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    Clinical Trial Results:
    Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children

    Summary
    EudraCT number
    2008-005791-27
    Trial protocol
    FI  
    Global end of trial date
    18 Jan 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    29 Jan 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GPA12
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00884182
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 5850, stephanie.pepin@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 5850, stephanie.pepin@sanofipasteur.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jul 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jan 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To describe the safety profiles (injection site reactions and systemic events) during the 21 days following each vaccination in subjects receiving the Day 0-Day 21 and the Day 0-Day 42 vaccination schedules, and 14 days and 21 days after Vaccination 1 and Vaccination 2, respectively, in subjects aged 9 to 17 years receiving the Day 0-Day 14 vaccination schedule • To describe the immune response 21 days after each vaccination in subjects receiving the Day 0-Day 21 vaccination schedule
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. 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 was also available on site in case of any immediate allergic reactions.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    02 Apr 2009
    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: 350
    Worldwide total number of subjects
    350
    EEA total number of subjects
    350
    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)
    31
    Children (2-11 years)
    233
    Adolescents (12-17 years)
    86
    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
    Study subjects were enrolled from 02 April 2009 to 12 May 2009 in 12 clinical sites in Finland.

    Pre-assignment
    Screening details
    A total of 350 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    9-17 years (30μg+Ad; D0-D14)
    Arm description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 14 days apart.
    Arm type
    Experimental

    Investigational medicinal product name
    FLU H5N1 30µgHA+aluminum hydroxide
    Investigational medicinal product code
    402
    Other name
    Inactivated split influenza virus A/Indonesia/5/05-RG2 (H5N1)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, Intramuscular (IM) into the deltoid (subjects ≥1 year of age) and thigh (subjects <1 year of age), one dose on Day 0 and Day 14.

    Arm title
    9-17 years (30μg+Ad; D0-D21)
    Arm description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.
    Arm type
    Experimental

    Investigational medicinal product name
    FLU H5N1 30µgHA+aluminum hydroxide
    Investigational medicinal product code
    402
    Other name
    Inactivated split influenza virus A/Indonesia/5/05-RG2 (H5N1)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, Intramuscular (IM) into the deltoid (subjects ≥1 year of age) and thigh (subjects <1 year of age), one dose on Day 0 and Day 21.

    Arm title
    9-17 years (30μg+Ad; D0-D42)
    Arm description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 42 days apart.
    Arm type
    Experimental

    Investigational medicinal product name
    FLU H5N1 30µgHA+aluminum hydroxide
    Investigational medicinal product code
    402
    Other name
    Inactivated split influenza virus A/Indonesia/5/05-RG2 (H5N1)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, Intramuscular (IM) into the deltoid (subjects ≥1 year of age) and thigh (subjects <1 year of age), one dose on Day 0 and Day 42.

    Arm title
    3-8 years (30μg+Ad; D0-D21)
    Arm description
    Subjects aged 3-8 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.
    Arm type
    Experimental

    Investigational medicinal product name
    FLU H5N1 30µgHA+aluminum hydroxide
    Investigational medicinal product code
    402
    Other name
    Inactivated split influenza virus A/Indonesia/5/05-RG2 (H5N1)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, Intramuscular (IM) into the deltoid (subjects ≥1 year of age) and thigh (subjects <1 year of age), one dose on Day 0 and Day 21.

    Arm title
    6-35 months (30μg+Ad; D0-D21)
    Arm description
    Subjects aged 6-35 months who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.
    Arm type
    Experimental

    Investigational medicinal product name
    FLU H5N1 30µgHA+aluminum hydroxide
    Investigational medicinal product code
    402
    Other name
    Inactivated split influenza virus A/Indonesia/5/05-RG2 (H5N1)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, Intramuscular (IM) into the deltoid (subjects ≥1 year of age) and thigh (subjects <1 year of age), one dose on Day 0 and Day 21.

    Number of subjects in period 1
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Started
    50
    50
    50
    100
    100
    Completed
    50
    49
    48
    96
    96
    Not completed
    0
    1
    2
    4
    4
         Protocol deviation
             -
             -
             1
             -
             1
         Adverse event, non-fatal
             -
             -
             -
             -
             1
         Consent withdrawn by subject
             -
             -
             -
             4
             1
         Lost to follow-up
             -
             1
             1
             -
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    9-17 years (30μg+Ad; D0-D14)
    Reporting group description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 14 days apart.

    Reporting group title
    9-17 years (30μg+Ad; D0-D21)
    Reporting group description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.

    Reporting group title
    9-17 years (30μg+Ad; D0-D42)
    Reporting group description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 42 days apart.

    Reporting group title
    3-8 years (30μg+Ad; D0-D21)
    Reporting group description
    Subjects aged 3-8 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.

    Reporting group title
    6-35 months (30μg+Ad; D0-D21)
    Reporting group description
    Subjects aged 6-35 months who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.

    Reporting group values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21) Total
    Number of subjects
    50 50 50 100 100 350
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 31 31
        Children (2-11 years)
    21 20 23 100 69 233
        Adolescents (12-17 years)
    29 30 27 0 0 86
        Adults (18-64 years)
    0 0 0 0 0 0
        From 65-84 years
    0 0 0 0 0 0
        85 years and over
    0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    13 ± 2.5 12.8 ± 2.3 12.8 ± 2.7 6 ± 1.5 2.2 ± 0.6 -
    Gender categorical
    Units: Subjects
        Female
    33 31 23 50 55 192
        Male
    17 19 27 50 45 158
    Subjects previously vaccinated with an influenza vaccine
    Units: Subjects
        Yes
    4 4 3 32 65 108
        No
    46 45 45 68 34 238
        Unknown
    0 1 2 0 1 4
    Subjects having experienced influenza-like illness since September 2008 included
    Units: Subjects
        Yes
    8 12 8 15 10 53
        No
    42 37 42 83 90 294
        Unknown
    0 1 0 2 0 3

    End points

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    End points reporting groups
    Reporting group title
    9-17 years (30μg+Ad; D0-D14)
    Reporting group description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 14 days apart.

    Reporting group title
    9-17 years (30μg+Ad; D0-D21)
    Reporting group description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.

    Reporting group title
    9-17 years (30μg+Ad; D0-D42)
    Reporting group description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 42 days apart.

    Reporting group title
    3-8 years (30μg+Ad; D0-D21)
    Reporting group description
    Subjects aged 3-8 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.

    Reporting group title
    6-35 months (30μg+Ad; D0-D21)
    Reporting group description
    Subjects aged 6-35 months who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.

    Primary: Summary of Geometric Mean Titers (GMTs) of Antibody Assayed by HI Horse Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Summary of Geometric Mean Titers (GMTs) of Antibody Assayed by HI Horse Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [1]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre vaccination) and Day 21 and Day 42 post-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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50 [2]
    50
    50 [3]
    100
    100
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    0 (0 to 0)
    4 (4 to 4)
    0 (0 to 0)
    4 (4 to 4)
    4 (4 to 4)
        Day 21
    0 (0 to 0)
    6.19 (5.11 to 7.5)
    0 (0 to 0)
    6.37 (5.57 to 7.27)
    6.26 (5.4 to 7.26)
        Day 42
    0 (0 to 0)
    73.7 (56.4 to 96.4)
    0 (0 to 0)
    80.6 (65.8 to 98.8)
    69.7 (56.7 to 85.7)
    Notes
    [2] - No vaccine outcome for this group at this time point.
    [3] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Primary: Summary of Geometric Mean Titers Ratios (GMTR) Antibody Assayed by HI Horse Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Summary of Geometric Mean Titers Ratios (GMTR) Antibody Assayed by HI Horse Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [4]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre vaccination) and Day 21 and Day 42 post-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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50 [5]
    50
    50 [6]
    100
    100
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        Day 21/Day 0
    0 (0 to 0)
    1.55 (1.28 to 1.87)
    0 (0 to 0)
    1.59 (1.39 to 1.82)
    1.56 (1.35 to 1.81)
        Day 42/Day 21
    0 (0 to 0)
    11.8 (9.25 to 15.1)
    0 (0 to 0)
    12.7 (10.7 to 15.2)
    11.2 (9.39 to 13.4)
        Day 42/Day 0
    0 (0 to 0)
    18.4 (14.1 to 24.1)
    0 (0 to 0)
    20.2 (16.5 to 24.7)
    17.4 (14.2 to 21.4)
    Notes
    [5] - No vaccine outcome data for this age group at this time point.
    [6] - No vaccine outcome data for this age group at this time point.
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Antibody Titers ≥ 8 (1/dil) or ≥ 32 (1/dil) Assayed by HI Horse Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Percentage of Subjects with Antibody Titers ≥ 8 (1/dil) or ≥ 32 (1/dil) Assayed by HI Horse Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [7]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre vaccination) and Day 21 and Day 42 post-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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50 [8]
    50
    50 [9]
    100
    100
    Units: Percentage of subjects
    number (not applicable)
        Day 0; ≥8 (1/dil)
    0
    0
    0
    0
    0
        Day 21; ≥8 (1/dil)
    0
    30
    0
    33
    30.2
        Day 42; ≥8 (1/dil)
    0
    98
    0
    98.9
    98.9
        Day 0; ≥32 (1/dil)
    0
    0
    0
    0
    0
        Day 21; ≥32 (1/dil)
    0
    6
    0
    4.3
    8.3
        Day 42; ≥32 (1/dil)
    0
    87.8
    0
    90
    84.9
    Notes
    [8] - No vaccine outcome for this group at this time point.
    [9] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Seroconversion or Significant Increase in Antibody Assayed by HI Horse Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Percentage of Subjects Achieving Seroconversion or Significant Increase in Antibody Assayed by HI Horse Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [10]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method. Seroconversion was defined as subjects with pre-vaccination titer <8 (1/dil) and with a post-vaccination titer ≥32 (1/dil) or significant increase was defined as subjects with pre-vaccination titer ≥8 (1/dil) and with at least a 4-fold increase in post-vaccination titer.
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50 [11]
    50
    50 [12]
    100
    100
    Units: Percentage of subjects
    number (not applicable)
        Day 21
    0
    6
    0
    4.3
    8.3
        Day 42
    0
    87.8
    0
    90
    84.9
    Notes
    [11] - No vaccine outcome for this group at this time point.
    [12] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Primary: Summary of Neutralizing Antibody Geometric Mean Titers (GMTs) Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Summary of Neutralizing Antibody Geometric Mean Titers (GMTs) Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [13]
    End point description
    Influenza vaccine antibodies were assessed using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre vaccination) and Day 21 and Day 42 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50 [14]
    50
    50 [15]
    100
    100
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    0 (0 to 0)
    5 (5 to 5)
    0 (0 to 0)
    5.04 (4.96 to 5.13)
    5 (5 to 5)
        Day 21
    0 (0 to 0)
    12.9 (9.52 to 17.4)
    0 (0 to 0)
    13.2 (10.7 to 16.2)
    12.9 (10.3 to 16.2)
        Day 42
    0 (0 to 0)
    332 (248 to 444)
    0 (0 to 0)
    368 (297 to 456)
    298 (233 to 379)
    Notes
    [14] - No vaccine outcome for this group at this time point.
    [15] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Primary: Summary of Neutralizing Titers Geometric Mean Titers Ratios (GMTR) of Neutralizing Antibodies Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Summary of Neutralizing Titers Geometric Mean Titers Ratios (GMTR) of Neutralizing Antibodies Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [16]
    End point description
    Influenza vaccine antibodies were assessed using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [16] - 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50 [17]
    50
    50 [18]
    100
    100
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        Day 21/Day 0
    0 (0 to 0)
    2.57 (1.9 to 3.47)
    0 (0 to 0)
    2.61 (2.13 to 3.21)
    2.58 (2.06 to 3.24)
        Day 42/Day 21
    0 (0 to 0)
