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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 July 22, 2014