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Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation

NCT03402776 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-06-06

No results posted yet for this study

Summary

It is recommended for patients who underwent an hematopoietic stem cell transplantation to receive 6 months after the graft 3 injections of hexavalent vaccine (diphteria-tetanus- poliomyelitis-pertussis-Hib-HBV) within 2 months followed by a booster dose one month after. The patients included in the study will have a measure of their antibody level against 5 pathogens (diphteria toxin, tetanus toxin, Haemophilus influenza b, hepatitis B virus, poliomyelitis virus) one month after the 3rd injection of hexavalent vaccine. If the antibody response is not sufficient, they will be randomized for a 4th dose in the following month. The antibody response will be again measured one month after the 1 year booster dose.

Conditions

  • Haemopoietic Stem Cell Transplantation
  • Allograft

Interventions

DRUG

4th dose of hexavalent vaccine 1 month after the 3rd dose

4th dose of hexavalent vaccine 1 month after the 3rd dose

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    collaborator OTHER

  • University Hospital of Saint-Etienne

    collaborator OTHER

  • Centre Hospitalier Universitaire de Besancon

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Olivier EPAULARD, MD, PhD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-05-31
Completion
2021-05-01

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 NCT03402776 on ClinicalTrials.gov