National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns (IPD)

April 23, 2026 updated by: Association Clinique Thérapeutique Infantile du val de Marne

Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For children under 18, hospitalized for IPD, the following data will be analyzed: risk factors, vaccination status, severity signs , treatment during hospitalization, biological analysis, the clinical location of the disease.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children with invasive pneumococcal disease for whom the pneumococcal strain is sent to the National reference Center for Pneumococci for serotyping

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Pneumococcal strain not transmetted to National Reference Center for Pneumococci or to Regional Pneumococci Observatory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort of invasive pneumococcal disease in children
Other: observational study
observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of invasive pneumococcal disease
Time Frame: before hospital discharge
Number of severe cases according to age and pneumococcal serotypes distribution
before hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of vaccines
Time Frame: before hospital discharge
Number of invasive pneumococcal disease according to vaccine serotypes
before hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Collaborators

Pfizer

Investigators

  • Study Director: Levy Corinne, Association Clinique Thérapeutique Infantile du val de Marne
  • Principal Investigator: Cohen Robert, Association Clinique Thérapeutique Infantile du val de Marne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2010

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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