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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034112
Receipt No. 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 2019/01/07

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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
Middle name
Last name Kenichiro MAJIMA
Organization Kameda Medical Center
Division name Department of Health Management,
Zip code
Address 929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL 04-7092-2211
Email majima.kenichiro@kameda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichiro MAJIMA
Organization Kameda Medical Center
Division name Department of Health Management,
Zip code
Address 929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL 04-7092-2211
Homepage URL
Email majima.kenichiro@kameda.jp

Sponsor
Institute Kameda Medical Center
Institute
Department

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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
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
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038052

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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