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RECRUITING
NCT06822907
PHASE4

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

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

View on ClinicalTrials.gov

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

BIOLOGICAL

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.

BIOLOGICAL

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