UMIN-CTR Clinical Trial

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
Email	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
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	Kameda General Hospital Clinical Research Review Committee
Address	929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
Tel	0470922211
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038052