TetanusPhase 4NCT01629589
Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
A Phase 4 study testing Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®) in people with Tetanus and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 8 sites in United States.
Trial summary
The aim of this study is to describe immunogenicity of a single booster dose of Adacel vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age. Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Diphtheria, Pertussis
- What is being tested?
- Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2012to Jun 2013
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject is 11 to < 13 years of age at the time of vaccination
- Received exactly 5 doses of pertussis vaccine at < 7 years of age
- Informed consent and assent forms have been signed and dated
- Subject is able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence for at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination
- Any condition that, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months)
- Known or suspected receipt of any whole-cell pertussis-containing vaccine
- A personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the last 2 years
Show all 19Show fewer
- A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving the vaccine
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the 2nd visit; except that influenza vaccine may have been received between 30 and 15 days (but no less than 15 days) before receiving study vaccine
- Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, at the discretion of the Sponsor
- Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the subject's parent/guardian
- Laboratory-confirmed thrombocytopenia, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for IM vaccination, at the discretion of the Investigator
- Personal history of Guillain-Barré syndrome
- Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. (A prospective subject should not be enrolled in the study until the condition has resolved or the febrile event has subsided.)
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Bardstown, Kentucky, 40040
Study site
Barnwell, South Carolina, 29812
Study site
Cleveland, Ohio, 44121
Study site
Kingsport, Tennessee, 37660
Study site
Sacramento, California, 95816
Study site
Salt Lake City, Utah, 84124
Study site
Vienna, Virginia, 22180
Study site
Woburn, Massachusetts, 07801
About this study
The aim of this study is to describe immunogenicity of a single booster dose of Adacel vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.
Primary objective:
Read more
- To describe seroprotection rates against tetanus and diphtheria in subjects randomized to receive either Adacel or Boostrix vaccine.
Observational objectives:
- To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean antibody concentrations (GMCs) in subjects randomized to receive either Adacel or Boostrix vaccine.
- To describe booster response rates against tetanus, diphtheria, and pertussis in subjects randomized to receive either Adacel or Boostrix vaccine.
- To describe the rates of adverse events (AEs) immediately post-vaccination, and the rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with Adacel or Boostrix vaccine from Visit 1 through Visit 2.
Read the detailed description
Participants will be randomized in a 1:1 ratio to receive either Adacel or Boostrix vaccine.
Subjects will be monitored for immediate reactions for 15 minutes post-vaccination. Unsolicited adverse events and serious adverse events will be collected from Visit 1 through Visit 2.
- Conditions
- Tetanus, Diphtheria, Pertussis, Whooping Cough
- Being tested
- Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®), Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)
- Keywords
- Adacel® vaccine, Tetanus, Diphtheria, whooping cough, Pertussis, BOOSTRIX® vaccine
- 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 Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)Biological
Also called Adacel®
0.5 mL, Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)Biological
Also called BOOSTRIX®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Adacel® Vaccine Group | Experimental | Participants randomized to receive a single dose of Adacel® vaccine Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) |
| Boostrix® Vaccine Group | Active comparator | Participants randomized to receive a single dose of Boostrix® vaccine Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL
Measured: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Secondary outcomes (5)
Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test
Measured: Day 0 (pre-vaccination) to Day 28 post-vaccination
Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration >2.56 IU/mL for diphtheria and >2.7 IU/mL for tetanus.
Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ.
Measured: Day 28 post-vaccination
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2\&3) were assayed by Enzyme-linked immunosorbent assay (ELISA)
Measured: Day 0 (pre-vaccination) to Day 28 post-vaccination
Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration >93 EU/mL for PT, >170 EU/mL for FHA, >115 EU/mL for PRN, or >285 EU/mL for FIM.
Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer <LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ.
Measured: Day 28 post-vaccination
Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs.
Measured: Up to 15 minutes 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 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2013
- Study completionJun 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 423 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
- NCT01629589
- Sponsor's protocol ID
- Td551
- Other IDs
- U1111-1127-6774
- Status last verified
- Feb 2016
- First submitted
- 22 Jun 2012
- Last updated
- 2 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Decker MD, Greenberg DP, Johnson DR, Pool V. Randomized study of immune responses to two Tdap vaccines among adolescents primed with DTaP and comparison with results among adolescents primed with DTwP. Vaccine. 2019 Aug 14;37(35):5003-5008. doi: 10.1016/j.vaccine.2019.07.015. Epub 2019 Jul 10.
PubMed 31301919
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
- ClinicalTrials.gov ID
- NCT01629589
- Acronym / sponsor ID
- Td551
- Conditions
- Tetanus, Diphtheria, Pertussis, Whooping Cough
- Keywords
- Adacel® vaccine, Tetanus, Diphtheria, whooping cough, Pertussis, BOOSTRIX® vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Posted 21 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to describe immunogenicity of a single booster dose of Adacel vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.
Primary objective:
- To describe seroprotection rates against tetanus and diphtheria in subjects randomized to receive either Adacel or Boostrix vaccine.
Observational objectives:
- To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean antibody concentrations (GMCs) in subjects randomized to receive either Adacel or Boostrix vaccine.
- To describe booster response rates against tetanus, diphtheria, and pertussis in subjects randomized to receive either Adacel or Boostrix vaccine.
- To describe the rates of adverse events (AEs) immediately post-vaccination, and the rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with Adacel or Boostrix vaccine from Visit 1 through Visit 2.
Detailed description
Participants will be randomized in a 1:1 ratio to receive either Adacel or Boostrix vaccine.
Subjects will be monitored for immediate reactions for 15 minutes post-vaccination. Unsolicited adverse events and serious adverse events will be collected from Visit 1 through Visit 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adacel® Vaccine Group | Experimental | Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)Participants randomized to receive a single dose of Adacel® vaccine |
| Boostrix® Vaccine Group | Active comparator | Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)Participants randomized to receive a single dose of Boostrix® vaccine |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject is 11 to < 13 years of age at the time of vaccination
- Received exactly 5 doses of pertussis vaccine at < 7 years of age
- Informed consent and assent forms have been signed and dated
- Subject is able to attend all scheduled visits and to comply with all trial procedures.
Key exclusion criteria (19 listed)
- Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence for at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination
- Any condition that, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months)
- Known or suspected receipt of any whole-cell pertussis-containing vaccine
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 Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)Also: Adacel®0.5 mL, Intramuscular | Biological | Adacel® Vaccine Group |
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)Also: BOOSTRIX®0.5 mL, Intramuscular | Biological | Boostrix® Vaccine Group |
Primary outcome
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL
5 secondary outcomes
Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Time frame: Day 0 (pre-vaccination) to Day 28 post-vaccination
Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Time frame: Day 28 post-vaccination
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Time frame: Day 0 (pre-vaccination) to Day 28 post-vaccination
Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Time frame: Day 28 post-vaccination
Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Time frame: Up to 15 minutes post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31301919Decker MD, Greenberg DP, Johnson DR, Pool V. Randomized study of immune responses to two Tdap vaccines among adolescents primed with DTaP and comparison with results among adolescents primed with DTwP. Vaccine. 2019 Aug 14;37(35):5003-5008. doi: 10.1016/j.vaccine.2019.07.015. Epub 2019 Jul 10.
- 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.
Medical Director study director
Sanofi Pasteur Inc.
8 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 Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®) in people with Tetanus and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 8 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 19 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 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2013). 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 With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine (time frame: Day 0 (pre-vaccination) to Day 28 (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 NCT01629589, 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 2 Mar 2016.