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Pneumo 2: PCV-13 and PPV-23 on Pneumococcal Colonisation
NCT04974294Phase 4
Key facts
- Status
- Unknown
- Start
- Jul 2021
- Primary completion
- Jul 2023
- Countries
- 1
- Sponsor
- Liverpool School of Tropical Medicine
- Modality
- Split/Subunit Vaccines
- Conditions
- pneumococcal disease
01
Overview
Phase 4, randomised, double-blind trial in pneumococcal disease comparing PCV13, PPV23 and Placebo (3 arms). Primary endpoint: Rate of experimental pneumococcal colonisation with SPN3 at 1 month. Status: unknown.
02
Design
3 arms- Study design
- RandomizedDouble-blind
PCV13
PCV13 Vaccine
PPV23
PPV23 Vaccine
Placebo
Saline Placebo
03
Who it enrols
Healthy adults aged 18-50 without prior pneumococcal vaccination, smoking history, or chronic illnesses.
04
Endpoints
Primary
Rate of experimental pneumococcal colonisation with SPN3
Secondary
Rate of experimental pneumococcal colonisation with SPN6B
Density of pneumococcal colonisation
Duration of pneumococcal colonisation
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