Vaccination of Children Following Allogeneic Stem Cell Transplantation

Heinrich-Heine University, Duesseldorf

Status and phase: Completed; Phase 3

Conditions: Allogeneic Haematopoietic Stem Cell Transplantation

Treatments: Biological: DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa; Biological: heptavalent pneumococcal conjugate vaccine, Prevenar

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00169728

IKAST-01

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)