PertussisNCT00524732
Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
An observational study of Pertussis and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Canada.
Trial summary
To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last previous administration of vaccine containing Diphtheria and Tetanus Toxoids (referred to as TD/Td). Read more about this study
- Who is it for?
- Ages 7 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis, Diphtheria
- What is being tested?
- Tetanus and diphtheria toxoids and acellular pertussis
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 7,156 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2004to Sep 2005
- Phase
- Observational
- 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 7 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and Adolescents 7 to 19 Years of Age, who have previously recieved Tetanus and Diphtheria Toxoids Vaccine
Who may be able to join
- Age > 7 years and < 20 years.
- Signed and dated IRB-approved informed consent form obtained from the participant, parent or legal guardian prior to the first study intervention.
- Judged to be in good health on the basis of reported medical history.
- Available for planned length of the study.
- Participant or parent or legal guardian (as applicable) can read and write English and can understand the informed consent documents and the study instructions.
- A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).
- A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.
Who cannot join
- Known or suspected allergy to ADACEL®, any of the vaccine's components, or prior allergic reaction to Diphtheria or Tetanus Toxoids or Acellular Pertussis Vaccine.
- Planned receipt of any other vaccine within the 14 days following administration of ADACEL® vaccine in this study.
- Any other medical condition that in the opinion of the investigator would cause an unexpected hazard or interfere with the study objective.
- Receipt of TD/Td within the preceding 12 months.
- Known or suspected to be pregnant.
- A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).
- A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Study site
Charlottetown, C1A 7N8
Study site
Halifax, Nova Scotia, NS B3K 6R8
About this study
To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last previous administration of vaccine containing Diphtheria and Tetanus Toxoids (referred to as TD/Td).
- Conditions
- Pertussis, Diphtheria
- Being tested
- Tetanus and diphtheria toxoids and acellular pertussis
- Keywords
- Pertussis, Tetanus, Diphtheria
- Medical subject headings
- Whooping Cough, Diphtheria, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus and diphtheria toxoids and acellular pertussisBiological
Also called ADACEL®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 1 | 18 to 30 months since last prior dose of TD/Td vaccine. Receives: Biological: Tetanus and diphtheria toxoids and acellular pertussis | |
| 2 | 30 to 42 months since last prior dose of TD/Td vaccine. Receives: Biological: Tetanus and diphtheria toxoids and acellular pertussis | |
| 3 | 42 to 54 months since last prior dose of TD/Td vaccine. Receives: Biological: Tetanus and diphtheria toxoids and acellular pertussis | |
| 4 | 54 to 66 months since last prior dose of TD/Td vaccine. Receives: Biological: Tetanus and diphtheria toxoids and acellular pertussis | |
| 5 | 66 to 78 months since last prior dose of TD/Td vaccine. Receives: Biological: Tetanus and diphtheria toxoids and acellular pertussis | |
| 6 | 78 to 90 months since last prior dose of TD/Td vaccine. Receives: Biological: Tetanus and diphtheria toxoids and acellular pertussis | |
| 7 | 90 to 102 months since last prior dose of TD/Td vaccine. Receives: Biological: Tetanus and diphtheria toxoids and acellular pertussis | |
| 8 | 102 to 114 months since last prior dose of TD/Td vaccine. Receives: Biological: Tetanus and diphtheria toxoids and acellular pertussis | |
| 9 | Control - over 114 months since last prior dose of TD/Td vaccine. Receives: Biological: Tetanus and diphtheria toxoids and acellular pertussis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide safety information on ADACEL® vaccine given at different time intervals.
Measured: Up to 114 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startSep 2004
- Primary completionDec 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PertussisStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 7,156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524732
- Sponsor's protocol ID
- TD511
- Status last verified
- Jan 2014
- First submitted
- 4 Sep 2007
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Halperin SA, Sweet L, Baxendale D, Neatby A, Rykers P, Smith B, Zelman M, Maus D, Lavigne P, Decker MD. How soon after a prior tetanus-diphtheria vaccination can one give adult formulation tetanus-diphtheria-acellular pertussis vaccine? Pediatr Infect Dis J. 2006 Mar;25(3):195-200. doi: 10.1097/01.inf.0000202082.56403.c4.
