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Multicenter Pilot Study Evaluating the Immunogenicity of an Innovative Pneumococcal Vaccination Strategy in Splenectomized Adults

NCT02052154 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-11-20

No results posted yet for this study

Summary

Evaluate the immunogenicity of an innovative pneumococcal vaccination strategy in splenectomized adults comprising 1 dose of Prevenar13® conjugate vaccine (PCV) at M0 followed by 1 dose of Pneumo23® or Pneumovax® polysaccharide vaccine (PPSV) at M2. Duration of follow-up of 36 months.

The main endpoint will be the proportion of subjects responsive to 9 of the 13 serotypes common to the PCV and PPSV vaccines, selected because of their frequency in invasive infections in adults in France and their potentially reduced susceptibility to penicillin (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).

Conditions

  • Splenectomized Patients

Interventions

BIOLOGICAL

Prime-boost pneumococcal immunization

2 months between the 2 vaccines

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Hélène COIGNARD-BIEHLER, MD · Service des Maladies Infectieuses et Tropicales, Hôpital Necker-Enfants Malades, APHP

  • Olivier LORTHOLARY, MD, PhD · Service des Maladies Infectieuses et Tropicales, Hôpital Necker-Enfants Malades, APHP

  • Odile LAUNAY, MD, PhD · CIC Vaccinologie Cochin-Pasteur (CIC BT505) - Hôpital Cochin

  • Marc MICHEL, MD, PhD · Service de médecine interne, Hôpital Henri Mondor

  • Frédéric BATTEUX, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Claude-Agnès REYNAUD, PhD · Institut National de la Santé Et de la Recherche Médicale, France

  • Pierre BUFFET, MD, PhD · INTS

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-10
Primary Completion
2016-07-19
Completion
2019-04-02

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 NCT02052154 on ClinicalTrials.gov