TetanusPhase 3NCT02089347
Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old
A Phase 3 study testing Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed and Diphtheria and Tetanus toxoids adsorbed in people with Tetanus and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 19 sites in Japan.
Trial summary
The aim of the study is to generate additional safety and immunogenicity data to support the registration of the product in Japan. Primary objectives: To demonstrate the non-inferiority of SP306 versus DT (DT 0.1mL) vaccine in terms of diphtheria and tetanus booster response rate (proportion of subjects with booster… 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?
- Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed and Diphtheria and Tetanus toxoids adsorbed
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 19 sitesJapan
- Study dates
- Mar 2014to Mar 2015
- Phase
- Phase 3
- 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
- Aged 11 or 12 years and considered healthy on the day of inclusion
- Informed consent form and assent form signed and dated by the parent(s) / legal representative(s) and the subject respectively
- Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e., received 4 doses of Japanese-produced DTaP vaccine), confirmed by checking immunization records and have not yet undergone additional DT vaccination
- Able to attend all scheduled visits and to comply with all trial procedures
- For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test.
Who cannot join
- Any conditions or diseases which, in the opinion of the Investigator:
- would pose a health risk to the subject
- or might interfere with the ability to participate fully in the study
- or might interfere with evaluation of the vaccine
- or would otherwise make participation inappropriate according to the Investigator's clinical judgment
- History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically
Show all 24Show fewer
- Suspected or known hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine
- Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis
- Known or suspected congenital immunodeficiency, or current / previous acquired immunodeficiency, or current / previous receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or current / previous (within the last 6 months) systemic corticosteroid therapy
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
- Planned participation in another clinical trial during the present trial period
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with assessment of the immune response
- Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before the study vaccine
- Planned receipt of any vaccine during the trial period
- Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
- At high risk for diphtheria, tetanus or pertussis infection during the trial
- Known pregnancy, or a positive urine pregnancy test
- Currently breastfeeding a child
- Known thrombocytopenia or history of thrombocytopenia
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion
- History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Identified as an employee of an Investigator, a study center, a study-affiliated vendor, or the Sponsor, with direct or indirect involvement in the proposed study or other studies under the direction of that Investigator or study center; or identified as a spouse or child (whether natural or adopted) of such an employee.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
Study site
Aichi, 451 8511
Study site
Chiba, 299 4503
Study site
Fukui, 910 0833
Study site
Fukui, 918 8205
Study site
Gunma, 372 0817
Study site
Hyōgo, 655 0017
Study site
Ibaraki, 312 0057
Study site
Kagoshima, 890 0034
Study site
Kanagawa, 223 0051
Study site
Nagano, 381 0025
Study site
Okayama, 701 0205
Study site
Okayama, 712 8064
Study site
Osaka, 574 0046
Study site
Shizuoka, 420 8623
Study site
Shizuoka, 426 0067
Study site
Tokyo, 146 0023
Study site
Tokyo, 146 0095
Study site
Tokyo, 167 0052
Study site
Tokyo, 183 0042
About this study
Official title: Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) Given Intramuscularly Compared to Diphtheria and Tetanus Toxoids Adsorbed (DT) Given Subcutaneously in Japanese Adolescents 11 - 12 Years of Age
The aim of the study is to generate additional safety and immunogenicity data to support the registration of the product in Japan.
Primary objectives:
Read more
- To demonstrate the non-inferiority of SP306 versus DT (DT 0.1mL) vaccine in terms of diphtheria and tetanus booster response rate (proportion of subjects with booster responses) and seroprotection rate (percentage of subjects with antitoxin concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.
- To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in terms of booster response rate (proportion of subjects with booster responses) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.
Secondary objectives:
- To further evaluate the immune response of the study vaccines against diphtheria, tetanus and pertussis antigens.
- To assess the safety of the study vaccines after one injection in Japanese adolescents 11-12 years of age.
Read the detailed description
Study participants will receive either a single dose of SP306 vaccine intramuscularly or a dose of DT vaccine subcutaneously. They will be monitored after vaccination for immediate adverse events (AEs) solicited injection site and systemic reactions and unsolicited AEs including serious adverse events throughout the study period, approximately 28 days (+7 days).
- Conditions
- Tetanus, Diphtheria, Pertussis
- Being tested
- Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, Diphtheria and Tetanus toxoids adsorbed
- Keywords
- Tetanus, Diphtheria, Pertussis, TdaP vaccine, DT 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.
Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbedBiological
Also called Adacel, SP306 (in Japan)
0.5 mL, intramuscularly.
Diphtheria and Tetanus toxoids adsorbedBiological
Also called DT vaccine
0.1 mL, Subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| SP306 Group | Experimental | Participants randomized to receive SP306 vaccine intramuscularly Receives: Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed |
| DT Group | Active comparator | Participants randomized to receive DT vaccine subcutaneously Receives: Biological: Diphtheria and Tetanus toxoids adsorbed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT
Diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.56 IU/mL. A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.7 IU/mL.
Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
Measured: Day 28 post-vaccination
Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine
Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL.
Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
Measured: Day 28 post-vaccination
Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine
Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2).
Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
Measured: Day 28 post-vaccination
Secondary outcomes (6)
Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine
Seroprotection was defined as the proportion of participants with pre-vaccination with diphtheria and tetanus antitoxin concentration ≥ 0.1 IU/mL.
Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
Measured: Pre-vaccination (Day 0)
Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine
Seroprotection was defined as the proportion of participants with diphtheria and tetanus antitoxin concentration level ≥ 0.01 IU/mL.
Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine
Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine
Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2).
Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
Measured: Day 28 post-vaccination
Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine
Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine
Solicited injection-site: Pain, Erythema, Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain Significant, prevents daily activity; Erythema and Swelling >100 mm. Grade 3 systemic reactions: Fever, >39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Measured: Day 0 up to Day 7 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionMar 2015
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 534 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
- NCT02089347
- Sponsor's protocol ID
- Td536 (EFC12579)
- Other IDs
- U1111-1124-7550
- Status last verified
- Apr 2017
- First submitted
- 13 Mar 2014
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) Given Intramuscularly Compared to Diphtheria and Tetanus Toxoids Adsorbed (DT) Given Subcutaneously in Japanese Adolescents 11 - 12 Years of Age
- ClinicalTrials.gov ID
- NCT02089347
- Acronym / sponsor ID
- Td536 (EFC12579)
- Conditions
- Tetanus, Diphtheria, Pertussis
- Keywords
- Tetanus, Diphtheria, Pertussis, TdaP vaccine, DT vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Posted 8 Oct 2015
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 the study is to generate additional safety and immunogenicity data to support the registration of the product in Japan.
Primary objectives:
- To demonstrate the non-inferiority of SP306 versus DT (DT 0.1mL) vaccine in terms of diphtheria and tetanus booster response rate (proportion of subjects with booster responses) and seroprotection rate (percentage of subjects with antitoxin concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.
- To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in terms of booster response rate (proportion of subjects with booster responses) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.
Secondary objectives:
- To further evaluate the immune response of the study vaccines against diphtheria, tetanus and pertussis antigens.
- To assess the safety of the study vaccines after one injection in Japanese adolescents 11-12 years of age.
Detailed description
Study participants will receive either a single dose of SP306 vaccine intramuscularly or a dose of DT vaccine subcutaneously. They will be monitored after vaccination for immediate adverse events (AEs) solicited injection site and systemic reactions and unsolicited AEs including serious adverse events throughout the study period, approximately 28 days (+7 days).
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 |
|---|---|---|
| SP306 Group | Experimental | Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbedParticipants randomized to receive SP306 vaccine intramuscularly |
| DT Group | Active comparator | Biological: Diphtheria and Tetanus toxoids adsorbedParticipants randomized to receive DT vaccine subcutaneously |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 11 or 12 years and considered healthy on the day of inclusion
- Informed consent form and assent form signed and dated by the parent(s) / legal representative(s) and the subject respectively
- Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e., received 4 doses of Japanese-produced DTaP vaccine), confirmed by checking immunization records and have not yet undergone additional DT vaccination
- Able to attend all scheduled visits and to comply with all trial procedures
- For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test.
Key exclusion criteria (24 listed)
- Any conditions or diseases which, in the opinion of the Investigator:
- would pose a health risk to the subject
- or might interfere with the ability to participate fully in the study
- or might interfere with evaluation of the vaccine
- or would otherwise make participation inappropriate according to the Investigator's clinical judgment
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 |
|---|---|---|
| Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbedAlso: Adacel, SP306 (in Japan)0.5 mL, intramuscularly. | Biological | SP306 Group |
| Diphtheria and Tetanus toxoids adsorbedAlso: DT vaccine0.1 mL, Subcutaneously | Biological | DT Group |
Primary outcome
Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT
Time frame: Day 28 post-vaccination
Diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.56 IU/mL. A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.7 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine
Time frame: Day 28 post-vaccination
Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine
Time frame: Day 28 post-vaccination
Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2). Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
6 secondary outcomes
Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine
Time frame: Pre-vaccination (Day 0)
Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine
Time frame: Day 28 post-vaccination
Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine
Time frame: Day 0 up to Day 7 post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Tetanus
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
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 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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed and Diphtheria and Tetanus toxoids adsorbed in people with Tetanus and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 19 sites in Japan.
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 24 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Oct 2015). 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 Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT (time frame: Day 28 post-vaccination). The study lists 3 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 30 May 2017.