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Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02587520
Collaborator
(none)
1,363
Enrollment
20
Locations
18
Arms
16
Actual Duration (Months)
68.2
Patients Per Site
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the United States (US).

Primary Objective

  • To describe the safety profile of each SP0173 investigational formulation.
Observational Objective:
  • To describe the immunogenicity of each SP0173 investigational formulation.
Condition or Disease Intervention/Treatment Phase
  • Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
  • Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
  • Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
  • Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
  • Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
  • Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
 Phase 1/Phase 2

Detailed Description

All participants received a single dose of vaccine, and were assessed for immunogenicity at baseline (pre-vaccination) and at 30 days post-vaccination. They were also monitored for safety from day of vaccination up to Day 180 post-vaccination.

Study Design

Study Type:
Interventional
Actual Enrollment :
1363 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults
Actual Study Start Date :
Oct 22, 2015
Actual Primary Completion Date :
Feb 21, 2017
Actual Study Completion Date :
Feb 21, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
0.5 milliliter (mL), Intramuscular
Other Names:
  • SP0173

    		•
    Experimental: Adolescents: SP0173 Formulation 2

    Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
    0.5 mL, Intramuscular
    Other Names:
  • SP0173

    		•
    Experimental: Adolescents: SP0173 Formulation 3

    Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
    0.5 mL, Intramuscular
    Other Names:
  • SP0173

    		•
    Experimental: Adolescents: SP0173 Formulation 4

    Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
    0.5 mL, Intramuscular
    Other Names:
  • SP0173

    		•
    Active Comparator: Adolescents: Adacel®

    Healthy participants aged 10-18 years received Adacel®.

    Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
    0.5 mL, Intramuscular
    Active Comparator: Adolescents: Boostrix®

    Healthy participants aged 10-18 years received Boostrix®.

    Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
    0.5 mL, Intramuscular
    Experimental: Adults: SP0173 Formulation 1

    Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
    0.5 milliliter (mL), Intramuscular
    Other Names:
  • SP0173

    		•
    Experimental: Adults: SP0173 Formulation 2

    Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
    0.5 mL, Intramuscular
    Other Names:
  • SP0173

    		•
    Experimental: Adults: SP0173 Formulation 3

    Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
    0.5 mL, Intramuscular
    Other Names:
  • SP0173

    		•
    Experimental: Adults: SP0173 Formulation 4

    Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
    0.5 mL, Intramuscular
    Other Names:
  • SP0173

    		•
    Active Comparator: Adults: Adacel®

    Healthy participants aged 19-64 years received Adacel®.

    Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
    0.5 mL, Intramuscular
    Active Comparator: Adults: Boostrix®

    Healthy participants aged 19-64 years received Boostrix®.

    Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
    0.5 mL, Intramuscular
    Experimental: Older Adults: SP0173 Formulation 1

    Healthy participants aged greater than equal to (>=65) years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
    0.5 milliliter (mL), Intramuscular
    Other Names:
  • SP0173

    		•
    Experimental: Older Adults: SP0173 Formulation 2

    Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
    0.5 mL, Intramuscular
    Other Names:
  • SP0173

    		•
    Experimental: Older Adults: SP0173 Formulation 3

    Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
    0.5 mL, Intramuscular
    Other Names:
  • SP0173

    		•
    Experimental: Older Adults: SP0173 Formulation 4

    Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
    0.5 mL, Intramuscular
    Other Names:
  • SP0173

    		•
    Active Comparator: Older Adults: Adacel®

    Healthy participants aged >=65 years received Adacel®.

    Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
    0.5 mL, Intramuscular
    Active Comparator: Older Adults: Boostrix®

    Healthy participants aged >=65 years received Boostrix®.

    Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
    0.5 mL, Intramuscular

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years [Within 7 days after vaccination]

      A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature & onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.

    2. Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years [Within 7 days after vaccination]

      An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.

    3. Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years [Within 7 days after vaccination]

      An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Aged 10 to 18 years, 19 to 64 years, or >= 65 years on the day of inclusion.

