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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044045
Receipt No. 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 2021/04/26

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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
Email 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
Email nagao.mizuho.yt@mail.hosp.go.jp

Sponsor
Institute National Hospital Oraganizationa, Mie National Hospital
Institute
Department

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
Email iwasaki.masayuki.ed@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
2021 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.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


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