NCT00336115

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2006

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 23, 2007

Status Verified

October 1, 2007

First QC Date

June 9, 2006

Last Update Submit

October 22, 2007

Conditions

Pertussis

Keywords

pertussisbone marrow transplant

Outcome Measures

Primary Outcomes (1)

  • Safety of the vaccine

    28 days post-dose

Secondary Outcomes (1)

  • Immunogenicity of vaccine

    60 days post-dose

Interventions

Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)BIOLOGICAL

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Active infection
  • Active GVHD
  • Recent IVIG
  • Allergy to components of vaccine
  • Diphtheria or tetanus vaccination within 18 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Whooping Cough

Interventions

Tetanus Toxoidadacel

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Monique L MacFarlane Conrad, MSc

    Dalhousie University Medical School

    PRINCIPAL INVESTIGATOR

  • Shelly McNeil, MD

    Queen Elizabeth II Health Sciences Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2006

First Posted

June 12, 2006

Study Start

July 1, 2006

Study Completion

May 1, 2008

Last Updated

October 23, 2007

Record last verified: 2007-10