    • 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:

    • Participant was pregnant, or lactating, or of childbearing potential, (to be considered of non-childbearing potential, a female must be premenarche or post-menopausal for at least 1 year) surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35205
    2 Fayetteville Arkansas United States 72703
    3 Jonesboro Arkansas United States 72401
    4 San Diego California United States 92108
    5 DeLand Florida United States 32720
    6 Miami Florida United States 33143
    7 Orlando Florida United States 32806
    8 Meridian Idaho United States 83642
    9 Bardstown Kentucky United States 40004
    10 Nicholasville Kentucky United States 40356
    11 Lincoln Nebraska United States 68516
    12 Las Vegas Nevada United States 89109
    13 Albuquerque New Mexico United States 87108
    14 Rochester New York United States 14609
    15 Cleveland Ohio United States 44122
    16 Erie Pennsylvania United States 16505
    17 Mount Pleasant South Carolina United States 29464
    18 Nashville Tennessee United States 37203
    19 Salt Lake City Utah United States 84109
    20 Salt Lake City Utah United States 84121

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur Inc.

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT02587520
    Other Study ID Numbers:
    • ADC01
    • U1111-1161-3027
    First Posted:
    Oct 27, 2015
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Sanofi Pasteur, a Sanofi Company
    Tetanus
    Diphtheria
    Pertussis
    SP0173
    Tdap vaccine
    Additional relevant MeSH terms:
    Whooping Cough
    Tetanus
    Diphtheria
    Tetany
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details Study participants were enrolled in 20 centers in the Unites States (US) from 22 October 2015 to 15 August 2016.
    Pre-assignment Detail A total of 1363 participants were randomized in a 1:1:1 ratio to 1 of the 6 formulation study groups. Randomization was stratified by age (adolescents: age 10-18 years, adults: age 19-64 years, and older adults: age greater than equal to [>=] 65 years).
    Arm/Group Title Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix® Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix® Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix®
    Arm/Group Description 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. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received Adacel®. Healthy participants aged 10-18 years received Boostrix®. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received Adacel®. Healthy participants aged 19-64 years received Boostrix®. Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine. Healthy subjects aged >=65 years received a single dose of the SP0173 Tdap vaccine. Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >=65 years received Adacel®. Healthy participants aged >=65 years received Boostrix®.
    Period Title: Overall Study
    STARTED 80 71 78 79 75 75 76 73 76 76 76 73 77 74 78 72 76 78
    Safety Analysis Set (SafAS) 79 71 77 77 75 75 76 73 76 76 76 72 77 73 78 72 76 78
    COMPLETED 78 69 77 74 75 72 73 71 73 71 73 69 77 73 78 72 76 78
    NOT COMPLETED 2 2 1 5 0 3 3 2 3 5 3 4 0 1 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix® Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix® Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix® Total
    Arm/Group Description 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. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received Adacel®. Healthy participants aged 10-18 years received Boostrix®. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received Adacel®. Healthy participants aged 19-64 years received Boostrix®. Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine. Healthy subjects aged >=65 years received a single dose of the SP0173 Tdap vaccine. Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >=65 years received Adacel®. Healthy participants aged >=65 years received Boostrix®. Total of all reporting groups
    Overall Participants 80 71 78 79 75 75 76 73 76 76 76 73 77 74 78 72 76 78 1363
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    10.8
    (1.3)
    11.0
    (1.3)
    11.1
    (1.6)
    10.8
    (1.4)
    10.8
    (1.5)
    11.1
    (1.6)
    42.5
    (12.5)
    41.2
    (12.1)
    40.1
    (12.8)
    42.1
    (13.0)
    41.3
    (12.7)
    42.5
    (13.2)
    71.3
    (5.4)
    71.8
    (5.4)
    70.9
    (4.8)
    70.8
    (5.1)
    70.9
    (5.0)
    71.3
    (4.8)
    41.2
    (25.9)
    Sex: Female, Male (Count of Participants)
    Female
    41
    51.3%
    33
    46.5%
    35
    44.9%
    37
    46.8%
    39
    52%
    40
    53.3%
    43
    56.6%
    46
    63%
    38
    50%
    39
    51.3%
    44
    57.9%
    36
    49.3%
    37
    48.1%
    38
    51.4%
    51
    65.4%
    38
    52.8%
    46
    60.5%
    45
    57.7%
    726
    53.3%
    Male
    39
    48.8%
    38
    53.5%
    43
    55.1%
    42
    53.2%
    36
    48%
    35
    46.7%
    33
    43.4%
    27
    37%
    38
    50%
    37
    48.7%
    32
    42.1%
    37
    50.7%
    40
    51.9%
    36
    48.6%
    27
    34.6%
    34
    47.2%
    30
    39.5%
    33
    42.3%
    637
    46.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    5%
    2
    2.8%
    3
    3.8%
    4
    5.1%
    4
    5.3%
    6
    8%
    17
    22.4%
    19
    26%
    8
    10.5%
    11
    14.5%
    15
    19.7%
    10
    13.7%
    11
    14.3%
    12
    16.2%
    13
    16.7%
    15
    20.8%
    12
    15.8%
    13
    16.7%
    179
    13.1%
    Not Hispanic or Latino
    76
    95%
    69
    97.2%
    75
    96.2%
    75
    94.9%
    71
    94.7%
    69
    92%
    59
    77.6%
    54
    74%
    68
    89.5%
    65
    85.5%
    61
    80.3%
    63
    86.3%
    64
    83.1%
    59
    79.7%
    64
    82.1%
    55
    76.4%
    63
    82.9%
    61
    78.2%
    1171
    85.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    2.6%
    3
    4.1%
    1
    1.3%
    2
    2.8%
    1
    1.3%
    4
    5.1%
    13
    1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.3%
    1
    1.4%
    0
    0%
    3
    3.9%
    0
    0%
    1
    1.4%
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8
    0.6%
    Asian
    0
    0%
    0
    0%
    1
    1.3%
    0
    0%
    2
    2.7%
    2
    2.7%
    2
    2.6%
    1
    1.4%
    4
    5.3%
    1
    1.3%
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    1
    1.4%
    1
    1.3%
    0
    0%
    16
    1.2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    1
    1.3%
    1
    1.3%
    0
    0%
    0
    0%
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    0.2%
    Black or African American
    7
    8.8%
    9
    12.7%
    2
    2.6%
    4
    5.1%
    8
    10.7%
    4
    5.3%
    23
    30.3%
    18
    24.7%
    24
    31.6%
    18
    23.7%
    23
    30.3%
    19
    26%
    7
    9.1%
    8
    10.8%
    8
    10.3%
    5
    6.9%
    6
    7.9%
    10
    12.8%
    203
    14.9%
    White
    71
    88.8%
    60
    84.5%
    71
    91%
    72
    91.1%
    63
    84%
    65
    86.7%
    48
    63.2%
    51
    69.9%
    46
    60.5%
    53
    69.7%
    52
    68.4%
    51
    69.9%
    69
    89.6%
    64
    86.5%
    70
    89.7%
    66
    91.7%
    69
    90.8%
    68
    87.2%
    1109
    81.4%
    More than one race
    2
    2.5%
    1
    1.4%
    3
    3.8%
    2
    2.5%
    2
    2.7%
    4
    5.3%
    2
    2.6%
    1
    1.4%
    2
    2.6%
    1
    1.3%
    1
    1.3%
    1
    1.4%
    1
    1.3%
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    24
    1.8%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
    Description A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature & onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
    Time Frame Within 7 days after vaccination

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set that was defined as those participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, "number analyzed"= number of participants with available data for each specified category.
    Arm/Group Title Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix®
    Arm/Group Description 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. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received Adacel®. Healthy participants aged 10-18 years received Boostrix®.
    Measure Participants 79 71 77 77 75 75
    Injection site pain
    59
    73.8%
    51
    71.8%
    50
    64.1%
    49
    62%
    59
    78.7%
    48
    64%
    Injection site erythema
    9
    11.3%
    4
    5.6%
    10
    12.8%
    1
    1.3%
    4
    5.3%
    2
    2.7%
    Injection site swelling
    7
    8.8%
    4
    5.6%
    8
    10.3%
    0
    0%
    1
    1.3%
    4
    5.3%
    Upper limb edema
    45
    56.3%
    41
    57.7%
    49
    62.8%
    46
    58.2%
    48
    64%
    33
    44%
    Extensive limb swelling
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Fever
    1
    1.3%
    0
    0%
    1
    1.3%
    0
    0%
    0
    0%
    1
    1.3%
    Headache
    21
    26.3%
    14
    19.7%
    19
    24.4%
    25
    31.6%
    20
    26.7%
    27
    36%
    Malaise
    14
    17.5%
    17
    23.9%
    14
    17.9%
    18
    22.8%
    12
    16%
    17
    22.7%
    Myalgia
    42
    52.5%
    35
    49.3%
    38
    48.7%
    42
    53.2%
    52
    69.3%
    38
    50.7%
    2. Primary Outcome
    Title Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
    Description An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
    Time Frame Within 7 days after vaccination

