Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04613375
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2020-10-19
Brief Title:
PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Low Intervention Study of the Effectiveness Of 13-Valent Pneumococcal Conjugate Vaccine PCV13 Against Vaccine Type Pneumococcal Hospitalised Community Acquired Pneumonia CAP in Adults 60 Years and Older Using A Test Negative Design Study in A Well-Defined Area of the South of Madrid Region
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Low interventional prospective multicentre hospital-based study involving adults 60 years of age and older hospitalised with CAP at participating sites
Detailed Description:
PCV13 efficacy for the prevention of vaccine-type community-acquired pneumonia VT-CAP and invasive pneumococcal disease IPD was established in the Community-acquired Pneumonia Immunization Trial in Adults CAPITA aged 65 and older However there are still few available real-life effectiveness estimates in adults The aim of this study is to evaluate the PCV13 vaccine effectiveness VE against hospitalised VT-pneumococcal CAP among adults aged 60 years in the Region of Madrid Spain Determination of the effectiveness of PCV13 to prevent hospitalised vaccine-type VT-pneumococcal CAP among adults aged 60 years in Madrid will be evaluated using a test-negative design study overall and among immunocompetent persons only
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIBELES | OTHER | Alias Study Number | None |