Coronavirus Disease (COVID-19)NCT04941144
Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination
An observational study of Coronavirus Disease (COVID-19), run by ModernaTX, Inc. at 1 site in Japan.
Trial summary
This study is a long-term follow-up survey of Japanese people after their second vaccination with the Moderna COVID-19 vaccine. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 8,538 participants
- Where
- 1 siteJapan
- Study dates
- 22 Dec 2021to 28 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population of this survey are vaccinated participants who meet the inclusion/exclusion criteria.
Who may be able to join
- Participants who have participated in the preceding cohort study and has subsequently provided written consent to participate in this study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: General Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) During the Early Phase of Treatment With Novel Corona Vaccine, Follow-up of Key Survey Participants
This study is a long-term follow-up survey of Japanese people after their second vaccination with the Moderna COVID-19 vaccine.
The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for long-term side effects of the COVID-19 vaccine. This will be from 28 days to 12 months after the second vaccination of the COVID-19 vaccine.
The number of visits to the clinic will depend on the clinic's standard practice.
- Conditions
- Coronavirus Disease (COVID-19)
- Being tested
- COVID-19 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.
COVID-19 VaccineBiological
Also called COVID-19 Vaccine Moderna Intramuscular Injection, Spikevax Intramuscular Injection
COVID-19 Vaccine Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Vaccine Intramuscular Injection 0.5 milliliters (mL) | COVID-19 vaccine intramuscular injection, 2 doses of 0.5 mL per dose administered intramuscularly at an interval of 4 weeks. Receives: Biological: COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Serious Adverse Events (SAE)
An SAE is defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event.
Measured: 11 months (From 28 days to 12 months after the second vaccination)
Secondary outcomes (3)
Number of Participants who Take COVID-19 Pathogen (Severe Acute Respiratory Syndrome coronavirus [SARS-CoV-2]) Test during the Study
Measured: 11 months (From 28 days to 12 months after the second vaccination)
Number of Participants who Developed COVID-19 during the Study
Measured: 11 months (From 28 days to 12 months after the second vaccination)
Number of Participants Who Have Severe COVID-19 Infection during the Study Evaluated by Investigator
Number of participants who have severe COVID-19 infection during the study evaluated by investigator will be reported. Investigator will evaluate the severity of COVID-19 infection with COVID-19 information entered in the case report form in reference to "Guidance for Clinical Practice of Novel Coronavirus Infection (COVID-19)".
Measured: 11 months (From 28 days to 12 months after the second vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start22 Dec 2021
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- 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
- 8,538 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941144
- Sponsor's protocol ID
- mRNA-1273-P918
- Other IDs
- jRCT2031210168
- Status last verified
- May 2023
- First submitted
- 25 Jun 2021
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) During the Early Phase of Treatment With Novel Corona Vaccine, Follow-up of Key Survey Participants
- ClinicalTrials.gov ID
- NCT04941144
- Acronym / sponsor ID
- mRNA-1273-P918
- Conditions
- Coronavirus Disease (COVID-19)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,538 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 28 Jun 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.
This study is a long-term follow-up survey of Japanese people after their second vaccination with the Moderna COVID-19 vaccine.
The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for long-term side effects of the COVID-19 vaccine. This will be from 28 days to 12 months after the second vaccination of the COVID-19 vaccine.
The number of visits to the clinic will depend on the clinic's standard practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Vaccine Intramuscular Injection 0.5 milliliters (mL) | – | Biological: COVID-19 VaccineCOVID-19 vaccine intramuscular injection, 2 doses of 0.5 mL per dose administered intramuscularly at an interval of 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of this survey are vaccinated participants who meet the inclusion/exclusion criteria.
Key inclusion criteria (1 listed)
- Participants who have participated in the preceding cohort study and has subsequently provided written consent to participate in this study.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| COVID-19 VaccineAlso: COVID-19 Vaccine Moderna Intramuscular Injection, Spikevax Intramuscular InjectionCOVID-19 Vaccine Intramuscular Injection | Biological | COVID-19 Vaccine Intramuscular Injection 0.5 milliliters (mL) |
Primary outcome
Percentage of Participants with Serious Adverse Events (SAE)
Time frame: 11 months (From 28 days to 12 months after the second vaccination)
An SAE is defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event.
3 secondary outcomes
Number of Participants who Take COVID-19 Pathogen (Severe Acute Respiratory Syndrome coronavirus [SARS-CoV-2]) Test during the Study
Time frame: 11 months (From 28 days to 12 months after the second vaccination)
Number of Participants who Developed COVID-19 during the Study
Time frame: 11 months (From 28 days to 12 months after the second vaccination)
Number of Participants Who Have Severe COVID-19 Infection during the Study Evaluated by Investigator
Time frame: 11 months (From 28 days to 12 months after the second vaccination)
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 19 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronavirus Disease (COVID-19), run by ModernaTX, Inc. at 1 site in Japan.
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 1 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 19 May 2023. 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 Japan. 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?
Percentage of Participants with Serious Adverse Events (SAE) (time frame: 11 months (From 28 days to 12 months after the second 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 19 May 2023.