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

Study acronym: PREV-HOSPIT
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2026 to Dec 17, 2025 · Site details revised at 24 of 24 sitesv7 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2026 to Dec 17, 2025
    • Site details revised at 24 of 24 sites
  2. Primary completion date: Jan 1, 2027 to Oct 1, 2028 Start date: Oct 2025 to Jan 2026 · Completion date: Jan 1, 2028 to Oct 1, 2028 · Collaborators: 1 to 2 · 1 morev6 Show 4 more changesShow less
    • Start date: Oct 2025 to Jan 2026
    • Completion date: Jan 1, 2028 to Oct 1, 2028
    • Collaborators: 1 to 2
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 22 to 24 Start date: Sep 2025 to Oct 2025v5 Show 1 more changeShow less
    • Start date: Sep 2025 to Oct 2025
  4. Start date: May 2025 to Sep 2025 Site details revised at 1 of 22 sitesv4 Show 1 more changeShow less
    • Site details revised at 1 of 22 sites
  5. Start date: Apr 1, 2025 to May 2025 Site details revised at 1 of 22 sitesv3 Show 1 more changeShow less
    • Site details revised at 1 of 22 sites
  6. Site details revised at 1 of 22 sitesv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06822907
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Ministry of Health, France, IREIVAC/COVIREIVAC Network
Conditions Acute Febrile Illness, Pneumococcal Infections
Enrollment 1,052 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov