NCT06822907

Brief Summary

Streptococcus pneumoniae is responsible for serious infections associated to numerous hospitalizations and high rate of mortality. The incidence and therefore the burden of pneumococcal infections have been significantly reduced thanks to the use of pneumococcal conjugate vaccines (PCVs). PCVs were shown to be effective against vaccine-type serotypes causing both non-invasive and invasive pneumococcal diseases (IPD) in children and adults. PCVs use in children was shown to have an impact on IPD incidence among adults due to herd immunity and on antimicrobial resistance. To increase the protection of at-risk patients against IPD, the 20-valent PCV (PCV-20) is recently recommended in adults, after a period where PCV-13 followed by pneumococcal polysaccharide vaccine 23 valent (PPV-23) was recommended. PCV-20 effectiveness against IPD and against pneumonia was inferred from immunobridging with PCV-13. Indeed PCV-13 was shown effective to reduce the incidence of low respiratory tract infections and IPD (bacteraemia and meningitis) in 65-years-old-adults and older. Currently immunization against S. pneumoniae is recommended with PCV-20 for adult patients at-risk for IPD such as immunocompromised (=high-risk patients) and in immunocompetent people with underlying chronic conditions (cardiovascular, liver, pulmonary, kidney diseases and diabetes mellitus) (=medium risk patients). However, vaccine coverage against IPD in adults remains low globally, and does not exceed 5 % in France. Reducing missed opportunities of vaccination for S. pneumoniae is crucial.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,052

participants targeted

Target at P75+ for phase_4

Timeline
28mo left

Started Dec 2025

Typical duration for phase_4

Geographic Reach
1 country

24 active sites

Status
recruiting

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 Progress18%
Dec 2025Oct 2028

First Submitted

Initial submission to the registry

February 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

December 17, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

February 7, 2025

Last Update Submit

March 25, 2026

Conditions

Acute Febrile IllnessPneumococcal Infections

Keywords

vaccinpneumococcalPrevenar 20Acute febrile illnessinfectionsPCV-20PCV-21

Outcome Measures

Primary Outcomes (1)

  • Proportion of immune "good responders" to PCV-20 in both arms

    Good responders is defined as - a seroconversion (a 2-fold increase in VT IgG after vaccination), for ≥10 vaccine serotypes (VT) among the 13 tested on 20 in ELISA, AND an immune protective response defined as ELISA IgG \> 1,3 μg/mL in ≥ 10 out 13 VT. OR \- -a seroconversion (a 4-fold increase in VT IgG after vaccination), for ≥10 vaccine serotypes (VT) among the 13 tested on 20 in ELISA, AND an immune protective response defined as ELISA IgG \< 1,3 μg/mL in ≥ 10 out 13 VT.

    1 month post vaccination

Secondary Outcomes (13)

  • Safety endpoints in both arms in the month following vaccination : adverse events

    1 month post vaccination

  • Frequency of local reactions

    1 month post vaccination

  • Frequency of systemic events related to the vaccination

    1 month post vaccination

  • Proportion of immune good responders serotype by serotype

    1 month post vaccination

  • opsonophagocytic activity (OPA) IgG titers for serotype by serotype

    1 month post vaccination

  • +8 more secondary outcomes

Study Arms (2)

Early vaccination

EXPERIMENTAL

The patient will receive unique dose of the PCV-20 vaccine as soon as possible and until 72h after apyrexia. The "Prevenar 20" will be used

Biological: Early intervention

Delayed vaccination

ACTIVE COMPARATOR

From 15 days and until 58 days after fever resolution (i.e after the first day with a body temperature \< 37.5°C without paracetamol use in the 6 previous hours) (whether or not the patient has been discharged) in the absence of fever, the patient will receive PCV-20 vaccination The "Prevenar 20" will be used

Biological: Delayed intervention

Interventions

Early interventionBIOLOGICAL

In this arm, patient will receive unique dose of the PCV-20 vaccine (Prevnar 20) as soon as possible and until 72h after apyrexia. The "Prevenar 20" will be used Prevenar 20 will be injected by intramuscular route. The preferred site of injection is the deltoid muscle of the upper arm in adults.

Early vaccination
Delayed interventionBIOLOGICAL

In this arm, from 15 days and until 58 days after fever resolution (i.e after the first day with a body temperature \< 37.5°C without paracetamol use in the 6 previous hours) (whether or not the patient has been discharged) in the absence of fever, the patient will receive unique dose of the PCV-20 vaccine (Prevnar 20). The "Prevenar 20" will be used Prevenar 20 will be injected by intramuscular route. The preferred site of injection is the deltoid muscle of the upper arm in adults.

Delayed vaccination

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of body temperature ≥ 38°C measured at least twice prior to randomization (Randomization must be performed as soon as possible on a febrile patient or 72 hours after apyrexia at the latest)
  • Having at least one comorbidity that defines patients as medium or high risk for pneumococcal invasive infection:
  • Medium risk: Cyanogenic congenital heart disease; chronic heart failure; chronic respiratory failure; chronic obstructive pulmonary disease; emphysema; severe asthma under chronic treatment; chronic renal failure; chronic liver disease; diabetes mellitus treated; Osteo-meningeal leak or cochlear implant; Age \> 65 years old.
  • High risk : Hypo or asplenic people; hereditary immunodeficiency syndromes; people living with HIV; solid organ transplanted; People under immunosuppressors (corticosteroids, biotherapy) for an auto-immune or an inflammatory chronic disease; patients with nephrotic syndrome
  • Hospitalization for \> 24 hours long
  • Social security affiliation
  • Signed informed consent

You may not qualify if:

  • Patient unable to give informed consent
  • Curators, wardship
  • History of previous vaccination with PCV-7 or PCV-13 or PCV-20
  • History of PPV-23 in the previous year
  • Patient with history of bone marrow transplantation
  • Patient with haematological malignancies
  • Patient under chemotherapy for solid tumor or with a history of chemotherapy in the past three months
  • Patient treated with Rituximab currently or in the past 6 months
  • Patient with Sequential Organ Failure Assessment (qSOFA ) score ≥ 2 at randomization (acute severe febrile illness)
  • Patient hospitalized in an Intensive Care Unit
  • Pregnancy
  • Breastfeeding woman
  • Recipients of polyclonal gammaglobulins in the past three months
  • Inability to follow the protocol
  • Bleeding disorder contra-indicating intramuscular injection according to the investigator
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

CHU de Saint-Etienne

Saint-Etienne, France, 42055, France

RECRUITING

Centre Hospitalier

Annecy, 74000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Besançon, 25000, France

NOT YET RECRUITING

Centre Hospitalier

Bordeaux, 33000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Brest, 29609, France

NOT YET RECRUITING

Centre Hospitalier

Brest, 29609, France

NOT YET RECRUITING

Centre Hospitalier General Metropole Savoie

Chambéry, 73011, France

NOT YET RECRUITING

Centre Hospitalier de Creteil

Créteil, 94000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Dijon, 21000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Grenoble, 38043, France

NOT YET RECRUITING

Centre Hospitalier

La Roche-sur-Yon, 85925, France

NOT YET RECRUITING

Centre Hospitalier General

Le Mans, 72000, France

NOT YET RECRUITING

Centre Hospitalier

Le Puy-en-Velay, 43000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Lille, 59037, France

NOT YET RECRUITING

Hospices Civils de Lyon

Lyon, 69004, France

NOT YET RECRUITING

Centre Hospitalier Regional Universitaire

Montpellier, 34295, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Nancy, 54511, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Nantes, 44093, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Nice, 06202, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Nîmes, 30029, France

NOT YET RECRUITING

Centre Hospitalier Bichat

Paris, 75012, France

NOT YET RECRUITING

Assistance Publique Hopitaux de Paris

Paris, 75679, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Rennes, 35000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Rouen, 76000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Pneumococcal InfectionsInfections

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Elisabeth BOTELHO-NEVERS, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth BOTELHO-NEVERS, MD PhD

CONTACT

(0)477829234Elisabeth.Botelho-Nevers@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective Randomised Open Blinded End-point trial (PROBE) Non inferiority design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 12, 2025

Study Start

December 17, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(24)