UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018230
Receipt number R000021102
Scientific Title Immunological persistence after booster doses of the inactivated polio vaccine
Date of disclosure of the study information 2015/07/07
Last modified on 2022/01/10 09:41:29

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Basic information

Public title

Immunological persistence after booster doses of the inactivated polio vaccine

Acronym

Immunological persistence after booster doses of the inactivated polio vaccine

Scientific Title

Immunological persistence after booster doses of the inactivated polio vaccine

Scientific Title:Acronym

Immunological persistence after booster doses of the inactivated polio vaccine

Region

Japan


Condition

Condition

Polio

Classification by specialty

Infectious disease Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is evaluate immunological persistence of booster dose of eIPV in Japanese adults

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Neutralizing antibody titer of poliovirus

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

healthy adult

Key exclusion criteria

acute febrile illness
immunodeficiency
allergy against vaccine contents
pregnancy

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Shinji
Middle name
Last name Fukushima

Organization

Tokyo Medical University Hospital

Division name

Travellers' Medical Center

Zip code

160-0023

Address

6-7-1 Nishishinjuku shinjukuku, Tokyo

TEL

03-3342-6111

Email

fuku789@tokyo-med.ac.jp


Public contact

Name of contact person

1st name Shinji
Middle name
Last name Fukushima

Organization

Tokyo Medical University Hospital

Division name

Travellers' Medical Center

Zip code

160-0023

Address

6-7-1 Nishishinjuku shinjukuku, Tokyo

TEL

03-3342-6111

Homepage URL

http://hospinfo.tokyo-med.ac.jp/shinryo/tokou/

Email

fuku789@tokyo-med.ac.jp


Sponsor or person

Institute

Tokyo Medical University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Institute of Infectious Diseases

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical University

Address

6-7-1 Nishishinjuku, Shinjuku, Tokyo, Japan

Tel

0333426111

Email

fuku789@tokyo-med.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

東京医科大学病院(東京都)、国立感染症研究所(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 07 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

Enrolling by invitation

Date of protocol fixation

2015 Year 02 Month 25 Day

Date of IRB

2015 Year 02 Month 25 Day

Anticipated trial start date

2015 Year 07 Month 07 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry

2023 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

We evaluate immunological persistence against polio virus.
(Serum neutralizing antibody titer against polio virus)


Management information

Registered date

2015 Year 07 Month 07 Day

Last modified on

2022 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021102


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name