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    Clinical Trial Results:
    Safety of the Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Healthy Children

    Summary
    EudraCT number
    		 2005-002965-35
    Trial protocol
    		 FI  
    Global end of trial date
    02 Jan 2006

    Results information
    Results version number
    		 v1
    This version publication date
    05 Feb 2016
    First version publication date
    03 Dec 2014
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GID18
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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 (0)4 37 37 58 50, stephanie.pepin@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 50, 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?
    Yes
    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
    25 Sep 2006
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jan 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety of the 9 µg formulation of the inactivated, split-virion influenza vaccine administered by the intradermal (ID) route in children aged 6 to 35 months and 3 to 8 years.
    Protection of trial subjects
    Only subjects that met all of 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 were 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
    26 Sep 2005
    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: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    38
    Children (2-11 years)
    62
    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
    		 Study subjects were enrolled from 26 September2005 to 28 October 2005 in 3 clinic centers in Finland.

    Pre-assignment
    Screening details
    		 A total of 100 subjects who met all of the 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
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ID Group (Age 3–8 years)
    Arm description
    		 Subjects aged 3 to 8 years at enrollment who received 2 intradermal (ID) doses of the 9 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Inactivated, split-virion influenza vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL, intradermal into the upper arm (deltoid area), one dose each at Day 0 and Day 28

    Arm title
    		 IM Group (Age 3–8 years)
    Arm description
    		 Subjects aged 3 to 8 years at enrollment who received 2 intramuscular (IM) doses of the 15 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Inactivated, split-virion influenza vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular in the deltoid muscle of subjects >1 years of age, one dose each at Day 0 and Day 28

    Arm title
    		 ID Group (Age 6-35 months)
    Arm description
    		 Subjects age 6 to 35 months at enrollment who received 2 intradermal (ID) doses of the 9 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Inactivated, split-virion influenza vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL, intradermal into the upper arm (deltoid area), one dose each at Day 0 and Day 28

    Arm title
    		 IM Group (Age 6-35 months)
    Arm description
    		 Subjects age 6 to 35 months at enrollment who received 2 intramuscular (IM) doses of the 7.5 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Inactivated, split-virion influenza vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.25 mL, intramuscular in the deltoid muscle of subjects >1 years of age and in the anterolateral aspect of the thigh in subjects <1 years of age, one dose each at Day 0 and Day 28.

    Number of subjects in period 1
    		ID Group (Age 3–8 years) IM Group (Age 3–8 years) ID Group (Age 6-35 months) IM Group (Age 6-35 months)
    Started
    30
    20
    30
    20
    Completed
    30
    20
    29
    20
    Not completed
    0
    0
    1
    0
         Consent withdrawn by subject
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ID Group (Age 3–8 years)
    Reporting group description
    		 Subjects aged 3 to 8 years at enrollment who received 2 intradermal (ID) doses of the 9 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.

    Reporting group title
    IM Group (Age 3–8 years)
    Reporting group description
    		 Subjects aged 3 to 8 years at enrollment who received 2 intramuscular (IM) doses of the 15 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.

    Reporting group title
    ID Group (Age 6-35 months)
    Reporting group description
    		 Subjects age 6 to 35 months at enrollment who received 2 intradermal (ID) doses of the 9 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.

    Reporting group title
    IM Group (Age 6-35 months)
    Reporting group description
    		 Subjects age 6 to 35 months at enrollment who received 2 intramuscular (IM) doses of the 7.5 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.

    Reporting group values
    		 ID Group (Age 3–8 years) IM Group (Age 3–8 years) ID Group (Age 6-35 months) IM Group (Age 6-35 months) Total
    Number of subjects
    		 30 20 30 20 100
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 24 14 38
        Children (2-11 years)
    		 30 20 6 6 62
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 58.8 ± 1.61 49.2 ± 1.04 13.8 ± 7.35 15.6 ± 8.32 -
    Gender categorical
    Units: Subjects
        Female
    		 10 10 17 12 49
        Male
    		 20 10 13 8 51

    End points

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    End points reporting groups
    Reporting group title
    ID Group (Age 3–8 years)
    Reporting group description
    		 Subjects aged 3 to 8 years at enrollment who received 2 intradermal (ID) doses of the 9 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.

