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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030705
Receipt No. R000035057
Scientific Title Influenza vaccine effectiveness among Japanese elementary school students (2017/18 season, pilot study)
Date of disclosure of the study information 2018/01/09
Last modified on 2019/01/07

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Basic information
Public title Influenza vaccine effectiveness among Japanese elementary school students (2017/18 season, pilot study)
Acronym Influenza vaccine effectiveness among Japanese elementary school students (2017/18 season, pilot study)
Scientific Title Influenza vaccine effectiveness among Japanese elementary school students (2017/18 season, pilot study)
Scientific Title:Acronym Influenza vaccine effectiveness among Japanese elementary school students (2017/18 season, pilot study)
Region
Japan

Condition
Condition Influenza
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to evaluate influenza vaccine effectiveness among Japanese elementary school students.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Influenza confirmed by rapid diagnostic testing
Key secondary outcomes

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
6 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria 1) Children with influenza-like illness (ILI) who visited collaborating pediatric clinics in Fukuoka prefecture, Japan, during the 2017/18 influenza season
2) Children who attend elementary school and those aged 6 to 12 years at the time of visit
3) Those who visited the clinics between 6 hours and 7 days after onset of fever (38.0 degree)
Key exclusion criteria Subjects are excluded if they:
- have a history of anaphylaxis after influenza vaccination
- had influenza antivirals administered for the current ILI
- experienced the current ILI during the hospitalization
- are institutionalized
- are non-residents in Fukuoka prefecture, Japan
Target sample size 270

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wakaba Fukushima
Organization Osaka City University Graduate School of Medicine
Division name Department of Public Health
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3756
Email wakaba@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wakaba Fukushima
Organization Osaka City University Graduate School of Medicine
Division name Department of Public Health
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3756
Homepage URL
Email wakaba@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
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 大阪市立大学大学院医学研究科公衆衛生学、高崎小児科医院(福岡県)、しんどう小児科医院(福岡県)、やました小児科医院(福岡県)、横山小児科医院(福岡県)、きよまつ小児科医院(福岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 09 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
Vaccine effectiveness (any doses) 
for all influenza: -7% (95%CI:-386% to 76%) 
for influenza type A: not applicable
for influenza type B: 35% (95%CI:-249% to 88%) 
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
2017 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 09 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 12 Month 28 Day

Other
Other related information 1) Study design: case-control study (test-negative design)
2) Cases and controls: cases are subjects with positive results for influenza tested by rapid diagnostic testing using nasal aspirates, whereas controls are subjects with negative results
3) Exposure: history of influenza vaccination during the each season

Management information
Registered date
2018 Year 01 Month 05 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=R000035057

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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