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    Clinical Trial Results:
    A phase II, open, study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine when administered as a booster dose to children aged 16-20 months, previously primed with GSK Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine, containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD] or with GSK Biologicals licensed DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) in the primary vaccination study DTPa-HBV-IPV-116 (106786).

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2007-005343-16
    Trial protocol
    		 FI  
    Global end of trial date
    18 Aug 2008

    Results information
    Results version number
    		 v2
    This version publication date
    08 Jul 2016
    First version publication date
    28 Jun 2015
    Other versions
    		 v1 (removed from public view) , v3
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results

    Trial information

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    Trial identification
    Sponsor protocol code
    111344
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00627458
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.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
    29 Mar 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Aug 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Aug 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity of the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of persistence of the antibodies to all vaccine antigens at the time of the booster vaccination. To assess the immunogenicity of a booster dose of DTPa-HBV-IPV/Hib vaccine given after primary vaccination with the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of response to all vaccine antigens.
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Feb 2008
    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
    Finland: 403
    Worldwide total number of subjects
    403
    EEA total number of subjects
    403
    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)
    403
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    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
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Preservative-free Group
    Arm description
    		 Subjects received the preservative-free (PF) formulation of DSSITGDPa-HBV-IPV/Hib in the primary phase and a booster dose of DTPa-HBV-IPV/Hib in the booster phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Preservative-free Infanrix hexa™
    Investigational medicinal product code
    Other name
    DSSI-TGD-Pa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one vaccine dose administered intramuscularly into the anterolateral quadrant of the right thigh.

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one booster dose of study vaccine, intramuscularly into the anterolateral right thigh.

    Arm title
    		 Preservative-containing Group
    Arm description
    		 Subjects received the preservative-containing (PC) formulation of DSSITGDPa-HBV-IPV/Hib in the primary phase and a booster dose of DTPa-HBV-IPV/Hib in the booster phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Preservative-containing Infanrix hexa™
    Investigational medicinal product code
    Other name
    DSSI-TGD-Pa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one vaccine dose administered intramuscularly into the anterolateral quadrant of the right thigh.

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one booster dose of study vaccine, intramuscularly into the anterolateral right thigh.

    Arm title
    		 Control Group
    Arm description
    		 Subjects received the licensed formulation of DTPa-HBV-IPV/Hib in the primary phase and a booster dose in the booster phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Licensed Infanrix hexa™
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one vaccine dose administered intramuscularly into the anterolateral quadrant of the right thigh, in the primary phase and one booster dose of the same vaccine in the booster phase.

    Number of subjects in period 1
    		Preservative-free Group Preservative-containing Group Control Group
    Started
    127
    137
    139
    Completed
    123
    130
    133
    Not completed
    4
    7
    6
         Consent withdrawn by subject
    2
    6
    5
         Migrated from study area
    1
    -
    1
         Lost to follow-up
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Preservative-free Group
    Reporting group description
    		 Subjects received the preservative-free (PF) formulation of DSSITGDPa-HBV-IPV/Hib in the primary phase and a booster dose of DTPa-HBV-IPV/Hib in the booster phase.

    Reporting group title
    Preservative-containing Group
    Reporting group description
    		 Subjects received the preservative-containing (PC) formulation of DSSITGDPa-HBV-IPV/Hib in the primary phase and a booster dose of DTPa-HBV-IPV/Hib in the booster phase.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received the licensed formulation of DTPa-HBV-IPV/Hib in the primary phase and a booster dose in the booster phase.

    Reporting group values
    		 Preservative-free Group Preservative-containing Group Control Group Total
    Number of subjects
    		 127 137 139 403
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 17.9 ± 1.12 18 ± 1.03 17.8 ± 1.11 -
    Gender categorical
    Units: Subjects
        Female
    		 56 66 59 181
        Male
    		 71 71 80 222

    End points

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    End points reporting groups
    Reporting group title
    Preservative-free Group
    Reporting group description
    		 Subjects received the preservative-free (PF) formulation of DSSITGDPa-HBV-IPV/Hib in the primary phase and a booster dose of DTPa-HBV-IPV/Hib in the booster phase.

    Reporting group title
    Preservative-containing Group
    Reporting group description
    		 Subjects received the preservative-containing (PC) formulation of DSSITGDPa-HBV-IPV/Hib in the primary phase and a booster dose of DTPa-HBV-IPV/Hib in the booster phase.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received the licensed formulation of DTPa-HBV-IPV/Hib in the primary phase and a booster dose in the booster phase.

    Primary: Number of subjects with anti-diphtheria and anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL

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    End point title
    		 Number of subjects with anti-diphtheria and anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    113
    119
    Units: Subjects
        Anti-D, PRE [N=112,117]
    22
    35
        Anti-D, PI(M1) [N=113,119]
    112
    118
        Anti-T, PRE [N=112,117]
    93
    103
        Anti-T, PI(M1) [N=113,119]
    113
    118
    No statistical analyses for this end point

    Primary: Number of subjects with anti-Hepatitis B surface antigen (HBs) antibody concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL

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    End point title
    		 Number of subjects with anti-Hepatitis B surface antigen (HBs) antibody concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    111
    118
    Units: Subjects
        Anti-HBs ≥ 10 mIU/mL, PRE [N=111,117]
    106
    112
        Anti-HBs ≥ 10 mIU/mL, PI(M1) [N=111,118]
    110
    117
        Anti HBs ≥ 100 mIU/mL, PRE [N=111,117]
    55
    54
        Anti HBs ≥ 100 mIU/mL, PI(M1) [N=111,118]
    105
    113
    No statistical analyses for this end point

    Primary: Number of subjects with anti-poliovirus type 1, type 2 and type 3 antibody titers ≥ 8

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    End point title
    		 Number of subjects with anti-poliovirus type 1, type 2 and type 3 antibody titers ≥ 8 [5] [6]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    112
    117
    Units: Subjects
        Anti-polio 1, PRE [N=110,117]
    67
    76
        Anti-polio 1, PI(M1) [N=111,117]
    110
    117
        Anti-polio 2, PRE [N=111,117]
    48
    51
        Anti-polio 2, PI(M1) [N=112,117]
    110
    117
        Anti-polio 3, PRE [N=111,117]
    58
    77
        Anti-polio 3, PI(M1) [N=112,117]
    111
    117
    No statistical analyses for this end point

    Primary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) concentrations ≥ 5 EL.U/mL

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    End point title
    		 Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) concentrations ≥ 5 EL.U/mL [7] [8]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    113
    119
    Units: Subjects
        Anti-PT, PRE [N=109,112]
    80
    81
        Anti-PT, PI(M1) [N=111,119]
    111
    118
        Anti-FHA, PRE [N=110,112]
    106
    107
        Anti-FHA, PI(M1) [N=112,119]
    112
    118
        Anti-PRN, PRE [N=112,117]
    81
    86
        Anti-PRN, PI(M1) [N=113,118]
    113
    117
    No statistical analyses for this end point

    Primary: Anti-diphtheria and anti-tetanus toxoids antibody concentrations

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    End point title
    		 Anti-diphtheria and anti-tetanus toxoids antibody concentrations [9] [10]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    113
    119
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D, PRE [N=112,117]
    0.064 (0.058 to 0.071)
    0.069 (0.062 to 0.076)
        Anti-D, PI(M1) [N=113,119]
    2.237 (1.877 to 2.666)
    2.242 (1.868 to 2.689)
        Anti-T, PRE [N=112,117]
    0.216 (0.184 to 0.254)
    0.248 (0.213 to 0.289)
        Anti-T, PI(M1) [N=113,119]
    9.799 (8.39 to 11.444)
    9.136 (7.838 to 10.648)
    No statistical analyses for this end point

    Primary: Anti-PT, anti-FHA, anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, anti-FHA, anti-PRN antibody concentrations [11] [12]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    113
    119
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, PRE [N=109,112]
    7.8 (6.7 to 9.1)
    7 (6.1 to 8.1)
        Anti-PT, PI(M1) [N=111,119]
    150.9 (132.9 to 171.2)
    117.1 (101.5 to 135)
        Anti-FHA, PRE [N=110,112]
    21.7 (18.1 to 25.9)
    22.1 (18.5 to 26.2)
        Anti-FHA, PI(M1) [N=112,119]
    609.6 (534.1 to 695.7)
    533.7 (463 to 615.1)
        Anti-PRN, PRE [N=112,117]
    8.6 (7.1 to 10.3)
    8.7 (7.3 to 10.2)
        Anti-PRN, PI(M1) [N=113,118]
    308.5 (261.3 to 364.2)
    311.7 (260.3 to 373.2)
    No statistical analyses for this end point

    Primary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations [13] [14]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [13] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    111
    118
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs, PRE [N=111,117]
    84.3 (65.7 to 108.2)
    86.2 (67.8 to 109.6)
        Anti-HBs, PI(M1) [N=111,118]
    3291.7 (2373.6 to 4565)
    3528.1 (2546.1 to 4888.9)
    No statistical analyses for this end point

    Primary: Anti-poliovirus type 1, type 2 and type 3 antibody titers

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    End point title
    		 Anti-poliovirus type 1, type 2 and type 3 antibody titers [15] [16]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [15] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    112
    117
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1, PRE [N=110,117]
    12.9 (10.3 to 16.3)
    15.2 (12.3 to 18.9)
        Anti-polio 1, PI(M1) [N=111,117]
    726.3 (560.4 to 941.4)
    942.4 (734.1 to 1209.7)
        Anti-polio 2, PRE [N=111,117]
    9.1 (7.3 to 11.3)
    8.7 (7.2 to 10.5)
        Anti-polio 2, PI(M1) [N=112,117]
    712.8 (529.1 to 960.4)
    812.9 (632.8 to 1044.3)
        Anti-polio 3, PRE [N=111,117]
    9.5 (7.9 to 11.6)
    16 (12.6 to 20.4)
        Anti-polio 3, PI(M1) [N=112,117]
    780 (591 to 1029.3)
    1145.8 (891.6 to 1472.5)
    No statistical analyses for this end point

    Primary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations [17] [18]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [17] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    112
    119
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, PRE [N=111,117]
    0.249 (0.199 to 0.31)
    0.314 (0.252 to 0.392)
        Anti-PRP, PI(M1) [N=112,119]
    36.866 (28.61 to 47.504)
    35.318 (27.447 to 45.445)
    No statistical analyses for this end point

    Primary: Number of subjects with a vaccine response to PT, FHA and PR

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    End point title
    		 Number of subjects with a vaccine response to PT, FHA and PR [19] [20]
    End point description
    Vaccine response was defined as appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations > cut-off value).
    End point type
    Primary
    End point timeframe
    One month after the booster dose
    Notes
    [19] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    112
    116
    Units: Subjects
        Anti-PT, S- [N=29,31]
    29
    30
        Anti-PT, S+ [N=78,81]
    78
    81
        Anti-PT, Total [N=107,112]
    107
    111
        Anti-FHA, S- [N=4,5]
    4
    4
        Anti-FHA, S+ [N=105,107]
    104
    106
        Anti-FHA, Total [N=109,112]
    108
    110
        Anti-PRN, S- [N=31,31]
    31
    30
        Anti-PRN, S+ [N=81,85]
    81
    85
        Anti-PRN, Total [N=112,116]
    112
    115
    No statistical analyses for this end point

    Primary: Number of subjects with anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL

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    End point title
    		 Number of subjects with anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL [21] [22]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [21] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Preservative-free Group Preservative-containing Group
    Number of subjects analysed
    112
    119
    Units: Subjects
        Anti-PRP ≥ 0.15μg/mL, PRE [N=111,117]
    71
    87
        Anti-PRP ≥ 0.15μg/mL, PI(M1) [N=112,119]
    112
    119
        Anti-PRP ≥ 1.0μg/mL, PRE [N=111,117]
    15
    23
        Anti-PRP ≥ 1.0μg/mL, PI(M1) [N=112,119]
    111
    117
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0–Day 3) follow-up period after the booster vaccination
    End point values
    		 Preservative-free Group Preservative-containing Group Control Group
    Number of subjects analysed
    126
    136
    138
    Units: Subjects
        Any Pain
    74
    76
    82
        Any Redness
    66
    79
    94
        Any Swelling
    44
    53
    60
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0–Day 3) follow-up period after the booster vaccination
    End point values
    		 Preservative-free Group Preservative-containing Group Control Group
    Number of subjects analysed
    126
    136
    138
    Units: Subjects
        Any Drowsiness
    50
    48
    58
        Any Fever (Rectal)
    22
    34
    31
        Any Irritability
    68
    86
    78
        Any Loss of Appetite
    37
    46
    45
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0–Day 30) follow-up period after the booster vaccination
    End point values
    		 Preservative-free Group Preservative-containing Group Control Group
    Number of subjects analysed
    127
    137
    139
    Units: Subjects
        Any AEs
    51
    54
    61
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From study vaccine administration during the study period
    End point values
    		 Preservative-free Group Preservative-containing Group Control Group
    Number of subjects analysed
    127
    137
    139
    Units: Subjects
        Any SAEs
    1
    2
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting concomitant medications

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    End point title
    		 Number of subjects reporting concomitant medications
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period
    End point values
    		 Preservative-free Group Preservative-containing Group Control Group
    Number of subjects analysed
    127
    137
    139
    Units: Subjects
        Any concomitant medication
    105
    111
    116
        Any antipyretic
    34
    35
    33
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-diphtheria and anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL

