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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Tetanus Immunisation (Healthy Volunteers); Diphtheria Immunisation (Healthy Volunteers); Pertussis Immunisation (Healthy Volunteers)

Treatments: Biological: Licensed Tdap vaccine; Biological: Investigational Tdap vaccine Formulation B; Biological: Investigational Tdap vaccine Formulation D; Biological: Investigational Tdap vaccine Formulation C; Biological: Investigational Tdap vaccine Formulation A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03958799

NGB00005

U1111-1217-2612 (Other Identifier)

Details and patient eligibility

About

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

Full description

Study duration per participant is approximately 1 year, which will include a safety follow-up contact at 12 months after vaccination

Enrollment: 71 patients

Sex: All

Ages: 19 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 9 patient groups

Group 1: Investigational Product (IP) Formulation A

Experimental group

Description:

IP Formulation A administration, participation in Stage 1 and Stage 2

Treatment:

Biological: Investigational Tdap vaccine Formulation A

Group 2: IP Formulation A

Experimental group

Description:

IP Formulation A administration, participation in Stage 1

Treatment:

Biological: Investigational Tdap vaccine Formulation A

Group 3: IP Formulation B

Experimental group

Description:

IP Formulation B administration, participation in Stage 1 and Stage 2

Treatment:

Biological: Investigational Tdap vaccine Formulation B

Group 4: IP Formulation B

Experimental group

Description:

IP Formulation B administration, participation in Stage 1

Treatment:

Biological: Investigational Tdap vaccine Formulation B

Group 5: IP Formulation C

Experimental group

Description:

IP Formulation C administration, participation in Stage 1 and Stage 2

Treatment:

Biological: Investigational Tdap vaccine Formulation C

Group 6: IP Formulation C

Experimental group

Description:

IP Formulation C administration, participation in Stage 1 and Stage 2

Treatment:

Biological: Investigational Tdap vaccine Formulation C

Group 7: IP Formulation D

Experimental group

Description:

IP Formulation D administration, participation in Stage 1 and Stage 2

Treatment:

Biological: Investigational Tdap vaccine Formulation D

Group 8: Tdap

Active Comparator group

Description:

TdaP administration, participation in Stage 1 and Stage 2

Treatment:

Biological: Licensed Tdap vaccine

Group 9: Tdap

Active Comparator group

Description:

TdaP administration, participation in Stage 1

Treatment:

Biological: Licensed Tdap vaccine