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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046211
Receipt No. R000052737
Scientific Title Efficacy and Safety of the third dose of mRNA COVID-19 Vaccine in healthy volunteers: An observational study.
Date of disclosure of the study information 2021/11/28
Last modified on 2022/01/11

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Basic information
Public title Efficacy and Safety of the third dose of mRNA COVID-19 Vaccine in healthy volunteers: An observational study.
Acronym mRNA vaccine third dose study in healthy volunteers
Scientific Title Efficacy and Safety of the third dose of mRNA COVID-19 Vaccine in healthy volunteers: An observational study.
Scientific Title:Acronym mRNA vaccine third dose study in healthy volunteers
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate the prevalence of positive SARS-CoV-2 IgG antibodies in healthy volunteers before and after the third dose of BNT162b2, and to evaluate the post-vaccination adverse reactions that occurred when these vaccines were administered.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint was the rate of positivity of the SARS-CoV-2 IgG antibody.
Key secondary outcomes Secondary endpoints will include SARS-CoV-2 IgG antibody titer, peripheral blood lymphocyte fraction, IgG, IgA, IgM, and presence and content of post-vaccination adverse reactions.

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Healthy adults who do not have any history or comorbidity requiring continuous medication or treatment at the time of study entry, or who have a history of chronic disease but whose condition is stable and who have not required any change in treatment or hospitalization within the past 6 weeks.
2) Willing to receive the SARS-CoV-2 vaccination initiated by the Japanese government or local government.
3) Those who have given written consent to participate in the study.
Key exclusion criteria 1) Those that the principal investigator or sub-investigator deems inappropriate for participation in the study
2) Patients with a history or coexistence of immunosuppressive medication, autoimmune diseases (systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis/polymyositis, mixed connective tissue disease, systemic scleroderma, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, spondyloarthritis and related diseases, vasculitis syndrome, inflammatory bowel disease, Guillain-Barre syndrome, multiple sclerosis, neuromyelitis optica) Multiple sclerosis, neuromyelitis optica).
3) Patients with a history of COVID-19
4) Patients who are unable to communicate with others
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Ishikawa
Organization Kobe City Medical Center General Hospital
Division name Department of Hematology
Zip code 650-0047
Address 2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
TEL 078-302-4321
Email ishikawa@kcho.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Nishikubo
Organization Kobe City Medical Center General Hospital
Division name Department of Hematology
Zip code 650-0047
Address 2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
TEL 078-302-4321
Homepage URL
Email masashi_nishikubo@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital, Department of Hematology
Institute
Department

Funding Source
Organization Kobe City Medical Center General Hospital, Department of Hematology
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 Kobe City Medical Center General Hospital
Address 2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
Tel 078-302-5176
Email rinken@kcho.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 11 Month 28 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 No longer recruiting
Date of protocol fixation
2021 Year 11 Month 28 Day
Date of IRB
2021 Year 12 Month 06 Day
Anticipated trial start date
2021 Year 11 Month 28 Day
Last follow-up date
2023 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing particular

Management information
Registered date
2021 Year 11 Month 28 Day
Last modified on
2022 Year 01 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052737

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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