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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Queen Elizabeth II Health Sciences Centre.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00336115
First Posted: June 12, 2006
Last Update Posted: October 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Queen Elizabeth II Health Sciences Centre
June 9, 2006
June 12, 2006
October 23, 2007
July 2006
Not Provided
Safety of the vaccine [ Time Frame: 28 days post-dose ]
Not Provided
Complete list of historical versions of study NCT00336115 on ClinicalTrials.gov Archive Site
Immunogenicity of vaccine [ Time Frame: 60 days post-dose ]
Not Provided
Not Provided
Not Provided
 
The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients
Safety and Immunogenicity of Adult Formulation Tetanus and Diphtheria Toxoids Adsorbed Combined With Acellular Pertussis (Tdap) Vaccine Following Blood and Morrow Transplantation in Adults
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pertussis
Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10
May 2008
Not Provided

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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00336115
qeii
No
Not Provided
Not Provided
Not Provided
Queen Elizabeth II Health Sciences Centre
Not Provided
Principal Investigator: Monique L MacFarlane Conrad, MSc Dalhousie University Medical School
Study Director: Shelly McNeil, MD QEII Health Sciences Centre
Queen Elizabeth II Health Sciences Centre
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP