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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044489
Receipt No. R000050818
Scientific Title Investigation on possible down-regulation of adverse effects of SARS-CoV-2 vaccination by type 2 allergic diseases using questionnaire to vaccine recipients
Date of disclosure of the study information 2021/06/11
Last modified on 2021/06/10

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Basic information
Public title Investigation on possible down-regulation of adverse effects of SARS-CoV-2 vaccination by type 2 allergic diseases using questionnaire to vaccine recipients
Acronym Investigation on possible down-regulation of adverse effects of SARS-CoV-2 vaccination by type 2 allergic diseases using questionnaire to vaccine recipients
Scientific Title Investigation on possible down-regulation of adverse effects of SARS-CoV-2 vaccination by type 2 allergic diseases using questionnaire to vaccine recipients
Scientific Title:Acronym Investigation on possible down-regulation of adverse effects of SARS-CoV-2 vaccination by type 2 allergic diseases using questionnaire to vaccine recipients
Region
Japan

Condition
Condition vaccine adverse effects
Classification by specialty
Clinical immunology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we will conduct a questionnaire survey to approximately 1,000 workers in our hospital. We will investigate the adverse effects following the first and second administration of Pfizer-BioNTech vaccine. The presence (and degrees) or absence of the injection site reactions, fever, tiredness, headache, and muscle pain will be questioned with the present and past histories of allergic diseases.
Basic objectives2 Others
Basic objectives -Others In this study, we will conduct a questionnaire survey to approximately 1,000 workers in our hospital. We will investigate the adverse effects following the first and second administration of Pfizer-BioNTech vaccine. The presence (and degrees) or absence of the injection site reactions, fever, tiredness, headache, and muscle pain will be questioned with the present and past histories of allergic diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of differences in vaccine adverse effects (injection reactions [pain, swelling, and erythema], fever, headache, fatigability, muscle pain, joint pain, and others) between recipients who have present and past allergic diseases (atopic dermatitis, allergic rhinitis, bronchial asthma, and others) and those without these allergic diseases.
Key secondary outcomes Evaluation of differences in the severity of vaccine adverse effects between recipients who have present and past allergic diseases (atopic dermatitis, allergic rhinitis, and bronchial asthma) and those without these allergic diseases.

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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Workers in Chutoen General Medical Hospital who received Cominaty vaccine and approve this project.
Key exclusion criteria Apparent loss or mistake in the questionnaire sheet.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Yoshiki
Middle name
Last name Tokura
Organization Allergic Disease Research Center,
Chutoen General Medical Center
Division name Allergic Disease Research Center
Zip code 436-8555
Address 1-1 Shoubu-ga-ike, Kakegawa, Japan
TEL 0537-21-5555
Email tokura@chutoen-hp.shizuoka.jp

Public contact
Name of contact person
1st name Yoshiki
Middle name
Last name Tokura
Organization Allergic Disease Research Center, Chutoen General Medical Center
Division name Allergic Disease Research Center
Zip code 436-8555
Address 1-1 Shoubu-ga-ike, Kakegawa, Japan
TEL 0537-21-5555
Homepage URL
Email tokura@chutoen-hp.shizuoka.jp

Sponsor
Institute Allergic Disease Research Center, Chutoen General Medical Center
Institute
Department

Funding Source
Organization Allergic Disease Research Center, Chutoen General Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Committee, Chutoen General Medical Center
Address 1-1 Shoubu-ga-ike, Kakegawa, Japan
Tel 0537-21-5555
Email rinshokenkyu@chutoen-hp.shizuoka.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 06 Month 11 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 06 Month 06 Day
Date of IRB
2021 Year 06 Month 07 Day
Anticipated trial start date
2021 Year 06 Month 09 Day
Last follow-up date
2021 Year 06 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Responders are approximately 1,100
workers in our hospital, including physicians, nurses, and other health care workers.
They were vaccinated with Cominaty (Pfizer BioNTech) in two doses about 21 day apart in our hospital. We will investigate the adverse effects following the first and second administration of Pfizer-BioNTech vaccine. The presence (and degrees) or absence of the injection site reactions, fever, tiredness, headache, and muscle pain is questioned with the present and past histories of allergic diseases. The questionnaire
survey is performed anonymously by marking the sheet. We evaluate differences in vaccine adverse effects (injection reactions [pain, swelling, and erythema], fever, headache, fatigability, muscle pain, joint pain, and others) between recipients who have present and past-histories of allergic diseases (atopic dermatitis, allergic rhinitis, bronchial asthma, and others) and those without these allergic diseases.

Management information
Registered date
2021 Year 06 Month 10 Day
Last modified on
2021 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050818

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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