants
Safety Issues
Enrolling by invitation
Pediatric Trauma Centers RE-AIM at Gun Safety
Firearm Injury, Safety Issues
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
Active, not recruitingPhase 1/2
Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis
Safety Issues, Pain
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.
Julitasari Sundoro, MD principal investigator
Indonesian Vaccine Safety Advisory Commitee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues, run by PT Bio Farma at 1 site 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 3 inclusion and 7 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Any serious adverse event occurring from inclusion until 30 minutes after the injection (time frame: Within 30 minutes after vaccination). 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 27 Jul 2022.