Vaccination of Children Following Allogeneic Stem Cell Transplantation
Phase 3
Completed
- Conditions
- Allogeneic Haematopoietic Stem Cell Transplantation
- Registration Number
- NCT00169728
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method serologic response at 1 months following primary three dose vaccination series first month
- Secondary Outcome Measures
Name Time Method serologic response at 1 months following booster immunization first month tolerability of primary and booster vaccination at least monthly identification of factors influencing immunogenicity and tolerability of study vaccines at least monthly
Trial Locations
- Locations (2)
University Childrens Hospital
🇩🇪Tübingen, Germany
University Children Hospital
🇩🇪Frankfurt, Germany