Actively Recruiting

Phase 4
Age: 18Years - 85Years
All Genders
NCT06822907

Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-03-30

1052

Participants Needed

24

Research Sites

145 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire de Saint Etienne

Lead Sponsor

M

Ministry of Health, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of body temperature 38 0C or higher measured at least twice before randomization
  • Randomization to be done as soon as possible on a febrile patient or within 72 hours after fever ends
  • Having at least one comorbidity defining medium or high risk for invasive pneumococcal infection such as cyanogenic congenital heart disease, chronic heart failure, chronic respiratory failure, COPD, emphysema, severe asthma under treatment, chronic kidney or liver disease, treated diabetes, osteo-meningeal leak or cochlear implant, or being over 65 years old (medium risk)
  • Having high risk conditions like absence of spleen, hereditary immunodeficiency, HIV infection, organ transplant, immunosuppressive treatment for autoimmune or inflammatory disease, or nephrotic syndrome
  • Hospitalized for more than 24 hours
  • Affiliated with social security
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Unable to give informed consent
  • Under curatorship or wardship
  • Previous vaccination with PCV-7, PCV-13, or PCV-20
  • Received PPV-23 vaccine within the last year
  • Received another vaccine within one month before or planned vaccination within one month after inclusion except for influenza vaccine
  • History of bone marrow transplantation
  • Having hematological malignancies
  • Receiving chemotherapy for solid tumors currently or within past three months
  • Treated with Rituximab currently or within past 6 months
  • Acute severe febrile illness with qSOFA score 2 or higher at randomization
  • Hospitalized in Intensive Care Unit
  • Pregnant or breastfeeding
  • Received polyclonal gammaglobulins in past three months
  • Unable to follow protocol
  • Bleeding disorder that contraindicates intramuscular injection
  • Allergy to PCV-20 or vaccine components
  • Current confirmed infection with Streptococcus pneumoniae causing hospitalization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 24 locations

1

CHU de Saint-Etienne

Saint-Etienne, France, France, 42055

Actively Recruiting

2

Centre Hospitalier

Annecy, France, 74000

Not Yet Recruiting

3

Centre Hospitalier Universitaire

Besançon, France, 25000

Not Yet Recruiting

4

Centre Hospitalier

Bordeaux, France, 33000

Not Yet Recruiting

5

Centre Hospitalier Universitaire

Brest, France, 29609

Not Yet Recruiting

6

Centre Hospitalier

Brest, France, 29609

Not Yet Recruiting

7

Centre Hospitalier General Metropole Savoie

Chambéry, France, 73011

Not Yet Recruiting

8

Centre Hospitalier de Creteil

Créteil, France, 94000

Not Yet Recruiting

9

Centre Hospitalier Universitaire

Dijon, France, 21000

Not Yet Recruiting

10

Centre Hospitalier Universitaire

Grenoble, France, 38043

Not Yet Recruiting

11

Centre Hospitalier

La Roche-sur-Yon, France, 85925

Not Yet Recruiting

12

Centre Hospitalier General

Le Mans, France, 72000

Not Yet Recruiting

13

Centre Hospitalier

Le Puy-en-Velay, France, 43000

Not Yet Recruiting

14

Centre Hospitalier Universitaire

Lille, France, 59037

Not Yet Recruiting

15

Hospices Civils de Lyon

Lyon, France, 69004

Not Yet Recruiting

16

Centre Hospitalier Regional Universitaire

Montpellier, France, 34295

Not Yet Recruiting

17

Centre Hospitalier Universitaire

Nancy, France, 54511

Not Yet Recruiting

18

Centre Hospitalier Universitaire

Nantes, France, 44093

Not Yet Recruiting

19

Centre Hospitalier Universitaire

Nice, France, 06202

Not Yet Recruiting

20

Centre Hospitalier Universitaire

Nîmes, France, 30029

Not Yet Recruiting

21

Centre Hospitalier Bichat

Paris, France, 75012

Not Yet Recruiting

22

Assistance Publique Hopitaux de Paris

Paris, France, 75679

Not Yet Recruiting

23

Centre Hospitalier Universitaire

Rennes, France, 35000

Not Yet Recruiting

24

Centre Hospitalier Universitaire

Rouen, France, 76000

Not Yet Recruiting

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Research Team

E

Elisabeth BOTELHO-NEVERS, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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