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on safety analysis set. Here, "number analyzed"=number of participants with available data for each specified category.
    Arm/Group Title Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix®
    Arm/Group Description Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received Adacel®. Healthy participants aged 19-64 years received Boostrix®.
    Measure Participants 76 73 76 76 76 72
    Injection site pain
    38
    47.5%
    34
    47.9%
    49
    62.8%
    42
    53.2%
    49
    65.3%
    35
    46.7%
    Injection site erythema
    2
    2.5%
    1
    1.4%
    2
    2.6%
    0
    0%
    5
    6.7%
    2
    2.7%
    Injection site swelling
    1
    1.3%
    3
    4.2%
    4
    5.1%
    1
    1.3%
    3
    4%
    1
    1.3%
    Upper limb edema
    28
    35%
    37
    52.1%
    41
    52.6%
    37
    46.8%
    35
    46.7%
    31
    41.3%
    Extensive limb swelling
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.3%
    0
    0%
    Fever
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    2.7%
    1
    1.3%
    Headache
    16
    20%
    11
    15.5%
    19
    24.4%
    19
    24.1%
    19
    25.3%
    19
    25.3%
    Malaise
    18
    22.5%
    9
    12.7%
    16
    20.5%
    19
    24.1%
    23
    30.7%
    15
    20%
    Myalgia
    32
    40%
    29
    40.8%
    35
    44.9%
    36
    45.6%
    39
    52%
    28
    37.3%
    3. Primary Outcome
    Title Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
    Description An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
    Time Frame Within 7 days after vaccination

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on safety analysis set. Here, "number analyzed"=number of participants with available data for each specified category.
    Arm/Group Title Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix®
    Arm/Group Description Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >=65 years received Adacel®. Healthy participants aged >=65 years received Boostrix®.
    Measure Participants 77 73 78 72 76 78
    Injection site pain
    21
    26.3%
    34
    47.9%
    34
    43.6%
    34
    43%
    28
    37.3%
    25
    33.3%
    Injection site erythema
    0
    0%
    1
    1.4%
    2
    2.6%
    2
    2.5%
    3
    4%
    1
    1.3%
    Injection site swelling
    1
    1.3%
    6
    8.5%
    6
    7.7%
    2
    2.5%
    1
    1.3%
    2
    2.7%
    Upper limb edema
    38
    47.5%
    43
    60.6%
    36
    46.2%
    38
    48.1%
    32
    42.7%
    40
    53.3%
    Extensive limb swelling
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Fever
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Headache
    6
    7.5%
    10
    14.1%
    20
    25.6%
    12
    15.2%
    11
    14.7%
    14
    18.7%
    Malaise
    6
    7.5%
    12
    16.9%
    14
    17.9%
    9
    11.4%
    8
    10.7%
    6
    8%
    Myalgia
    12
    15%
    21
    29.6%
    30
    38.5%
    23
    29.1%
    23
    30.7%
    17
    22.7%

    Adverse Events

    Time Frame Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
    Adverse Event Reporting Description A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
    Arm/Group Title Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix® Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix® Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix®
    Arm/Group Description 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. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 10-18 years received Adacel®. Healthy participants aged 10-18 years received Boostrix®. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged 19-64 years received Adacel®. Healthy participants aged 19-64 years received Boostrix®. Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine. Healthy participants aged >= 65 years received Adacel®. Healthy participants aged >= 65 years received Boostrix®.
    All Cause Mortality
    Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix® Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix® Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/79 (0%) 0/71 (0%) 0/77 (0%) 0/77 (0%) 0/75 (0%) 0/75 (0%) 0/76 (0%) 0/73 (0%) 0/76 (0%) 0/76 (0%) 0/76 (0%) 1/72 (1.4%) 0/77 (0%) 0/73 (0%) 0/78 (0%) 0/72 (0%) 0/76 (0%) 0/78 (0%)
    Serious Adverse Events
    Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix® Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix® Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/79 (0%) 0/71 (0%) 0/77 (0%) 1/77 (1.3%) 0/75 (0%) 0/75 (0%) 1/76 (1.3%) 1/73 (1.4%) 1/76 (1.3%) 1/76 (1.3%) 0/76 (0%) 2/72 (2.8%) 0/77 (0%) 3/73 (4.1%) 4/78 (5.1%) 1/72 (1.4%) 2/76 (2.6%) 2/78 (2.6%)
    Cardiac disorders
    Cardiac Failure Congestive 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 1/76 (1.3%) 1 0/78 (0%) 0
    Coronary Artery Disease 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 1/73 (1.4%) 1 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Ventricular Fibrillation 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 1/72 (1.4%) 1 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    General disorders
    Device Dislocation 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 1/78 (1.3%) 1 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Drug Withdrawal Syndrome 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 1/78 (1.3%) 1
    Non-Cardiac Chest Pain 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 1/78 (1.3%) 1 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Immune system disorders
    Drug Hypersensitivity 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 1/78 (1.3%) 1 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Infections and infestations
    Appendicitis Perforated 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 1/76 (1.3%) 1 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Pneumonia 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 1/76 (1.3%) 1 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Injury, poisoning and procedural complications
    Humerus Fracture 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 1/73 (1.4%) 1 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Laceration 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 1/77 (1.3%) 1 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer Recurrent 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 1/78 (1.3%) 1
    Nervous system disorders
    Embolic Cerebral Infarction 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 1/76 (1.3%) 1 0/78 (0%) 0
    Transient Ischaemic Attack 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 1/72 (1.4%) 1 0/76 (0%) 0 0/78 (0%) 0
    Psychiatric disorders
    Post-Traumatic Stress Disorder 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 1/72 (1.4%) 1 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Renal and urinary disorders
    Acute Kidney Injury 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 1/78 (1.3%) 1 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 1/73 (1.4%) 1 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Chronic Obstructive Pulmonary Disease 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 1/76 (1.3%) 1 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Vascular disorders
    Aortic Stenosis 0/79 (0%) 0 0/71 (0%) 0 0/77 (0%) 0 0/77 (0%) 0 0/75 (0%) 0 0/75 (0%) 0 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 1/73 (1.4%) 1 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Other (Not Including Serious) Adverse Events
    Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix® Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix® Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 71/79 (89.9%) 64/71 (90.1%) 67/77 (87%) 68/77 (88.3%) 71/75 (94.7%) 66/75 (88%) 52/76 (68.4%) 53/73 (72.6%) 67/76 (88.2%) 54/76 (71.1%) 62/76 (81.6%) 50/72 (69.4%) 53/77 (68.8%) 60/73 (82.2%) 58/78 (74.4%) 53/72 (73.6%) 49/76 (64.5%) 56/78 (71.8%)
    Gastrointestinal disorders
    Abdominal Pain 3/79 (3.8%) 3 3/71 (4.2%) 3 4/77 (5.2%) 4 1/77 (1.3%) 1 3/75 (4%) 3 1/75 (1.3%) 1 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    General disorders
    Change In Limb Circumference 45/79 (57%) 45 41/71 (57.7%) 41 49/77 (63.6%) 49 46/77 (59.7%) 46 48/75 (64%) 48 33/75 (44%) 33 28/76 (36.8%) 28 37/73 (50.7%) 37 41/76 (53.9%) 41 37/76 (48.7%) 37 35/76 (46.1%) 35 31/72 (43.1%) 31 38/77 (49.4%) 38 43/73 (58.9%) 43 36/78 (46.2%) 36 38/72 (52.8%) 38 32/76 (42.1%) 32 40/78 (51.3%) 40
    Injection Site Erythema 9/79 (11.4%) 9 4/71 (5.6%) 4 10/77 (13%) 10 1/77 (1.3%) 1 4/75 (5.3%) 4 2/75 (2.7%) 2 2/76 (2.6%) 2 1/73 (1.4%) 1 2/76 (2.6%) 2 0/76 (0%) 0 5/76 (6.6%) 5 2/72 (2.8%) 2 0/77 (0%) 0 1/73 (1.4%) 1 2/78 (2.6%) 2 2/72 (2.8%) 2 3/76 (3.9%) 3 1/78 (1.3%) 1
    Injection Site Pain 59/79 (74.7%) 59 51/71 (71.8%) 51 50/77 (64.9%) 50 49/77 (63.6%) 49 59/75 (78.7%) 59 48/75 (64%) 48 38/76 (50%) 38 34/73 (46.6%) 34 49/76 (64.5%) 49 42/76 (55.3%) 42 49/76 (64.5%) 49 35/72 (48.6%) 35 22/77 (28.6%) 22 34/73 (46.6%) 34 34/78 (43.6%) 34 34/72 (47.2%) 34 28/76 (36.8%) 28 25/78 (32.1%) 25
    Injection Site Swelling 7/79 (8.9%) 7 4/71 (5.6%) 4 8/77 (10.4%) 8 0/77 (0%) 0 1/75 (1.3%) 1 4/75 (5.3%) 4 1/76 (1.3%) 1 3/73 (4.1%) 3 4/76 (5.3%) 4 1/76 (1.3%) 1 3/76 (3.9%) 3 1/72 (1.4%) 1 1/77 (1.3%) 1 6/73 (8.2%) 6 6/78 (7.7%) 6 2/72 (2.8%) 2 1/76 (1.3%) 1 2/78 (2.6%) 2
    Malaise 14/79 (17.7%) 14 17/71 (23.9%) 17 14/77 (18.2%) 14 18/77 (23.4%) 18 12/75 (16%) 12 17/75 (22.7%) 17 18/76 (23.7%) 18 9/73 (12.3%) 9 16/76 (21.1%) 16 19/76 (25%) 19 23/76 (30.3%) 23 15/72 (20.8%) 15 6/77 (7.8%) 6 12/73 (16.4%) 12 14/78 (17.9%) 14 9/72 (12.5%) 9 8/76 (10.5%) 8 6/78 (7.7%) 6
    Infections and infestations
    Pharyngitis 3/79 (3.8%) 3 7/71 (9.9%) 10 3/77 (3.9%) 3 5/77 (6.5%) 5 3/75 (4%) 5 2/75 (2.7%) 2 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Pharyngitis Streptococcal 5/79 (6.3%) 5 4/71 (5.6%) 4 5/77 (6.5%) 7 5/77 (6.5%) 5 2/75 (2.7%) 2 4/75 (5.3%) 5 0/76 (0%) 0 1/73 (1.4%) 1 1/76 (1.3%) 1 0/76 (0%) 0 1/76 (1.3%) 1 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Viral Pharyngitis 3/79 (3.8%) 3 4/71 (5.6%) 4 2/77 (2.6%) 3 2/77 (2.6%) 2 0/75 (0%) 0 1/75 (1.3%) 1 0/76 (0%) 0 0/73 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/77 (0%) 0 0/73 (0%) 0 0/78 (0%) 0 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0
    Musculoskeletal and connective tissue disorders
    Myalgia 42/79 (53.2%) 42 35/71 (49.3%) 35 38/77 (49.4%) 38 42/77 (54.5%) 42 52/75 (69.3%) 52 38/75 (50.7%) 38 32/76 (42.1%) 32 29/73 (39.7%) 29 35/76 (46.1%) 35 36/76 (47.4%) 36 39/76 (51.3%) 39 28/72 (38.9%) 28 12/77 (15.6%) 12 21/73 (28.8%) 21 31/78 (39.7%) 31 23/72 (31.9%) 23 23/76 (30.3%) 23 18/78 (23.1%) 18
    Nervous system disorders
    Headache 23/79 (29.1%) 25 15/71 (21.1%) 15 19/77 (24.7%) 21 25/77 (32.5%) 26 22/75 (29.3%) 22 29/75 (38.7%) 30 16/76 (21.1%) 16 11/73 (15.1%) 11 19/76 (25%) 19 19/76 (25%) 19 19/76 (25%) 19 19/72 (26.4%) 21 6/77 (7.8%) 6 10/73 (13.7%) 10 20/78 (25.6%) 20 12/72 (16.7%) 12 11/76 (14.5%) 11 14/78 (17.9%) 15
    Respiratory, thoracic and mediastinal disorders
    Cough 1/79 (1.3%) 1 4/71 (5.6%) 4 4/77 (5.2%) 4 3/77 (3.9%) 3 2/75 (2.7%) 3 0/75 (0%) 0 0/76 (0%) 0 1/73 (1.4%) 1 2/76 (2.6%) 2 1/76 (1.3%) 1 2/76 (2.6%) 2 1/72 (1.4%) 1 0/77 (0%) 0 0/73 (0%) 0 2/78 (2.6%) 2 1/72 (1.4%) 1 0/76 (0%) 0 2/78 (2.6%) 2
    Oropharyngeal Pain 2/79 (2.5%) 2 5/71 (7%) 5 2/77 (2.6%) 2 2/77 (2.6%) 2 4/75 (5.3%) 5 0/75 (0%) 0 1/76 (1.3%) 1 2/73 (2.7%) 2 4/76 (5.3%) 5 1/76 (1.3%) 1 0/76 (0%) 0 2/72 (2.8%) 2 0/77 (0%) 0 0/73 (0%) 0 1/78 (1.3%) 1 0/72 (0%) 0 0/76 (0%) 0 0/78 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.

    Results Point of Contact

    Name/Title Trial Transparency Team
    Organization Sanofi Pasteur
    Phone 800-633-1610 ext 1#
    Email Contact-US@sanofi.com
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT02587520
    Other Study ID Numbers:
    • ADC01
    • U1111-1161-3027
    First Posted:
    Oct 27, 2015
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022