Supplementary immunization after hematopoietic stem cell transplantation for patients not reponding at M3.

Phase 1

Conditions: Our aim is to determine whether an additional dose of inactivated vaccine can increase the rate of responders among patients who have not responded adequately after 3 injections
MedDRA version: 20.0Level: LLTClassification code 10067859Term: Allogenic stem cell transplantationSystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2017-003523-30-FR

Lead Sponsor: niversity Hospital Grenoble

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

- Age greater than or equal to 18 years
- Realization of an allograft of haematopoietic stem cells at least 6 months, and at the most 24 months before inclusion
- Discontinuation of immunosuppressive therapy for at least 3 months
- Absence of GVH superior to grade I at the initiation of vaccination
- Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnant, parturient or nursing women
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, subject to administrative or judicial supervision
- Patients who received supplementation in the last 3 months with multivalent immunoglobulins, or for whom this treatment is planned
- Contra-indication to Infanrix hexa® (hypersensitivity during an earlier injection)
- Fever (=38 ° C) during consultation (delays inclusion at 1 week)