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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03958799
Recruitment Status : Suspended (Suspended (Due to Covid-19))
First Posted : May 22, 2019
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diphtheria Tetanus

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958799


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

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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    Key Record Dates
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/

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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:
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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