drugset / Trial / NCT03402776
Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation
Phase 3
Unknown
200 enrolled
University Hospital, Grenoble
Centre Hospitalier Universitaire de Besancon · collabCentre Hospitalier Universitaire de Nice · collabUniversity Hospital of Saint-Etienne · collabUniversity Hospital, Clermont-Ferrand · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2018-05-01
- Primary completion
- 2020-05-31
- Completion
- 2021-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hexavalent vaccine | Vaccine | — | — |