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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012017
Receipt No. 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 2015/10/10

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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
Email 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
Email shimakaz@juntendo.ac.jp

Sponsor
Institute Department of Cardiology, Juntendo University School of Medicine
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2013 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 10 Day
Last modified on
2015 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014039

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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