Pediatric Invasive Pneumococcal Disease Spectrum Before Third-Generation Pneumococcal Conjugate Vaccine Implementation.
Corinne Levy, Aude Estivaux, Emmanuelle Varon...
https://pubmed.ncbi.nlm.nih.gov/40492721Actively Recruiting
Age: 1Day - 18Years
All Genders
ID04664556
Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France
Led by Association Clinique Thérapeutique Infantile du val de Marne · Updated on 2026-04-28
2500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Association Clinique Thérapeutique Infantile du val de Marne
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of pneumococcal conjugate vaccines (7-valent and 13-valent) on invasive pneumococcal disease (IPD) in children and newborns under 18 years old in France. The study aims to describe the clinical features of IPD, including pneumococcus serotypes, underlying health conditions, and vaccination status. This observational study analyzes data from children hospitalized with IPD, focusing on risk factors, vaccination history, severity signs, treatments during hospitalization, biological tests, and disease location. The study does not involve interventions but collects detailed clinical and laboratory information. Participants will have their clinical and biological data reviewed during their hospital stay. Researchers will assess the severity of IPD before hospital discharge and evaluate the impact of vaccination on the disease. The study continues until 2030, monitoring outcomes related to IPD severity and vaccine effects.
CONDITIONS
Brief Title
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Who Can Participate
Age: 1Day - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 18 years
- Hospitalized with invasive pneumococcal disease (IPD)
- Confirmed isolation of Streptococcus pneumoniae from blood, pleural fluid, joint fluid, cerebrospinal fluid, or other normally sterile body sites, or positive blood PCR for pneumococcus
You will not qualify if you...
- Pneumococcal strain not transmitted to the National Reference Center for Pneumococci or Regional Pneumococci Observatory
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Duration of hospitalization
Participants who are hospitalized with invasive pneumococcal disease are observed to analyze risk factors, vaccination status, severity signs, treatment during hospitalization, biological analysis, and clinical location of the disease.
Data collected during hospital stay
Trial Site Locations
Total: 1 location
1
ACTIV
Créteil, France, 94000
Actively Recruiting
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Research Team
L
Levy Corinne
B
Bechet Stephane
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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