Clinical study on revaccination with pneumococcal polysaccharide vaccine. -Safety and immunogenicity of revaccination

Not Applicable

• Conditions: Chronic lung disease

• Registration Number: JPRN-UMIN000002439
• Lead Sponsor: ational Hospital Organization, Tokyo National Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-03
• Study Completion: 2009-11-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Immunogenicity: antibody titer on the 28th day after revaccination.