ClinicalTrials.Veeva

Menu

Vaccination of Children Following Allogeneic Stem Cell Transplantation

H

Heinrich-Heine University, Duesseldorf

Status and phase

Completed
Phase 3

Conditions

Allogeneic Haematopoietic Stem Cell Transplantation

Treatments

Biological: DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa
Biological: heptavalent pneumococcal conjugate vaccine, Prevenar

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00169728
IKAST-01

Details and patient eligibility

About

The purpose of this study is to determine the immunogenicity and tolerability of the DTaP-IPV-HBV/Hib combination vaccine Infanrix hexa and the heptavalent pneumococcal conjugate vaccine Prevenar in pediatric recipients of allogeneic haematopoietic stem cell transplantation.

Enrollment

53 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • pediatric recipient of allogeneic haematopoietic stem cell transplantation
  • complete remission of underlying malignant disease (if applicable)
  • stable haematopoietic engraftment
  • Lansky-/Karnofsky-score >= 60%

Exclusion criteria

  • primary immunodeficiency
  • hepatitis B or C, HIV infection
  • application of radio-/ chemotherapy following stem cell transplantation
  • extended chronic graft-versus-host disease (Karnofsky-scale < 60%)
  • coagulopathy
  • known allergy/hypersensitivity towards ingredients of study vaccines
  • seizure disorder, progressive neurologic disease

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

11

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems