UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030704 |
|---|---|
| Receipt number | R000035055 |
| Scientific Title | Monitoring of influenza vaccine effectiveness among Japanese children (2017/18 - 2019/20 season) |
| Date of disclosure of the study information | 2018/01/09 |
| Last modified on | 2021/05/06 19:28:05 |
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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
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
wakaba@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035055
