Pneumococcal InfectionsIPDNCT04664556
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
An observational study of Pneumococcal Infections and Pneumococcal Conjugate Vaccine, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Pneumococcal Infections, Pneumococcal Conjugate Vaccine, Antibiotic Treatment
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2010to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with invasive pneumococcal disease for whom the pneumococcal strain is sent to the National reference Center for Pneumococci for serotyping
Who may be able to join
- 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).
Who cannot join
- Pneumococcal strain not transmetted to National Reference Center for Pneumococci or to Regional Pneumococci Observatory
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ACTIV
Créteil, 94000
Corinne Levy, MD, 0033148850404, corinne.levy@activ-france.fr
Stéphane Béchet, MSc, 0033148850404, stephane.bechet@activ-france.fr
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Pneumococcal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of invasive pneumococcal disease
Number of severe cases according to age and pneumococcal serotypes distribution
Measured: before hospital discharge
Secondary outcomes (1)
Impact of vaccines
Number of invasive pneumococcal disease according to vaccine serotypes
Measured: before hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start13 Dec 2010
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Levy Corinne, Study director, Association Clinique Thérapeutique Infantile du val de MarneCohen Robert, Principal investigator, Association Clinique Thérapeutique Infantile du val de Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664556
- Sponsor's protocol ID
- IPD
- Acronym
- IPD
- Status last verified
- Oct 2026
- First submitted
- 7 Dec 2020
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40492721
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France
- ClinicalTrials.gov ID
- NCT04664556
- Acronym / sponsor ID
- IPD / IPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 13 Dec 2010 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with invasive pneumococcal disease for whom the pneumococcal strain is sent to the National reference Center for Pneumococci for serotyping
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Pneumococcal strain not transmetted to National Reference Center for Pneumococci or to Regional Pneumococci Observatory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of invasive pneumococcal disease
Time frame: before hospital discharge
Number of severe cases according to age and pneumococcal serotypes distribution
1 secondary outcome
Impact of vaccines
Time frame: before hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Results publication: PubMed 40492721Levy 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.
- Invasive Disease Potential of Pneumococcal Serotypes in Children After PCV13 ImplementationLink provided by the sponsor.
- Changes in Invasive Pneumococcal Disease Spectrum After 13-Valent Pneumococcal Conjugate Vaccine ImplementationLink provided by the sponsor.
- Pediatric Invasive Pneumococcal Disease Spectrum Before Third-Generation Pneumococcal Conjugate Vaccine ImplementationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Levy Corinne study director
Association Clinique Thérapeutique Infantile du val de Marne
Cohen Robert principal investigator
Association Clinique Thérapeutique Infantile du val de Marne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Infections and Pneumococcal Conjugate Vaccine, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Levy Corinne (1 48 85 04 04 ext. +33, corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of invasive pneumococcal disease (time frame: before hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04664556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.