Vaccination of Children Following Allogeneic Stem Cell Transplantation

Allogeneic Haematopoietic Stem Cell Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169728
• Other study ID #: IKAST-01
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 6, 2012
• Start date: September 2003
• Est. completion date: October 2006

Study information

• Verified date: June 2012
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allogeneic Haematopoietic Stem Cell Transplantation

Intervention

Biological:
• DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa

• heptavalent pneumococcal conjugate vaccine, Prevenar

Locations

Country	Name	City	State
Germany	University Childrens Hospital	Berlin
Germany	University Children Hospital	Duesseldorf
Germany	University Children Hospital	Erlangen
Germany	University Children Hospital	Frankfurt
Germany	University Childrens Hospital	Freiburg
Germany	University Childrens Hospital	Giessen
Germany	University Childrens Hospital	Hamburg
Germany	University Childrens Hospital	Hannover
Germany	University Childrens Hospital	Jena
Germany	University Childrens Hospital	Muenster
Germany	University Childrens Hospital	Tübingen

Sponsors (3)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	GlaxoSmithKline, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

Meisel R, Kuypers L, Dirksen U, Schubert R, Gruhn B, Strauss G, Beutel K, Groll AH, Duffner U, Blütters-Sawatzki R, Holter W, Feuchtinger T, Grüttner HP, Schroten H, Zielen S, Ohmann C, Laws HJ, Dilloo D; Impfung von Kindern nach allogener Stammzelltransp — View Citation

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serologic response at 1 months following primary three dose vaccination series		first month	No
Secondary	serologic response at 1 months following booster immunization		first month	No
Secondary	tolerability of primary and booster vaccination		at least monthly	Yes
Secondary	identification of factors influencing immunogenicity and tolerability of study vaccines		at least monthly	Yes