Back to resultsThe Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients
Primary Purpose
Pertussis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)
Sponsored by
About this trial
This is an interventional prevention trial for Pertussis focused on measuring pertussis, bone marrow transplant
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Safety of the vaccine
Secondary Outcome Measures
Immunogenicity of vaccine
Full Information
NCT ID
NCT00336115
First Posted
June 9, 2006
Last Updated
October 22, 2007
Sponsor
Queen Elizabeth II Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT00336115
Brief Title
The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients
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 Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Queen Elizabeth II Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis
Keywords
pertussis, bone marrow transplant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)
Primary Outcome Measure Information:
Title
Safety of the vaccine
Time Frame
28 days post-dose
Secondary Outcome Measure Information:
Title
Immunogenicity of vaccine
Time Frame
60 days post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique L MacFarlane Conrad, MSc
Organizational Affiliation
Dalhousie University Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shelly McNeil, MD
Organizational Affiliation
Queen Elizabeth II Health Sciences Centre
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients
We'll reach out to this number within 24 hrs