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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

September 13, 2005
June 6, 2012
September 2003
June 2006   (final data collection date for primary outcome measure)
serologic response at 1 months following primary three dose vaccination series [ Time Frame: first month ] [ Designated as safety issue: No ]
serologic response at 1 months following primary three dose vaccination series
Complete list of historical versions of study NCT00169728 on ClinicalTrials.gov Archive Site
  • 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 ]
  • serologic response at 1 months following booster immunization
  • tolerability of primary and booster vaccination
  • identification of factors influencing immunogenicity and tolerability of study vaccines
Not Provided
Not Provided
 
Vaccination of Children Following Allogeneic Stem Cell Transplantation
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Allogeneic Haematopoietic Stem Cell Transplantation
  • Biological: DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa
  • Biological: heptavalent pneumococcal conjugate vaccine, Prevenar
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
October 2006
June 2006   (final data collection date for primary outcome measure)

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00169728
IKAST-01
Not Provided
Heinrich-Heine University, Duesseldorf
Heinrich-Heine University, Duesseldorf
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • GlaxoSmithKline
Principal Investigator: Dagmar Dilloo, MD, PhD University Hospital Duesseldorf, Department of Pediatric Oncolgy, Hematolgy and Immunology
Heinrich-Heine University, Duesseldorf
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP