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    Clinical Trial Results:
    Immune Response to Pertussis After Vaccination With a Tdap-IPV Booster Vaccine in Children in the Republic of South Africa: Effect of Homologous and Heterologous Pertussis Vaccination Priming Background

    Summary
    EudraCT number
    		 2022-002452-40
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Jan 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Jul 2024
    First version publication date
    15 Oct 2023
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TD500056
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04300192
    WHO universal trial number (UTN)
    		 U1111-1223-5186
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    14 Espace Henry Vallée, Lyon, France, 69007
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Humoral Immune Response: - To describe the long-term humoral immune responses to pertussis, diphtheria and tetanus after homologous and heterologous pertussis vaccine priming regimens. - To determine the effects of the priming regimen on humoral responses to booster vaccination with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis- inactivated poliomyelitis vaccine (Tdap-IPV) vaccine. Cell-mediated Immunity: - To describe the long-term cell-mediated immune responses to pertussis after homologous and heterologous pertussis vaccine priming regimens. - To determine the effects of the priming regimen on cell-mediated immune response to booster vaccination with Tdap-IPV vaccine.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 274
    Worldwide total number of subjects
    274
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    113
    Adolescents (12-17 years)
    161
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 3 active sites in South Africa from 27 January 2021 to 11 January 2023. Subjects primed with whole-cell pertussis (wP) and/or acellular pertussis (aP) vaccines in various combination as per national recommendation during their first 2 years of life were enrolled in this study.

    Pre-assignment
    Screening details
    		 A total of 274 subjects were enrolled in the study, of which 1 subject was not assigned to any of the study groups and was not vaccinated due to determination of protocol deviation post-enrollment.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Adacel Quadra® vaccine
    Arm description
    		 Subjects primed with primary pertussis vaccination (4 doses of wP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as intramuscular (IM) injection on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
    Investigational medicinal product code
    Other name
    Adacel Quadra®, Repevax®, Triaxis® Polio, ADACEL®-POLIO
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 millilitres (mL) IM injection into the deltoid muscle on Day 0.

    Arm title
    		 Group 2: Adacel Quadra® vaccine
    Arm description
    		 Subjects primed with primary pertussis vaccination (3 doses of wP vaccine followed by 1 dose of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
    Investigational medicinal product code
    Other name
    Adacel Quadra®, Repevax®, Triaxis® Polio, ADACEL®-POLIO
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection into the deltoid muscle on Day 0.

    Arm title
    		 Group 3: Adacel Quadra® vaccine
    Arm description
    		 Subjects primed with primary pertussis vaccination (2 doses of wP vaccine followed by 2 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
    Investigational medicinal product code
    Other name
    Adacel Quadra®, Repevax®, Triaxis® Polio, ADACEL®-POLIO
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection into the deltoid muscle on Day 0.

    Arm title
    		 Group 4: Adacel Quadra® vaccine
    Arm description
    		 Subjects primed with primary pertussis vaccination (1 dose of wP vaccine followed by 3 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
    Investigational medicinal product code
    Other name
    Adacel Quadra®, Repevax®, Triaxis® Polio, ADACEL®-POLIO
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection into the deltoid muscle on Day 0.

    Arm title
    		 Group 5: Adacel Quadra® vaccine
    Arm description
    		 Subjects primed with primary pertussis vaccination (4 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
    Investigational medicinal product code
    Other name
    Adacel Quadra®, Repevax®, Triaxis® Polio, ADACEL®-POLIO
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection into the deltoid muscle on Day 0.

    Arm title
    		 Group 6: Adacel Quadra® vaccine (HIV positive)
    Arm description
    		 Subjects with human immunodeficiency virus (HIV) infection and primed with primary pertussis vaccination (4 doses of wP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
    Investigational medicinal product code
    Other name
    Adacel Quadra®, Repevax®, Triaxis® Polio, ADACEL®-POLIO
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection into the deltoid muscle on Day 0.

    Arm title
    		 Group 7: Adacel Quadra® vaccine (HIV positive)
    Arm description
    		 Subjects with HIV infection and primed with primary pertussis vaccination (4 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
    Investigational medicinal product code
    Other name
    Adacel Quadra®, Repevax®, Triaxis® Polio, ADACEL®-POLIO
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection into the deltoid muscle on Day 0.

    Number of subjects in period 1 [1]
    		Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Started
    103
    29
    4
    1
    103
    10
    23
    Vaccinated
    103
    29
    4
    1
    102
    10
    22
    Completed
    103
    29
    4
    1
    102
    7
    18
    Not completed
    0
    0
    0
    0
    1
    3
    5
         Protocol deviation
    -
    -
    -
    -
    1
    3
    5
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One subject was not assigned to any of the study groups and was not vaccinated due to determination of protocol deviation post-enrollment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (4 doses of wP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as intramuscular (IM) injection on Day 0.

    Reporting group title
    Group 2: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (3 doses of wP vaccine followed by 1 dose of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 3: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (2 doses of wP vaccine followed by 2 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 4: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (1 dose of wP vaccine followed by 3 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 5: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (4 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 6: Adacel Quadra® vaccine (HIV positive)
    Reporting group description
    		 Subjects with human immunodeficiency virus (HIV) infection and primed with primary pertussis vaccination (4 doses of wP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 7: Adacel Quadra® vaccine (HIV positive)
    Reporting group description
    		 Subjects with HIV infection and primed with primary pertussis vaccination (4 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive) Total
    Number of subjects
    		 103 29 4 1 103 10 23 273
    Age categorical
    Units: Subjects
    Age continuous
    Here, '99999' was used as a space filler which denotes that standard deviation (SD) was not calculable because only one subject was involved in the analysis.
    Units: years
        arithmetic mean (standard deviation)
    		 14.0 ( 0.685 ) 12.5 ( 0.509 ) 12.0 ( 0 ) 12.0 ( 99999 ) 10.4 ( 0.803 ) 13.2 ( 1.32 ) 10.8 ( 0.984 ) -
    Gender categorical
    Units: Subjects
        Female
    		 60 10 2 0 50 2 10 134
        Male
    		 43 19 2 1 53 8 13 139

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (4 doses of wP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as intramuscular (IM) injection on Day 0.

    Reporting group title
    Group 2: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (3 doses of wP vaccine followed by 1 dose of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 3: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (2 doses of wP vaccine followed by 2 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 4: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (1 dose of wP vaccine followed by 3 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 5: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (4 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 6: Adacel Quadra® vaccine (HIV positive)
    Reporting group description
    		 Subjects with human immunodeficiency virus (HIV) infection and primed with primary pertussis vaccination (4 doses of wP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 7: Adacel Quadra® vaccine (HIV positive)
    Reporting group description
    		 Subjects with HIV infection and primed with primary pertussis vaccination (4 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Subject analysis set title
    Group 1: Adacel Quadra® vaccine (FAS CMI subset)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects primed with primary pertussis vaccination (4 doses of wP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0. Here, FAS=Full analysis set and CMI=Cell-mediated immunity.

    Subject analysis set title
    Group 2: Adacel Quadra® vaccine (FAS CMI subset)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects primed with primary pertussis vaccination (3 doses of wP vaccine followed by 1 dose of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Subject analysis set title
    Group 3: Adacel Quadra® vaccine (FAS CMI subset)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects primed with primary pertussis vaccination (2 doses of wP vaccine followed by 2 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Subject analysis set title
    Group 4: Adacel Quadra® vaccine (FAS CMI subset)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects primed with primary pertussis vaccination (1 dose of wP vaccine followed by 3 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Subject analysis set title
    Group 5: Adacel Quadra® vaccine (FAS CMI subset)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects primed with primary pertussis vaccination (4 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Subject analysis set title
    Group 6: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects with HIV infection and primed with primary pertussis vaccination (4 doses of wP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Subject analysis set title
    Group 7: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects with HIV infection and primed with primary pertussis vaccination (4 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Primary: Geometric Mean Concentrations (GMCs) of Total Immunoglobulin G (IgG) Anti-pertussis Antibodies Against Pertussis Antigens at Day 0 (pre-vaccination)

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Total Immunoglobulin G (IgG) Anti-pertussis Antibodies Against Pertussis Antigens at Day 0 (pre-vaccination) [1]
    End point description
    GMCs of IgG anti-pertussis antibodies: anti-pertussis (anti-PT) toxin, anti-filamentous hemagglutinin (anti-FHA), anti-pertactin (anti-PRN) and anti-fimbriae (anti-FIM) types 2 and 3 were measured by multiplexed meso scale discovery electrochemiluminescence (MSD ECL) assay. Results were expressed in enzyme-linked immunosorbent assay (ELISA) units (EU)/mL. Analysis was performed on full analysis set (FAS) which included subjects who received a dose of the study vaccine and with pre-vaccination or post-vaccination blood sample results available. Here, '-99999 and 99999' were used as a space filler which denotes that 95 percent (%) confidence interval (CI) was not computable due to the low number of subjects.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Number of subjects analysed
    103
    29
    4
    1
    102
    10
    22
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-PT IgG
    9.13 (6.96 to 12.0)
    9.01 (6.03 to 13.5)
    10.9 (-99999 to 99999)
    11.3 (-99999 to 99999)
    7.08 (5.76 to 8.71)
    12.1 (5.83 to 25.0)
    26.5 (17.2 to 40.8)
        Anti-FHA IgG
    48.0 (38.8 to 59.2)
    37.1 (26.2 to 52.5)
    39.7 (-99999 to 99999)
    23.7 (-99999 to 99999)
    42.5 (35.8 to 50.4)
    52.3 (25.3 to 108)
    104 (63.4 to 170)
        Anti-PRN IgG
    7.63 (5.83 to 10.0)
    2.81 (1.88 to 4.22)
    3.98 (-99999 to 99999)
    1.00 (-99999 to 99999)
    1.65 (1.41 to 1.93)
    4.46 (1.86 to 10.7)
    3.36 (2.05 to 5.50)
        Anti-FIM 2 & 3 IgG
    38.7 (30.5 to 49.1)
    15.1 (9.00 to 25.2)
    9.33 (-99999 to 99999)
    7.48 (-99999 to 99999)
    2.11 (1.71 to 2.60)
    13.0 (3.68 to 46.0)
    1.83 (1.10 to 3.03)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Total Immunoglobulin G Anti-pertussis Antibodies Against Pertussis Antigens at Day 30 (post-vaccination)

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    End point title
    		 Geometric Mean Concentrations of Total Immunoglobulin G Anti-pertussis Antibodies Against Pertussis Antigens at Day 30 (post-vaccination) [2]
    End point description
    GMCs of IgG anti-pertussis antibodies: anti-PT toxin, anti-FHA, anti-PRN and anti-FIM types 2 and 3 were measured by multiplexed MSD ECL assay. Results were expressed in EU/mL. Analysis was performed on FAS. Here, 'number of subjects analysed' = subjects with available data for this endpoint and '-99999 and 99999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Number of subjects analysed
    101
    29
    4
    1
    102
    10
    22
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-PT IgG
    102 (82.9 to 124)
    141 (107 to 187)
    142 (-99999 to 99999)
    110 (-99999 to 99999)
    117 (98.1 to 138)
    117 (49.7 to 276)
    148 (108 to 201)
        Anti-FHA IgG
    410 (351 to 479)
    379 (306 to 470)
    233 (-99999 to 99999)
    199 (-99999 to 99999)
    366 (318 to 422)
    439 (239 to 806)
    549 (387 to 779)
        Anti-PRN IgG
    484 (370 to 632)
    250 (174 to 361)
    410 (-99999 to 99999)
    438 (-99999 to 99999)
    74.0 (50.4 to 109)
    174 (52.3 to 577)
    87.1 (36.5 to 208)
        Anti-FIM 2 & 3 IgG
    2097 (1750 to 2513)
    1039 (648 to 1664)
    1542 (-99999 to 99999)
    1133 (-99999 to 99999)
    168 (117 to 242)
    1226 (527 to 2853)
    78.9 (39.6 to 157)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Total Immunoglobulin G Anti-diphteria Antibodies at Day 30 (post-vaccination)

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    End point title
    		 Geometric Mean Concentrations of Total Immunoglobulin G Anti-diphteria Antibodies at Day 30 (post-vaccination) [3]
    End point description
    GMCs of IgG anti-diphteria antibodies were measured by multiplexed MSD ECL assay. Results were expressed in IU/mL. Analysis was performed on FAS. Here, 'number of subjects analysed' = subjects with available data for this endpoint; and '-99999 and 99999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Number of subjects analysed
    101
    29
    4
    1
    102
    10
    22
    Units: IU/mL
        geometric mean (confidence interval 95%)
    2.03 (1.69 to 2.44)
    2.06 (1.48 to 2.89)
    3.79 (-99999 to 99999)
    6.49 (-99999 to 99999)
    4.79 (4.03 to 5.68)
    0.913 (0.206 to 4.04)
    2.49 (1.44 to 4.32)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Total Immunoglobulin G Anti-diphteria Antibodies at Day 0 (pre-vaccination)

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    End point title
    		 Geometric Mean Concentrations of Total Immunoglobulin G Anti-diphteria Antibodies at Day 0 (pre-vaccination) [4]
    End point description
    GMCs of IgG anti-diphteria antibodies were measured by multiplexed MSD ECL assay. Results were expressed in international units per millilitre (IU/mL). Analysis was performed on FAS. Here, '-99999 and 99999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Number of subjects analysed
    103
    29
    4
    1
    102
    10
    22
    Units: IU/mL
        geometric mean (confidence interval 95%)
    0.104 (0.075 to 0.147)
    0.123 (0.056 to 0.271)
    0.432 (-99999 to 99999)
    0.050 (-99999 to 99999)
    0.279 (0.202 to 0.386)
    0.039 (0.009 to 0.174)
    0.103 (0.036 to 0.298)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Total Immunoglobulin G Anti-tetanus Antibodies at Day 0 (pre-vaccination)

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    End point title
    		 Geometric Mean Concentrations of Total Immunoglobulin G Anti-tetanus Antibodies at Day 0 (pre-vaccination) [5]
    End point description
    GMCs of IgG anti-tetanus antibodies were measured by multiplexed MSD ECL assay. Results were expressed in IU/mL. Analysis was performed on FAS. Here, '-99999 and 99999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Number of subjects analysed
    103
    29
    4
    1
    102
    10
    22
    Units: IU/mL
        geometric mean (confidence interval 95%)
    0.706 (0.483 to 1.03)
    1.51 (0.716 to 3.17)
    2.38 (-99999 to 99999)
    0.040 (-99999 to 99999)
    0.528 (0.374 to 0.746)
    0.112 (0.025 to 0.494)
    0.319 (0.126 to 0.809)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Total Immunoglobulin G Anti-tetanus Antibodies at Day 30 (post-vaccination)

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    End point title
    		 Geometric Mean Concentrations of Total Immunoglobulin G Anti-tetanus Antibodies at Day 30 (post-vaccination) [6]
    End point description
    GMCs of IgG anti-tetanus antibodies were measured by multiplexed MSD ECL assay. Results were expressed in IU/mL. Analysis was performed on FAS. Here, 'number of subjects analysed' = subjects with available data for this endpoint; and '-99999 and 99999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Number of subjects analysed
    101
    29
    4
    1
    102
    10
    22
    Units: IU/mL
        geometric mean (confidence interval 95%)
    14.8 (12.8 to 17.2)
    13.7 (10.3 to 18.2)
    11.5 (-99999 to 99999)
    13.3 (-99999 to 99999)
    9.99 (8.58 to 11.6)
    9.69 (3.91 to 24.0)
    8.65 (5.08 to 14.7)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Total Immunoglobulin A (IgA) Anti-pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 0 (pre-vaccination)

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    End point title
    		 Geometric Mean Concentrations of Total Immunoglobulin A (IgA) Anti-pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 0 (pre-vaccination) [7]
    End point description
    GMCs of IgA anti-pertussis antibodies: anti-PT toxin, anti-FHA, anti-PRN, anti-FIM types 2 and 3, and anti-heat-killed B. pertussis (HK Bp) were measured by multiplexed MSD ECL assay. Results were expressed in Arbitrary unit (AU)/mL. Analysis was performed on FAS CMI subset which included subset of subjects from the CMI subset and included in the FAS. Here, '-99999 and 99999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine (FAS CMI subset) Group 2: Adacel Quadra® vaccine (FAS CMI subset) Group 3: Adacel Quadra® vaccine (FAS CMI subset) Group 4: Adacel Quadra® vaccine (FAS CMI subset) Group 5: Adacel Quadra® vaccine (FAS CMI subset) Group 6: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset) Group 7: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset)
    Number of subjects analysed
    31
    29
    4
    1
    32
    10
    22
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Anti-PT IgA
    1.23 (0.871 to 1.75)
    1.19 (0.917 to 1.55)
    1.10 (-99999 to 99999)
    0.580 (-99999 to 99999)
    1.75 (1.23 to 2.50)
    2.96 (1.56 to 5.62)
    2.40 (1.56 to 3.69)
        Anti-FHA IgA
    3.44 (2.11 to 5.60)
    2.10 (1.39 to 3.19)
    3.71 (-99999 to 99999)
    0.470 (-99999 to 99999)
    2.73 (1.65 to 4.52)
    4.82 (1.78 to 13.1)
    10.0 (6.10 to 16.5)
        Anti-PRN IgA
    2.16 (1.22 to 3.82)
    0.924 (0.714 to 1.20)
    1.37 (-99999 to 99999)
    0.390 (-99999 to 99999)
    0.941 (0.683 to 1.30)
    1.27 (0.600 to 2.70)
    1.25 (0.746 to 2.09)
        Anti-FIM 2 & 3 IgA
    1.10 (0.728 to 1.67)
    0.926 (0.722 to 1.19)
    0.554 (-99999 to 99999)
    1.00 (-99999 to 99999)
    0.979 (0.823 to 1.16)
    1.10 (0.592 to 2.04)
    0.855 (0.619 to 1.18)
        Anti-HK Bp IgA
    7.24 (4.89 to 10.7)
    5.23 (3.90 to 6.99)
    7.56 (-99999 to 99999)
    3.39 (-99999 to 99999)
    6.05 (4.76 to 7.68)
    9.63 (5.41 to 17.1)
    9.74 (6.46 to 14.7)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Total Immunoglobulin A Anti-pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 30 (post-vaccination)

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    End point title
    		 Geometric Mean Concentrations of Total Immunoglobulin A Anti-pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 30 (post-vaccination) [8]
    End point description
    GMCs of IgA anti-pertussis antibodies: anti-PT toxin, anti-FHA, anti-PRN, anti-FIM types 2 and 3, and anti- HK Bp were measured by multiplexed MSD ECL assay. Results were expressed in AU/mL. Analysis was performed on FAS CMI subset which included subset of subjects from the CMI subset and included in the FAS. Here, '-99999 and 99999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine (FAS CMI subset) Group 2: Adacel Quadra® vaccine (FAS CMI subset) Group 3: Adacel Quadra® vaccine (FAS CMI subset) Group 4: Adacel Quadra® vaccine (FAS CMI subset) Group 5: Adacel Quadra® vaccine (FAS CMI subset) Group 6: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset) Group 7: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset)
    Number of subjects analysed
    31
    29
    4
    1
    32
    10
    22
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Anti-PT IgA
    8.31 (4.68 to 14.8)
    6.48 (3.96 to 10.6)
    15.4 (-99999 to 99999)
    15.8 (-99999 to 99999)
    7.59 (4.53 to 12.7)
    11.9 (3.94 to 36.0)
    7.40 (4.75 to 11.5)
        Anti-FHA IgA
    22.8 (14.4 to 36.2)
    18.0 (12.3 to 26.5)
    32.5 (-99999 to 99999)
    2.90 (-99999 to 99999)
    12.0 (7.27 to 19.9)
    30.8 (10.5 to 91.0)
    27.7 (16.9 to 45.4)
        Anti-PRN IgA
    15.2 (8.30 to 27.9)
    13.5 (7.61 to 23.9)
    36.2 (-99999 to 99999)
    180 (-99999 to 99999)
    7.07 (3.12 to 16.0)
    15.5 (4.49 to 53.4)
    9.56 (3.94 to 23.2)
        Anti-FIM 2 & 3 IgA
    27.2 (17.3 to 42.8)
    12.5 (7.21 to 21.5)
    41.3 (-99999 to 99999)
    34.1 (-99999 to 99999)
    6.61 (3.36 to 13.0)
    18.6 (5.61 to 61.3)
    3.45 (1.60 to 7.40)
        Anti-HK Bp IgA
    19.1 (14.5 to 25.2)
    15.1 (11.4 to 20.1)
    32.0 (-99999 to 99999)
    15.5 (-99999 to 99999)
    11.2 (8.45 to 14.9)
    22.7 (11.7 to 44.3)
    15.0 (10.4 to 21.6)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Subclasses of Immunoglobulin G Anti-Pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 0 (pre-vaccination)

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    End point title
    		 Geometric Mean Concentrations of Subclasses of Immunoglobulin G Anti-Pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 0 (pre-vaccination) [9]
    End point description
    GMCs of IgG subclasses (IgG1, IgG2, IgG3, and IgG4) anti-pertussis antibodies: anti-PT toxin, anti-FHA, anti-PRN, anti-FIM types 2 and 3, and anti- HK Bp were measured by multiplexed MSD ECL assay. Results were expressed in EU/mL. Analysis was performed on FAS CMI subset which included subset of subjects from the CMI subset and included in the FAS. Here, 'number of subjects analyzed' = subjects with available data for this endpoint and 'n'= number of subjects with available data for each specific IgG subclasses. '-99999 and 99999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects. If number of subjects analyzed were as 0, then '5555' was used as a space filler for Geometric mean and '-55555 to 55555' was used as a space filler for 95% CI.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine (FAS CMI subset) Group 2: Adacel Quadra® vaccine (FAS CMI subset) Group 3: Adacel Quadra® vaccine (FAS CMI subset) Group 4: Adacel Quadra® vaccine (FAS CMI subset) Group 5: Adacel Quadra® vaccine (FAS CMI subset) Group 6: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset) Group 7: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset)
    Number of subjects analysed
    31
    29
    4
    1
    32
    10
    22
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 0:Anti-PT IgG1 (n=19, 14, 2, 1, 23, 7, 20)
    8946 (5194 to 15408)
    8185 (4974 to 13470)
    4884 (-99999 to 99999)
    2957 (-99999 to 99999)
    6028 (4027 to 9022)
    12626 (6576 to 24243)
    16471 (10776 to 25174)
        Day 0:Anti-PT IgG2 (n=19, 14, 2, 1, 23, 7, 20)
    123 (91.3 to 165)
    130 (88.2 to 191)
    100 (-99999 to 99999)
    933 (-99999 to 99999)
    217 (123 to 381)
    139 (62.4 to 308)
    330 (169 to 646)
        Day 0:Anti-PT IgG3 (n=19, 14, 2, 1, 23, 7, 20)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
        Day 0:Anti-PT IgG4 (n=19, 14, 2, 1, 23, 7, 20)
    109 (90.8 to 131)
    131 (73.0 to 235)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    629 (276 to 1433)
    151 (55.1 to 413)
    536 (240 to 1197)
        Day 0:Anti-FHA IgG1 (n=31,29,4,1,32,10,22)
    39008 (24733 to 61522)
    24107 (15635 to 37169)
    21604 (-99999 to 99999)
    14701 (-99999 to 99999)
    58333 (37035 to 91880)
    57991 (23283 to 144442)
    118244 (66112 to 211483)
        Day 0:Anti-FHA IgG2 (n=31,29,4,1,32,10,22)
    785 (457 to 1351)
    485 (241 to 976)
    282 (-99999 to 99999)
    907 (-99999 to 99999)
    3226 (1878 to 5543)
    1048 (387 to 2836)
    3228 (1481 to 7036)
        Day 0:Anti-FHA IgG3 (n=31,29,4,1,32,10,22)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
        Day 0:Anti-FHA IgG4 (n=31,29,4,1,32,10,22)
    197 (124 to 312)
    415 (197 to 871)
    100 (-99999 to 99999)
    1671 (-99999 to 99999)
    1838 (742 to 4552)
    167 (52.2 to 536)
    1613 (422 to 6164)
        Day 0:Anti-PRN IgG1 (n=20,12,2,0,4,6,9)
    25294 (11366 to 56285)
    5446 (3575 to 8296)
    9333 (-99999 to 99999)
    5555 (-55555 to 55555)
    16962 (-99999 to 99999)
    7480 (2044 to 27381)
    3024 (740 to 12352)
        Day 0:Anti-PRN IgG2 (n=20,12,2,0,4,6,9)
    427 (206 to 884)
    171 (91.7 to 318)
    100 (-99999 to 99999)
    5555 (-55555 to 55555)
    161 (-99999 to 99999)
    100 (-99999 to 99999)
    226 (81.4 to 627)
        Day 0:Anti-PRN IgG3 (n=20,12,2,0,4,6,9)
    109 (91.4 to 129)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    5555 (-55555 to 55555)
    100 (-99999 to 99999)
    169 (43.7 to 657)
    436 (40.2 to 4729)
        Day 0:Anti-PRN IgG4 (n=20,12,2,0,4,6,9)
    251 (123 to 514)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    5555 (-55555 to 55555)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
        Day 0:Anti-FIM 2 & 3 IgG1 (n=28 14, 0, 0, 7, 6, 3)
    10565 (6461 to 17275)
    4943 (3000 to 8144)
    5555 (-55555 to 55555)
    5555 (-55555 to 55555)
    4057 (2467 to 6673)
    7901 (4177 to 14944)
    4403 (-99999 to 99999)
        Day 0:Anti-FIM 2 & 3 IgG2 (n=28 14, 0, 0, 7, 6, 3)
    259 (143 to 469)
    140 (82.9 to 237)
    5555 (-55555 to 55555)
    5555 (-55555 to 55555)
    197 (67.5 to 572)
    184 (38.5 to 877)
    390 (-99999 to 99999)
        Day 0:Anti-FIM 2 & 3 IgG3 (n=28 14, 0, 0, 7, 6, 3)
    106 (93.9 to 120)
    100 (-99999 to 99999)
    5555 (-55555 to 55555)
    5555 (-55555 to 55555)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
        Day 0:Anti-FIM 2 & 3 IgG4 (n=28 14, 0, 0, 7, 6, 3)
    128 (96.4 to 170)
    100 (-99999 to 99999)
    5555 (-55555 to 55555)
    5555 (-55555 to 55555)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
        Day 0:Anti-HK Bp IgG1 (n=27, 17, 3, 1, 13, 8, 8)
    5863 (4110 to 8365)
    3822 (3206 to 4557)
    1911 (-99999 to 99999)
    836 (-99999 to 99999)
    4789 (3126 to 7337)
    4671 (2457 to 8877)
    5401 (2456 to 11876)
        Day 0:Anti-HK Bp IgG2 (n=27, 17, 3, 1, 13, 8, 8)
    409 (236 to 708)
    184 (101 to 332)
    191 (-99999 to 99999)
    1334 (-99999 to 99999)
    265 (118 to 595)
    483 (159 to 1462)
    276 (108 to 703)
        Day 0:Anti-HK Bp IgG3 (n=27, 17, 3, 1, 13, 8, 8)
    118 (93.0 to 150)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    123 (75.2 to 202)
        Day 0:Anti-HK Bp IgG4 (n=27, 17, 3, 1, 13, 8, 8)
    118 (83.9 to 166)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    130 (69.6 to 245)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Subclasses of Immunoglobulin G Anti-Pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 30 (post-vaccination)

