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Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
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.
Official title: Immunogenicity and Safety of the 20-Valent Pneumococcal Conjugate Vaccine (PCV-20) Administered During an Acute Febrile Illness in Adults: a Multicentric Randomized Non-inferiority Trial
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
1052
Start Date
2025-12-17
Completion Date
2028-10-01
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
Early intervention
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.
Delayed intervention
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.
Locations (24)
CHU de Saint-Etienne
Saint-Etienne, France, France
Centre Hospitalier
Annecy, France
Centre Hospitalier Universitaire
Besançon, France
Centre Hospitalier
Bordeaux, France
Centre Hospitalier Universitaire
Brest, France
Centre Hospitalier
Brest, France
Centre Hospitalier General Metropole Savoie
Chambéry, France
Centre Hospitalier de Creteil
Créteil, France
Centre Hospitalier Universitaire
Dijon, France
Centre Hospitalier Universitaire
Grenoble, France
Centre Hospitalier
La Roche-sur-Yon, France
Centre Hospitalier General
Le Mans, France
Centre Hospitalier
Le Puy-en-Velay, France
Centre Hospitalier Universitaire
Lille, France
Hospices Civils de Lyon
Lyon, France
Centre Hospitalier Regional Universitaire
Montpellier, France
Centre Hospitalier Universitaire
Nancy, France
Centre Hospitalier Universitaire
Nantes, France
Centre Hospitalier Universitaire
Nice, France
Centre Hospitalier Universitaire
Nîmes, France
Centre Hospitalier Bichat
Paris, France
Assistance Publique Hopitaux de Paris
Paris, France
Centre Hospitalier Universitaire
Rennes, France
Centre Hospitalier Universitaire
Rouen, France