The VACIRiSS trial is a phase-IV, multi-centre placebo controlled randomised trial of conjugate pneumococcal vaccine in adult sepsis survivors.
The aim of VACIRiSS trial is to evaluate the immunogenicity and heterologous effects of single dose 13-valent conjugate pneumococcal vaccine (PCV-13) in preventing infection related rehospitalisation in sepsis survivors and to collect outcome event data with necessary precision to inform future definitive trial design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
214
Pneumococcal polysaccharide conjugate vaccine
Placebo
Belfast Health and Social Care Trust
Belfast, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Primary - Time to Event
Comparison of the time taken for infection related rehospitalisation or death between intervention and control arms.
Time frame: Up to 365 days
Secondary - Precision Estimates
Outcome event data to inform future definitive trial, including: \- proportion of rehospitalisation
Time frame: Up to 365 days
Secondary - Precision Estimates
\- proportions of reinfections
Time frame: Up to 365 days
Secondary - Precision Estimates
\- proportions of reinfection related rehospitalisation
Time frame: Up to 365 days
Secondary - Precision Estimates
\- time to first all cause rehospitalisation and
Time frame: Up to 365 days
Secondary - Precision Estimates
\- time to first infection requiring antibiotic therapy
Time frame: Up to 365 days
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Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Aneurin Bevan University Health Board
Newport, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
...and 2 more locations