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

October 22, 2007 updated by: Queen Elizabeth II Health Sciences Centre

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of the vaccine
Time Frame: 28 days post-dose
28 days post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity of vaccine
Time Frame: 60 days post-dose
60 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Elizabeth II Health Sciences Centre

Investigators

  • Study Director: Shelly McNeil, MD, Queen Elizabeth II Health Sciences Centre
  • Principal Investigator: Monique L MacFarlane Conrad, MSc, Dalhousie University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Anticipated)

May 1, 2008

Study Registration Dates

First Submitted

June 9, 2006

First Submitted That Met QC Criteria

June 9, 2006

First Posted (Estimate)

June 12, 2006

Study Record Updates

Last Update Posted (Estimate)

October 23, 2007

Last Update Submitted That Met QC Criteria

October 22, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qeii

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pertussis

Clinical Trials on Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe