Vaccination of Children Following Allogeneic Stem Cell Transplantation

• Sponsor: Heinrich-Heine University, Duesseldorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT00169728
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer (Industry), GlaxoSmithKline (Industry)
• Enrollment: 53
• Locations: 11
• Duration (Months): 37
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allogeneic Haematopoietic Stem Cell Transplantation	Biological: DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa; Biological: heptavalent pneumococcal conjugate vaccine, Prevenar	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Jun 1, 2006
• Actual Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

1. serologic response at 1 months following primary three dose vaccination series [first month]

Secondary Outcome Measures

1. serologic response at 1 months following booster immunization [first month]

2. tolerability of primary and booster vaccination [at least monthly]

3. identification of factors influencing immunogenicity and tolerability of study vaccines [at least monthly]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Childrens Hospital	Berlin		Germany	D-13353
2	University Children Hospital	Duesseldorf		Germany	D-40225
3	University Children Hospital	Erlangen		Germany	D-91054
4	University Children Hospital	Frankfurt		Germany	D-60590
5	University Childrens Hospital	Freiburg		Germany	D-79106
6	University Childrens Hospital	Giessen		Germany	D-35385
7	University Childrens Hospital	Hamburg		Germany	D-20246
8	University Childrens Hospital	Hannover		Germany	D-30625
9	University Childrens Hospital	Jena		Germany	D-07740
10	University Childrens Hospital	Muenster		Germany	D-48129
11	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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
• Other Study ID Numbers: IKAST-01
• First Posted: Sep 15, 2005
• Last Update Posted: Jun 7, 2012
• Last Verified: Jun 1, 2012

• 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
• Additional relevant MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

No Results Posted as of Jun 7, 2012