Vaccination of Children Following Allogeneic Stem Cell Transplantation

June 6, 2012 updated by: Heinrich-Heine University, Duesseldorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, D-13353
        • University Childrens Hospital
      • Duesseldorf, Germany, D-40225
        • University Children hospital
      • Erlangen, Germany, D-91054
        • University Children hospital
      • Frankfurt, Germany, D-60590
        • University Children hospital
      • Freiburg, Germany, D-79106
        • University Childrens Hospital
      • Giessen, Germany, D-35385
        • University Childrens Hospital
      • Hamburg, Germany, D-20246
        • University Childrens Hospital
      • Hannover, Germany, D-30625
        • University Childrens Hospital
      • Jena, Germany, D-07740
        • University Childrens Hospital
      • Muenster, Germany, D-48129
        • University Childrens Hospital
      • Tübingen, Germany, D-72076
        • University Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serologic response at 1 months following primary three dose vaccination series
Time Frame: first month
first month

Secondary Outcome Measures

Outcome Measure
Time Frame
serologic response at 1 months following booster immunization
Time Frame: first month
first month
tolerability of primary and booster vaccination
Time Frame: at least monthly
at least monthly
identification of factors influencing immunogenicity and tolerability of study vaccines
Time Frame: at least monthly
at least monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKAST-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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