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NCT00336115 Clinical Trial

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

Pertussis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00336115
Other study ID # qeii
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received June 9, 2006
Last updated October 22, 2007
Start date July 2006
Est. completion date May 2008

Study information
Verified date October 2007
Source Queen Elizabeth II Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 10
Est. completion date May 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Queen Elizabeth II Health Sciences Centre

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of the vaccine 28 days post-dose
Secondary Immunogenicity of vaccine 60 days post-dose
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