    25.3 (19.6 to 32.7)
    0 (0 to 0)
    27.7 (22.8 to 33.7)
    23.1 (18.8 to 28.4)
        Day 42/Day 0
    0 (0 to 0)
    66.3 (49.5 to 88.9)
    0 (0 to 0)
    72.9 (58.8 to 90.4)
    59.5 (46.7 to 75.9)
    Notes
    [17] - No vaccine outcome data for this age group at this time point.
    [18] - No vaccine outcome data for this age group at this time point.
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Neutralizing Antibody titers ≥ 10 (1/dil) Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Percentage of Subjects with Neutralizing Antibody titers ≥ 10 (1/dil) Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [19]
    End point description
    Influenza vaccine antibodies were assessed using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre vaccination) and Day 21 and Day 42 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50 [20]
    50
    50 [21]
    100
    100
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    0
    0
    0
    1
    0
        Day 21
    0
    52
    0
    55.1
    51.5
        Day 42
    0
    100
    0
    100
    98.9
    Notes
    [20] - No vaccine outcome for this group at this time point.
    [21] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving a 2-fold or 4-fold Increase in Neutralizing Antibody Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Percentage of Subjects Achieving a 2-fold or 4-fold Increase in Neutralizing Antibody Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [22]
    End point description
    Influenza vaccine antibodies were assessed using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 post-vaccination
    Notes
    [22] - 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50 [23]
    50
    50 [24]
    100
    100
    Units: Percentage of subjects
    number (not applicable)
        2-fold increase from Day 0 (Day 21)
    0
    52
    0
    55.1
    51.5
        2-fold increase from Day 0 (Day 42)
    0
    100
    0
    100
    98.9
        4-fold increase from Day 0 (Day 21)
    0
    32
    0
    35.7
    33
        4-fold increase from Day 0 (Day 42)
    0
    100
    0
    98.9
    97.9
    Notes
    [23] - No vaccine outcome for this group at this time point.
    [24] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers (GMTs) of Antibody Assayed by HI Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Summary of Geometric Mean Titers (GMTs) of Antibody Assayed by HI Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
    End point type
    Other pre-specified
    End point timeframe
    V01 (pre-vaccination) and V02 (D14 for subjects on D0-D14 schedule, D21 for D0-D21 schedule, or D42 for D0-D42 schedule) and V03 (D35 for subjects on D0-D14 schedule, D42 for D0-D21 schedule, or D63 for D0-D42 schedule) post-vaccination
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50
    50
    50
    100 [25]
    100 [26]
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        V01
    4 (4 to 4)
    4 (4 to 4)
    4 (4 to 4)
    0 (0 to 0)
    0 (0 to 0)
        V02
    4.53 (4.07 to 5.05)
    6.19 (5.11 to 7.5)
    7.77 (6.12 to 9.85)
    0 (0 to 0)
    0 (0 to 0)
        V03
    50.6 (36.3 to 70.5)
    73.7 (56.4 to 96.4)
    49.5 (37.5 to 65.4)
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [25] - No vaccine outcome for this group at this time point.
    [26] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers Ratios (GMTR) Antibody Assayed by HI Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Summary of Geometric Mean Titers Ratios (GMTR) Antibody Assayed by HI Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
    End point type
    Other pre-specified
    End point timeframe
    V01 (pre-vaccination) and V02 (D14 for subjects on D0-D14 schedule, D21 for D0-D21 schedule, or D42 for D0-D42 schedule) and V03 (D35 for subjects on D0-D14 schedule, D42 for D0-D21 schedule, or D63 for D0-D42 schedule) post-vaccination
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50
    50
    50
    100 [27]
    100 [28]
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        V02/V01
    1.13 (1.02 to 1.26)
    1.55 (1.28 to 1.87)
    1.94 (1.53 to 2.46)
    0 (0 to 0)
    0 (0 to 0)
        V03/V02
    11.2 (8.05 to 15.5)
    11.8 (9.25 to 15.1)
    6.29 (4.94 to 8)
    0 (0 to 0)
    0 (0 to 0)
        V03/V01
    12.6 (9.07 to 17.6)
    18.4 (14.1 to 24.1)
    12.4 (9.38 to 16.4)
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [27] - No vaccine outcome data for this age group at this time point.
    [28] - No vaccine outcome data for this age group at this time point.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Antibody Titers ≥ 8 (1/dil) or ≥ 32 (1/dil) Assayed by HI Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Percentage of Subjects with Antibody Titers ≥ 8 (1/dil) or ≥ 32 (1/dil) Assayed by HI Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
    End point type
    Other pre-specified
    End point timeframe
    V01 (pre-vaccination) and V02 (D14 for subjects on D0-D14 schedule, D21 for D0-D21 schedule, or D42 for D0-D42 schedule) and V03 (D35 for subjects on D0-D14 schedule, D42 for D0-D21 schedule, or D63 for D0-D42 schedule) post-vaccination
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50
    50
    50
    100 [29]
    100 [30]
    Units: Percentage of subjects
    number (not applicable)
        V01; ≥8 (1/dil)
    0
    0
    0
    0
    0
        V02; ≥8 (1/dil)
    10
    30
    42.6
    0
    0
        V03; ≥8 (1/dil)
    92
    98
    97.8
    0
    0
        V01; ≥32 (1/dil)
    0
    0
    0
    0
    0
        V02; ≥32 (1/dil)
    2
    6
    12.8
    0
    0
        V03; ≥32 (1/dil)
    72
    87.8
    78.3
    0
    0
    Notes
    [29] - No vaccine outcome for this group at this time point.
    [30] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Achieving Seroconversion or Significant Increase in Antibody Assayed by HI Turkey Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Percentage of Subjects Achieving Seroconversion or Significant Increase in Antibody Assayed by HI Turkey Erythrocytes Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method. Seroconversion was defined as subjects with pre-vaccination titer <8 (1/dil) and with a post-vaccination titer ≥32 (1/dil) or significant increase was defined as subjects with pre-vaccination titer ≥8 (1/dil) and with at least a 4-fold increase in post-vaccination titer.
    End point type
    Other pre-specified
    End point timeframe
    V02 (D14 for subjects on D0-D14 schedule, D21 for D0-D21 schedule, or D42 for D0-D42 schedule) and V03 (D35 for subjects on D0-D14 schedule, D42 for D0-D21 schedule, or D63 for D0-D42 schedule) post-vaccination
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50
    50
    50
    100 [31]
    100 [32]
    Units: Percentage of subjects
    number (not applicable)
        V02
    2
    6
    12.8
    0
    0
        V03
    72
    87.8
    78.3
    0
    0
    Notes
    [31] - No vaccine outcome for this group at this time point.
    [32] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers (GMTs) of Antibody Assayed Seroneutralization Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Summary of Geometric Mean Titers (GMTs) of Antibody Assayed Seroneutralization Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine
    End point description
    Influenza vaccine antibodies were assessed using the seroneutralization method.
    End point type
    Other pre-specified
    End point timeframe
    V01 (pre-vaccination) and V02 (D14 for subjects on D0-D14 schedule, D21 for D0-D21 schedule, or D42 for D0-D42 schedule) and V03 (D35 for subjects on D0-D14 schedule, D42 for D0-D21 schedule, or D63 for D0-D42 schedule) post-vaccination
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50
    50
    50
    100 [33]
    100 [34]
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        V01
    5 (5 to 5)
    5 (5 to 5)
    5 (5 to 5)
    0 (0 to 0)
    0 (0 to 0)
        V02
    6.86 (5.61 to 8.38)
    12.9 (9.52 to 17.4)
    30.7 (22.4 to 42)
    0 (0 to 0)
    0 (0 to 0)
        V03
    189 (132 to 271)
    332 (248 to 444)
    303 (230 to 400)
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [33] - No vaccine outcome for this group at this time point.
    [34] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers Ratios (GMTR) Antibody Assayed by Seroneutralization Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Summary of Geometric Mean Titers Ratios (GMTR) Antibody Assayed by Seroneutralization Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine
    End point description
    Influenza vaccine antibodies were assessed using the seroneutralization method.
    End point type
    Other pre-specified
    End point timeframe
    V01 (pre-vaccination) and V02 (D14 for subjects on D0-D14 schedule, D21 for D0-D21 schedule, or D42 for D0-D42 schedule) and V03 (D35 for subjects on D0-D14 schedule, D42 for D0-D21 schedule, or D63 for D0-D42 schedule) post-vaccination
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50
    50
    50
    100 [35]
    100 [36]
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        V02/V01
    1.37 (1.12 to 1.68)
    2.57 (1.9 to 3.47)
    6.13 (4.48 to 8.4)
    0 (0 to 0)
    0 (0 to 0)
        V03/V02
    27.6 (19.2 to 39.7)
    25.3 (19.6 to 32.7)
    9.66 (7.29 to 12.8)
    0 (0 to 0)
    0 (0 to 0)
        V03/V01
    37.9 (26.4 to 54.3)
    66.3 (49.5 to 88.9)
    60.7 (46 to 80)
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [35] - No vaccine outcome data for this age group at this time point.
    [36] - No vaccine outcome data for this age group at this time point.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Antibody titers ≥10 (1/dil) Assayed by Seroneutralization Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Percentage of Subjects with Antibody titers ≥10 (1/dil) Assayed by Seroneutralization Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine
    End point description
    Influenza vaccine antibodies were assessed using the seroneutralization method.
    End point type
    Other pre-specified
    End point timeframe
    V01 (pre-vaccination) and V02 (D14 for subjects on D0-D14 schedule, D21 for D0-D21 schedule, or D42 for D0-D42 schedule) and V03 (D35 for subjects on D0-D14 schedule, D42 for D0-D21 schedule, or D63 for D0-D42 schedule) post-vaccination
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50
    50
    50
    100 [37]
    100 [38]
    Units: Percentage of subjects
    number (not applicable)
        V01
    0
    0
    0
    0
    0
        V02
    20
    52
    85.4
    0
    0
        V03
    98
    100
    100
    0
    0
    Notes
    [37] - No vaccine outcome for this group at this time point.
    [38] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with 2- and 4-fold Increase in Antibody titers Assayed by Seroneutralization Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Percentage of Subjects with 2- and 4-fold Increase in Antibody titers Assayed by Seroneutralization Method Against A/Indonesia/5/2005/RG2 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine
    End point description
    Influenza vaccine antibodies were assessed using the seroneutralization method.
    End point type
    Other pre-specified
    End point timeframe
    V02 (D14 for subjects on D0-D14 schedule, D21 for D0-D21 schedule, or D42 for D0-D42 schedule) and V03 (D35 for subjects on D0-D14 schedule, D42 for D0-D21 schedule, or D63 for D0-D42 schedule) post-vaccination
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50
    50
    50
    100 [39]
    100 [40]
    Units: Percentage of subjects
    number (not applicable)
        2-fold increase from V01 (V02)
    20
    52
    85.4
    0
    0
        2-fold increase from V01 (V03)
    98
    100
    100
    0
    0
        4-fold increase from V01 (V02)
    10
    32
    68.8
    0
    0
        4-fold increase from V01 (V03)
    94
    100
    100
    0
    0
    Notes
    [39] - No vaccine outcome for this group at this time point.
    [40] - No vaccine outcome for this group at this time point.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Aged 2 years and over Reporting a Solicited Injection-site or Systemic Reactions Within 7 Days after Injection with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Percentage of Subjects Aged 2 years and over Reporting a Solicited Injection-site or Systemic Reactions Within 7 Days after Injection with Inactivated Split-Virion, Pandemic Influenza Vaccine
    End point description
    Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited Injection site reactions: Pain – Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema, Swelling, Induration, and Ecchymosis - ≥5 cm. Grade 3 Solicited systemic reactions: Fever - ≥39˚C; Headache, Malaise, Myalgia, and Shivering – Prevents daily activities.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 7 post-each vaccination
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50
    50
    50
    100
    69 [41]
    Units: Percentage of subjects
    number (not applicable)
        Inj. site Pain; Post-inj. 1
    56
    65.3
    69.4
    58.6
    41.2
        Grade 3 Inj. site Pain; Post-inj. 1
    0
    0
    0
    0
    0
        Inj. site Erythema; Post-inj. 1
    30
    22.4
    24.5
    32.3
    23.5
        Grade 3 Inj. site Erythema; Post-inj. 1
    0
    2
    2
    2
    2.9
        Inj. site Swelling; Post-inj. 1
    10
    18.4
    10.2
    15.2
    8.8
        Grade 3 Inj. site Swelling; Post-inj. 1
    2
    2
    2
    0
    2.9
        Inj. site Induration; Post-inj. 1
    12
    10.2
    12.2
    23.2
    20.6
        Grade 3 Inj. site Induration; Post-inj. 1
    0
    0
    0
    0
    0
        Inj. site Ecchymosis; Post-inj. 1
    24
    16.3
    12.2
    14.1
    17.6
        Grade 3 Inj. site Ecchymosis; Post-inj. 1
    0
    0
    2
    0
    0
        Fever; Post-inj. 1
    2
    8.2
    2
    4
    5.9
        Grade 3 Fever; Post-inj. 1
    0
    2
    0
    0
    0
        Headache; Post-inj. 1
    38
    42.9
    38.8
    15.2
    8.8
        Grade 3 Headache; Post-inj. 1
    2
    0
    0
    0
    0
        Malaise; Post-inj. 1
    16
    34.7
    16.3
    11.1
    7.4
        Grade 3 Malaise; Post-inj. 1
    0
    2
    0
    3
    1.5
        Myalgia; Post-inj. 1
    28
    44.9
    24.5
    13.1
    7.4
        Grade 3 Myalgia; Post-inj. 1
    0
    2
    0
    0
    0
        Shivering; Post-inj. 1
    16
    16.3
    6.1
    4
    2.9
        Grade 3 Shivering; Post-inj. 1
    0
    0
    0
    0
    0
        Inj. site Pain; Post-inj. 2
    48
    55.1
    46.8
    56.8
    33.3
        Grade 3 Inj. site Pain; Post-inj. 2
    0
    2
    2.1
    1.1
    0
        Inj. site Erythema; Post-inj. 2
    24
    16.3
    14.9
    25.3
    19.7
        Grade 3 Inj. site Erythema; Post-inj. 2
    4
    0
    2.1
    0
    1.5
        Inj. site Swelling; Post-inj. 2
    6
    14.3
    4.3
    15.8
    9.1
        Grade 3 Inj. site Swelling; Post-inj. 2
    2
    0
    0
    0
    0
        Inj. site Induration; Post-inj. 2
    16
    18.4
    6.4
    18.9
    18.2
        Grade 3 Inj. site Induration; Post-inj. 2
    2
    0
    0
    0
    1.5
        Inj. site Ecchymosis; Post-inj. 2
    6
    14.3
    6.4
    10.5
    9.1
        Grade 3 Inj. site Ecchymosis; Post-inj. 2
    0
    0
    2.1
    0
    0
        Fever; Post-inj. 2
    0
    0
    0
    2.1
    3
        Grade 3 Fever; Post-inj. 2
    0
    0
    0
    0
    0
        Headache; Post-inj. 2
    28
    34.7
    21.3
    17.9
    6.1
        Grade 3 Headache; Post-inj. 2
    0
    2
    0
    0
    0
        Malaise; Post-inj. 2
    8
    26.5
    14.9
    12.6
    7.6
        Grade 3 Malaise; Post-inj. 2
    0
    0
    0
    1.1
    0
        Myalgia; Post-inj. 2
    20
    28.6
    17
    7.4
    7.6
        Grade 3 Myalgia; Post-inj. 2
    0
    0
    2.1
    0
    0
        Shivering; Post-inj. 2
    12
    12.2
    2.1
    1.1
    0
        Grade 3 Shivering; Post-inj. 2
    0
    0
    0
    0
    0
        Inj. site Pain; Post-any inj.
    68
    71.4
    77.6
    73.7
    50
        Grade 3 Inj. site Pain; Post-any inj.
    0
    2
    2
    1
    0
        Inj. site Erythema; Post-any inj.
    38
    26.5
    30.6
    43.4
    33.8
        Grade 3 Inj. site Erythema; Post-any inj.
    4
    2
    4.1
    2
    4.4
        Inj. site Swelling; Post-any inj.
    16
    22.4
    12.2
    21.2
    13.2
        Grade 3 Inj. site Swelling; Post-any inj.
    4
    2
    2
    0
    2.9
        Inj. site Induration; Post-any inj.
    20
    24.5
    16.3
    33.3
    29.4
        Grade 3 Inj. site Induration; Post-any inj.
    2
    0
    0
    0
    1.5
        Inj. site Ecchymosis; Post-any inj.
    26
    26.5
    16.3
    20.2
    20.6
        Grade 3 Inj. site Ecchymosis; Post-any inj.
    0
    0
    2
    0
    0
        Fever; Post-any inj.
    2
    8.2
    2
    6.1
    7.4
        Grade 3 Fever; Post-any inj.
    0
    2
    0
    0
    0
        Headache; Post-any inj.
    50
    55.1
    42.9
    24.2
    11.8
        Grade 3 Headache; Post-any inj.
    2
    2
    0
    0
    0
        Malaise; Post-any inj.
    20
    44.9
    24.5
    19.2
    11.8
        Grade 3 Malaise; Post-any inj.
    0
    2
    0
    4
    1.5
        Myalgia; Post-any inj.
    36
    49
    32.7
    18.2
    11.8
        Grade 3 Myalgia; Post-any inj.
    0
    2
    2
    0
    0
        Shivering; Post-any inj.
    22
    22.4
    8.2
    5.1
    2.9
        Grade 3 Shivering; Post-any inj.
    0
    0
    0
    0
    0
    Notes
    [41] - Outcome is based on a subset of the subjects aged 24-35 months.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects aged 2 years and over with at Least One Reaction within 3 Days after Any Vaccine Injections listed in the EMEA note for Guidance Following Primary Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine

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    End point title
    Percentage of Subjects aged 2 years and over with at Least One Reaction within 3 Days after Any Vaccine Injections listed in the EMEA note for Guidance Following Primary Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine
    End point description
    Solicited injection site reactions: Injection site induration ≥5 cm for at least 4 consecutive days and Injection site ecchymosis. Solicited systemic reactions: Pyrexia (recorded temperature > 38°C) for at least one day, Malaise, and Shivering.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 3 post-each vaccination
    End point values
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Number of subjects analysed
    50
    50
    50
    100
    69 [42]
    Units: Percentage of subjects
    number (not applicable)
        At least 1 reaction listed in EMEA
    42
    57.1
    32.7
    32.3
    32.4
        At least 1 reaction listed in EMEA; Post-inj. 1
    36
    42.9
    28.6
    21.2
    23.5
        At least 1 reaction listed in EMEA; Post-inj. 2
    22
    36.7
    17
    17.9
    16.7
        Inj. site induration ≥5 cm for 4 days
    0
    0
    0
    0
    0
        Inj. site induration ≥5 cm for 4 days; Post-inj. 1
    0
    0
    0
    0
    0
        Inj. site induration ≥5 cm for 4 days; Post-inj. 2
    0
    0
    0
    0
    0
        Inj. site ecchymosis
    24
    24.5
    16.3
    20.2
    19.1
        Inj. site ecchymosis; Post-inj. 1
    22
    14.3
    12.2
    14.1
    14.7
        Inj. site ecchymosis; Post-inj. 2
    6
    14.3
    6.4
    10.5
    9.1
        Temperature >38°C (pyrexia) for 1 day
    0
    0
    0
    0
    15
        Temperature >38°C (pyrexia) for 1 day; Post-inj. 1
    0
    0
    0
    0
    1.5
        Temperature >38°C (pyrexia) for 1 day; Post-inj. 2
    0
    0
    0
    0
    0
        Malaise
    14
    36.7
    20.4
    15.2
    11.8
        Malaise; Post-inj. 1
    8
    24.5
    12.2
    8.1
    7.4
        Malaise; Post-inj. 2
    8
    22.4
    10.6
    8.4
    7.6
        Shivering
    20
    22.4
    8.2
    4
    2.9
        Shivering; Post-inj. 1
    14
    16.3
    6.1
    3
    2.9
        Shivering; Post-inj. 2
    12
    10.2
    2.1
    1.1
    0
    Notes
    [42] - Outcome is based on a subset of the subjects aged 24-35 months.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    9-17 years (30μg+Ad; D0-D14)
    Reporting group description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 14 days apart.

    Reporting group title
    9-17 years (30μg+Ad; D0-D21)
    Reporting group description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.

    Reporting group title
    9-17 years (30μg+Ad; D0-D42)
    Reporting group description
    Subjects aged 9-17 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 42 days apart.

    Reporting group title
    3-8 years (30μg+Ad; D0-D21)
    Reporting group description
    Subjects aged 3-8 years who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.

    Reporting group title
    6-35 months (30μg+Ad; D0-D21)
    Reporting group description
    Subjects aged 6-35 months who received two intramuscular administrations of the 30μg HA+aluminum hydroxide vaccine 21 days apart.

    Serious adverse events
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchitis chronic
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Appendicitis perforated
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    9-17 years (30μg+Ad; D0-D14) 9-17 years (30μg+Ad; D0-D21) 9-17 years (30μg+Ad; D0-D42) 3-8 years (30μg+Ad; D0-D21) 6-35 months (30μg+Ad; D0-D21)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 50 (68.00%)
    35 / 50 (70.00%)
    38 / 50 (76.00%)
    73 / 100 (73.00%)
    34 / 100 (34.00%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed [1]
    2 / 50 (4.00%)
    5 / 50 (10.00%)
    1 / 49 (2.04%)
    14 / 99 (14.14%)
    17 / 98 (17.35%)
         occurrences all number
    2
    5
    1
    14
    17
    Pharyngolaryngeal pain
         subjects affected / exposed [2]
    2 / 50 (4.00%)
    5 / 50 (10.00%)
    1 / 49 (2.04%)
    8 / 99 (8.08%)
    0 / 98 (0.00%)
         occurrences all number
    2
    5
    1
    8
    0
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    25 / 50 (50.00%)
    27 / 49 (55.10%)
    21 / 49 (42.86%)
    24 / 99 (24.24%)
    8 / 68 (11.76%)
         occurrences all number
    25
    27
    21
    24
    8
    General disorders and administration site conditions
    Injection site pruritus
         subjects affected / exposed [4]
    1 / 50 (2.00%)
    2 / 50 (4.00%)
    0 / 49 (0.00%)
    5 / 99 (5.05%)
    2 / 98 (2.04%)
         occurrences all number
    1
    2
    0
    5
    2
    Irritability
         subjects affected / exposed [5]
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 99 (0.00%)
    6 / 98 (6.12%)
         occurrences all number
    0
    0
    0
    0
    6
    Pyrexia
         subjects affected / exposed [6]
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    4 / 99 (4.04%)
    11 / 98 (11.22%)
         occurrences all number
    1
    0
    0
    4
    11
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    34 / 50 (68.00%)
    35 / 49 (71.43%)
    38 / 49 (77.55%)
    73 / 99 (73.74%)
    34 / 68 (50.00%)
         occurrences all number
    34
    35
    38
    73
    34
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    19 / 50 (38.00%)
    13 / 49 (26.53%)
    15 / 49 (30.61%)
    43 / 99 (43.43%)
    23 / 68 (33.82%)
         occurrences all number
    19
    13
    15
    43
    23
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    8 / 50 (16.00%)
    11 / 49 (22.45%)
    6 / 49 (12.24%)
    21 / 99 (21.21%)
    9 / 68 (13.24%)
         occurrences all number
    8
    11
    6
    21
    9
    Injection site ecchymosis
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    13 / 50 (26.00%)
    13 / 49 (26.53%)
    8 / 49 (16.33%)
    20 / 99 (20.20%)
    14 / 68 (20.59%)
         occurrences all number
    13
    13
    8
    20
    14
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    1 / 50 (2.00%)
    4 / 49 (8.16%)
    1 / 49 (2.04%)
    6 / 99 (6.06%)
    5 / 68 (7.35%)
         occurrences all number
    1
    4
    1
    6
    5
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    10 / 50 (20.00%)
    22 / 49 (44.90%)
    12 / 49 (24.49%)
    19 / 99 (19.19%)
    8 / 68 (11.76%)
         occurrences all number
    10
    22
    12
    19
    8
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    11 / 50 (22.00%)
    11 / 49 (22.45%)
    4 / 49 (8.16%)
    5 / 99 (5.05%)
    2 / 68 (2.94%)
         occurrences all number
    11
    11
    4
    5
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed [14]
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    1 / 49 (2.04%)
    1 / 99 (1.01%)
    8 / 98 (8.16%)
         occurrences all number
    0
    1
    1
    1
    8
    Skin and subcutaneous tissue disorders
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    10 / 50 (20.00%)
    12 / 49 (24.49%)
    8 / 49 (16.33%)
    33 / 99 (33.33%)
    20 / 68 (29.41%)
         occurrences all number
    10
    12
    8
    33
    20
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    18 / 50 (36.00%)
    24 / 49 (48.98%)
    16 / 49 (32.65%)
    18 / 99 (18.18%)
    8 / 68 (11.76%)
         occurrences all number
    18
    24
    16
    18
    8
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed [17]
    1 / 50 (2.00%)
    4 / 50 (8.00%)
    2 / 49 (4.08%)
    6 / 99 (6.06%)
    6 / 98 (6.12%)
         occurrences all number
    1
    4
    2
    6
    6
    Nasopharyngitis
         subjects affected / exposed [18]
    2 / 50 (4.00%)
    2 / 50 (4.00%)
    0 / 49 (0.00%)
    5 / 99 (5.05%)
    5 / 98 (5.10%)
         occurrences all number
    2
    2
    0
    5
    5
    Otitis media
         subjects affected / exposed [19]
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 49 (0.00%)
    1 / 99 (1.01%)
    7 / 98 (7.14%)
         occurrences all number
    0
    1
    0
    1
    7
    Rhinitis
         subjects affected / exposed [20]
    3 / 50 (6.00%)
    1 / 50 (2.00%)
    1 / 49 (2.04%)
    19 / 99 (19.19%)
    22 / 98 (22.45%)
         occurrences all number
    3
    1
    1
    19
    22
    Upper respiratory tract infection
         subjects affected / exposed [21]
    1 / 50 (2.00%)
    4 / 50 (8.00%)
    4 / 49 (8.16%)
    6 / 99 (6.06%)
    10 / 98 (10.20%)
         occurrences all number
    1
    4
    4
    6
    10
    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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was an solicited adverse event recorded in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was an solicited adverse event recorded in a diary card within 7 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [8] - 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: This was an solicited adverse event recorded in a diary card within 7 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [9] - 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: This was an solicited adverse event recorded in a diary card within 7 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [10] - 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: This was an solicited adverse event that were spontaneously reported in a diary card within 7 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [11] - 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: This was an solicited adverse event recorded in a diary card within 7 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [12] - 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: This was an solicited adverse event recorded in a diary card within 7 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [13] - 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: This was an solicited adverse event recorded in a diary card within 7 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [14] - 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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [15] - 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: This was an solicited adverse event that were spontaneously reported in a diary card within 7 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [16] - 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: This was an solicited adverse event recorded in a diary card within 7 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [17] - 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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [18] - 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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [19] - 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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [20] - 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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [21] - 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: This was an unsolicited adverse event that were spontaneously reported in a diary card within 21 days after each vaccination; therefore, the total number (N) of subjects reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

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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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