Coronavirus Disease (COVID-19)NCT04892888
Survey of the Moderna COVID-19 Vaccine in People at High-Risk of Developing Severe COVID-19 Symptoms
An observational study of Coronavirus Disease (COVID-19), run by Takeda at 1 site in Japan.
Trial summary
This study is a survey of the Moderna COVID-19 vaccine in Japanese people at high risk of developing severe COVID-19 symptoms. 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
- 0 participants
- Where
- 1 siteJapan
- Study dates
- 1 Aug 2022to 30 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 vaccinees who meet the inclusion/exclusion criteria.
Who may be able to join
- The participant is capable of understanding the contents of the investigation, recording his/her own symptoms in the health observation diary, and has obtained written consent to participate in the investigation from the vaccinee himself/herself (If minor, parent or legal guardian).
- The participant has an underlying disease at the time of this drug vaccination that is considered to pose a high risk of aggravation of COVID-19.
Who cannot join
- 1. The subject has any contraindication to this drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) for Subjects With Underlying Disease Considered to be at High Risk for Severe Illness, Acute Phase Safety Surveillance (COVID-19)
This study is a survey of the Moderna COVID-19 vaccine in Japanese people at high risk of developing severe COVID-19 symptoms. 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 side effects of the Moderna COVID-19 vaccine in this group. This will be from the first vaccination to 28 days after the second vaccination.
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 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 at least One Adverse Events (AEs)
An adverse event (Adverse Event: AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (Including laboratory abnormalities), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: 56 days
Percentage of Participants with Specified AEs (Local Reactions) at the Vaccination Site
Specified AEs (Local reactions) at the vaccination site are defined as injection site pain, redness and swelling. The participants will evaluate the symptoms at the vaccination site (local reactions) and systemic symptoms (systemic events) and will record with the health observation diary. Percentage of participants with specified AEs (local reactions) at the vaccination site will be reported.
Measured: 56 days
Percentage of Participants with Specified AEs (Systemic Events)
Specified AEs (Systemic events) are defined as vomiting, diarrhoea, headache, malaise, chills, myalgia, and arthralgia. The participants will evaluate the symptoms at the vaccination site (local reactions) and systemic symptoms (systemic events) and will record with the health observation diary. Percentage of participants with specified AEs (systemic events) at the vaccination site will be reported.
Measured: 56 days
Secondary outcomes (3)
Number of Participants who Take COVID-19 Pathogen (SARS-COV-2) Test during the Study
Measured: 56 days
Number of Participants who Developed COVID-19 during the Study
Measured: 56 days
Number of Participants Who Have Sever COVID-19 Infection during the Study Evaluated by Investigator
Number of participants who have sever 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: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Aug 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Why it stopped: Business decision
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 TakedaThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892888
- Sponsor's protocol ID
- PNR-1475
- Other IDs
- jRCT2031210095
- Status last verified
- Jul 2022
- First submitted
- 18 May 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) for Subjects With Underlying Disease Considered to be at High Risk for Severe Illness, Acute Phase Safety Surveillance (COVID-19)
- ClinicalTrials.gov ID
- NCT04892888
- Acronym / sponsor ID
- PNR-1475
- Conditions
- Coronavirus Disease (COVID-19)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 19 May 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 survey of the Moderna COVID-19 vaccine in Japanese people at high risk of developing severe COVID-19 symptoms. 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 side effects of the Moderna COVID-19 vaccine in this group. This will be from the first vaccination to 28 days after the second vaccination.
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 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 vaccinees who meet the inclusion/exclusion criteria.
Key inclusion criteria (2 listed)
- The participant is capable of understanding the contents of the investigation, recording his/her own symptoms in the health observation diary, and has obtained written consent to participate in the investigation from the vaccinee himself/herself (If minor, parent or legal guardian).
- The participant has an underlying disease at the time of this drug vaccination that is considered to pose a high risk of aggravation of COVID-19.
Key exclusion criteria (1 listed)
- 1. The subject has any contraindication to this drug.
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 mL |
Primary outcome
Percentage of Participants with at least One Adverse Events (AEs)
Time frame: 56 days
An adverse event (Adverse Event: AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (Including laboratory abnormalities), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Percentage of Participants with Specified AEs (Local Reactions) at the Vaccination Site
Time frame: 56 days
Specified AEs (Local reactions) at the vaccination site are defined as injection site pain, redness and swelling. The participants will evaluate the symptoms at the vaccination site (local reactions) and systemic symptoms (systemic events) and will record with the health observation diary. Percentage of participants with specified AEs (local reactions) at the vaccination site will be reported.
Percentage of Participants with Specified AEs (Systemic Events)
Time frame: 56 days
Specified AEs (Systemic events) are defined as vomiting, diarrhoea, headache, malaise, chills, myalgia, and arthralgia. The participants will evaluate the symptoms at the vaccination site (local reactions) and systemic symptoms (systemic events) and will record with the health observation diary. Percentage of participants with specified AEs (systemic events) at the vaccination site will be reported.
3 secondary outcomes
Number of Participants who Take COVID-19 Pathogen (SARS-COV-2) Test during the Study
Time frame: 56 days
Number of Participants who Developed COVID-19 during the Study
Time frame: 56 days
Number of Participants Who Have Sever COVID-19 Infection during the Study Evaluated by Investigator
Time frame: 56 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
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 Takeda 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 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: withdrawn, as of the sponsor's last update on 28 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 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 was withdrawn before enrolling participants, so there are no results.
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 at least One Adverse Events (AEs) (time frame: 56 days). The study lists 3 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 28 Jul 2022.