National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
IPD
Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France
1 other identifier
observational
2,500
1 country
1
Brief Summary
After 7 then 13 valent pneumococcal conjugate vaccine (PCV) implementation in France in children, we will evaluate the impact of this vaccination on invasive pneumococcal disease (IPD). We will describe the clinical characteristics of IPD, pneumococcus serotyping, underlying conditions and vaccination status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2010
CompletedFirst Submitted
Initial submission to the registry
December 7, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
April 28, 2026
April 1, 2026
19.1 years
December 7, 2020
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Severity of invasive pneumococcal disease
Number of severe cases according to age and pneumococcal serotypes distribution
before hospital discharge
Secondary Outcomes (1)
Impact of vaccines
before hospital discharge
Interventions
Eligibility Criteria
Children with invasive pneumococcal disease for whom the pneumococcal strain is sent to the National reference Center for Pneumococci for serotyping
You may qualify if:
- Isolate of Streptococcus pneumoniae from at least one blood culture, or pleural fluid, or joint fluid, or cerebrospinal fluid or other normally sterile body site, or if there is a positive blood polymerase chain reaction (PCR).
You may not qualify if:
- Pneumococcal strain not transmetted to National Reference Center for Pneumococci or to Regional Pneumococci Observatory
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ACTIV
Créteil, 94000, France
Related Publications (1)
Levy C, Estivaux A, Varon E, Bechet S, Ouldali N, Hau I, Cohen R. Pediatric Invasive Pneumococcal Disease Spectrum Before Third-Generation Pneumococcal Conjugate Vaccine Implementation. J Pediatric Infect Dis Soc. 2025 Aug 7;14(7):piaf056. doi: 10.1093/jpids/piaf056.
PMID: 40492721RESULT
Related Links
- Invasive Disease Potential of Pneumococcal Serotypes in Children After PCV13 Implementation
- Changes in Invasive Pneumococcal Disease Spectrum After 13-Valent Pneumococcal Conjugate Vaccine Implementation
- Pediatric Invasive Pneumococcal Disease Spectrum Before Third-Generation Pneumococcal Conjugate Vaccine Implementation
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Levy Corinne
Association Clinique Thérapeutique Infantile du val de Marne
- PRINCIPAL INVESTIGATOR
Cohen Robert
Association Clinique Thérapeutique Infantile du val de Marne
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2020
First Posted
December 11, 2020
Study Start
December 13, 2010
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2030
Last Updated
April 28, 2026
Record last verified: 2026-04