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Tests treatment safety and results for Acute Febrile Illness
Official title Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults
ClinicalTrials.gov ID: NCT06822907
What this study is testing
What is Early intervention?
Early intervention is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for acute febrile illness.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- History of body temperature ≥ 38°C measured at least twice prior to randomization (Randomization must be performed as soon as possible on a febrile...
- 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 respiratory failure; chronic obstructive pulmonary disease...
- High risk : Hypo or asplenic people; hereditary immunodeficiency syndromes; people living with HIV; solid organ transplanted; People under...
- Hospitalization for \> 24 hours long
You likely can't join if
- Patient unable to give informed consent
- Curators, 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...
- Patient with history of bone marrow transplantation
See the full eligibility criteria
- 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 respiratory failure; chronic obstructive pulmonary disease; emphysema; severe asthma under chronic treatment; chronic renal failure...
- 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...
- Hospitalization for \> 24 hours long
- Social security affiliation
- Signed informed consent
- Patient unable to give informed consent
- Curators, 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 vaccine.
- Patient with history of bone marrow transplantation
- Patient with haematological 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
- Patient with Sequential Organ Failure Assessment (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.
- S. pneumoniae infection with laboratory confirmation (blood culture, culture from a sterile site, urinary or Cerebrospinal fluid antigens, sputum culture with \> 10\^7 colony forming unit (CFU)/mL) being the cause of...
The study team makes the final eligibility decision.
Where it's taking place
- Saint-Etienne, France, France
- Annecy, France
- Besançon, France
- Bordeaux, France
- Brest, France
- Chambéry, France
- Créteil, France
- Dijon, France
- Grenoble, France
- La Roche-sur-Yon, France
- Le Mans, France
- Le Puy-en-Velay, France
- Lille, France
- Lyon, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Nice, France
- Nîmes, France
- Paris, France
+ 2 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint-Etienne, France, France; Annecy, France; Besançon, France; Bordeaux, France; Brest, France; Chambéry, France and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.