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    End point title
    		 Number of subjects with anti-diphtheria and anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL [23]
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    119
    Units: Subjects
        Anti-D, PRE [N=111]
    40
        Anti-D, PI(M1) [N=119]
    119
        Anti-T, PRE [N=111]
    95
        Anti-T, PI(M1) [N=119]
    119
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-Hepatitis B surface antigen (HBs) antibody concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL

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    End point title
    		 Number of subjects with anti-Hepatitis B surface antigen (HBs) antibody concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL [24]
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    118
    Units: Subjects
        Anti-HBs ≥ 10 mIU/mL, PRE [N=110]
    106
        Anti-HBs ≥ 10 mIU/mL, PI(M1) [N=118]
    118
        Anti HBs ≥ 100 mIU/mL, PRE [N=110]
    67
        Anti HBs ≥ 100 mIU/mL, PI(M1) [N=118]
    114
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-poliovirus type 1, type 2 and type 3 antibody titers ≥ 8

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    End point title
    		 Number of subjects with anti-poliovirus type 1, type 2 and type 3 antibody titers ≥ 8 [25]
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    113
    Units: Subjects
        Anti-polio 1, PRE [N=109]
    84
        Anti-polio 1, PI(M1) [N=113]
    112
        Anti-polio 2, PRE [N=109]
    56
        Anti-polio 2, PI(M1) [N=113]
    112
        Anti-polio 3, PRE [N=109]
    82
        Anti-polio 3, PI(M1) [N=113]
    113
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5 EL.U/mL

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    End point title
    		 Number of subjects with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5 EL.U/mL [26]
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    119
    Units: Subjects
        Anti-PT, PRE [N=110]
    93
        Anti-PT, PI(M1) [N=119]
    119
        Anti-FHA, PRE [N=109]
    109
        Anti-FHA, PI(M1) [N=119]
    119
        Anti-PRN, PRE [N=111]
    99
        Anti-PRN, PI(M1) [N=119]
    119
    No statistical analyses for this end point

    Secondary: Anti-diphtheria and anti-tetanus toxoids antibody concentrations

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    End point title
    		 Anti-diphtheria and anti-tetanus toxoids antibody concentrations [27]
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    119
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D, PRE [N=111]
    0.084 (0.073 to 0.097)
        Anti-D, PI(M1) [N=119]
    3.952 (3.365 to 4.642)
        Anti-T, PRE [N=111]
    0.261 (0.219 to 0.31)
        Anti-T, PI(M1) [N=119]
    10.833 (9.505 to 12.347)
    No statistical analyses for this end point

    Secondary: Anti-PT, anti-FHA, anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, anti-FHA, anti-PRN antibody concentrations [28]
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    119
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, PRE [N=110]
    8.9 (7.7 to 10.3)
        Anti-PT, PI(M1) [N=119]
    153.7 (135.1 to 174.9)
        Anti-FHA, PRE [N=109]
    33.7 (27.6 to 41.1)
        Anti-FHA, PI(M1) [N=119]
    791.9 (708.8 to 884.8)
        Anti-PRN, PRE [N=111]
    15.3 (12.6 to 18.5)
        Anti-PRN, PI(M1) [N=119]
    564.1 (489.5 to 650.1)
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations [29]
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    118
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs, PRE [N=110]
    139.8 (107.2 to 182.3)
        Anti-HBs, PI(M1) [N=118]
    6132.7 (4587.8 to 8197.9)
    No statistical analyses for this end point

    Secondary: Anti-poliovirus type 1, type 2 and type 3 antibody titers

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    End point title
    		 Anti-poliovirus type 1, type 2 and type 3 antibody titers [30]
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    113
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1, PRE [N=109]
    21.6 (17.1 to 27.4)
        Anti-polio 1, PI(M1) [N=113]
    1288.8 (1029.1 to 1614)
        Anti-polio 2, PRE [N=109]
    11.8 (9.2 to 15)
        Anti-polio 2, PI(M1) [N=113]
    1231 (961 to 1576.9)
        Anti-polio 3, PRE [N=109]
    21.3 (16.4 to 27.7)
        Anti-polio 3, PI(M1) [N=113]
    1794.8 (1426.8 to 2257.7)
    No statistical analyses for this end point

    Secondary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations [31]
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    119
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, PRE [N=111]
    0.487 (0.383 to 0.62)
        Anti-PRP, PRE [N=119]
    77.087 (60.224 to 98.672)
    No statistical analyses for this end point

    Secondary: Number of subjects with a vaccine response to PT, FHA and PR

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    End point title
    		 Number of subjects with a vaccine response to PT, FHA and PR [32]
    End point description
    Vaccine response was defined as appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations > cut-off value).
    End point type
    Secondary
    End point timeframe
    One month after the booster dose
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    111
    Units: Subjects
        Anti-PT, S- [N=17]
    17
        Anti-PT, S+ [N=93]
    93
        Anti-PT, Total [N=110]
    110
        Anti-FHA, S- [N=0]
    0
        Anti-FHA, S+ [N=109]
    105
        Anti-FHA, Total [N=109]
    105
        Anti-PRN, S- [N=12]
    12
        Anti-PRN, S+ [N=99]
    98
        Anti-PRN, Total [N=111]
    110
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL

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    End point title
    		 Number of subjects with anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL [33]
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after the booster vaccination [PI(M1)]
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by treatment group. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Control Group
    Number of subjects analysed
    119
    Units: Subjects
        Anti-PRP ≥ 0.15μg/mL, PRE [N=111]
    92
        Anti-PRP ≥ 0.15μg/mL, PI(M1) [N=119]
    119
        Anti-PRP ≥ 1.0μg/mL, PRE [N=111]
    32
        Anti-PRP ≥ 1.0μg/mL, PI(M1) [N=119]
    118
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: during the 4-day (Day 0–Day 3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Day 0–Day 30) period after the booster vaccination. SAEs: during the entire study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Preservative-free Group
    Reporting group description
    		 Subjects received the preservative-free (PF) formulation of DSSITGDPa-HBV-IPV/Hib in the primary phase and a booster dose of DTPa-HBV-IPV/Hib in the booster phase.

    Reporting group title
    Preservative-containing Group
    Reporting group description
    		 Subjects received the preservative-containing (PC) formulation of DSSITGDPa-HBV-IPV/Hib in the primary phase and a booster dose of DTPa-HBV-IPV/Hib in the booster phase.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received the licensed formulation of DTPa-HBV-IPV/Hib in the primary phase and a booster dose in the booster phase.

    Serious adverse events
    		 Preservative-free Group Preservative-containing Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 137 (1.46%)
    1 / 139 (0.72%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia adenoviral
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 137 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Preservative-free Group Preservative-containing Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    74 / 127 (58.27%)
    86 / 137 (62.77%)
    94 / 139 (67.63%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    74 / 126 (58.73%)
    76 / 136 (55.88%)
    82 / 138 (59.42%)
         occurrences all number
    74
    76
    82
    Redness
         subjects affected / exposed [2]
    66 / 126 (52.38%)
    79 / 136 (58.09%)
    94 / 138 (68.12%)
         occurrences all number
    66
    79
    94
    Swelling
         subjects affected / exposed [3]
    44 / 126 (34.92%)
    53 / 136 (38.97%)
    60 / 138 (43.48%)
         occurrences all number
    44
    53
    60
    Drowsiness
         subjects affected / exposed [4]
    50 / 126 (39.68%)
    48 / 136 (35.29%)
    58 / 138 (42.03%)
         occurrences all number
    50
    48
    58
    Fever/(Rectal)
         subjects affected / exposed [5]
    22 / 126 (17.46%)
    34 / 136 (25.00%)
    31 / 138 (22.46%)
         occurrences all number
    22
    34
    31
    Irritability
         subjects affected / exposed [6]
    68 / 126 (53.97%)
    86 / 136 (63.24%)
    78 / 138 (56.52%)
         occurrences all number
    68
    86
    78
    Loss of appetite
         subjects affected / exposed [7]
    37 / 126 (29.37%)
    46 / 136 (33.82%)
    45 / 138 (32.61%)
         occurrences all number
    37
    46
    45
    Pyrexia
         subjects affected / exposed
    6 / 127 (4.72%)
    5 / 137 (3.65%)
    8 / 139 (5.76%)
         occurrences all number
    6
    5
    8
    Injection site induration
         subjects affected / exposed
    5 / 127 (3.94%)
    2 / 137 (1.46%)
    10 / 139 (7.19%)
         occurrences all number
    5
    2
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 127 (5.51%)
    4 / 137 (2.92%)
    5 / 139 (3.60%)
         occurrences all number
    7
    4
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 127 (1.57%)
    9 / 137 (6.57%)
    0 / 139 (0.00%)
         occurrences all number
    2
    9
    0
    Infections and infestations
    Otitis media
         subjects affected / exposed
    4 / 127 (3.15%)
    7 / 137 (5.11%)
    14 / 139 (10.07%)
         occurrences all number
    4
    7
    14
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 127 (7.09%)
    8 / 137 (5.84%)
    6 / 139 (4.32%)
         occurrences all number
    9
    8
    6
    Rhinitis
         subjects affected / exposed
    3 / 127 (2.36%)
    8 / 137 (5.84%)
    9 / 139 (6.47%)
         occurrences all number
    3
    8
    9
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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