UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008694
Receipt number R000010221
Scientific Title The incidence of childhood pneumonia in Chiba City after pneumococcal vaccination
Date of disclosure of the study information 2012/08/15
Last modified on 2014/02/18 08:55:13

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Basic information

Public title

The incidence of childhood pneumonia in Chiba City after pneumococcal vaccination

Acronym

Childhood pneumonia after pneumococcal vaccination

Scientific Title

The incidence of childhood pneumonia in Chiba City after pneumococcal vaccination

Scientific Title:Acronym

Childhood pneumonia after pneumococcal vaccination

Region

Japan


Condition

Condition

Pneumonia

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the incidence of childhood pneumonia before and after the introduction of heptavalent pneumococcal vaccine in Chiba City.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To compare the incidence of overall pneumonia

Key secondary outcomes

To find out the seroprevelance of the
Streptococcus Pneumonia after the introducion of the pneumococcal vaccine.


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

1 months-old <

Age-upper limit

180 months-old >=

Gender

Male and Female

Key inclusion criteria

Children who are admitted to the hospital because of pneumonia in Chiba City.

Key exclusion criteria

Patients who refused to participate in this research.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuhiko Ishiwada

Organization

Chiba University

Division name

Division od Control and Treatment of Infectious Diseases

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Chiba University

Division name

Division od Control and Treatment of Infectious Diseases

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Division od Control and Treatment of Infectious Diseases

Institute

Department

Personal name



Funding Source

Organization

Funding from Ministry of Health and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2012 Year 08 Month 15 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

2012 Year 03 Month 26 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2013 Year 09 Month 30 Day

Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete

2013 Year 12 Month 31 Day

Date analysis concluded



Other

Other related information

Number of patient with pneumonia
Hsitory of Vaccination
Causative microorganisms


Management information

Registered date

2012 Year 08 Month 15 Day

Last modified on

2014 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010221


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name