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Immunogenicity and safety of the 20-Valent pneumococcal conjugate vaccine (PCV-20) administered during an acute febrile illness in adults
EU CTIS ID: 2024-517411-73-00
What this study is testing
To demonstrate that the immune response at one month after 20-valent pneumococcal conjugate vaccine (PCV-20) administered during an acute febrile illness is non-inferior to the immune response obtained at one month after PCV-20 administered 15-58 days after resolution of the acute febrile illness in unvaccinated patients at high and medium risk for pneumococcal infections.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 and <85 years-old
- History of body temperature ≥ 38°C measured at least twice prior to randomization (Randomization must be performed as soon as possible on a febrile patient or 72 hours after apyrexia at the latest)
- Having at least one comorbidity that defines patients as medium or high risk for pneumococcal invasive infection: · Medium risk: Cyanogenic congenital heart disease; chronic heart failure; chronic cardiopathy; chronic respiratory failure; chronic obstructive pulmonary disease; emphysema; severe asthma under chronic treatment; chronic renal failure; chronic liver disease; diabetes mellitus treated; Osteo-meningeal leak or cochlear implant ;65 years old and more High risk : Hypo or asplenic people; hereditary immunodeficiency syndromes; people living with HIV; solid organ transplanted; People under immunosuppressors (corticosteroids, biotherapy) for an auto-immune or an inflammatory chronic disease; patients with nephrotic syndrome
- Scheduled hospitalization for > 24 hours long
- Social security affiliation
- Signed informed consent
You likely can't join if
- Patient unable to give informed consent
- S. pneumoniae infection with laboratory confirmation (blood culture, culture from a sterile site, urinary or Cerebrospinal fluid antigens, sputum culture with > 10^7 CFU/mL), if available and if the result is known before randomization.
- Curatorship, wardship
- History of previous vaccination with PCV-7 or PCV-13 or PCV-20
- History of PPV-23 in the previous year
- Patient having received another vaccination within one month prior to inclusion or planning another vaccination in the month after inclusion except for Influenza and and mRNA COVID-19 vaccines.
See the full eligibility criteria
- Age ≥18 and <85 years-old
- History of body temperature ≥ 38°C measured at least twice prior to randomization (Randomization must be performed as soon as possible on a febrile patient or 72 hours after apyrexia at the latest)
- Having at least one comorbidity that defines patients as medium or high risk for pneumococcal invasive infection: · Medium risk: Cyanogenic congenital heart disease; chronic heart failure; chronic cardiopathy; chronic respiratory failure; chronic obstructive pulmonary disease; emphysema; severe asthma under chronic treatment; chronic renal failure; chronic liver disease; diabetes mellitus treated; Osteo-meningeal leak or cochlear implant ;65 years old and more High risk : Hypo or asplenic people; hereditary immunodeficiency syndromes; people living with HIV; solid organ transplanted; People under immunosuppressors (corticosteroids, biotherapy) for an auto-immune or an inflammatory chronic disease; patients with nephrotic syndrome
- Scheduled hospitalization for > 24 hours long
- Social security affiliation
- Signed informed consent
- Patient unable to give informed consent
- S. pneumoniae infection with laboratory confirmation (blood culture, culture from a sterile site, urinary or Cerebrospinal fluid antigens, sputum culture with > 10^7 CFU/mL), if available and if the result is known before randomization.
- Curatorship, wardship
- History of previous vaccination with PCV-7 or PCV-13 or PCV-20
- History of PPV-23 in the previous year
- Patient having received another vaccination within one month prior to inclusion or planning another vaccination in the month after inclusion except for Influenza and and mRNA COVID-19 vaccines.
- Patient with history of bone marrow transplantation
- Patient with haemotological malignancies
- Patient under chemotherapy for solid tumor or with a history of chemotherapy in the past three months
- Patient treated with Rituximab currently or in the past 6 months
- Impossibility of providing comprehensible information to the patient
- Patient with qSOFA score ≥ 2 at randomization (acute severe febrile illness)
- Patient hospitalized in an Intensive Care Unit
- Pregnancy
- Breastfeeding woman
- Recipients of polyclonal gammaglobulins in the past three months
- Inability to follow the protocol
- Bleeding disorder contra-indicating intramuscular injection according to the investigator
- History of allergy to PCV-20 or vaccine-related components.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.