UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033095
Receipt number R000037670
Scientific Title Estimated revaccination coverage rate of pneumococcal vaccines among adults aged 65 years or older in Japan
Date of disclosure of the study information 2018/06/22
Last modified on 2020/02/18 11:21:48

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Basic information

Public title

Estimated revaccination coverage rate of pneumococcal vaccines among adults aged 65 years or older in Japan

Acronym

Estimated revaccination coverage rate of pneumococcal vaccines among adults aged 65 years or older in Japan

Scientific Title

Estimated revaccination coverage rate of pneumococcal vaccines among adults aged 65 years or older in Japan

Scientific Title:Acronym

Estimated revaccination coverage rate of pneumococcal vaccines among adults aged 65 years or older in Japan

Region

Japan


Condition

Condition

infectious disease of pneumococci

Classification by specialty

Medicine in general Pneumology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess PPSV23 revaccination coverage rate among primary vaccinated aged 65 years or older in Japan

Basic objectives2

Others

Basic objectives -Others

To assess PPSV23 revaccination coverage rate among primary vaccinated aged 65 years or older in Japan

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Subjects' panel:
-Revaccination coverage rate of the PPSV23 in primary vaccinated older adults (aged 65+)

Key secondary outcomes

Subjects' panel:
-Reasons for receiving or not receiving the PPSV23 revaccination in older adults (aged 65+)
-Predictors of the PPSV23 revaccination in older adults (aged 65+)
-Revaccination coverage rate of the PPSV23 in older adults (aged 65+)
(Revaccinated: two times of receiving the PPSV23)
(Revaccination coverage rate: Number of revaccinated subjects devided by all replied subjects)
Doctors' panel
-Reasons for recommending or not recommending the PPSV23 revaccination to older adults


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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects criteria:
Provide completed informed consent
Aged 65 years and older
Available for internet based survey

Doctors criteria:
Provide completed informed consent
Treating more than 100 subjects of aged 65 years and older per month
Available for internet based survey

Key exclusion criteria

No exclusion criteria

Target sample size

5000


Research contact person

Name of lead principal investigator

1st name Tomoharu
Middle name
Last name ino

Organization

MSD K.K.

Division name

Medical Affairs Vaccine

Zip code

1028667

Address

1-13-12 Kudan-kita Chitaku Tokyo

TEL

03-6272-2049

Email

ldgproject@merck.com


Public contact

Name of contact person

1st name Tomoharu
Middle name
Last name Iino

Organization

MSD K.K.

Division name

Medical Affairs Vaccine

Zip code

1028667

Address

1-13-12 Kudan-kita Chitaku Tokyo

TEL

03-6272-2049

Homepage URL


Email

ldgproject@merck.com


Sponsor or person

Institute

MSD K.K.

Institute

Department

Personal name



Funding Source

Organization

MSD K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The ethics review board of the Medical Corporation Toukeikai Kitamachi Clinic

Address

Kitamachi 1-1-3, Kichijoji, Musashino-shi, Tokyo, Japan

Tel

070-5011-8550

Email

shingo-namiki@j-smo.com


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

2018 Year 06 Month 22 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/32045317

Publication of results

Partially published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/32045317

Number of participants that the trial has enrolled

5085

Results

In total, 1,648 elderly adults had received at least one PPSV23 dose; of these, 58 had received it at least twice (revaccination coverage rate: 3.5%). The most commonly cited justification for revaccination with PPSV23 among the surveyed physicians was that the benefits of revaccination exceed the risks of revaccination.

Results date posted

2020 Year 02 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We asked an array of questions related to PPSV23 revaccination to Elderly adults and doctors across Japan via Web-based surveys in June 2018.

Participant flow

The sampled population consisted of 5,085 men and women aged 65 and older.400 internal medicine physicians were surveyed and asked about their reasons for recommending PPSV23 revaccination to elderly patients.

Adverse events

No adverse event was reported.

Outcome measures

Outcomes assessed were PPSV23 revaccination coverage rate (primary), first-dose coverage rate, and the interval between primary vaccination and revaccination.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 06 Month 01 Day

Date of IRB

2018 Year 06 Month 19 Day

Anticipated trial start date

2018 Year 06 Month 22 Day

Last follow-up date

2018 Year 07 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 12 Month 03 Day


Other

Other related information

Internet based survey
This study is a cross-sectional survey
targeting adults eligible for pneumoco
ccal vaccination 'subjects' and 'doctor
s'


Management information

Registered date

2018 Year 06 Month 21 Day

Last modified on

2020 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=R000037670


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name