Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors (NCT03565159) | Clinical Trial Compass
CompletedPhase 4
Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors
United Kingdom214 participantsStarted 2018-08-02
Plain-language summary
The VACIRiSS trial is a phase-IV, multi-centre placebo controlled randomised trial of conjugate pneumococcal vaccine in adult sepsis survivors.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria:
Patients who meet all the following inclusion criteria are eligible to participate in the trial.
* Male or female adult patients aged 18 years or older on the date of screening for the trial
* Registered with a General Practitioner
* Reason for admission to intensive care unit or high dependence unit (HDU) was sepsis
* Clinical condition has improved and the patient is ready for step down to HDU or ward based care in the next 24 - 48 hours
* Provision of written informed consent by the patient OR by patient's Legal Representative OR Professional Consultee.
Exclusion Criteria:
Patients who meet one or more of the following will be excluded from the trial.
* Core temperature ≥38.0°C within the past 24 hours prior to study IMP administration. As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
* Hypersensitivity reaction (e.g., anaphylaxis) to any component of Prevenar 13 or any diphtheria toxoid-containing vaccine.
* Recent vaccination defined as any vaccination administered to subjects within 7 days of enrolment.
* Pregnant and lactating women.
* Limitations of care set including not for resuscitation, not for readmission to critical care.
* Residence in a nursing home, long-term care facility, or other institution, or requirement of semiskilled nursing care. (A…