on-randomized clinical trial to compare the immunogenicity of revaccination with 23-valent pneumococcal polysaccharide vaccine between healthy elderly and those with diabetes in Korea
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005125
- Lead Sponsor
- MSD Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 254
? subjects aged 70-75 years who received PPSV23 in previous 5-7 years, Subjects who after hearing and fully understanding the details of this clinical trial, voluntarily decides to participate and agrees in writing to comply, who is determined to be appropriate to participate in this clinical trial through self-disease, physical examination, and researcher's clinical judgment that can be visited and traced to all predetermined schedules of this clinical trial.
Those who have been identified for pneumococcal infection in the past 5 years, those who have been treated with anti-cancer therapy for malignant tumors within the past 30 days, those who have received high doses of systemic steroids within the past 30 days (Prednisolone>0.5 mg/kg/day ), those who have received a blood product within the past 6 months, patients with significant acute or chronic infections within the past 7 days, or those who have had a fever in the previous day, who have a serious chronic or progressive disease, for medical reasons or other reasons, therefore, the investigator is determined to be unsuitable for participation in the clinical trial.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GMT and seroconversion rates of IgG antibody titers against 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F);GMT and seroconversion rates of opsonophagocytic killing assay (OPA) for 4 pneumococcal serotypes (serotypes 5, 6B, 18C, 19A)
- Secondary Outcome Measures
Name Time Method Evaluation of adverse reactions in the inoculation site such as pain, tenderness, induration, and redness;systemic adverse reactions such as fever, fatigue, muscle pain, and headache;All unexpected adverse events that occur within 1 month after inoculation in addition to the expected adverse events.