PertussisPhase 4NCT00336115
The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients
A Phase 4 study testing Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel) in people with Pertussis, run by Queen Elizabeth II Health Sciences Centre.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pertussis
- What is being tested?
- Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to May 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Active infection
- Active GVHD
- Recent IVIG
- Allergy to components of vaccine
- Diphtheria or tetanus vaccination within 18 months
About this study
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
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.
- Conditions
- Pertussis
- Being tested
- Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)
- Keywords
- pertussis, bone marrow transplant
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the vaccine
Measured: 28 days post-dose
Secondary outcomes (1)
Immunogenicity of vaccine
Measured: 60 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startJul 2006
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Elizabeth II Health Sciences Centre
- Sponsor type
- University, hospital or other
- Investigators
- Monique L MacFarlane Conrad, MSc, Principal investigator, Dalhousie University Medical SchoolShelly McNeil, MD, Study director, Queen Elizabeth II Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336115
- Sponsor's protocol ID
- qeii
- Status last verified
- Oct 2007
- First submitted
- 9 Jun 2006
- Last updated
- 23 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00336115
- Acronym / sponsor ID
- qeii
- Conditions
- Pertussis
- Keywords
- pertussis, bone marrow transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Queen Elizabeth II Health Sciences CentreUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- May 2008 (estimated)
- First posted
- 12 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Active infection
- Active GVHD
- Recent IVIG
- Allergy to components of vaccine
- Diphtheria or tetanus vaccination within 18 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel) | Biological | – |
Primary outcome
Safety of the vaccine
Time frame: 28 days post-dose
1 secondary outcome
Immunogenicity of vaccine
Time frame: 60 days post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2007.
Related trials for Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique L MacFarlane Conrad, MSc principal investigator
Dalhousie University Medical School
Shelly McNeil, MD study director
Queen Elizabeth II Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel) in people with Pertussis, run by Queen Elizabeth II Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the vaccine (time frame: 28 days post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2007.