Vaccination of Children Following Allogeneic Stem Cell Transplantation

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169728

Enrollment

Registered

2005-09-15

Start date

2003-09-30

Completion date

2006-10-31

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic Haematopoietic Stem Cell Transplantation

Keywords

allogeneic haematopoietic stem cell transplantation, bone marrow transplantation, children, vaccination, invasive pneumococcal disease, tetanus, diphtheria, poliomyelitis, pertussis, Hepatitis B, Haemophilus influenzae type B infection

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.

Interventions

BIOLOGICALDTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa

BIOLOGICALheptavalent pneumococcal conjugate vaccine, Prevenar

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

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

Design outcomes

Primary

Measure	Time frame
serologic response at 1 months following primary three dose vaccination series	first month

Secondary

Measure	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	at least monthly

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026