UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003720
Receipt number R000004500
Scientific Title Trial in adults aged 65 years or older to evaluate the immunogenicity of influenza vaccine.
Date of disclosure of the study information 2010/06/07
Last modified on 2011/01/19 13:57:55

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Basic information

Public title

Trial in adults aged 65 years or older to evaluate the immunogenicity of influenza vaccine.

Acronym

Trial in adults aged 65 years or older to evaluate the immunogenicity of influenza vaccine.

Scientific Title

Trial in adults aged 65 years or older to evaluate the immunogenicity of influenza vaccine.

Scientific Title:Acronym

Trial in adults aged 65 years or older to evaluate the immunogenicity of influenza vaccine.

Region

Japan


Condition

Condition

non

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the immunogenicity of influenza vaccine

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Seroconversion rate
Seroprotection rate
Geometric mean fold rise

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

vaccinate

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)written informed consent obtained from the subject.
2)healthy adults aged 65 years or older at time of the first vaccination.

Key exclusion criteria

1)history of previous administration of novel [H1N1]v vaccine.
2)clinically or virologically confirmed influenza infection within 12 months preceding the study start.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideyuki Ikematsu

Organization

influenza vaccine Research Group

Division name

office of clinical research

Zip code


Address

6-40-8, aoba, higashi-ku, fukuoka-shi, Fukuoka Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Tsutomu Takeda

Organization

Clinical support

Division name

Quality Management division

Zip code


Address

1-9-17-7F, tenjin, chuo-ku, fukuoka-shi, Fukuoka Japan

TEL

092-738-0500

Homepage URL


Email

tsutomu.takeda@clinicalsupport.co.jp


Sponsor or person

Institute

influenza vaccine Research Group

Institute

Department

Personal name



Funding Source

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

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

2010 Year 06 Month 07 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

2010 Year 05 Month 05 Day

Date of IRB


Anticipated trial start date

2010 Year 06 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry

2011 Year 02 Month 01 Day

Date trial data considered complete

2011 Year 02 Month 01 Day

Date analysis concluded

2011 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 06 Month 07 Day

Last modified on

2011 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004500


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name