Chronic lung disease
Conditions
Interventions
Single vaccination of pneumococcal polysaccharide vaccine (0.5 ml) intramuscularly or subcutaneously.
Sponsors
National Hospital Organization, Tokyo National Hospital
Laboratory of Clinical Research in Infectious Diseases, International Research Center for Infectious Diseases, Research Institute for Microbial Diseases, Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with chronic lung disease of 65 years old and over. 2) Patients who received any multi-valent pneumococcal polysaccharide vaccine more than 5 years prior to the study enrollment. 3) Patients whose blood specimen was collected for antibody titration upon the first vaccination, and has been kept in the clinical study organization. 4) Patients who understand the procedure of this study and give informed consent in written voluntarily before participation in the study.
Exclusion criteria
Exclusion criteria: 1) Patients under treatment of radiotherapy and immunosuppressant at present and/or soon after revaccination. 2) Patients who have fever obviously. 3) Patients who have serious acute diseases obviously. 4) Patients who have ever showed anaphylaxis due to ingredient(s) of this vaccine. 5) Patients who are not appropriate to be vaccinated for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: body temperature, local adverse reaction and systemic symptoms for 6 days after revaccination. Clinical symptom for 14 days after revaccination. Blood tests (both general and biochemical items) for pre- and the 14th day after revaccination. Any other adverse reactions observed for 28 days after revaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: antibody titer on the 28th day after revaccination. | — |
Countries
Japan
Contacts
Public ContactHideaki Nagai M.D., Ph.D.
National Hospital Organization, Tokyo National Hospital Department of Pulmonary Diseases
Outcome results
None listed