National, Non Interventional Study of Invasive Pneumococc... | NCT04664556

Studies
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns

NCT04664556

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Status

Recruiting

Last Update Posted

Apr 28, 2026Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Pneumococcal Infections
Pneumococcal Conjugate Vaccine
Antibiotic Treatment
Mortality

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2010Actual

Primary Completion Date

Jan 1, 2030Estimated

Completion Date

Jan 1, 2030Estimated

First Submitted Date

Dec 7, 2020

First Submission Date that Met QC Criteria

Dec 7, 2020

First Posted Date

Dec 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2026

Last Update Posted Date

Apr 28, 2026Actual

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Levy Corinne	Contact	1 48 85 04 04	+33	corinne.levy@activ-france.fr
Bechet Stephane	Contact	1 48 85 96 68	+33	stephane.bechet@activ-france.fr

Overall Officials

Name	Affiliation	Role
Levy Corinne	Association Clinique Thérapeutique Infantile du val de Marne	Study Director
Cohen Robert	Association Clinique Thérapeutique Infantile du val de Marne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ACTIV	Recruiting	Créteil		94000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40492721	Result	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.

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses