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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038760
Receipt No. R000043619
Scientific Title Study of the immunogenicity of 13-valent pneumococcal conjugate vaccine in high-risk patients who were outside recommended ages for routine vaccination
Date of disclosure of the study information 2019/12/02
Last modified on 2019/12/02

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Basic information
Public title Study of the immunogenicity of 13-valent pneumococcal conjugate vaccine in high-risk patients who were outside recommended ages for routine vaccination
Acronym Study of the immunogenicity of PCV13 in high-risk patients
Scientific Title Study of the immunogenicity of 13-valent pneumococcal conjugate vaccine in high-risk patients who were outside recommended ages for routine vaccination
Scientific Title:Acronym Study of the immunogenicity of PCV13 in high-risk patients
Region
Japan

Condition
Condition hematological malignancies and post hematopoietic stem cell transplantations
Classification by specialty
Hematology and clinical oncology Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To invastigate about immunogenicity of 13-valent pneumococcal conjugate vaccine in high-risk patients such as hematological malignancies and post hematopoietic stem cell transplantations who were outside recommended ages for routine vaccination
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We investigate the following three immunological markers before and 1 month, 6 months, 12 months after PCV13 vaccinations.

1. pneumococcal serotype specific IgG concentrations against serotypes which are present in PCV13.
2. pneumococcal serotype specific opsonophagocytic killing assay titers against serotypes which are present in PCV13.
3. the number of pneumococcal serotype specific memory B cells against serotypes which are present in PCV13.

Key secondary outcomes 1. the number of leukocyte and lymphocyte (before and 1 month, 6 months, 12 months after PCV13 vaccinations)
2. serum IgG consentrations and IgG subclasses (before and 12 months after PCV13 vaccinations)
3. pneumococcal detection from nasopharyngeal swab or saliva (before and 12 months after PCV13 vaccinations)
4. the incidence of adverse effects (1 month after PCV13 vaccinations)
5. the incidence of invasive pneumococcal diseases (12 months after PCV13 vaccinations)

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
6 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Patients aged 6-64 years old who have underlying diseases such as hematological malignancies, and post hematopoietic stem cell transplantation.
Patients with prior written consents of PCV13 vaccination suggested from their attending doctor.
Key exclusion criteria Patients who were determined as unsuitable subjects by investigators.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Naruhiko
Middle name
Last name Ishiwada
Organization Medical Mycology Research Center, Chiba University
Division name Department of Infectious Diseases
Zip code 260-8673
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL 043-226-2799
Email ishiwada@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Kenichi
Middle name
Last name Takeshita
Organization Graduate School of Medicine, Chiba University
Division name Department of Pediatrics
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL 043-226-2144
Homepage URL
Email take1nek@yahoo.co.jp

Sponsor
Institute Chiba university
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba university School of Medicine IRB
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel 043-222-7171
Email inohana-rinri@chiba-u.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

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 02 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 05 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information investigate host immunogenecities of pneumococcus before and after receiving PCV13, and observe the incidence of invasive pneumococcal
disease for one year.

Management information
Registered date
2019 Year 12 Month 02 Day
Last modified on
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043619

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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