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Sequential Versus Simultaneous Pneumococcal Vaccination in Elderly: Immunological Memory and Antibody Levels

Pneumococcal Infections Clinical Trial

Official title:
Sequential Versus Simultaneous Vaccination With Pneumococcal Conjugate Vaccine (Prevenar 13) and Pneumococcal Polysaccharide Vaccine (Pneumovax 23) in Elderly: Immunological Memory and Antibody Levels

Clinical Trial Summary

The purpose of the present study is to compare the immunological response of pneumococcal serotype specific B-cells, the humoral immune response and safety after sequential vaccination versus simultaneous vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent polysaccharide vaccine (PPV23) versus single vaccination with PPV23 in a prospective, randomized controlled monocentric head-to head clinical study in elderly. The hypothesis of this study is that simultaneous vaccination with PCV13 and PPV23 might achieve an improved immune-response compared to sequential vaccination or single vaccination. Adults >=60 years without previous pneumococcal vaccination will be randomized in three groups and receive either PCV13 on day 0 plus PPV23 6 months later (sequential vaccination) or they receive PCV13 plus PPV23 simultaneous on day 0 (simultaneous vaccination) or they receive PPV23 on day 0 (single vaccination). Blood will be taken for pneumococcal serotype-specific B-memory cells against four vaccine-serotypes (ST), included in PCV13 and PPV23, vaccine-serotype 3 (ST3), vaccine-serotype 14 (ST14), vaccine-serotype 19A (ST19A) and vaccine-serotype 23F (ST23F) at visit 1, 2,4,5,7 and 8 and for antibody levels against the 12 vaccine-serotypes included in PCV13 and PPV23 at visit 1, 3, 4, 6, 7 and 8 in all three groups. Adverse events will be recorded for 28 days after each vaccination.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02637583
Study type Interventional
Source Jena University Hospital
Contact
Status Completed
Phase Phase 4
Start date October 18, 2017
Completion date November 6, 2023
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