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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043851
Receipt No. R000050049
Scientific Title Short-term safety of the BNT162b2 mRNA COVID-19 vaccine
Date of disclosure of the study information 2021/04/10
Last modified on 2021/10/06

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Basic information
Public title Short-term safety of the BNT162b2 mRNA COVID-19 vaccine
Acronym safety of the mRNA COVID-19 vaccine
Scientific Title Short-term safety of the BNT162b2 mRNA COVID-19 vaccine
Scientific Title:Acronym safety of the mRNA COVID-19 vaccine
Region
Japan

Condition
Condition Medical workers / Adult
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary endpoints were the efficacy of the vaccine against laboratory-confirmed Covid-19 and safety.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The efficacy of the vaccine against laboratory-confirmed Covid-19 (pre, post, 3M, 6M).
Key secondary outcomes The efficacy of the vaccine safety (pre, post, 3M, 6M).

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 medical workers
Key exclusion criteria Healthcare workers who have withdrawn their consent to participate in this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hisakazu
Middle name
Last name Degawa
Organization Kawasaki Physicians Association
Division name President
Zip code 216-0017
Address 2-5-2 kodai, Miyamaeku,Kawasaki-city, Kanagawa,Japan
TEL 044-888-6600
Email hdegawa@h2.dion.ne.jp

Public contact
Name of contact person
1st name Yoshiyuki
Middle name Watanabe
Last name Watanabe
Organization St. Marianna University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 2168511
Address 2-16-1 Sugao Miyamaeku, Kawasaki-city, Kanagawa, Japan
TEL 0449778111
Homepage URL http://kawa_nai.umin.jp/
Email ponponta@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine, Dept. of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization self funding
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 Kanagawa Prefecture Medical Association
Address 3-1 Fujimicho,Nakaku,Yokohama-city, Kanagawa, Japan
Tel 044-888-6600
Email h-yoda@kanagawa.med.or.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 10 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 240
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 No longer recruiting
Date of protocol fixation
2021 Year 04 Month 06 Day
Date of IRB
2021 Year 03 Month 11 Day
Anticipated trial start date
2021 Year 04 Month 06 Day
Last follow-up date
2021 Year 10 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analysis
1. Anti-SARS-CoV-2 S-RBD protein Human IgM ELISA
2. Anti-SARS-CoV-2 S-RBD protein Human IgG ELISA
3. MBL SARS-CoV-2 Neutralization Antibody Detection

Management information
Registered date
2021 Year 04 Month 06 Day
Last modified on
2021 Year 10 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050049

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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