Ignite Creation Date:
2024-05-06 @ 7:57 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02637583
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2015-10-21
Brief Title:
Sequential Versus Simultaneous Pneumococcal Vaccination in Elderly Immunological Memory and Antibody Levels
Sponsor:
Jena University Hospital
Organization:
Jena University Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 2457 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
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 2457 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None