Status:
COMPLETED
Vaccination of Children Following Allogeneic Stem Cell Transplantation
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
GlaxoSmithKline
Conditions:
Allogeneic Haematopoietic Stem Cell Transplantation
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- pediatric recipient of allogeneic haematopoietic stem cell transplantation
- complete remission of underlying malignant disease (if applicable)
- stable haematopoietic engraftment
- Lansky-/Karnofsky-score \>= 60%
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00169728
Start Date
September 1 2003
End Date
October 1 2006
Last Update
June 7 2012
Active Locations (11)
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1
University Childrens Hospital
Berlin, Germany, D-13353
2
University Children Hospital
Düsseldorf, Germany, D-40225
3
University Children Hospital
Erlangen, Germany, D-91054
4
University Children Hospital
Frankfurt, Germany, D-60590