PubMed 16511379
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
- ClinicalTrials.gov ID
- NCT00524732
- Acronym / sponsor ID
- TD511
- Conditions
- Pertussis, Diphtheria
- Keywords
- Pertussis, Tetanus, Diphtheria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,156 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 5 Sep 2007 (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.
To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last previous administration of vaccine containing Diphtheria and Tetanus Toxoids (referred to as TD/Td).
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: Tetanus and diphtheria toxoids and acellular pertussis18 to 30 months since last prior dose of TD/Td vaccine. |
| 2 | – | Biological: Tetanus and diphtheria toxoids and acellular pertussis30 to 42 months since last prior dose of TD/Td vaccine. |
| 3 | – | Biological: Tetanus and diphtheria toxoids and acellular pertussis42 to 54 months since last prior dose of TD/Td vaccine. |
| 4 | – | Biological: Tetanus and diphtheria toxoids and acellular pertussis54 to 66 months since last prior dose of TD/Td vaccine. |
| 5 | – | Biological: Tetanus and diphtheria toxoids and acellular pertussis66 to 78 months since last prior dose of TD/Td vaccine. |
| 6 | – | Biological: Tetanus and diphtheria toxoids and acellular pertussis78 to 90 months since last prior dose of TD/Td vaccine. |
| 7 | – | Biological: Tetanus and diphtheria toxoids and acellular pertussis90 to 102 months since last prior dose of TD/Td vaccine. |
| 8 | – | Biological: Tetanus and diphtheria toxoids and acellular pertussis102 to 114 months since last prior dose of TD/Td vaccine. |
| 9 | – | Biological: Tetanus and diphtheria toxoids and acellular pertussisControl - over 114 months since last prior dose of TD/Td vaccine. |
Who may qualify
- Ages
- 7 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and Adolescents 7 to 19 Years of Age, who have previously recieved Tetanus and Diphtheria Toxoids Vaccine
Key inclusion criteria (7 listed)
- Age > 7 years and < 20 years.
- Signed and dated IRB-approved informed consent form obtained from the participant, parent or legal guardian prior to the first study intervention.
- Judged to be in good health on the basis of reported medical history.
- Available for planned length of the study.
- Participant or parent or legal guardian (as applicable) can read and write English and can understand the informed consent documents and the study instructions.
Key exclusion criteria (7 listed)
- Known or suspected allergy to ADACEL®, any of the vaccine's components, or prior allergic reaction to Diphtheria or Tetanus Toxoids or Acellular Pertussis Vaccine.
- Planned receipt of any other vaccine within the 14 days following administration of ADACEL® vaccine in this study.
- Any other medical condition that in the opinion of the investigator would cause an unexpected hazard or interfere with the study objective.
- Receipt of TD/Td within the preceding 12 months.
- Known or suspected to be pregnant.
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 and acellular pertussisAlso: ADACEL®0.5 mL, Intramuscular | Biological | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
Primary outcome
To provide safety information on ADACEL® vaccine given at different time intervals.
Time frame: Up to 114 months post-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Results publication: PubMed 16511379Halperin SA, Sweet L, Baxendale D, Neatby A, Rykers P, Smith B, Zelman M, Maus D, Lavigne P, Decker MD. How soon after a prior tetanus-diphtheria vaccination can one give adult formulation tetanus-diphtheria-acellular pertussis vaccine? Pediatr Infect Dis J. 2006 Mar;25(3):195-200. doi: 10.1097/01.inf.0000202082.56403.c4.
- Related InfoLink provided by the sponsor.
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)
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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.
Medical Director study director
Sanofi Pasteur Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Canada.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To provide safety information on ADACEL® vaccine given at different time intervals. (time frame: Up to 114 months post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524732, which also lists 1 linked publication.
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 14 Jan 2014.