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

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ClinicalTrials.gov Identifier: NCT00336115
Recruitment Status : Unknown
Verified October 2007 by Queen Elizabeth II Health Sciences Centre.
Recruitment status was:  Enrolling by invitation
First Posted : June 12, 2006
Last Update Posted : October 23, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pertussis Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2006
Estimated Study Completion Date : May 2008

Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336115

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

ClinicalTrials.gov Identifier: NCT00336115     History of Changes
Other Study ID Numbers: qeii
First Posted: June 12, 2006    Key Record Dates
Last Update Posted: October 23, 2007
Last Verified: October 2007

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

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