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

NCT03873727 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-10-12

No results posted yet for this study

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.

Conditions

  • Splenectomised Patients

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.

Sponsors & Collaborators

  • EUCLID Clinical Trial Platform

    collaborator OTHER

  • Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

    collaborator OTHER

  • CIC 1417 Cochin-Pasteur

    collaborator OTHER

  • I-REIVAC Innovative Clinical Research Network In Vaccinology

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Odile Launay, MD,PhD · CIC 1417 Clinical Center Investigation - Cochin Hospital, AP-HP

  • Olivier Lortholary, Md,PhD · Service des Maladies Infectieuses et Tropicales, Necker-Enfants malades Hospital, AP-HP

  • Hélène Coignard-Biehler, MD,PhD · COREB - Hospices Civils de Lyon

  • Marc Michel, MD,PhD · Service de médecine interne, Henri Mondor Hospital, APHP

  • Benjamin Rossi, MD · Service de Médecine interne et de Maladies infectieuses, Robert Ballanger Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2023-06-30
Completion
2024-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03873727 on ClinicalTrials.gov