Vaccination of Children Following Allogeneic Stem Cell Transplantation
Immunogenicity 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
1 other identifier
interventional
53
1 country
11
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 pediatric recipients of allogeneic haematopoietic stem cell transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2003
Typical duration for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedJune 7, 2012
June 1, 2012
2.8 years
September 13, 2005
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serologic response at 1 months following primary three dose vaccination series
first month
Secondary Outcomes (3)
serologic response at 1 months following booster immunization
first month
tolerability of primary and booster vaccination
at least monthly
identification of factors influencing immunogenicity and tolerability of study vaccines
at least monthly
Interventions
Eligibility Criteria
You may qualify if:
- pediatric recipient of allogeneic haematopoietic stem cell transplantation
- complete remission of underlying malignant disease (if applicable)
- stable haematopoietic engraftment
- Lansky-/Karnofsky-score \>= 60%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heinrich-Heine University, Duesseldorflead
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
- GlaxoSmithKlinecollaborator
Study Sites (11)
University Childrens Hospital
Berlin, D-13353, Germany
University Children Hospital
Düsseldorf, D-40225, Germany
University Children Hospital
Erlangen, D-91054, Germany
University Children Hospital
Frankfurt, D-60590, Germany
University Childrens Hospital
Freiburg im Breisgau, D-79106, Germany
University Childrens Hospital
Giessen, D-35385, Germany
University Childrens Hospital
Hamburg, D-20246, Germany
University Childrens Hospital
Hanover, D-30625, Germany
University Childrens Hospital
Jena, D-07740, Germany
University Childrens Hospital
Münster, D-48129, Germany
University Childrens Hospital
Tübingen, D-72076, Germany
Related Publications (4)
Meisel R, Laws HJ, Dilloo D. Vaccination of pediatric recipients of allogeneic hematopoietic stem cell grafts using a hexavalent combination vaccine and a pneumococcal conjugate vaccine - a prospective trial of the PÄD-AG-KBT - Bone Marrow Transplantation 30(S1): S63, 2002 (abstract)
BACKGROUNDMeisel R, Dilloo D. Pneumococcal vaccination of children after hematopoietic stem cell transplantation: timing is crucial. Clin Infect Dis. 2007 Aug 1;45(3):397-8; author reply 398-9. doi: 10.1086/518981. No abstract available.
PMID: 17599322BACKGROUNDHilgendorf I, Freund M, Jilg W, Einsele H, Gea-Banacloche J, Greinix H, Halter J, Lawitschka A, Wolff D, Meisel R. Vaccination of allogeneic haematopoietic stem cell transplant recipients: report from the international consensus conference on clinical practice in chronic GVHD. Vaccine. 2011 Apr 5;29(16):2825-33. doi: 10.1016/j.vaccine.2011.02.018. Epub 2011 Feb 20.
PMID: 21345379BACKGROUNDMeisel R, Kuypers L, Dirksen U, Schubert R, Gruhn B, Strauss G, Beutel K, Groll AH, Duffner U, Blutters-Sawatzki R, Holter W, Feuchtinger T, Gruttner HP, Schroten H, Zielen S, Ohmann C, Laws HJ, Dilloo D; Impfung von Kindern nach allogener Stammzelltransplantation (IKAST) Study Group. Pneumococcal conjugate vaccine provides early protective antibody responses in children after related and unrelated allogeneic hematopoietic stem cell transplantation. Blood. 2007 Mar 15;109(6):2322-6. doi: 10.1182/blood-2006-06-032284. Epub 2006 Nov 7.
PMID: 17090650RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dagmar Dilloo, MD, PhD
University Hospital Duesseldorf, Department of Pediatric Oncolgy, Hematolgy and Immunology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
September 1, 2003
Primary Completion
June 1, 2006
Study Completion
October 1, 2006
Last Updated
June 7, 2012
Record last verified: 2012-06