Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors
Who is this study for? Adult patients with Sepsis
What treatments are being studied? Prevnar 13-Valent Pneumococcal Conjugate Vaccine
Status: Completed
Location: See all (12) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The VACIRiSS trial is a phase-IV, multi-centre placebo controlled randomised trial of conjugate pneumococcal vaccine in adult sepsis survivors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
⁃ 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.
Locations
Other Locations
United Kingdom
Belfast Health and Social Care Trust
Belfast
Cambridge University Hospitals NHS Foundation Trust
Cambridge
NHS Lothian
Edinburgh
Royal Surrey County Hospital NHS Foundation Trust
Guildford
Guy's and St Thomas' NHS Foundation Trust
London
King's College Hospital NHS Foundation Trust
London
University College London Hospitals NHS Foundation Trust
London
Manchester University NHS Foundation Trust
Manchester
Aneurin Bevan University Health Board
Newport
Oxford University Hospitals NHS Foundation Trust
Oxford
Portsmouth Hospitals NHS Trust
Portsmouth
South Tyneside and Sunderland NHS Foundation Trust
Sunderland
Time Frame
Start Date: 2018-08-02
Completion Date: 2023-08-31
Participants
Target number of participants: 214
Treatments
Active_comparator: Prevenar 13
A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label.
Placebo_comparator: Sodium chloride 0.9%
A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label.
Authors
Related Therapeutic Areas
Sponsors
Leads: Guy's and St Thomas' NHS Foundation Trust
Collaborators: National Institute for Health Research, United Kingdom