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

• ClinicalTrials.gov Identifier: NCT03958799
• Recruitment Status: Suspended
• First Posted: May 22, 2019
• Last Update Posted: April 15, 2020
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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

Condition or disease	Intervention/treatment	Phase
Tetanus Immunisation (Healthy Volunteers); Diphtheria Immunisation (Healthy Volunteers); Pertussis Immunisation (Healthy Volunteers)	Biological: Investigational Tdap vaccine Formulation B; Biological: Investigational Tdap vaccine Formulation C; Biological: Investigational Tdap vaccine Formulation A; Biological: Investigational Tdap vaccine Formulation D; Biological: Licensed Tdap vaccine	Phase 1

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Safety and Immunogenicity of an Investigational Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Adsorbed (Tdap) Vaccine in Young Adults
• Actual Study Start Date: June 26, 2019
• Estimated Primary Completion Date: May 2021
• Estimated Study Completion Date: May 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of participants reporting immediate adverse events (AEs) [ Time Frame: Within 30 minutes post-vaccination ]
   AEs, including those related to the product administered
2. 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
3. Number of participants reporting unsolicited AEs [ Time Frame: Within 30 days post-vaccination ]
   AEs other than solicited reactions
4. Number of participants reporting serious adverse events (SAEs) [ Time Frame: Up to 12 months post-vaccination ]
   SAEs, including adverse event of special interest (AESIs)
5. 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
6. 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
7. Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities [ Time Frame: Within 60 days post-vaccination ]
   Haematological and biochemical laboratory parameters
8. 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)
9. 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
10. 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
11. Geometric means of antigen-specific cells [ Time Frame: From Day 0 to Day 360 ]
    Antigen specific cells will be measured by FLUOROSPOT
12. Percentages of antigen-specific cells [ Time Frame: From Day 0 to Day 360 ]
    Antigen specific cells will be measured by FLUOROSPOT

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 21 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Canada

Investigational Site Number 1240006

Halifax, Canada, B3K 6R8

Investigational Site Number 1240009

Pierrefonds, Canada, H9H 4Y6

Investigational Site Number 1240004

Quebec, Canada, G1N 4V3

Investigational Site Number 1240005

Sherbrooke, Canada, J1L 0H8

Investigational Site Number 1240003

Truro, Canada, B2N 1L2

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi Pasteur, a Sanofi Company

More Information

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT03958799
• Other Study ID Numbers: NGB00005; U1111-1217-2612 ( Other Identifier: UTN )
• First Posted: May 22, 2019
• Last Update Posted: April 15, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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://www.clinicalstudydatarequest.com/

• 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

Additional relevant MeSH terms:

Whooping Cough; Tetanus; Diphtheria; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Respiratory Tract Infections; Infection; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs