Safety and efficacy of combined pneumococcal and influenza vaccinations in patients with coronary artery disease
- Conditions
- Patients with coronary artery disease
- Registration Number
- JPRN-UMIN000012017
- Lead Sponsor
- Department of Cardiology, Juntendo University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and efficacy for cardiovascular biomarkers
- Secondary Outcome Measures
Name Time Method Prevalence of influenza and pneumococcal infection, changes of complete blood cell count, liver function, renal function, glucose tolerance, and lipid profiles