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

Heinrich-Heine University, Duesseldorf2 sites in 1 country53 target enrollmentSeptember 2003

ConditionsAllogeneic Haematopoietic Stem Cell Transplantation

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Allogeneic Haematopoietic Stem Cell Transplantation
Sponsor: Heinrich-Heine University, Duesseldorf
Enrollment: 53
Locations: 2
Primary Endpoint: serologic response at 1 months following primary three dose vaccination series
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

October 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Heinrich-Heine University, Duesseldorf

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

serologic response at 1 months following primary three dose vaccination series

Time Frame: first month

Secondary Outcomes

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)