Tetanus Immunisation (Healthy Volunteers)Phase 1NCT03958799
A Study to Describe the Safety Profile and Compare the Immune Response of 4 Different Formulations of an Investigational Tdap Vaccine When Compared to Licensed Tdap Vaccine in Young Adults in Canada
A Phase 1 study testing Investigational Tdap vaccine Formulation B, Investigational Tdap vaccine Formulation C and Investigational Tdap vaccine Formulation A in people with Tetanus Immunisation (Healthy Volunteers) and Diphtheria Immunisation (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 5 sites in Canada.
Trial summary
The primary objectives of this study are: To describe the safety profile of each of the investigational vaccine formulations for all participants To describe the humoral and cell-mediated immune responses to all of the investigational vaccine formulations To evaluate the dose response to vaccine components To describe… Read more about this study
- Who is it for?
- Ages 19 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus Immunisation (Healthy Volunteers), Diphtheria Immunisation (Healthy Volunteers), Pertussis Immunisation (Healthy Volunteers)
- What is being tested?
- Investigational Tdap vaccine Formulation B, Investigational Tdap vaccine Formulation C and Investigational Tdap vaccine Formulation A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 5 sitesCanada
- Study dates
- 26 Jun 2019to 6 Apr 2021
- Phase
- Phase 1
- 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 19 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals born in Canada and vaccinated with a combination vaccine in accordance with the National Immunization Program (NIP).
- Aged ≥ 19 years and < 22 years on the day of inclusion.
- Able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- Pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 3 months after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
- 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 first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or after any study vaccination except for influenza vaccination only, which may be received at least 2 weeks before or 2 weeks after any study vaccination.
- History of autoimmune disorder.
- History of cardiovascular disorder.
- History of Guillain-Barré syndrome.
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- 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 (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) 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.
- 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 ≥ 38.0 C). A prospective participant should not be included 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 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Investigational Site Number 1240006
Halifax, B3K 6R8
Investigational Site Number 1240009
Pierrefonds, H9H 4Y6
Investigational Site Number 1240004
Québec, G1N 4V3
Investigational Site Number 1240005
Sherbrooke, J1L 0H8
Investigational Site Number 1240003
Truro, B2N 1L2
About this study
Official title: Safety and Immunogenicity of an Investigational Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Adsorbed (Tdap) Vaccine in Young Adults
The primary objectives of this study are:
- To describe the safety profile of each of the investigational vaccine formulations for all participants
- To describe the humoral and cell-mediated immune responses to all of the investigational vaccine formulations
- To evaluate the dose response to vaccine components
- To describe the magnitude, quality, and longevity of immune responses to each of the investigational vaccine formulations
Read the detailed description
Study duration per participant is approximately 1 year, which will include a safety follow-up contact at 12 months after vaccination
- Conditions
- Tetanus Immunisation (Healthy Volunteers), Diphtheria Immunisation (Healthy Volunteers), Pertussis Immunisation (Healthy Volunteers)
- Being tested
- Investigational Tdap vaccine Formulation B, Investigational Tdap vaccine Formulation C, Investigational Tdap vaccine Formulation A, Investigational Tdap vaccine Formulation D, Licensed Tdap vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Tdap vaccine Formulation BBiological
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Investigational Tdap vaccine Formulation CBiological
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Investigational Tdap vaccine Formulation ABiological
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Investigational Tdap vaccine Formulation DBiological
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Licensed Tdap vaccineBiological
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Investigational Product (IP) Formulation A | Experimental | IP Formulation A administration, participation in Stage 1 and Stage 2 Receives: Biological: Investigational Tdap vaccine Formulation A |
| Group 2: IP Formulation A | Experimental | IP Formulation A administration, participation in Stage 1 Receives: Biological: Investigational Tdap vaccine Formulation A |
| Group 3: IP Formulation B | Experimental | IP Formulation B administration, participation in Stage 1 and Stage 2 Receives: Biological: Investigational Tdap vaccine Formulation B |
| Group 4: IP Formulation B | Experimental | IP Formulation B administration, participation in Stage 1 Receives: Biological: Investigational Tdap vaccine Formulation B |
| Group 5: IP Formulation C | Experimental | IP Formulation C administration, participation in Stage 1 and Stage 2 Receives: Biological: Investigational Tdap vaccine Formulation C |
| Group 6: IP Formulation C | Experimental | IP Formulation C administration, participation in Stage 1 and Stage 2 Receives: Biological: Investigational Tdap vaccine Formulation C |
| Group 7: IP Formulation D | Experimental | IP Formulation D administration, participation in Stage 1 and Stage 2 Receives: Biological: Investigational Tdap vaccine Formulation D |
| Group 8: Tdap | Active comparator | TdaP administration, participation in Stage 1 and Stage 2 Receives: Biological: Licensed Tdap vaccine |
| Group 9: Tdap | Active comparator | TdaP administration, participation in Stage 1 Receives: Biological: Licensed Tdap vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting immediate adverse events (AEs)
AEs, including those related to the product administered
Measured: Within 30 minutes post-vaccination
Number of participants reporting solicited injection sites or systemic reactions
Solicited reaction: adverse reaction prelisted in the case report book (CRB) Injection site reactions: pain, erythema, swelling Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
Measured: Within 7 days post-vaccination
Number of participants reporting unsolicited AEs
AEs other than solicited reactions
Measured: Within 30 days post-vaccination
Number of participants reporting serious adverse events (SAEs)
SAEs, including adverse event of special interest (AESIs)
Measured: Up to 12 months post-vaccination
Number of participants reporting medically attended adverse events (MAAEs)
MAAE: a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or emergency department
Measured: Up to 12 months post-vaccination
Number of participants reporting adverse events of special interest (AESIs)
AESIs are reported until the end of the safety follow-up period
Measured: Up to 12 months post-vaccination
Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities
Haematological and biochemical laboratory parameters
Measured: Within 60 days post-vaccination
Geometric mean concentrations (GMCs) of anti-pertussis antigen immunoglobulins
Anti-pertussis antigen immunoglobulins concentration will be measured by mesoscale discovery electrochemiluminescence (MSD ECL)
Measured: From Day 0 to Day 360
GMCs of anti-diphtheria toxoid immunoglobulins
Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL
Measured: From Day 0 to Day 360
GMCs of anti-tetanus toxoid immunoglobulins
Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL
Measured: From Day 0 to Day 360
Geometric means of antigen-specific cells
Antigen specific cells will be measured by FLUOROSPOT
Measured: From Day 0 to Day 360
Percentages of antigen-specific cells
Antigen specific cells will be measured by FLUOROSPOT
Measured: From Day 0 to Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start26 Jun 2019
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetanus Immunisation (Healthy Volunteers)Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Modified double-blind: the study participant, the Investigator, and other study personnel remain unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator will administer the appropriate vaccine but will not be involved in safety assessment and data collection.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958799
- Sponsor's protocol ID
- NGB00005
- Other IDs
- U1111-1217-2612
- Status last verified
- Apr 2022
- First submitted
- 20 May 2019
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of an Investigational Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Adsorbed (Tdap) Vaccine in Young Adults
- ClinicalTrials.gov ID
- NCT03958799
- Acronym / sponsor ID
- NGB00005
- Conditions
- Tetanus Immunisation (Healthy Volunteers), Diphtheria Immunisation (Healthy Volunteers), Pertussis Immunisation (Healthy Volunteers)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 22 May 2019 (actual)
- 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 primary objectives of this study are:
- To describe the safety profile of each of the investigational vaccine formulations for all participants
- To describe the humoral and cell-mediated immune responses to all of the investigational vaccine formulations
- To evaluate the dose response to vaccine components
- To describe the magnitude, quality, and longevity of immune responses to each of the investigational vaccine formulations
Detailed description
Study duration per participant is approximately 1 year, which will include a safety follow-up contact at 12 months after vaccination
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- Modified double-blind: the study participant, the Investigator, and other study personnel remain unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator will administer the appropriate vaccine but will not be involved in safety assessment and data collection.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Investigational Product (IP) Formulation A | Experimental | Biological: Investigational Tdap vaccine Formulation AIP Formulation A administration, participation in Stage 1 and Stage 2 |
| Group 2: IP Formulation A | Experimental | Biological: Investigational Tdap vaccine Formulation AIP Formulation A administration, participation in Stage 1 |
| Group 3: IP Formulation B | Experimental | Biological: Investigational Tdap vaccine Formulation BIP Formulation B administration, participation in Stage 1 and Stage 2 |
| Group 4: IP Formulation B | Experimental | Biological: Investigational Tdap vaccine Formulation BIP Formulation B administration, participation in Stage 1 |
| Group 5: IP Formulation C | Experimental | Biological: Investigational Tdap vaccine Formulation CIP Formulation C administration, participation in Stage 1 and Stage 2 |
| Group 6: IP Formulation C | Experimental | Biological: Investigational Tdap vaccine Formulation CIP Formulation C administration, participation in Stage 1 and Stage 2 |
| Group 7: IP Formulation D | Experimental | Biological: Investigational Tdap vaccine Formulation DIP Formulation D administration, participation in Stage 1 and Stage 2 |
| Group 8: Tdap | Active comparator | Biological: Licensed Tdap vaccineTdaP administration, participation in Stage 1 and Stage 2 |
| Group 9: Tdap | Active comparator | Biological: Licensed Tdap vaccineTdaP administration, participation in Stage 1 |
Who may qualify
- Ages
- 19 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals born in Canada and vaccinated with a combination vaccine in accordance with the National Immunization Program (NIP).
- Aged ≥ 19 years and < 22 years on the day of inclusion.
- Able to attend all scheduled visits and to comply with all trial procedures.
Key exclusion criteria (15 listed)
- Pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 3 months after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
- 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 first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or after any study vaccination except for influenza vaccination only, which may be received at least 2 weeks before or 2 weeks after any study vaccination.
- History of autoimmune disorder.
- History of cardiovascular disorder.
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 |
|---|---|---|
| Investigational Tdap vaccine Formulation BPharmaceutical form:Suspension for injection Route of administration: Intramuscular | Biological | Group 3: IP Formulation B, Group 4: IP Formulation B |
| Investigational Tdap vaccine Formulation CPharmaceutical form:Suspension for injection Route of administration: Intramuscular | Biological | Group 5: IP Formulation C, Group 6: IP Formulation C |
| Investigational Tdap vaccine Formulation APharmaceutical form:Suspension for injection Route of administration: Intramuscular | Biological | Group 1: Investigational Product (IP) Formulation A, Group 2: IP Formulation A |
| Investigational Tdap vaccine Formulation DPharmaceutical form:Suspension for injection Route of administration: Intramuscular | Biological | Group 7: IP Formulation D |
| Licensed Tdap vaccinePharmaceutical form:Suspension for injection Route of administration: Intramuscular | Biological | Group 8: Tdap, Group 9: Tdap |
Primary outcome
Number of participants reporting immediate adverse events (AEs)
Time frame: Within 30 minutes post-vaccination
AEs, including those related to the product administered
Number of participants reporting solicited injection sites or systemic reactions
Time frame: Within 7 days post-vaccination
Solicited reaction: adverse reaction prelisted in the case report book (CRB) Injection site reactions: pain, erythema, swelling Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
Number of participants reporting unsolicited AEs
Time frame: Within 30 days post-vaccination
AEs other than solicited reactions
Number of participants reporting serious adverse events (SAEs)
Time frame: Up to 12 months post-vaccination
SAEs, including adverse event of special interest (AESIs)
Number of participants reporting medically attended adverse events (MAAEs)
Time frame: Up to 12 months post-vaccination
MAAE: a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or emergency department
Number of participants reporting adverse events of special interest (AESIs)
Time frame: Up to 12 months post-vaccination
AESIs are reported until the end of the safety follow-up period
Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities
Time frame: Within 60 days post-vaccination
Haematological and biochemical laboratory parameters
Geometric mean concentrations (GMCs) of anti-pertussis antigen immunoglobulins
Time frame: From Day 0 to Day 360
Anti-pertussis antigen immunoglobulins concentration will be measured by mesoscale discovery electrochemiluminescence (MSD ECL)
GMCs of anti-diphtheria toxoid immunoglobulins
Time frame: From Day 0 to Day 360
Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL
GMCs of anti-tetanus toxoid immunoglobulins
Time frame: From Day 0 to Day 360
Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL
Geometric means of antigen-specific cells
Time frame: From Day 0 to Day 360
Antigen specific cells will be measured by FLUOROSPOT
Percentages of antigen-specific cells
Time frame: From Day 0 to Day 360
Antigen specific cells will be measured by FLUOROSPOT
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 25 Apr 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigational Tdap vaccine Formulation B, Investigational Tdap vaccine Formulation C and Investigational Tdap vaccine Formulation A in people with Tetanus Immunisation (Healthy Volunteers) and Diphtheria Immunisation (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 5 sites in Canada.
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 3 inclusion and 15 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants reporting immediate adverse events (AEs) (time frame: Within 30 minutes post-vaccination). The study lists 12 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 25 Apr 2022.