drugset / Trial / NCT03402776

Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation

NCT03402776

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

EvaluationDrugModalityDoseRoute
Subject Hexavalent vaccine Vaccine