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COMPLETED
NCT03873727
PHASE2

Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients.

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Prevenar13 (PCV13) and Pneumovax (PPS23)

One dose of PCV13 at Month 0 and one dose of PPS23 at Month 12

BIOLOGICAL

Placebo / Pneumovax (PPS23)

One dose of Placebo at Month 0 and one dose of PPS23 at Month 12

BIOLOGICAL

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