UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012017 |
|---|---|
| Receipt number | R000014039 |
| Scientific Title | Safety and efficacy of combined pneumococcal and influenza vaccinations in patients with coronary artery disease |
| Date of disclosure of the study information | 2013/10/11 |
| Last modified on | 2022/08/23 14:53:38 |
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Basic information
Public title
Safety and efficacy of combined pneumococcal and influenza vaccinations in patients with coronary artery disease
Acronym
Safety and efficacy of combined pneumococcal and influenza vaccinations in patients with coronary artery disease
Scientific Title
Safety and efficacy of combined pneumococcal and influenza vaccinations in patients with coronary artery disease
Scientific Title:Acronym
Safety and efficacy of combined pneumococcal and influenza vaccinations in patients with coronary artery disease
Region
| Japan |
Condition
Condition
Patients with coronary artery disease
Classification by specialty
| Cardiology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy for cardiovascular biomarkers of combined pneumococcal and influenza vaccinations in patients with coronary artery disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and efficacy for cardiovascular biomarkers
Key secondary outcomes
Prevalence of influenza and pneumococcal infection, changes of complete blood cell count, liver function, renal function, glucose tolerance, and lipid profiles
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Pneumococcal vaccination
Interventions/Control_2
Influenza vaccination
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who request influenza vaccination
2) Patients with coronary artery disease
(1) Patients with >=50% diameter stenosis diagnosed by coronary angiography
(2) History of myocardial infarction
(3) History of coronary revascularization
Key exclusion criteria
1) History of pneumococcal infection
2) Patients treated with pneumococcal vaccination previously
3) Patients treated with another vaccination within 3 months
4) Patients with allergy against vaccine component, egg, chicken, and chicken-derived ingredients
5) Patients with fever
6) Patients with acute and severe diseases
7) Patients with liver disorder (AST and/or ALT: 2.5 times or larger than upper normal limits)
8) Patients with renal disorder (creatinine level >= 2.0 mg/dL)
9) History of myocardial infarction within 6 months
10) History of coronary revascularization within 3 months
11) Patients with congestive heart failure (NYHA Class III or IV)
12) Patients with poor control diabetes (HbA1c >= 10%)
13) Patients with poor control hypertension (SBP >= 200mmHg or DBP >= 110mmHg)
14) Patients who judged as ineligible by clinical investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Daida |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiology
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
daida@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Shimada |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiology
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
Homepage URL
shimakaz@juntendo.ac.jp
Sponsor or person
Institute
Department of Cardiology, Juntendo University School of Medicine
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
Address
Tel
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
| 2013 | Year | 10 | Month | 11 | 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
| 2013 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 15 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 10 | Day |
Last modified on
| 2022 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014039
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| Registered date | File name |
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