TetanusPhase 4NCT00347958
Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
A Phase 4 study testing Tetanus-diphtheria-acellular pertussis (Tdap) vaccine in people with Tetanus and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 10 sites in 2 countries.
Trial summary
Objectives: To provide safety data on revaccination with ADACEL® vaccine. To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination. Read more about this study
- Who is it for?
- Ages 15 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Diphtheria, Pertussis
- What is being tested?
- Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 545 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Aug 2006to Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 69 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Previously received ADACEL vaccine as part of Aventis Pasteur studies Td501, Td502, or Td505.
- At least 15 but no greater than 69 years of age at the time of vaccination in this trial.
- Signed Institutional Review Board (IRB)-approved informed assent / consent form.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a woman, inability to become pregnant or negative serum/urine pregnancy test.
Who cannot join
- Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
- Serious chronic disease (ie, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that might:
- interfere with the ability to participate fully in the study; or
- interfere with evaluation of the vaccine.
- Known or suspected impairment of immunologic function.
- Febrile illness within the last 72 hours or an oral temperature ≥100.4°F (≥38°C) at the time of inclusion.
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- History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
- Known or suspected receipt of a tetanus-, diphtheria- or pertussis-containing vaccine since participation in Study Td501, Td502, or Td505. (Receipt of Menactra vaccine at any time prior to the present study is permitted, subject to the next exclusion criterion).
- Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 28-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment
- Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
- Suspected or known hypersensitivity to any of the vaccine components or to latex.
- Unable to attend the scheduled visits or to comply with the study procedures.
- In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment.
- Nursing mother.
- Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial visits or procedures.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
- Subject deprived of freedom by an administrative or court order, or under the stress of an emergency setting, or hospitalized without his/her consent.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Canada6 sites
Study site
Beauport, Quebec, G1E 7G9
Study site
Coquitlam, British Columbia, V3C 4J2
Study site
Halifax, Nova Scotia, B3K-6R8
Study site
Montreal, Quebec, H3H LP3
Study site
Surrey, British Columbia, V3R-8P8
Study site
Winnipeg, Manitoba, R3E 3P4
United States4 sites
Study site
Bossier City, Louisiana, 71111
Study site
Jonesboro, Arkansas, 72401
Study site
Pittsburgh, Pennsylvania, 15241
Study site
University Heights, Ohio, 44118
About this study
Official title: Safety Among Adolescents and Adults of Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) 4 to 5 Years After a Previous Dose
Objectives:
To provide safety data on revaccination with ADACEL® vaccine.
To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.
- Conditions
- Tetanus, Diphtheria, Pertussis
- Being tested
- Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
- Keywords
- Tetanus,, Diphtheria,, Pertussis
- Medical subject headings
- Tetanus, Diphtheria, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus-diphtheria-acellular pertussis (Tdap) vaccineBiological
Also called Adacel®
0.5mL, Intramuscular (IM)
| Study group | Role | What they receive |
|---|---|---|
| Adacel vaccine group | Experimental | Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518. Receives: Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.
Measured: 0-14 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionFeb 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TetanusStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347958
- Sponsor's protocol ID
- TD518
- Status last verified
- Nov 2013
- First submitted
- 3 Jul 2006
- Last updated
- 4 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Among Adolescents and Adults of Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) 4 to 5 Years After a Previous Dose
- ClinicalTrials.gov ID
- NCT00347958
- Acronym / sponsor ID
- TD518
- Conditions
- Tetanus, Diphtheria, Pertussis
- Keywords
- Tetanus,, Diphtheria,, Pertussis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Posted 22 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
To provide safety data on revaccination with ADACEL® vaccine.
To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adacel vaccine group | Experimental | Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccineParticipants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518. |
Who may qualify
- Ages
- 15 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Previously received ADACEL vaccine as part of Aventis Pasteur studies Td501, Td502, or Td505.
- At least 15 but no greater than 69 years of age at the time of vaccination in this trial.
- Signed Institutional Review Board (IRB)-approved informed assent / consent form.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a woman, inability to become pregnant or negative serum/urine pregnancy test.
Key exclusion criteria (18 listed)
- Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
- Serious chronic disease (ie, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that might:
- Known or suspected impairment of immunologic function.
- Febrile illness within the last 72 hours or an oral temperature ≥100.4°F (≥38°C) at the time of inclusion.
- History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
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-diphtheria-acellular pertussis (Tdap) vaccineAlso: Adacel®0.5mL, Intramuscular (IM) | Biological | Adacel vaccine group |
Primary outcome
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Time frame: 0-14 days post-vaccination
Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Clinical Trials study director
Sanofi Pasteur, a Sanofi Company
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetanus-diphtheria-acellular pertussis (Tdap) vaccine in people with Tetanus and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 10 sites in 2 countries.
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 18 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 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, United States. 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.
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?
Yes. Results are posted in the registry (first posted 22 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination (time frame: 0-14 days post-vaccination). 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 4 Dec 2013.