Clinical trial NCT00169728: Vaccination of Children Following Allogeneic Stem Cell Transplantation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allogeneic Haematopoietic Stem Cell Transplantation
Keywords: allogeneic haematopoietic stem cell transplantation
bone marrow transplantation
children
vaccination
invasive pneumococcal disease
tetanus
diphtheria
poliomyelitis
pertussis
Hepatitis B
Haemophilus influenzae type B infection
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
name: GlaxoSmithKline
First posted: 2005-09-15
Enrollment: 53
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: serologic response at 1 months following primary three dose vaccination series
timeFrame: first month
Secondary outcomes:
measure: serologic response at 1 months following booster immunization
timeFrame: first month
measure: tolerability of primary and booster vaccination
timeFrame: at least monthly
measure: identification of factors influencing immunogenicity and tolerability of study vaccines
timeFrame: at least monthly
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: University Childrens Hospital
city: Duesseldorf
country: Germany
facility: University Children Hospital
city: Erlangen
country: Germany
facility: University Children Hospital
city: Frankfurt
country: Germany
facility: University Children Hospital
city: Freiburg
country: Germany
facility: University Childrens Hospital
city: Giessen
country: Germany
facility: University Childrens Hospital
city: Hamburg
country: Germany
facility: University Childrens Hospital
city: Hannover
country: Germany
facility: University Childrens Hospital
city: Jena
country: Germany
facility: University Childrens Hospital
city: Muenster
country: Germany
facility: University Childrens Hospital
city: Tübingen
country: Germany
facility: University Childrens Hospital
Study officials:
affiliation: University Hospital Duesseldorf, Department of Pediatric Oncolgy, Hematolgy and Immunology
name: Dagmar Dilloo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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)
citation: Meisel 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.
citation: Hilgendorf 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.
citation: Meisel 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.