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Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients.
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
This research is a multi-center French randomized and double blind phase IIb clinical trial evaluating 2 revaccination strategies against pneumococcal infections among splenectomised patients. The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus PPS23 alone) in splenectomised adults.
Official title: Evaluation of Immunological Response Following a Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2019-08-27
Completion Date
2024-05-16
Last Updated
2026-07-01
Healthy Volunteers
No
Conditions
Interventions
Prevenar13 (PCV13) and Pneumovax (PPS23)
One dose of PCV13 at Month 0 and one dose of PPS23 at Month 12
Placebo / Pneumovax (PPS23)
One dose of Placebo at Month 0 and one dose of PPS23 at Month 12
Blood sample
an additional 5 mL sample of blood at one of the visits, preferably at the first visit, concerning patients included in Parisian centers who did not participate in SPLENEVAC 1 study.
Locations (1)
CIC 1417 Cochin-Pasteur - GH Broca-Cochin-Hôtel-Dieu
Paris, France