PertussisPhase 4NCT00319553
Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
A Phase 4 study testing ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed and BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed in people with Pertussis and Tetanus, run by Sanofi at 10 sites in United States.
Trial summary
This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis, Tetanus, Diphtheria
- What is being tested?
- ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed and BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 647 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2006to Dec 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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 11 - 18 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 female, 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 (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) 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.
Show all 12Show fewer
- History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
- Known or suspected receipt of a tetanus or diphtheria-containing vaccine within the preceding 2 years.
- Known or suspected receipt of a pertussis-containing vaccine within the preceding 5 years.
- Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other therapy expected to materially alter immune function 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.
- Received any vaccine in the 21-day period prior to enrollment or scheduled to receive any vaccination after enrollment and prior to visit 2.
- Suspected or known hypersensitivity to any of the vaccine components or to latex.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Annapolis, Maryland, 21401
Study site
Baltimore, Maryland, 21201
Study site
Bellevue, Washington, 98005
Study site
Durham, North Carolina, 27704
Study site
Durham, North Carolina, 27705
Study site
Franklin, Tennessee, 37067
Study site
Frederick, Maryland, 21702
Study site
Mercer Island, Washington, 98040-2758
Study site
Sammamish, Washington, 98075
Study site
Seattle, Washington, 98105
About this study
Official title: Comparison in US Adolescents of the Safety and Immunogenicity of Two Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccines: ADACEL™ and BOOSTRIX®
This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
- Conditions
- Pertussis, Tetanus, Diphtheria
- Being tested
- ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed, BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
- Keywords
- Tetanus, diphtheria, acellular pertussis
- Medical subject headings
- Whooping Cough, Tetanus, Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis AdsorbedBiological
Also called ADACEL®
0.5 mL, IM
BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis AdsorbedBiological
Also called BOOSTRIX®
0.5 mL, IM
| Study group | Role | What they receive |
|---|---|---|
| Adacel® Vaccine Group | Experimental | Not described Receives: Biological: ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed |
| BOOSTRIX® Vaccine Group | Active comparator | Not described Receives: Biological: BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®
Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities.
Measured: Day 0 to 7 post-vaccination
Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Measured: Day 0 and 28 days post-vaccination
Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Measured: Day 0 and 28 days post-vaccination
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.
Measured: Day 0 and 28 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 posted27 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionOct 2008
- Study completionDec 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 PertussisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319553
- Sponsor's protocol ID
- Td516
- Status last verified
- Sep 2012
- First submitted
- 28 Apr 2006
- Last updated
- 5 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison in US Adolescents of the Safety and Immunogenicity of Two Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccines: ADACEL™ and BOOSTRIX®
- ClinicalTrials.gov ID
- NCT00319553
- Acronym / sponsor ID
- Td516
- Conditions
- Pertussis, Tetanus, Diphtheria
- Keywords
- Tetanus, diphtheria, acellular pertussis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Posted 21 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adacel® Vaccine Group | Experimental | Biological: ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed |
| BOOSTRIX® Vaccine Group | Active comparator | Biological: BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 11 - 18 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 female, negative serum/urine pregnancy test.
Key exclusion criteria (12 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 (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) 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 |
|---|---|---|
| ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis AdsorbedAlso: ADACEL®0.5 mL, IM | Biological | Adacel® Vaccine Group |
| BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis AdsorbedAlso: BOOSTRIX®0.5 mL, IM | Biological | BOOSTRIX® Vaccine Group |
Primary outcome
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®
Time frame: Day 0 to 7 post-vaccination
Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities.
Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time frame: Day 0 and 28 days post-vaccination
Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time frame: Day 0 and 28 days post-vaccination
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time frame: Day 0 and 28 days post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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)
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.
Medical Director study director
Sanofi Pasteur Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed and BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed in people with Pertussis and Tetanus, run by Sanofi at 10 sites in United States.
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 4 inclusion and 12 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 5 Oct 2012. 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 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 21 Oct 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?
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® (time frame: Day 0 to 7 post-vaccination). The study lists 4 primary outcomes in all. 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 5 Oct 2012.