UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015324
Receipt number R000017819
Scientific Title Investigation into clinical data of quadrivalent influenza vaccination
Date of disclosure of the study information 2014/10/02
Last modified on 2018/04/05 09:12:58

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Basic information

Public title

Investigation into clinical data of quadrivalent influenza vaccination

Acronym

Clinical research on quadrivalent influenza vaccine(QIV-FLU)

Scientific Title

Investigation into clinical data of quadrivalent influenza vaccination

Scientific Title:Acronym

Clinical research on quadrivalent influenza vaccine(QIV-FLU)

Region

Japan


Condition

Condition

Prevention of influenza

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of immunogenicity and safety after one or two doses of quadrivalent influenza vaccine subcutaneously to healthy child volunteers

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Serum antibody titers were measured prior to the first injection and the second injection (21plus-minus7days starting with the first injection) and 21 days after the second dose(HI antibody against influenza A and B)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

Serum antibody titers obtained prior to vaccination and 21-28 days after the first and second dose of quadrivalent influenza vaccine were tested, and adverse events were reported.

Interventions/Control_2

Serum antibody titers obtained prior to vaccination and 21-28 days after the first and second dose of trivalent influenza vaccine were tested, and adverse events were reported.

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

216 months-old >

Gender

Male and Female

Key inclusion criteria

1)Subjects aged 6 months to 18 years old at the time of first vaccination.
2) Subjects who are able to follow the regulation of the trial and written informed consent can be obtained from their legal guardian.

Key exclusion criteria

1)Subjects with the history of influenza infection within 6 months (counted from the date of vaccination). (obtained by guardians)
2)Subjects vaccinated with influenza vaccine within 6 months (counted from the date of vaccination).
3)Subjects who had history of anaphylaxy to foods or medicines previously.
4)Subjects with severe diseases in cardiovascular, blood, respiratory, liver, kidney, digestive or neurological systems in their clinical recording.
5)Subjects with a history of Guillain-Barre syndrome, acute disseminated encephalomyelitis, thrombocytopenic purpura, thrombocytopenia, anaphylactoid purpura, encephalitis,encephalopathy and myelitis in the past.
6)Subjects vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine,toxoid within six days (counting from the date of vaccination).
7)Subjects received with gamma globulin or blood transfusion within three months, or received the formulation of high dose of gamma globulin therapy (200 mg / kg or more) within six months (counting from the date of vaccination).
8)Subjects judged as inadequate by the researchers.

Target sample size

384


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name SHIGERU SUGA

Organization

National Hospital Organization Mie Hospital

Division name

Instisute for Clinical Research

Zip code


Address

357,Ozato,Kubota,Tsu,Mie

TEL

059-232-2531

Email

sugas@mie-m.hosp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name SHIGERU SUGA

Organization

National Hospital Organization Mie Hospital

Division name

Instisute for Clinical Research

Zip code


Address

357,Ozato,Kubota,Tsu,Mie

TEL

059-232-2531

Homepage URL


Email

sugas@mie-m.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Mie Hospital

Institute

Department

Personal name



Funding Source

Organization

1)The Chemo-Sero-Therapeutic Research Institute
2)KITASATO DAIICHI SANKYO VACCINE CO., LTD.
3)Denka Seiken Co., Ltd.
4)The Research Foundation for Microbial Diseases of Osaka University

Organization

Division

Category of Funding Organization

Profit 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

三重病院(三重県)、落合小児科医院(三重県)、白子クリニック小児科(三重県)、すずかこどもクリニック(三重県)、まつだ小児科クリニック(三重県)、うめもとこどもクリニック(三重県)、かとう小児科(三重県)、くまがい小児科(北海道)、さいわいこどもクリニック(東京都)、岡藤小児科医院(兵庫県)、鈴木小児科医院(山口県)


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 02 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


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

2014 Year 07 Month 08 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 02 Day

Last modified on

2018 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017819


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name