UMIN-CTR Clinical Trial

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

Influenza

Classification by specialty

Infectious disease

Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Influenza confirmed by rapid diagnostic testing

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Osaka City University

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare, Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2018

Year

01

Month

09

Day

URL releasing protocol

http://mhlw-grants.niph.go.jp/

Publication of results

Published

URL related to results and publications

http://mhlw-grants.niph.go.jp/

Number of participants that the trial has enrolled

193

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

2019

Year

07

Month

26

Day

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

Participant flow

Details are presented in annual reports funded by Ministry of Health, Labour and Welfare Japan

Adverse events

None

Outcome measures

Medically attended laboratory-confirmed influenza using rapid diagnostic testing

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

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

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 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

Registered date

2018

Year

01

Month

05

Day

Last modified on

2019

Year

07

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035057