Vaccination of Children Following Allogeneic Stem Cell Transplantation

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Heinrich-Heine University, Duesseldorf Wyeth GlaxoSmithKline
Information provided by:	Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:	NCT00169728

Purpose

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.

Condition	Intervention	Phase
Allogeneic Haematopoietic Stem Cell Transplantation	Biological: DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa Biological: heptavalent pneumococcal conjugate vaccine, Prevenar	Phase III

Drug Information available for: Hepatitis B Vaccines Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Infanrix hexa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:

serologic response at 1 months following primary three dose vaccination series

Secondary Outcome Measures:

serologic response at 1 months following booster immunization
tolerability of primary and booster vaccination
identification of factors influencing immunogenicity and tolerability of study vaccines

Estimated Enrollment:	81
Study Start Date:	September 2003

Eligibility

Ages Eligible for Study:	up to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169728

Locations

Germany
University Childrens Hospital
Berlin, Germany, D-13353
University Children Hospital
Duesseldorf, Germany, D-40225
University Children Hospital
Erlangen, Germany, D-91054
University Children Hospital
Frankfurt, Germany, D-60590
University Childrens Hospital
Freiburg, Germany, D-79106
University Childrens Hospital
Tübingen, Germany, D-72076
University Childrens Hospital
Hamburg, Germany, D-20246
University Childrens Hospital
Hannover, Germany, D-30625
University Childrens Hospital
Jena, Germany, D-07740
University Childrens Hospital
Muenster, Germany, D-48129
University Childrens Hospital
Giessen, Germany, D-35385

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

Wyeth

GlaxoSmithKline

Investigators

Principal Investigator:

Dagmar Dilloo, MD, PhD

University Hospital Duesseldorf, Department of Pediatric Oncolgy, Hematolgy and Immunology

More Information

Publications:

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)

Publications indexed to this study:

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. Epub 2006 Nov 7.

Study ID Numbers:	IKAST-01
Study First Received:	September 13, 2005
Last Updated:	February 1, 2006
ClinicalTrials.gov Identifier:	NCT00169728
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Heinrich-Heine University, Duesseldorf:

allogeneic haematopoietic stem cell transplantation
bone marrow transplantation
children
vaccination
invasive pneumococcal disease
tetanus

diphtheria
poliomyelitis
pertussis
Hepatitis B
Haemophilus influenzae type B infection

Study placed in the following topic categories:

Hepatitis
Haemophilus influenzae
Poliomyelitis
Influenza, Human
Hepatitis B

Whooping Cough
Diphtheria
Tetanus
Whooping cough

ClinicalTrials.gov processed this record on January 13, 2009