COVID-19NCT06006858
Post Authorization Safety Study Moderna COVID-19 Primary Vaccine
An observational study of COVID-19, run by PT Bio Farma at 18 sites in Indonesia.
Trial summary
This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Moderna COVID-19 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 1,284 participants
- Where
- 18 sitesIndonesia
- Study dates
- 3 Nov 2022to 31 Mar 2023
- 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: 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 accepted to be enrolled in this study.
Who cannot join
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Indonesia18 sites
Palmerah Public Health Center
Jakarta, 11480
Kebon Jeruk Public Health Center
Jakarta, 11530
Cengkareng Public Health Center
Jakarta, 11730
Kebayoran Lama Public Health Center
Jakarta, 12240
Tebet Public Health Center
Jakarta, 12820
Setiabudi Public Health Center
Jakarta, 12980
Pulo Gadung Public Health Center
Jakarta, 13260
Duren Sawit Public Health Center
Jakarta, 13420
Regional Hospital Duren Sawit
Jakarta, 13440
Kramat Jati Public Health Center
Jakarta, 13510
Cilincing Public Health Center
Jakarta, 14120
Koja Public Health Center
Jakarta, 14260
Tanjung Priok Public Health Center
Jakarta, 14310
Pademangan Public Health Center
Jakarta, 14410
Gambir Public Health Center
Jakarta Pusat, Jakarta Special Capital Region, 10130
Johar Baru Public Health Center
Jakarta Pusat, Jakarta Special Capital Region, 10560
Cempaka Putih Public Health Center
Jakarta Pusat, Jakarta Special Capital Region, 10570
Kemayoran Public Health Center
Jakarta Pusat, Jakarta Special Capital Region, 10640
About this study
Official title: Safety Profile Following Moderna COVID-19 Primary Vaccine in Healthy Adults Aged ≥ 18 Years in Indonesia
This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine
Read the 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.
- Conditions
- COVID-19
- Being tested
- Moderna COVID-19 Vaccine
- Keywords
- COVID-19, Moderna Vaccine, 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.
Moderna COVID-19 VaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderna COVID-19 Vaccine | Clinically healthy adults aged ≥ 18 years who received Primary Moderna COVID-19 Vaccine Receives: Biological: Moderna COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Reactions Following Moderna COVID-19 Vaccine
Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine.
Measured: 28 Days after each dose
Systemic Reactions Following Moderna COVID-19 Vaccine
Percentage of subject with systemic reactions following immunization with Moderna COVID-19
Measured: 28 Days after each dose
Secondary outcomes (5)
Immediate Reactions
percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
Measured: 30 minutes after each dose
1-3 Days Reactions
percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
Measured: 1-3 minutes after each dose
4-7 Days Reactions
percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
Measured: 4-7 Days after each dose
8-28 Days Reactions
percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
Measured: 8-28 Days after each dose
Serious Reactions
Any serious adverse events following immunization with Moderna COVID-19 vaccine
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 posted23 Aug 2023
- Study start3 Nov 2022
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,284 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Advisory Immunization Committee Indonesia
- Responsible party
- Sponsor
- Investigators
- Julitasari Sundoro, MD, Principal investigator, National Advisory Immunization Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006858
- Sponsor's protocol ID
- COV19M-0422
- Status last verified
- Nov 2023
- First submitted
- 22 Aug 2023
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile Following Moderna COVID-19 Primary Vaccine in Healthy Adults Aged ≥ 18 Years in Indonesia
- ClinicalTrials.gov ID
- NCT06006858
- Acronym / sponsor ID
- COV19M-0422
- Conditions
- COVID-19
- Keywords
- COVID-19, Moderna Vaccine, Safety Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,284 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- National Advisory Immunization Committee Indonesia
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 23 Aug 2023 (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 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderna COVID-19 Vaccine | – | Biological: Moderna COVID-19 VaccineClinically healthy adults aged ≥ 18 years who received Primary Moderna COVID-19 Vaccine |
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
Key inclusion criteria (2 listed)
- Clinically healthy adults aged ≥ 18 years.
- Subjects have been informed properly regarding the study and accepted to be enrolled in this study.
Key exclusion criteria (1 listed)
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderna COVID-19 VaccineModerna 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. | Biological | Moderna COVID-19 Vaccine |
Primary outcome
Local Reactions Following Moderna COVID-19 Vaccine
Time frame: 28 Days after each dose
Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine.
Systemic Reactions Following Moderna COVID-19 Vaccine
Time frame: 28 Days after each dose
Percentage of subject with systemic reactions following immunization with Moderna COVID-19
5 secondary outcomes
Immediate Reactions
Time frame: 30 minutes after each dose
1-3 Days Reactions
Time frame: 1-3 minutes after each dose
4-7 Days Reactions
Time frame: 4-7 Days after each dose
8-28 Days Reactions
Time frame: 8-28 Days after each dose
Serious 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 18 Nov 2023.
- 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.
Julitasari Sundoro, MD principal investigator
National Advisory Immunization Committee
18 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 18 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 2 inclusion and 1 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Local Reactions Following Moderna COVID-19 Vaccine (time frame: 28 Days after each dose). The study lists 2 primary outcomes in all. 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 18 Nov 2023.