DiphtheriaPhase 3NCT01993173
Sanofi Pasteur's Tdap Combined Vaccine as a Booster Versus Local DT Vaccine in Children or Versus Local Td Vaccine in Adolescents and Adults in China.
A Phase 3 study testing Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL), DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed) and Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed) in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 1 site in China.
Trial summary
The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in participants in China. Read more about this study
- Who is it for?
- Ages 4 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL), DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed) and Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Apr 2015
- Phase
- Phase 3
- 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 4 to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 4 through 64 years on day of inclusion
- For children and adolescents (4 through 17 years): Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and assent form has been signed and dated by the subject if aged 8 through 17 years
- For adults (18 years and over): Informed consent form has been signed and dated by the subject
- Subject and parent / legally acceptable representative (for subjects up to 17 years) are able to attend all schedule visits and to comply with all trial procedures
- According to China National Immunization Recommendations, written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) vaccine for subjects aged 4 through 7 years and a written documentation or oral confirmation of complete primary series and fourth dose of DTP vaccine for subjects aged 8 through 64 years
Who cannot join
- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- Previous vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except Tetanus-prone wound management for adults) in the past 12 months.
- Previous fifth vaccination against pertussis disease.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- 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.
Show all 22Show fewer
- Known (laboratory-confirmed / self-reported) Human Immunodeficiency Virus (HIV) or Hepatitis C seropositivity.
- History of diphtheria, tetanus, or pertussis infection (confirmed either clinically, serologically or microbiologically).
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
- Laboratory-confirmed / self-reported thrombocytopenia, contraindicating intramuscular vaccination.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- History of contra-indication to vaccination with pertussis containing vaccine, including:
- Encephalopathy (e.g, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause
- Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy
- Axillary temperature >39.4°C within 48 hours not attributable to another identifiable cause
- Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
- Prior personal history of Guillain-Barré syndrome.
- 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.
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the vaccination and until at least 4 weeks after the vaccination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Sanofi Pasteur's Tdap Combined Vaccine (ADACEL) as a Booster Dose, Versus Local DT Vaccine in Healthy Children or Versus Local Td Vaccine in Healthy Adolescents and Adults in China
The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in participants in China.
Primary objective:
- To describe diphtheria and tetanus seroprotection rates and pertussis booster response rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups), local DT vaccine (in children), and local Td vaccine (in adolescents and adults).
Secondary Objectives:
- To further describe in each group the immunogenicity of the study vaccines at baseline and 1 month after vaccination.
- To describe the safety of the study vaccines
Read the detailed description
Study participants will receive a single booster dose of ADACEL (Tdap vaccine) or a single booster dose of local DT or local Td vaccine, depending on the age subgroup.
Immunogenicity will be assessed before and 28 days post-vaccination; safety profile will be assessed in all subjects up to Day 35 post vaccination.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Being tested
- Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL), DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed), Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)
- Keywords
- Diphtheria, Tetanus, Pertussis, ADACEL®, Tdap vaccine
- Medical subject headings
- Diphtheria, Tetanus, 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 Tdap (ADACEL)Biological
Also called ADACEL
0.5 mL, Intramuscular
DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed)Biological
0.5 mL, Intramuscular
Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)Biological
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| ADACEL Vaccine Group | Experimental | Children, adolescents and adults randomized to receive a single booster dose of ADACEL (Tdap vaccine) Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL) |
| Local DT/Td Vaccine Group | Active comparator | Participants randomized to receive either a single booster dose of local DT vaccine (children aged 4 through 11 years) or local Td vaccine (adolescents and adults aged 12 through 64 years) Receives: Biological: DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed); Biological: Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with anti-diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL
Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Measured: 28 Days post-vaccination
Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL
Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Measured: 28 Days post-vaccination
Percentage of participants with a booster response for antibodies to Pertussis Toxoid (PT), Filamentous hemagglutinin (FHA), pertactin (PRN), Fimbriae types 2 and 3 (FIM) following vaccination with ADACEL or Local DT or Local Td Vaccine
Booster response for antibodies to Pertussis Toxoid (PT), Filamentous hemagglutinin (FHA), pertactin (PRN), Fimbriae types 2 and 3 (FIM) will be determined by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Secondary outcomes (6)
Percentage of participants with anti diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL at baseline
Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 0 (pre-vaccination)
Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL at baseline
Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 0 (pre-vaccination)
Percentage of participants with anti-diphtheria antibody concentrations ≥ 1.0 international unit (IU)/mL at baseline and post booster vaccination
Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of participants with anti-tetanus antibody concentrations ≥ 1.0 IU/mL at baseline and post booster vaccination
Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric mean of individual antibody concentrations at baseline and post-booster vaccination
Antibody concentrations to all vaccine antigens will be determined by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse reactions, and serious adverse events occurring during the trial
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia
Measured: Day 0 up to Day 28 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,440 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
- NCT01993173
- Sponsor's protocol ID
- Td528
- Other IDs
- U1111-1127-7835
- Status last verified
- May 2015
- First submitted
- 19 Nov 2013
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Sanofi Pasteur's Tdap Combined Vaccine (ADACEL) as a Booster Dose, Versus Local DT Vaccine in Healthy Children or Versus Local Td Vaccine in Healthy Adolescents and Adults in China
- ClinicalTrials.gov ID
- NCT01993173
- Acronym / sponsor ID
- Td528
- Conditions
- Diphtheria, Tetanus, Pertussis
- Keywords
- Diphtheria, Tetanus, Pertussis, ADACEL®, Tdap vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Nov 2013 (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.
The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in participants in China.
Primary objective:
- To describe diphtheria and tetanus seroprotection rates and pertussis booster response rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups), local DT vaccine (in children), and local Td vaccine (in adolescents and adults).
Secondary Objectives:
- To further describe in each group the immunogenicity of the study vaccines at baseline and 1 month after vaccination.
- To describe the safety of the study vaccines
Detailed description
Study participants will receive a single booster dose of ADACEL (Tdap vaccine) or a single booster dose of local DT or local Td vaccine, depending on the age subgroup.
Immunogenicity will be assessed before and 28 days post-vaccination; safety profile will be assessed in all subjects up to Day 35 post vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADACEL Vaccine Group | Experimental | Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL)Children, adolescents and adults randomized to receive a single booster dose of ADACEL (Tdap vaccine) |
| Local DT/Td Vaccine Group | Active comparator | Biological: DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed), Biological: Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)Participants randomized to receive either a single booster dose of local DT vaccine (children aged 4 through 11 years) or local Td vaccine (adolescents and adults aged 12 through 64 years) |
Who may qualify
- Ages
- 4 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged 4 through 64 years on day of inclusion
- For children and adolescents (4 through 17 years): Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and assent form has been signed and dated by the subject if aged 8 through 17 years
- For adults (18 years and over): Informed consent form has been signed and dated by the subject
- Subject and parent / legally acceptable representative (for subjects up to 17 years) are able to attend all schedule visits and to comply with all trial procedures
- According to China National Immunization Recommendations, written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) vaccine for subjects aged 4 through 7 years and a written documentation or oral confirmation of complete primary series and fourth dose of DTP vaccine for subjects aged 8 through 64 years
Key exclusion criteria (22 listed)
- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- Previous vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except Tetanus-prone wound management for adults) in the past 12 months.
- Previous fifth vaccination against pertussis disease.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
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 Tdap (ADACEL)Also: ADACEL0.5 mL, Intramuscular | Biological | ADACEL Vaccine Group |
| DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed)0.5 mL, Intramuscular | Biological | Local DT/Td Vaccine Group |
| Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)0.5 mL, Intramuscular | Biological | Local DT/Td Vaccine Group |
Primary outcome
Percentage of participants with anti-diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL
Time frame: 28 Days post-vaccination
Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL
Time frame: 28 Days post-vaccination
Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Percentage of participants with a booster response for antibodies to Pertussis Toxoid (PT), Filamentous hemagglutinin (FHA), pertactin (PRN), Fimbriae types 2 and 3 (FIM) following vaccination with ADACEL or Local DT or Local Td Vaccine
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Booster response for antibodies to Pertussis Toxoid (PT), Filamentous hemagglutinin (FHA), pertactin (PRN), Fimbriae types 2 and 3 (FIM) will be determined by enzyme-linked immunosorbent assay (ELISA)
6 secondary outcomes
Percentage of participants with anti diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL at baseline
Time frame: Day 0 (pre-vaccination)
Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL at baseline
Time frame: Day 0 (pre-vaccination)
Percentage of participants with anti-diphtheria antibody concentrations ≥ 1.0 international unit (IU)/mL at baseline and post booster vaccination
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of participants with anti-tetanus antibody concentrations ≥ 1.0 IU/mL at baseline and post booster vaccination
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric mean of individual antibody concentrations at baseline and post-booster vaccination
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse reactions, and serious adverse events occurring during the trial
Time frame: Day 0 up to Day 28 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 19 May 2015.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL), DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed) and Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed) in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 1 site in China.
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 22 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 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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?
Percentage of participants with anti-diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL (time frame: 28 Days 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 19 May 2015.