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LAIV effect on Pneumococcal Carriage
NCT03502291Phase 4
Key facts
- Status
- Completed
- Start
- Aug 2015
- Primary completion
- May 2017
- Countries
- 1
- Sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- influenza
01
Overview
Phase 4, randomised, double-blind trial of live attenuated influenza vaccine in influenza (4 arms), sponsored by Liverpool University Hospitals NHS Foundation Trust. Primary endpoint: Detection of pneumococcal bacteria in the nasal wash sample at 6 weeks. Started Aug 2015; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Study One: LAIV + Inoculation
LAIV Nasal Spray + IM Placebo then Pneumococcal Inoculation
Study One: Placebo + Inoculation
QIV IM + Nasal Placebo then Pneumococcal Inoculation
Study Two: Inoculation + LAIV
Pneumococcal Inoculation then LAIV Nasal Spray + IM Placebo
Study Two: Inoculation + placebo
Pneumococcal Inoculation then QIV IM + Nasal Placebo
03
Endpoints
Primary
Detection of pneumococcal bacteria in the nasal wash sample
Secondary
Pneumococcal carriage density
Pneumococcal carriage duration
Clinical symptoms
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