Vaccination of Children Following Allogeneic Stem Cell Transplantation
This study has been completed.
Sponsor:
Heinrich-Heine University, Duesseldorf
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Drug Information available for:
Boostrix
Heptavalent pneumococcal conjugate vaccine
Adacel
Pneumococcal Vaccines
U.S. FDA Resources
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:
Vaccination schedule for pediatric recipients of allogeneic haematopoietic stem cell transplantation
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)
| 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 May 16, 2013