UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016961
Receipt number R000019687
Scientific Title Surveillance for adverse reactions by vaccination in health infants: 2nd Prospective Study ( in Japan )
Date of disclosure of the study information 2015/03/31
Last modified on 2015/03/29 19:10:42

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Basic information

Public title

Surveillance for adverse reactions by vaccination in health infants:
2nd Prospective Study ( in Japan )

Acronym

2nd safety surveillance for vaccination

Scientific Title

Surveillance for adverse reactions by vaccination in health infants:
2nd Prospective Study ( in Japan )

Scientific Title:Acronym

2nd safety surveillance for vaccination

Region

Japan


Condition

Condition

Healthy children

Classification by specialty

Pediatrics Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the safety of single vaccination and simultaneous vaccination with multiple vaccines (DTP-IPV, PCV13 etc.).

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse reactions occur within 14 days after vaccination (general reaction and local reaction)

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

2 months-old <=

Age-upper limit

60 months-old >

Gender

Male and Female

Key inclusion criteria

Age: over 2 month and under 5 years of age
Subjects whose parents require single vaccination or simultaneous vaccination,
Each vaccine are determined to be appropriate on pre examination by physicians

Key exclusion criteria

Age: under 2 and over 5 years of age
Subjects whose parents do not require vaccination to their children
Vaccination is determined to be inappropriate on pre-examination by physicians

Target sample size

5000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Tahara

Organization

Tahara clinic

Division name

Director

Zip code


Address

47 Ushirogawara, Yamaguchi city, Yamaguchi prefecture

TEL

083-923-3415

Email

drtak@juno.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashiro Tahara

Organization

Tahara clinic

Division name

Director

Zip code


Address

47 Ushirogawara, Yamaguchi city, Yamaguchi prefecture

TEL

083-923-3415

Homepage URL

http://www.taharaclinic.com/

Email

drtak@juno.ocn.ne.jp


Sponsor or person

Institute

The society of ambulatory and general pediatrics in Japan

Institute

Department

Personal name



Funding Source

Organization

The society of ambulatory and general pediatrics in Japan

Organization

Division

Category of Funding Organization

Other

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

2015 Year 03 Month 31 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

Open public recruiting

Date of protocol fixation

2013 Year 10 Month 25 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 01 Day

Last follow-up date

2015 Year 05 Month 31 Day

Date of closure to data entry

2015 Year 07 Month 31 Day

Date trial data considered complete

2015 Year 08 Month 31 Day

Date analysis concluded

2015 Year 08 Month 31 Day


Other

Other related information

To analyze adverse reactions occur within 14 days after vaccination (general reaction and local reaction) to compare between single injection and simultaneous injection.


Management information

Registered date

2015 Year 03 Month 29 Day

Last modified on

2015 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019687


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name