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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa | Biological | |||
| heptavalent pneumococcal conjugate vaccine, Prevenar | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| serologic response at 1 months following primary three dose vaccination series | first month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dagmar Dilloo, MD, PhD | University Hospital Duesseldorf, Department of Pediatric Oncolgy, Hematolgy and Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Childrens Hospital | Berlin | D-13353 | Germany | |||
| University Children Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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) | ||
| 17599322 | Background | Meisel R, Dilloo D. Pneumococcal vaccination of children after hematopoietic stem cell transplantation: timing is crucial. Clin Infect Dis. 2007 Aug 1;45(3):397-8; author reply 398-9. doi: 10.1086/518981. No abstract available. | |
| 21345379 |
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| at least monthly |
| Düsseldorf |
| D-40225 |
| Germany |
| University Children Hospital | Erlangen | D-91054 | Germany |
| University Children Hospital | Frankfurt | D-60590 | Germany |
| University Childrens Hospital | Freiburg im Breisgau | D-79106 | Germany |
| University Childrens Hospital | Giessen | D-35385 | Germany |
| University Childrens Hospital | Hamburg | D-20246 | Germany |
| University Childrens Hospital | Hanover | D-30625 | Germany |
| University Childrens Hospital | Jena | D-07740 | Germany |
| University Childrens Hospital | Münster | D-48129 | Germany |
| University Childrens Hospital | Tübingen | D-72076 | Germany |
| Background |
| Hilgendorf I, Freund M, Jilg W, Einsele H, Gea-Banacloche J, Greinix H, Halter J, Lawitschka A, Wolff D, Meisel R. Vaccination of allogeneic haematopoietic stem cell transplant recipients: report from the international consensus conference on clinical practice in chronic GVHD. Vaccine. 2011 Apr 5;29(16):2825-33. doi: 10.1016/j.vaccine.2011.02.018. Epub 2011 Feb 20. |
| 17090650 | Result | Meisel R, Kuypers L, Dirksen U, Schubert R, Gruhn B, Strauss G, Beutel K, Groll AH, Duffner U, Blutters-Sawatzki R, Holter W, Feuchtinger T, Gruttner HP, Schroten H, Zielen S, Ohmann C, Laws HJ, Dilloo D; Impfung von Kindern nach allogener Stammzelltransplantation (IKAST) Study Group. Pneumococcal conjugate vaccine provides early protective antibody responses in children after related and unrelated allogeneic hematopoietic stem cell transplantation. Blood. 2007 Mar 15;109(6):2322-6. doi: 10.1182/blood-2006-06-032284. Epub 2006 Nov 7. |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D004165 | Diphtheria |
| D011051 | Poliomyelitis |
| D014917 | Whooping Cough |
| D006509 | Hepatitis B |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D016871 | Pasteurellaceae Infections |
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| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
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