UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015263
Receipt number R000017705
Scientific Title Monitoring of influenza vaccine effectiveness among Japanese children: a pilot study during the 2013/14 season
Date of disclosure of the study information 2014/10/01
Last modified on 2014/09/26 16:13:25

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Basic information

Public title

Monitoring of influenza vaccine effectiveness among Japanese children: a pilot study during the 2013/14 season

Acronym

Monitoring of influenza vaccine effectiveness among Japanese children: a pilot study during the 2013/14 season

Scientific Title

Monitoring of influenza vaccine effectiveness among Japanese children: a pilot study during the 2013/14 season

Scientific Title:Acronym

Monitoring of influenza vaccine effectiveness among Japanese children: a pilot study during the 2013/14 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. In the 2013/14 season, we conduct a pilot study to assess the feasibility.

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

59 months-old >

Gender

Male and Female

Key inclusion criteria

1) Children with influenza-like illness (ILI) who visited one of four collaborating pediatric clinics in Osaka prefecture, Japan, during the 2013/14 influenza season
2) Aged less than 6 years at the time of visit
3) Within 7 days of onset of ILI
4) Aged 6 months or more, as of September 1st, 2013

Key exclusion criteria

Subjects are excluded if they:
- are previously diagnosed as any types of laboratory-confirmed influenza in the 2013/14 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 the Osaka prefecture, Japan

Target sample size

1200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshio Hirota

Organization

Medical Co. LTA

Division name

Clinical Epidemiology Research Center

Zip code


Address

3-6-1 Kashii-Teriha Higashi-ku, Fukuoka, 813-0017, Japan

TEL

092-662-3608

Email

hiro8yoshi@lta-med.com


Public contact

Name of contact person

1st name
Middle name
Last name Wakaba Fukushima

Organization

Osaka City University Faculty of Medicine

Division name

Department of Public Health

Zip code


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 or person

Institute

Osaka City University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare, Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 01 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

Vaccine effectiveness: 51%

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

Completed

Date of protocol fixation

2013 Year 12 Month 04 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 20 Day

Last follow-up date

2014 Year 04 Month 15 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
2) Exposure: history of influenza vaccination during the 2013/14 season


Management information

Registered date

2014 Year 09 Month 26 Day

Last modified on

2014 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017705


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name