Interventional Recruiting Phase 4
NCT04974294 on ClinicalTrials.gov
PREVENTING PNEUMOcoccal Disease Through Vaccination (Study 2)
Official title: A Phase IV Double Blind Randomised Controlled Trial (DBRCT) to Investigate the Effect of PCV-13 and PPV-23 on Pneumococcal Colonisation Using the Experimental Human Pneumococcal Challenge (EHPC) Model in Healthy Adults
- Sponsor: Liverpool School of Tropical Medicine
- Collaborators: Pfizer
- Enrollment: 516 (Estimated)
- Study start: 2021-07-28 (Actual)
- Primary completion: 2023-07-31 (Estimated)
- Study completion: 2023-12-31 (Estimated)
- Allocation: Randomized
- InterventionModel: Crossover
- InterventionModelDescription: double blind RCT
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- PrimaryPurpose: Prevention
Brief Summary
To determine the effect of PCV-13 and PPV-23 vaccination versus control on experimental pneumococcal colonisation of 2 clades of serotypes 3 and 6B at 1 month and 6 months post vaccination respectively, using the EHPC model.
Conditions
- Streptococcus Pneumonia
Intervention / Treatment
- Biological: PPV23
- Biological: PCV13
- Other: Saline for injection
Primary Outcome Measures
-
The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods
(any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.)
The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods at any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.
Countries
United Kingdom
Locations and Investigators
-
Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Recruiting)
- angela hyder wright