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    End point title
    		 Geometric Mean Concentrations of Subclasses of Immunoglobulin G Anti-Pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 30 (post-vaccination) [10]
    End point description
    GMCs of IgG subclasses (IgG1, IgG2, IgG3, and IgG4) anti-pertussis antibodies: anti-PT toxin, anti-FHA, anti-PRN, anti-FIM types 2 and 3, and anti- HK Bp were measured by multiplexed MSD ECL assay. Results were expressed in EU/mL. Analysis was performed on FAS CMI subset which included subset of subjects from the CMI subset and included in the FAS. Here, 'number of subjects analyzed' = subjects with available data for this endpoint and 'n'= number of subjects with available data for each specific IgG subclasses. '-99999 and 99999' and '-999999 and 999999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects. If number of subjects analyzed were as 0, then '5555' was used as a space filler for Geometric mean and '-55555 to 55555' was used as a space filler for 95% CI.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine (FAS CMI subset) Group 2: Adacel Quadra® vaccine (FAS CMI subset) Group 3: Adacel Quadra® vaccine (FAS CMI subset) Group 4: Adacel Quadra® vaccine (FAS CMI subset) Group 5: Adacel Quadra® vaccine (FAS CMI subset) Group 6: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset) Group 7: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset)
    Number of subjects analysed
    31
    29
    4
    1
    32
    10
    22
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 30:Anti-PT IgG1(n=30,29,4,1,32,10,22)
    102830 (69880 to 151316)
    94218 (67676 to 131171)
    104494 (-999999 to 999999)
    66855 (-99999 to 99999)
    64677 (42746 to 97860)
    81350 (29224 to 226456)
    89645 (59770 to 134451)
        Day 30:Anti-PT IgG2(n=30,29,4,1,32,10,22)
    985 (574 to 1691)
    1516 (945 to 2433)
    1158 (-99999 to 99999)
    2345 (-99999 to 99999)
    2936 (2090 to 4124)
    835 (338 to 2065)
    2168 (1317 to 3569)
        Day 30:Anti-PT IgG3(n=30,29,4,1,32,10,22)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    127 (74.3 to 216)
    111 (89.1 to 139)
        Day 30:Anti-PT IgG4(n=30,29,4,1,32,10,22)
    221 (133 to 368)
    555 (270 to 1143)
    280 (-99999 to 99999)
    17387 (-99999 to 99999)
    5907 (2269 to 15379)
    155 (57.5 to 419)
    2454 (833 to 7228)
        Day 30:Anti-FHA IgG1(n=31,29,4,1,32,10,22)
    538864 (417937 to 694781)
    475855 (368755 to 614062)
    281955 (-999999 to 999999)
    244138 (-999999 to 999999)
    492380 (361655 to 670358)
    576671 (340082 to 977852)
    751540 (496054 to 1138609)
        Day 30:Anti-FHA IgG2(n=31,29,4,1,32,10,22)
    8750 (6110 to 12530)
    10650 (7464 to 15197)
    7215 (-99999 to 99999)
    12366 (-99999 to 99999)
    18055 (13640 to 23900)
    7855 (3809 to 16195)
    16246 (9201 to 28684)
        Day 30:Anti-FHA IgG3(n=31,29,4,1,32,10,22)
    122 (97.3 to 152)
    151 (99.4 to 231)
    186 (-99999 to 99999)
    100 (-99999 to 99999)
    144 (104 to 199)
    202 (89.0 to 456)
    224 (117 to 427)
        Day 30:Anti-FHA IgG4(n=31,29,4,1,32,10,22)
    988 (403 to 2422)
    3783 (1266 to 11302)
    657 (-99999 to 99999)
    111012 (-999999 to 999999)
    16670 (5075 to 54759)
    336 (50.7 to 2232)
    6149 (1384 to 27328)
        Day 30:Anti-PRN IgG1(n=31,29,4,1,27,10,21)
    641550 (447748 to 919237)
    361109 (248824 to 524064)
    648330 (-999999 to 999999)
    870487 (-999999 to 999999)
    102671 (45105 to 233707)
    222876 (63950 to 776763)
    114475 (44787 to 292594)
        Day 30:Anti-PRN IgG2(n=31,29,4,1,27,10,21)
    5284 (3388 to 8242)
    4049 (2686 to 6104)
    3630 (-99999 to 99999)
    3956 (-99999 to 99999)
    985 (447 to 2172)
    1676 (699 to 4014)
    1290 (623 to 2674)
        Day 30:Anti-PRN IgG3(n=31,29,4,1,27,10,21)
    147 (105 to 205)
    251 (140 to 449)
    378 (-99999 to 99999)
    100 (-99999 to 99999)
    721 (278 to 1870)
    494 (101 to 2430)
    954 (300 to 3039)
        Day 30:Anti-PRN IgG4(n=31,29,4,1,27,10,21)
    1119 (377 to 3322)
    1979 (607 to 6457)
    244 (-99999 to 99999)
    100 (-99999 to 99999)
    181 (113 to 290)
    352 (77.5 to 1596)
    125 (89.6 to 176)
        Day 30:Anti-FIM 2 & 3 IgG1(n=31,29,4,1,28, 10,21)
    567808 (374973 to 859809)
    259951 (149920 to 450737)
    426132 (-999999 to 999999)
    443077 (-999999 to 999999)
    96325 (52623 to 176323)
    310333 (115799 to 831675)
    22967 (11661 to 45237)
        Day 30:Anti-FIM 2 & 3 IgG2(n=31,29,4,1,28,10,21)
    9838 (5947 to 16278)
    5315 (2784 to 10145)
    11661 (-99999 to 99999)
    4357 (-99999 to 99999)
    2517 (1303 to 4864)
    6739 (3401 to 13351)
    803 (332 to 1945)
        Day 30:Anti-FIM 2 & 3 IgG3(n=31,29,4,1,28,10,21)
    165 (106 to 257)
    257 (143 to 465)
    406 (-99999 to 99999)
    100 (-99999 to 99999)
    320 (156 to 659)
    190 (66.5 to 543)
    146 (101 to 211)
        Day 30:Anti-FIM 2 & 3 IgG4(n=31,29,4,1,28,10,21)
    405 (182 to 899)
    292 (158 to 542)
    329 (-99999 to 99999)
    714 (-99999 to 99999)
    215 (124 to 375)
    100 (-99999 to 99999)
    118 (83.8 to 165)
        Day 30:Anti-HK Bp IgG1(n=31,29,4,1,30,10,22)
    33863 (27766 to 41300)
    22653 (17914 to 28644)
    21659 (-99999 to 99999)
    11928 (-99999 to 99999)
    9278 (7560 to 11387)
    16829 (9999 to 28325)
    12055 (9040 to 16075)
        Day 30:Anti-HK Bp IgG2(n=31,29,4,1,30,10,22)
    941 (624 to 1418)
    503 (319 to 793)
    344 (-99999 to 99999)
    1522 (-99999 to 99999)
    296 (192 to 455)
    675 (258 to 1763)
    791 (509 to 1229)
        Day 30:Anti-HK Bp IgG3(n=31,29,4,1,30,10,22)
    113 (94.8 to 136)
    118 (93.0 to 149)
    100 (-99999 to 99999)
    100 (-99999 to 99999)
    113 (94.8 to 135)
    130 (72.0 to 234)
    128 (87.6 to 187)
        Day 30:Anti-HK Bp IgG4(n=31,29,4,1,30,10,22)
    144 (93.0 to 223)
    154 (106 to 223)
    100 (-99999 to 99999)
    548 (-99999 to 99999)
    284 (169 to 478)
    119 (80.6 to 175)
    229 (125 to 422)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration of Spot Forming Cells (SFC) Anti-Pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 0 (pre-vaccination)

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    End point title
    		 Geometric Mean Concentration of Spot Forming Cells (SFC) Anti-Pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 0 (pre-vaccination) [11]
    End point description
    GMCs of SFC subclasses (Interleukin [IL]-4, Interferon [IFN]-gamma [ɣ], and IL-17 secreting cells) anti-pertussis antibodies: Antigen complex and anti-HK Bp interferon were measured by FluoroSpot. The samples were run in triplicate, valid data were averaged, and converted to SFC/10^6 Peripheral blood mononuclear cells (PBMCS). Analysis was performed on FAS CMI subset which included subset of subjects from the CMI subset and included in the FAS. Here, 'number of subjects analyzed' = subjects with available data for this endpoint and 'n'= number of subjects with available data for each specific SFC subclasses. '-99999 and 99999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine (FAS CMI subset) Group 2: Adacel Quadra® vaccine (FAS CMI subset) Group 3: Adacel Quadra® vaccine (FAS CMI subset) Group 4: Adacel Quadra® vaccine (FAS CMI subset) Group 5: Adacel Quadra® vaccine (FAS CMI subset) Group 6: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset) Group 7: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset)
    Number of subjects analysed
    30
    28
    4
    1
    32
    10
    21
    Units: SFC/10^6 PBMC
    geometric mean (confidence interval 95%)
        Antigen complex IL-4 (n=30, 28, 4,1, 32, 10, 21)
    13.6 (10.7 to 17.4)
    12.7 (9.96 to 16.1)
    10.0 (-99999 to 99999)
    10.0 (-99999 to 99999)
    38.8 (26.1 to 57.7)
    13.5 (8.21 to 22.1)
    14.6 (10.8 to 19.6)
        Antigen complex IFN-γ (n=30, 28, 4,1, 32, 10, 21)
    164 (93.0 to 288)
    218 (123 to 387)
    61.6 (-99999 to 99999)
    22.5 (-99999 to 99999)
    181 (128 to 256)
    128 (51.1 to 321)
    136 (86.5 to 214)
        Antigen complex IL-17 (n=30, 28, 4,1, 32, 10, 21)
    40.8 (27.8 to 59.9)
    38.3 (26.1 to 56.3)
    44.1 (-99999 to 99999)
    23.0 (-99999 to 99999)
    38.1 (28.4 to 51.1)
    33.2 (14.8 to 74.8)
    31.2 (21.7 to 44.8)
        Anti-HK Bp IL-4 (n=27, 27, 4, 1, 31, 10, 20)
    12.6 (9.92 to 16.1)
    11.9 (9.64 to 14.7)
    10.0 (-99999 to 99999)
    26.0 (-99999 to 99999)
    18.0 (13.0 to 24.9)
    13.6 (8.36 to 22.3)
    12.0 (9.57 to 15.1)
        Anti-HK Bp IFN-γ (n=27, 27, 4, 1, 31, 10, 20)
    1299 (871 to 1937)
    1265 (843 to 1899)
    1084 (-99999 to 99999)
    5000 (-99999 to 99999)
    862 (612 to 1213)
    1341 (667 to 2695)
    952 (534 to 1699)
        Anti-HK Bp IL-17 (n=27, 27, 4, 1, 31, 10, 20)
    58.9 (39.0 to 89.0)
    38.9 (27.9 to 54.2)
    42.5 (-99999 to 99999)
    160 (-99999 to 99999)
    38.5 (26.9 to 55.2)
    54.6 (25.4 to 117)
    44.1 (28.8 to 67.6)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration of Spot Forming Cells Anti-Pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 30 (post-vaccination)

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    End point title
    		 Geometric Mean Concentration of Spot Forming Cells Anti-Pertussis Antibodies Against Pertussis Antigens (FAS CMI subset) at Day 30 (post-vaccination) [12]
    End point description
    GMCs of SFC (IL-4, IFN-ɣ, and IL-17 secreting cells) anti-pertussis antibodies: anti-antigen complex and anti- HK Bp interferon were measured by multiplexed FluoroSpot. The samples were run in triplicate, valid data were averaged, and converted to SFC/10^6 PBMCS. Analysis was performed on FAS CMI subset which included subset of subjects from the CMI subset and included in the FAS. Here, 'number of subjects analyzed' = subjects with available data for this endpoint and 'n'= number of subjects with available data for each specific IgG subclasses. '-99999 and 99999' were used as a space filler which denotes that 95% CI was not computable due to the low number of subjects.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Group 1: Adacel Quadra® vaccine (FAS CMI subset) Group 2: Adacel Quadra® vaccine (FAS CMI subset) Group 3: Adacel Quadra® vaccine (FAS CMI subset) Group 4: Adacel Quadra® vaccine (FAS CMI subset) Group 5: Adacel Quadra® vaccine (FAS CMI subset) Group 6: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset) Group 7: Adacel Quadra® vaccine (HIV positive)(FAS CMI subset)
    Number of subjects analysed
    31
    27
    4
    1
    31
    10
    20
    Units: SFC/10^6 PBMC
    geometric mean (confidence interval 95%)
        Antigen complex IL-4 (n=31, 27, 4, 1, 31, 10, 20)
    20.1 (15.0 to 27.1)
    15.9 (11.5 to 22.0)
    12.3 (-99999 to 99999)
    70.0 (-99999 to 99999)
    77.0 (51.8 to 114)
    30.9 (13.7 to 69.6)
    24.6 (15.1 to 40.0)
        Antigen complex IFN-γ (n=31, 27, 4, 1, 31, 10, 20)
    290 (153 to 549)
    347 (186 to 647)
    348 (-99999 to 99999)
    301 (-99999 to 99999)
    236 (152 to 366)
    337 (127 to 895)
    186 (115 to 301)
        Antigen complex IL-17 (n=31, 27, 4, 1, 31, 10, 20)
    81.0 (56.1 to 117)
    81.9 (60.6 to 111)
    63.0 (-99999 to 99999)
    83.0 (-99999 to 99999)
    45.8 (33.4 to 63.0)
    82.8 (45.5 to 151)
    49.6 (32.0 to 76.8)
        Anti-HK Bp IL-4 (n=31, 27, 4, 1, 30, 10, 19)
    13.4 (10.7 to 16.7)
    11.0 (9.55 to 12.8)
    10.0 (-99999 to 99999)
    48.0 (-99999 to 99999)
    24.4 (16.9 to 35.2)
    16.5 (8.68 to 31.2)
    15.7 (10.5 to 23.6)
        Anti-HK Bp IFN-γ (n=31, 27, 4, 1, 30, 10, 19)
    1106 (703 to 1741)
    1643 (1176 to 2294)
    1929 (-99999 to 99999)
    5000 (-99999 to 99999)
    959 (671 to 1370)
    2210 (1340 to 3643)
    1084 (539 to 2178)
        Anti-HK Bp IL-17 (n=31, 27, 4, 1, 30, 10, 19)
    76.3 (52.8 to 110)
    72.7 (57.5 to 91.9)
    44.3 (-99999 to 99999)
    212 (-99999 to 99999)
    46.6 (33.6 to 64.5)
    79.7 (52.1 to 122)
    42.3 (26.1 to 68.5)
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting Immediate Unsolicited Injection Site Reaction and Systemic Adverse Events (AEs)

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    End point title
    		 Number of Participants Reporting Immediate Unsolicited Injection Site Reaction and Systemic Adverse Events (AEs)
    End point description
    An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. An injection site reaction was an adverse reaction (AR) at and around the injection site. Systemic AEs were all AEs that were not injection or administration site reactions. Analysis was performed on the Safety analysis set which included all subjects who received the study vaccine and had any safety data available.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes post-vaccination
    End point values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Number of subjects analysed
    103
    29
    4
    1
    102
    10
    22
    Units: Participants
        Unsolicited Injection Site reaction
    0
    0
    0
    0
    0
    0
    0
        Unsolicited Systemic Adverse Events
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number Of Participants Reporting Solicited Injection Site Reaction and Systemic AEs

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    End point title
    		 Number Of Participants Reporting Solicited Injection Site Reaction and Systemic AEs
    End point description
    A solicited reaction was an “expected” AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection site reaction was an AR at and around the injection site. Systemic AEs were all AEs that were not injection or administration site reactions. Analysis was performed on the Safety analysis set which included all subjects who received the study vaccine and had any safety data available.
    End point type
    Secondary
    End point timeframe
    Within 7 days post-vaccination
    End point values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Number of subjects analysed
    103
    29
    4
    1
    102
    10
    22
    Units: Participants
        Solicited Injection Site reaction
    82
    19
    3
    0
    64
    7
    20
        Solicited Systemic AEs
    57
    8
    3
    1
    23
    6
    7
    No statistical analyses for this end point

    Secondary: Number Of Participants Reporting Unsolicited Injection Site Reaction and Systemic AEs

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    End point title
    		 Number Of Participants Reporting Unsolicited Injection Site Reaction and Systemic AEs
    End point description
    An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. An injection site reaction was an AR at and around the injection site. Systemic AEs were all AEs that were not injection or administration site reactions. Analysis was performed on the Safety analysis set which included all subjects who received the study vaccine and had any safety data available.
    End point type
    Secondary
    End point timeframe
    Within 30 days post-vaccination
    End point values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Number of subjects analysed
    103
    29
    4
    1
    102
    10
    22
    Units: Participants
        Unsolicited Injection Site Reaction
    8
    3
    0
    0
    5
    0
    3
        Unsolicited Systemic AEs
    15
    5
    0
    0
    18
    1
    9
    No statistical analyses for this end point

    Secondary: Number Of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)

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    End point title
    		 Number Of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
    End point description
    An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor’s product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. Analysis was performed on the Safety analysis set which included all subjects who received the study vaccine and had any safety data available.
    End point type
    Secondary
    End point timeframe
    From Day 1 throughout the study (Up to Day 30)
    End point values
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Number of subjects analysed
    103
    29
    4
    1
    102
    10
    22
    Units: Participants
        SAEs
    0
    0
    0
    0
    0
    0
    0
        AESIs
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited adverse event (AE) data was collected from Day 0 up to 30 days after vaccination. Solicited reactions data was collected within 7 days after vaccination. Serious adverse events data was collected throughout the study (i.e., up to Day 30)
    Adverse event reporting additional description
    Analysis was performed on Safety analysis set which included all subjects who received the study vaccine and had any safety data available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Group 1: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (4 doses of wP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 2: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (3 doses of wP vaccine followed by 1 dose of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 3: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (2 doses of wP vaccine followed by 2 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 4: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (1 dose of wP vaccine followed by 3 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 5: Adacel Quadra® vaccine
    Reporting group description
    		 Subjects primed with primary pertussis vaccination (4 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 6: Adacel Quadra® vaccine (HIV positive)
    Reporting group description
    		 Subjects with HIV infection and primed with primary pertussis vaccination (4 doses of wP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Reporting group title
    Group 7: Adacel Quadra® vaccine (HIV positive)
    Reporting group description
    		 Subjects with HIV infection and primed with primary pertussis vaccination (4 doses of aP vaccine during first 2 years of life) received a single dose of Adacel Quadra® vaccine as IM injection on Day 0.

