UMIN-CTR Clinical Trial

Basic information
Public title	Monitoring of influenza vaccine effectiveness among Japanese children (2017/18 - 2019/20 season)
Acronym	Monitoring of influenza vaccine effectiveness among Japanese children (2017/18 - 2019/20 season)
Scientific Title	Monitoring of influenza vaccine effectiveness among Japanese children (2017/18 - 2019/20 season)
Scientific Title:Acronym	Monitoring of influenza vaccine effectiveness among Japanese children (2017/18 - 2019/20 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	72 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 2017/18, 2018/19 and 2019/20 influenza season 2) Aged less than 6 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: - are aged less than 6 months, as of the last September 1st before each season - 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 Osaka/Fukuoka prefecture, Japan
Target sample size	3600

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	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka City University Graduate School of Medicine Institutional Review Board
Address	1-5-7, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
Tel	06-6645-3457
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、大阪健康安全基盤研究所、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）、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	https://mhlw-grants.niph.go.jp/system/files/2018/182111/201818022A_upload/201818022A0009.pdf
Publication of results	Partially published

Result
URL related to results and publications	https://mhlw-grants.niph.go.jp/system/files/2018/182111/201818022A_upload/201818022A0009.pdf
Number of participants that the trial has enrolled	2054
Results	Vaccine effectiveness of 2 doses 2017-18 season (under 6 years of age): 63% 2018-19 season (under 3 years of age): 42% 2019-20 season (under 3 years of age): 62%
Results date posted	2020 Year 01 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	2017-18 season: 1,015 children aged less than 6 years (boys: 561, girls: 454, mean age: 2.8 years) 2018-19 season: 397 children aged less than 3 years (boys: 216, girls: 181, mean age: 1.3 years) 2019-20 season: 642 children aged less than 3 years (boys: 334, girls: 308, mean age: 1.4 years)
Participant flow	Prospective, active and systematic recruitment from children aged less than 6 years (2017-18 season) or less than 3 years (2018-19 season and 2019-20 season) who visited collaborating pediatric clinics due to influenza-like illness during influenza season
Adverse events	None
Outcome measures	Influenza vaccine effectiveness against laboratory-confirmed influenza based on real-time RT-PCR
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	2017 Year 11 Month 30 Day
Anticipated trial start date	2018 Year 01 Month 09 Day
Last follow-up date	2020 Year 04 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 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	2021 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035055