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

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

Study Overview

• Status: Completed
• Conditions: Tetanus Immunisation (Healthy Volunteers); Diphtheria Immunisation (Healthy Volunteers); Pertussis Immunisation (Healthy Volunteers)
• Intervention / Treatment: Biological: Investigational Tdap vaccine Formulation A; Biological: Investigational Tdap vaccine Formulation B; Biological: Investigational Tdap vaccine Formulation C; Biological: Investigational Tdap vaccine Formulation D; Biological: Licensed Tdap vaccine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Halifax, Canada, B3K 6R8
    • Investigational Site Number 1240006
  • Pierrefonds, Canada, H9H 4Y6
    • Investigational Site Number 1240009
  • Quebec, Canada, G1N 4V3
    • Investigational Site Number 1240004
  • Sherbrooke, Canada, J1L 0H8
    • Investigational Site Number 1240005
  • Truro, Canada, B2N 1L2
    • Investigational Site Number 1240003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 21 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1: Investigational Product (IP) Formulation A; IP Formulation A administration, participation in Stage 1 and Stage 2	Biological: Investigational Tdap vaccine Formulation A; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
EXPERIMENTAL: Group 2: IP Formulation A; IP Formulation A administration, participation in Stage 1	Biological: Investigational Tdap vaccine Formulation A; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
EXPERIMENTAL: Group 3: IP Formulation B; IP Formulation B administration, participation in Stage 1 and Stage 2	Biological: Investigational Tdap vaccine Formulation B; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
EXPERIMENTAL: Group 4: IP Formulation B; IP Formulation B administration, participation in Stage 1	Biological: Investigational Tdap vaccine Formulation B; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
EXPERIMENTAL: Group 5: IP Formulation C; IP Formulation C administration, participation in Stage 1 and Stage 2	Biological: Investigational Tdap vaccine Formulation C; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
EXPERIMENTAL: Group 6: IP Formulation C; IP Formulation C administration, participation in Stage 1 and Stage 2	Biological: Investigational Tdap vaccine Formulation C; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
EXPERIMENTAL: Group 7: IP Formulation D; IP Formulation D administration, participation in Stage 1 and Stage 2	Biological: Investigational Tdap vaccine Formulation D; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
ACTIVE_COMPARATOR: Group 8: Tdap; TdaP administration, participation in Stage 1 and Stage 2	Biological: Licensed Tdap vaccine; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
ACTIVE_COMPARATOR: Group 9: Tdap; TdaP administration, participation in Stage 1	Biological: Licensed Tdap vaccine; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants reporting unsolicited AEs	AEs other than solicited reactions	Within 30 days post-vaccination
Number of participants reporting immediate adverse events (AEs)	AEs, including those related to the product administered	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	Within 7 days post-vaccination
Number of participants reporting serious adverse events (SAEs)	SAEs, including adverse event of special interest (AESIs)	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	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	Up to 12 months post-vaccination
Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities	Haematological and biochemical laboratory parameters	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)	From Day 0 to Day 360
GMCs of anti-diphtheria toxoid immunoglobulins	Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL	From Day 0 to Day 360
GMCs of anti-tetanus toxoid immunoglobulins	Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL	From Day 0 to Day 360
Geometric means of antigen-specific cells	Antigen specific cells will be measured by FLUOROSPOT	From Day 0 to Day 360
Percentages of antigen-specific cells	Antigen specific cells will be measured by FLUOROSPOT	From Day 0 to Day 360

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2019
• Primary Completion (ACTUAL): April 6, 2021
• Study Completion (ACTUAL): April 6, 2021

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (ACTUAL): May 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Clostridium Infections; Corynebacterium Infections; Whooping Cough; Tetanus; Diphtheria; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: NGB00005; U1111-1217-2612 (OTHER: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No