Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
NCT ID: NCT02587520
Last Updated: 2022-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
1363 participants
INTERVENTIONAL
2015-10-22
2017-02-21
Brief Summary
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Primary Objective
* To describe the safety profile of each SP0173 investigational formulation.
Observational Objective:
* To describe the immunogenicity of each SP0173 investigational formulation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Adolescents: SP0173 Formulation 1
Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
0.5 milliliter (mL), Intramuscular
Adolescents: SP0173 Formulation 2
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
0.5 mL, Intramuscular
Adolescents: SP0173 Formulation 3
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
0.5 mL, Intramuscular
Adolescents: SP0173 Formulation 4
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
0.5 mL, Intramuscular
Adolescents: Adacel®
Healthy participants aged 10-18 years received Adacel®.
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular
Adolescents: Boostrix®
Healthy participants aged 10-18 years received Boostrix®.
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
0.5 mL, Intramuscular
Adults: SP0173 Formulation 1
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
0.5 milliliter (mL), Intramuscular
Adults: SP0173 Formulation 2
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
0.5 mL, Intramuscular
Adults: SP0173 Formulation 3
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
0.5 mL, Intramuscular
Adults: SP0173 Formulation 4
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
0.5 mL, Intramuscular
Adults: Adacel®
Healthy participants aged 19-64 years received Adacel®.
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular
Adults: Boostrix®
Healthy participants aged 19-64 years received Boostrix®.
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
0.5 mL, Intramuscular
Older Adults: SP0173 Formulation 1
Healthy participants aged greater than equal to (\>=65) years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
0.5 milliliter (mL), Intramuscular
Older Adults: SP0173 Formulation 2
Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
0.5 mL, Intramuscular
Older Adults: SP0173 Formulation 3
Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
0.5 mL, Intramuscular
Older Adults: SP0173 Formulation 4
Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
0.5 mL, Intramuscular
Older Adults: Adacel®
Healthy participants aged \>=65 years received Adacel®.
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular
Older Adults: Boostrix®
Healthy participants aged \>=65 years received Boostrix®.
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
0.5 mL, Intramuscular
Interventions
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Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
0.5 milliliter (mL), Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
0.5 mL, Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
0.5 mL, Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
0.5 mL, Intramuscular
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent form had been signed and dated by the participant, or assent form had been signed and dated by the participant and informed consent form had been signed and dated by the parent/guardian
* Participant or participant and parent/guardian able to attend all scheduled visits and to comply with all study procedures.
Exclusion Criteria
* Participation at the time of study enrollment or planned participation during the present study period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
* Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine between Visit 1 and Visit 2.
* Known or suspected receipt of a tetanus toxoid, reduced diphtheria toxoid, and Acellular pertussis (Tdap) vaccine or Tdap-containing vaccine at any point in time, or receipt of a tetanus and diphtheria containing vaccine in the preceding 5 years.
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* History of diphtheria, tetanus, or pertussis infection (confirmed either serologically or microbiologically).
* Known or suspected systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the study vaccine or a vaccine containing the same substances.
* Laboratory-confirmed / self-reported thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
* History of encephalopathy (e.g., coma, decreased level of consciousness, or prolonged seizures) not attributable to another identifiable cause within 7 days of administration of a previous dose of diphtheria and tetanus toxoids and pertussis (DTP), or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol abuse or drug addiction.
* Chronic illness that was at a stage where it might interfere with trial conduct or completion.
* Moderate or severe acute illness/infection on the day of vaccination or febrile illness (temperature \>= 100.4°F).
* 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 (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
10 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Birmingham, Alabama, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
San Diego, California, United States
DeLand, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Meridian, Idaho, United States
Bardstown, Kentucky, United States
Nicholasville, Kentucky, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Rochester, New York, United States
Cleveland, Ohio, United States
Erie, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Nashville, Tennessee, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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U1111-1161-3027
Identifier Type: OTHER
Identifier Source: secondary_id
ADC01
Identifier Type: -
Identifier Source: org_study_id
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