The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Queen Elizabeth II Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00336115
First received: June 9, 2006
Last updated: October 22, 2007
Last verified: October 2007
  Purpose

The purpose of this study is to determine if pertussis (whooping cough) vaccine is safe and produces an appropriate immune response against pertussis in blood and marrow transplant patients.


Condition Intervention Phase
Pertussis
Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Adult Formulation Tetanus and Diphtheria Toxoids Adsorbed Combined With Acellular Pertussis (Tdap) Vaccine Following Blood and Morrow Transplantation in Adults

Resource links provided by NLM:


Further study details as provided by Queen Elizabeth II Health Sciences Centre:

Primary Outcome Measures:
  • Safety of the vaccine [ Time Frame: 28 days post-dose ]

Secondary Outcome Measures:
  • Immunogenicity of vaccine [ Time Frame: 60 days post-dose ]

Estimated Enrollment: 10
Study Start Date: July 2006
Estimated Study Completion Date: May 2008
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-64
  • BMT at the QEII Health Sciences Centre
  • BMT within last 12 months
  • Able to read and write English language
  • Able to give consent

Exclusion Criteria:

  • Active infection
  • Active GVHD
  • Recent IVIG
  • Allergy to components of vaccine
  • Diphtheria or tetanus vaccination within 18 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336115

Sponsors and Collaborators
Queen Elizabeth II Health Sciences Centre
Investigators
Principal Investigator: Monique L MacFarlane Conrad, MSc Dalhousie University Medical School
Study Director: Shelly McNeil, MD QEII Health Sciences Centre
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00336115     History of Changes
Other Study ID Numbers: qeii
Study First Received: June 9, 2006
Last Updated: October 22, 2007
Health Authority: Canada: Health Canada

Keywords provided by Queen Elizabeth II Health Sciences Centre:
pertussis
bone marrow transplant

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014