UMIN-CTR Clinical Trial

Basic information
Public title	Monitoring of influenza vaccine effectiveness among Japanese children (2020/21 - 2022/23 season)
Acronym	Monitoring of influenza vaccine effectiveness among Japanese children (2020/21 - 2022/23 season)
Scientific Title	Monitoring of influenza vaccine effectiveness among Japanese children (2020/21 - 2022/23 season)
Scientific Title:Acronym	Monitoring of influenza vaccine effectiveness among Japanese children (2020/21 - 2022/23 season)
Region	Japan

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

Objectives
Narrative objectives1	We aim to monitor influenza vaccine effectiveness among Japanese children.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Laboratory-confirmed influenza
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 months-old <=
Age-upper limit	36 months-old >
Gender	Male and Female
Key inclusion criteria	1) Children with influenza-like illness (ILI) who visited collaborating pediatric clinics in Osaka/Fukuoka prefecture, Japan, during the 2020/21, 2021/22 and 2022/23 influenza season 2) Aged less than 3 years at the time of visit 3) Those who visited the clinics within 7 days after onset of fever (38.0 degree)
Key exclusion criteria	Subjects are excluded if they: - are aged less than 6 months, as of the last October 1st before each season - have a history of anaphylaxis after influenza vaccination - had been administered influenza antivirals for the current ILI - experienced the current ILI during the hospitalization - are institutionalized - are non-residents in Osaka/Fukuoka prefecture, Japan - are judged to be inappropriate for participation by doctors in charge
Target sample size	2250

Research contact person
Name of lead principal investigator	1st name Wakaba Middle name Last name Fukushima
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Public Health
Zip code	545-8585
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 Wakaba Middle name Last name Fukushima
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Public Health
Zip code	545-8585
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	Ethical Committee of Osaka City University Graduate School of Medicine
Address	Abeno Medix 6F, 1-2-7, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
Tel	06-6645-3456
Email	ethics@med.osaka-cu.ac.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	大阪市立大学大学院医学研究科公衆衛生学（大阪府）、大阪健康安全基盤研究所（大阪府）、ふじおか小児科（大阪府）、松下こどもクリニック（大阪府）、くぼたこどもクリニック（大阪府）、八木小児科（大阪府）、高崎小児科医院（福岡県）、しんどう小児科医院（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	2021 Year 02 Month 22 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 01 Day
Date of IRB	2020 Year 10 Month 01 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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 real-time reverse transcription polymerase chain reaction using nasal discharge specimen, whereas controls are subjects with negative results 3) Exposure: history of influenza vaccination during the each season

Management information
Registered date	2021 Year 02 Month 21 Day
Last modified on	2021 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049553

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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