Vaccination of Children Following Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
GlaxoSmithKline
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00169728
First received: September 13, 2005
Last updated: June 6, 2012
Last verified: June 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • serologic response at 1 months following primary three dose vaccination series [ Time Frame: first month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serologic response at 1 months following booster immunization [ Time Frame: first month ] [ Designated as safety issue: No ]
  • tolerability of primary and booster vaccination [ Time Frame: at least monthly ] [ Designated as safety issue: Yes ]
  • identification of factors influencing immunogenicity and tolerability of study vaccines [ Time Frame: at least monthly ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: September 2003
Study Completion Date: October 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 17 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
Giessen, Germany, D-35385
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
Tübingen, Germany, D-72076
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Wyeth is now a wholly owned subsidiary of Pfizer
GlaxoSmithKline
Investigators
Principal Investigator: Dagmar Dilloo, MD, PhD University Hospital Duesseldorf, Department of Pediatric Oncolgy, Hematolgy and Immunology
  More Information

Additional Information:
Publications:
Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT00169728     History of Changes
Other Study ID Numbers: IKAST-01
Study First Received: September 13, 2005
Last Updated: June 6, 2012
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

ClinicalTrials.gov processed this record on April 16, 2014