drugset / Trial / NCT02052154

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

NCT02052154

NaSingle-groupOpen-labelPrevention

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Pneumovax 23 Vaccine
Subject Prevnar 13 Vaccine

Indications

No indication recorded.