UMIN-CTR Clinical Trial
| Recruitment status | No longer recruiting |
| Unique ID issued by UMIN | UMIN000016012 |
| Receipt No. | R000018611 |
| Scientific Title | Monitoring of influenza vaccine effectiveness among Japanese children (2014/15 - 2016/17 season) |
| Date of disclosure of the study information | 2014/12/20 |
| Last modified on | 2019/07/26 (Ver. 12) |
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| Basic information | ||
| Public title | Monitoring of influenza vaccine effectiveness among Japanese children (2014/15 - 2016/17 season) | |
| Acronym | Monitoring of influenza vaccine effectiveness among Japanese children (2014/15 - 2016/17 season) | |
| Scientific Title | Monitoring of influenza vaccine effectiveness among Japanese children (2014/15 - 2016/17 season) | |
| Scientific Title:Acronym | Monitoring of influenza vaccine effectiveness among Japanese children (2014/15 - 2016/17 season) | |
| Region |
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| Condition | |||
| Condition | Influenza | ||
| Classification by specialty |
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| 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 |
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| Age-upper limit |
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| 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 2014/15, 2015/16 and 2016/17 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) |
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| 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 |
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| Target sample size | 3600 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| Institute | Osaka City University Graduate School of Medicine |
| 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 | Osaka City University Graduate School of Medicine Institutional Review Board |
| Address | 1-5-7, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan |
| Tel | 06-6645-3435 |
| 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、大阪府立公衆衛生研究所、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）、武知小児科内科（大阪府）、高崎小児科医院（福岡県）、しんどう小児科（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 |
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| Related information | |
| URL releasing protocol | http://mhlw-grants.niph.go.jp/ |
| Publication of results | Partially published |
| Result | |||||||
| URL related to results and publications | http://mhlw-grants.niph.go.jp/ | ||||||
| Number of participants that the trial has enrolled | 2778 | ||||||
| Results | Vaccine effectiveness (2 doses) 2014-15 season: 50% 2015-16 season: 60% 2016-17 season: 41% |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Details are presented in annual reports funded by Ministry of Health, Labour and Welfare Japan |
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| Participant flow | Details are presented in annual reports funded by Ministry of Health, Labour and Welfare Japan |
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| Adverse events | None |
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| Outcome measures | Medically attended laboratory-confirmed influenza using real-time RT-PCT |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | No longer recruiting | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded |
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| 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 2) Exposure: history of influenza vaccination during the each season |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018611 |
