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Completed

NCT Number: NCT00169728

Vaccination of Children Following Allogeneic 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.

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Key information

Conditions

Allogeneic Haematopoietic Stem Cell Transplantation Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Picornaviridae Infections Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Tetanus Virus Diseases Whooping Cough

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Childrens Hospital, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

heptavalent pneumococcal conjugate vaccine, Prevenar

Biological

Primary outcomes

  1. serologic response at 1 months following primary three dose vaccination series

    Time frame: first month

Secondary outcomes

  1. serologic response at 1 months following booster immunization

    Time frame: first month

  2. tolerability of primary and booster vaccination

    Time frame: at least monthly

  3. identification of factors influencing immunogenicity and tolerability of study vaccines

    Time frame: at least monthly

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • GlaxoSmithKline
  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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