    Serious adverse events
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 102 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: Adacel Quadra® vaccine Group 2: Adacel Quadra® vaccine Group 3: Adacel Quadra® vaccine Group 4: Adacel Quadra® vaccine Group 5: Adacel Quadra® vaccine Group 6: Adacel Quadra® vaccine (HIV positive) Group 7: Adacel Quadra® vaccine (HIV positive)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    88 / 103 (85.44%)
    20 / 29 (68.97%)
    3 / 4 (75.00%)
    1 / 1 (100.00%)
    71 / 102 (69.61%)
    8 / 10 (80.00%)
    21 / 22 (95.45%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    43 / 103 (41.75%)
    6 / 29 (20.69%)
    3 / 4 (75.00%)
    1 / 1 (100.00%)
    23 / 102 (22.55%)
    4 / 10 (40.00%)
    4 / 22 (18.18%)
         occurrences all number
    45
    6
    3
    1
    24
    4
    4
    General disorders and administration site conditions
    Injection Site Pain
         subjects affected / exposed
    74 / 103 (71.84%)
    18 / 29 (62.07%)
    3 / 4 (75.00%)
    0 / 1 (0.00%)
    62 / 102 (60.78%)
    5 / 10 (50.00%)
    17 / 22 (77.27%)
         occurrences all number
    74
    18
    3
    0
    62
    5
    17
    Injection Site Erythema
         subjects affected / exposed
    23 / 103 (22.33%)
    3 / 29 (10.34%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    13 / 102 (12.75%)
    2 / 10 (20.00%)
    5 / 22 (22.73%)
         occurrences all number
    23
    3
    0
    0
    13
    2
    5
    Injection Site Swelling
         subjects affected / exposed
    29 / 103 (28.16%)
    9 / 29 (31.03%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    27 / 102 (26.47%)
    3 / 10 (30.00%)
    11 / 22 (50.00%)
         occurrences all number
    29
    9
    0
    0
    27
    3
    11
    Malaise
         subjects affected / exposed
    31 / 103 (30.10%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    5 / 102 (4.90%)
    1 / 10 (10.00%)
    6 / 22 (27.27%)
         occurrences all number
    31
    1
    0
    1
    5
    1
    6
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 103 (0.97%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 102 (0.98%)
    0 / 10 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    0
    0
    1
    0
    3
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    25 / 103 (24.27%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 102 (0.98%)
    1 / 10 (10.00%)
    3 / 22 (13.64%)
         occurrences all number
    25
    1
    0
    0
    1
    1
    3
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 103 (3.88%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    6 / 102 (5.88%)
    1 / 10 (10.00%)
    4 / 22 (18.18%)
         occurrences all number
    4
    0
    0
    0
    6
    1
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2019
    Following changes were made: The word 'minutes' was added as per EC's comment; Added statement: "The parents or their child may withdraw their consent to the storage of samples at any time during the study. If at the age of 18, the child decides to withdraw his/her consent for the storage of his/her samples, he/she will have to contact the site who will inform the sponsor of the study to destroy his/her samples."; throughout the study the age of subject was changed from 8 through 12 years to 9 through 13 years; To align to Art 46 of Regulation (EC) No 1901/2006 for pediatric studies and also to the public disclosure of the study results modalities, the study results should be submitted no later than 6 months after the last visit of last subject (LVLS). As the cell-mediated immunity (CMI) results would be available later than 6 months after the LVLS, it was decided to release a first CSR with available data 6 months after the LVLS and the final clinical study report (CSR) when the CMI results are available; Text was updated to reflect that there was no coordinating investigator but there was a principal investigator; Planned study timelines were updated; Updated the exclusion criteria text to reflect: If the subject has a primary physician who is not the Investigator, the site must obtain the subject’s/subject’s parent or legal guardian’s consent prior to contacting this physician and informing him/her of the subject’s participation in the study; Updated text to reflect: All statistical analyses will be performed under the responsibility of the Sponsor’s Biostatistics Platform using the SAS® software, Version 9.4 or newer (SAS Institute, Cary, North Carolina, USA);Updated table of study procedures.
    14 Oct 2020
    Following changes were made: The cover page was updated with details of the new regional trial manager; Number of subjects was corrected throughout; Corrected and clarified the synopsis and immunogenicity endpoints; Updated identity of study product; Updated visit procedures; Updated planned study calendar; Updated randomization and allocation procedures to provide clarification of subject number; Updated blood samples for CMI; Clarified sample storage and shipment to Global Clinical Immunology (GCI); Corrected sample storage and shipment to research-Eu Marcy l'Etoile, France; Corrected future use of stored serum samples for research; Updated immunogenicity assessment method. Updated the cover page to replace the age of subjects by the years of birth, updated details of the new medical study leader and global safety office; Updated synopsis, study design, schedule of study procedures and methodology; Updated inclusion and exclusion criteria; Updated background section, recruitment procedures, identity of study product; timelines in the planned study calendar section were updated.
    18 Oct 2022
    Following changes were made: Updated title page to reflect changes within the company; Replaced 'subject' with 'participant', 'trial' with 'study' and Research-EU Human Immunology Platform was replaced by Vaccine R&D, Clinical Exploratory Research Platform throughout the document; Clarified regarding the number of subjects concerned by blood sampling for the humoral immune response; Updated the study calender; Clarified on the HIV treatment medications; Updated the immunogenicity endpoints due to the development of a more sensitive assay; The exploratory assay for the quantification of the memory B cells by Fluorospot was suppressed because of the difficult interpretation of the results for IgM and IgA secreting cells. The dual color Fluorospot was replaced by a more sensitive triple Fluorospot to measure interferon (IFN)-γ, Interleukin (IL)-17, and IL-4 to interrogate the Th profile. The Luminex assay on culture supernatant was also suppressed as this assay is redundant and less sensitive than the Fluorospot assay.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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