The Safety and Immunogenicity of Acellular Pertussis Vacc... | NCT00336115

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

NCT00336115

Sponsor

Queen Elizabeth II Health Sciences Centre

Status

Unknown status

Last Update Posted

Oct 23, 2007Estimated

Enrollment

10Estimated

Phase

Phase 4

Conditions

Pertussis

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

May 2008Estimated

First Submitted Date

Jun 9, 2006

First Submission Date that Met QC Criteria

Jun 9, 2006

First Posted Date

Jun 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2007

Last Update Posted Date

Oct 23, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Name	Type	Description	Arm Group Labels	Other Names
Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)	Biological

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

Measure	Description	Time Frame
Immunogenicity of vaccine		60 days post-dose

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014917	Whooping Cough

Ancestor Terms

ID	Term
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013745	Tetanus Toxoid
C509326	adacel

Ancestor Terms

ID	Term
D014121	Toxoids
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided