Clinical trial NCT03958799: 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
Official title: Safety and Immunogenicity of an Investigational Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Adsorbed (Tdap) Vaccine in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tetanus Immunisation (Healthy Volunteers)
Diphtheria Immunisation (Healthy Volunteers)
Pertussis Immunisation (Healthy Volunteers)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-05-22
Enrollment: 71
Sex: ALL
Minimum age (years): 19
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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 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

Eligibility criteria: Inclusion criteria :

* 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.

Exclusion criteria:

* 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.
* 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.

Primary outcomes:
measure: Number of participants reporting immediate adverse events (AEs)
timeFrame: Within 30 minutes post-vaccination
measure: Number of participants reporting solicited injection sites or systemic reactions
timeFrame: Within 7 days post-vaccination
measure: Number of participants reporting unsolicited AEs
timeFrame: Within 30 days post-vaccination
measure: Number of participants reporting serious adverse events (SAEs)
timeFrame: Up to 12 months post-vaccination
measure: Number of participants reporting medically attended adverse events (MAAEs)
timeFrame: Up to 12 months post-vaccination
measure: Number of participants reporting adverse events of special interest (AESIs)
timeFrame: Up to 12 months post-vaccination
measure: Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities
timeFrame: Within 60 days post-vaccination
measure: Geometric mean concentrations (GMCs) of anti-pertussis antigen immunoglobulins
timeFrame: From Day 0 to Day 360
measure: GMCs of anti-diphtheria toxoid immunoglobulins
timeFrame: From Day 0 to Day 360
measure: GMCs of anti-tetanus toxoid immunoglobulins
timeFrame: From Day 0 to Day 360
measure: Geometric means of antigen-specific cells
timeFrame: From Day 0 to Day 360
measure: Percentages of antigen-specific cells
timeFrame: From Day 0 to Day 360
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Investigational Site Number 1240006
city: Pierrefonds
country: Canada
facility: Investigational Site Number 1240009
city: Quebec
country: Canada
facility: Investigational Site Number 1240004
city: Sherbrooke
country: Canada
facility: Investigational Site Number 1240005
city: Truro
country: Canada
facility: Investigational Site Number 1240003
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: