UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044045 |
|---|---|
| Receipt number | R000050291 |
| Scientific Title | Epidemiological and immunological investigation of the causes and risk factors of adverse reactions after COVID-19 vaccination |
| Date of disclosure of the study information | 2021/04/27 |
| Last modified on | 2022/04/28 08:37:07 |
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Basic information
Public title
Investigation of adverse reactions after COVID-19 vaccination
Acronym
Investigation of adverse reactions after COVID-19 vaccination
Scientific Title
Epidemiological and immunological investigation of the causes and risk factors of adverse reactions after COVID-19 vaccination
Scientific Title:Acronym
Investigation of the causes and risk factors of adverse reactions after COVID-19 vaccination
Region
| Japan |
Condition
Condition
Adverse reaction to vaccines
Classification by specialty
| Medicine in general | Clinical immunology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the causal component, pathogenic mechanisms, and risk factors in patients with COVID-19 vaccine-induced allergic reaction including anaphylaxis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient factors associated with the vaccine adverse reactions
*demographics
*history of anaphylaxis
*comorbid allergic diseases
*other underlying diseases
*use of polyethylene glycol-containing cosmetics, daily necessities, and drugs
Key secondary outcomes
Exploratory investigation of culprit components of vaccines and mechanisms to cause the reaction.
*in vitro and in vivo tests using vaccines, vaccine components and polyethylene glycols
- skin test (prick and intradermal)
- specific IgE and IgG antibodies
- basophil activation test
- other immunological tests
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*Patients who had an adverse reaction after COVID-19 vaccination and gave informed consent for this study. The criteria for anaphylaxis were based on the Brighton criteria.
*Matched control subjects who have consented to have blood samples taken and who have not experienced allergic symptoms by vaccination.
Key exclusion criteria
*Those who did not give informed consent.
*Those who are judged to be ineligible by the physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mizuho |
| Middle name | |
| Last name | Nagao |
Organization
National Hospital Organization Mie National Hospital
Division name
Institute for Clinical Research
Zip code
514-0125
Address
357 Osato Kubota, Tsu, Mie, Japan
TEL
059-232-2531
nagao.mizuho.yt@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Nagao |
Organization
National Hospital Organization Mie National Hospital
Division name
Institute for Clinical Research
Zip code
514-0125
Address
357 Osato Kubota, Tsu, Mie, Japan
TEL
059-232-2531
Homepage URL
nagao.mizuho.yt@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Oraganizationa, Mie National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of National Hospital Organization Mie National Hospital
Address
357 Osato Kubota, Tsu, Mie, Japan
Tel
059-232-2531
itoi.michifumi.eb@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects will be recruited from medical institutions that have treated patients who have experienced anaphylaxis after COVID-19 vaccination.
Management information
Registered date
| 2021 | Year | 04 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050291
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
