UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029855
Receipt number R000034082
Scientific Title Safety and Immunogenicity of DTP-IPV among Japanese adults
Date of disclosure of the study information 2017/11/08
Last modified on 2019/03/30 13:45:34

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Basic information

Public title

Safety and Immunogenicity of DTP-IPV among Japanese adults

Acronym

Safety and Immunogenicity of DTP-IPV among Japanese adults

Scientific Title

Safety and Immunogenicity of DTP-IPV among Japanese adults

Scientific Title:Acronym

Safety and Immunogenicity of DTP-IPV among Japanese adults

Region

Japan


Condition

Condition

Diphtheria, Tetanus, Pertussis, Polio

Classification by specialty

Infectious disease Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is to evaluate safety and immunogenicity of DTP-IPV among Japanese adults.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Diphtheria toxin antibody
Tetanus toxin antibody
anti-Pertussis antibody
anti-poliovirus antibody

Key secondary outcomes

Adverse event


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-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

vaccination of DTP-IPV

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 components
pregnancy

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Fukushima

Organization

Tokyo Medical University Hospital

Division name

Travellers' Medical Center

Zip code


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
Middle name
Last name Shinji Fukushima

Organization

Tokyo Medical University Hospital

Division name

Travellers' Medical Center

Zip code


Address

6-7-1 Nishishinjuku, Shinjukuku, Tokyo

TEL

03-3342-6111

Homepage URL


Email

fuku789@tokyo-med.ac.jp


Sponsor or person

Institute

Tokyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

National Institute of Infectious Diseases
The Kitasato Institute

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

東京医科大学病院(東京都)、国立感染症研究所(東京都)、学校法人北里研究所(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 08 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

Terminated

Date of protocol fixation

2017 Year 04 Month 03 Day

Date of IRB

2017 Year 04 Month 03 Day

Anticipated trial start date

2017 Year 11 Month 08 Day

Last follow-up date

2019 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 11 Month 07 Day

Last modified on

2019 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034082


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name