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Vaccination of Children Following Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169728
First Posted: September 15, 2005
Last Update Posted: June 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
GlaxoSmithKline
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • serologic response at 1 months following booster immunization [ Time Frame: first month ]
  • tolerability of primary and booster vaccination [ Time Frame: at least monthly ]
  • identification of factors influencing immunogenicity and tolerability of study vaccines [ Time Frame: at least monthly ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: June 7, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs