Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- History of body temperature 380C 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
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
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
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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