UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038760 |
|---|---|
| Receipt number | 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 | 2022/06/08 15:22:06 |
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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
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
take1nek@yahoo.co.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
42
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
| 2019 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 04 | Day |
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
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043619
