UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034112 |
|---|---|
| Receipt number | R000038052 |
| Scientific Title | Investigation of Incidence of influenza symptom and adverse reaction by subcutaneous or intramuscular injection in influenza vaccine. |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2021/01/27 15:02:19 |
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Basic information
Public title
Investigation of Incidence of influenza symptom and adverse reaction by subcutaneous or intramuscular injection in influenza vaccine.
Acronym
Investigation of Incidence of influenza symptom and adverse reaction by subcutaneous or intramuscular injection in influenza vaccine.
Scientific Title
Investigation of Incidence of influenza symptom and adverse reaction by subcutaneous or intramuscular injection in influenza vaccine.
Scientific Title:Acronym
Investigation of Incidence of influenza symptom and adverse reaction by subcutaneous or intramuscular injection in influenza vaccine.
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main aim of this study is to clarify the difference of incidence about influenza symptom and adverse reaction in the subcutaneous injection and the intramuscular injection in influenza vaccine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of influenza symptom(influenza-like illnesses)
Key secondary outcomes
Incidence rate of local adverse reactions that interfere with daily life.
degree of local adverse reaction.
Pain at the time of injection.
Feeling resistance to receiving next vaccination.
Serious adverse reaction.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hospital staff and university students who received influenza vaccine.
Key exclusion criteria
Influenza vaccine contraindicated.
No acceptance of research consent.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | MAJIMA |
Organization
Kameda Medical Center
Division name
Department of Health Management,
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
majima.kenichiro@kameda.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | MAJIMA |
Organization
Kameda Medical Center
Division name
Department of Health Management,
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
Homepage URL
majima.kenichiro@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
self funding, Kameda 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
Kameda General Hospital Clinical Research Review Committee
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
Tel
0470922211
clinical_research@kameda.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
| 2018 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 09 | Month | 12 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038052
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