    Reporting group title
    IM Group (Age 3–8 years)
    Reporting group description
    		 Subjects aged 3 to 8 years at enrollment who received 2 intramuscular (IM) doses of the 15 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.

    Reporting group title
    ID Group (Age 6-35 months)
    Reporting group description
    		 Subjects age 6 to 35 months at enrollment who received 2 intradermal (ID) doses of the 9 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.

    Reporting group title
    IM Group (Age 6-35 months)
    Reporting group description
    		 Subjects age 6 to 35 months at enrollment who received 2 intramuscular (IM) doses of the 7.5 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28.

    Primary: Percentage of Subjects Reporting Solicited Injection Site or Systemic Reaction Following Any Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection Site or Systemic Reaction Following Any Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route [1]
    End point description
    Solicited injection site reactions (children 3–8 years): Pain, Erythema, Edema, and Induration. Solicited systemic reactions (children 3–8 years): Fever, Headache, Malaise, and Myalgia. Solicited injection site reactions (infants 6–35 months): Tenderness, Erythema, Swelling, and Induration. Solicited systemic reactions (infants 6–35 months): Fever, Vomiting, Abnormal crying, Drowsiness, Appetite loss, and Irritability.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-each vaccination) up to 7 days post-each 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
    		 ID Group (Age 3–8 years) IM Group (Age 3–8 years) ID Group (Age 6-35 months) IM Group (Age 6-35 months)
    Number of subjects analysed
    30
    20
    30
    20
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    63.3
    65
    0
    0
        Injection site Erythema
    90
    35
    80
    25
        Injection site Edema
    56.7
    10
    0
    0
        Injection site Induration
    46.7
    30
    53.3
    15
        Fever
    3.3
    20
    26.7
    50
        Headache
    10
    10
    0
    0
        Malaise
    13.3
    20
    0
    0
        Myalgia
    3.3
    10
    0
    0
        Injection site Tenderness
    0
    0
    43.3
    20
        Injection site Swelling
    0
    0
    23.3
    15
        Vomiting
    0
    0
    13.3
    5
        Abnormal crying
    0
    0
    53.3
    30
        Drowsiness
    0
    0
    43.3
    15
        Appetite loss
    0
    0
    50
    35
        Irritability
    0
    0
    63.3
    60
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection Site or Systemic Reactions Within Seven Days Following the First Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection Site or Systemic Reactions Within Seven Days Following the First Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route [2]
    End point description
    Solicited injection site reactions (children 3–8 years): Pain, Erythema, Edema, and Induration. Solicited systemic reactions (children 3–8 years): Fever, Headache, Malaise, and Myalgia. Solicited injection site reactions (infants 6–35 months): Tenderness, Erythema, Swelling, and Induration. Solicited systemic reactions (infants 6–35 months): Fever, Vomiting, Abnormal crying, Drowsiness, Appetite loss, and Irritability.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) up to 7 days post-first vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 ID Group (Age 3–8 years) IM Group (Age 3–8 years) ID Group (Age 6-35 months) IM Group (Age 6-35 months)
    Number of subjects analysed
    30
    20
    30
    20
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    53.3
    45
    0
    0
        Injection site Erythema
    66.7
    20
    53.3
    10
        Injection site Edema
    26.7
    10
    0
    0
        Injection site Induration
    23.3
    20
    13.3
    5
        Fever
    3.3
    10
    23.3
    40
        Headache
    6.7
    10
    0
    0
        Malaise
    6.7
    20
    0
    0
        Myalgia
    3.3
    10
    0
    0
        Injection site Tenderness
    0
    0
    23.3
    15
        Injection site Swelling
    0
    0
    10
    5
        Vomiting
    0
    0
    6.7
    0
        Abnormal crying
    0
    0
    33.3
    15
        Drowsiness
    0
    0
    26.7
    15
        Appetite loss
    0
    0
    40
    25
        Irritability
    0
    0
    46.7
    50
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection Site or Systemic Reaction Within Seven Days Following the Second Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection Site or Systemic Reaction Within Seven Days Following the Second Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route [3]
    End point description
    Solicited injection site reactions (children 3–8 years): Pain, Erythema, Edema, and Induration. Solicited systemic reactions (children 3–8 years): Fever, Headache, Malaise, and Myalgia. Solicited injection site reactions (infants 6–35 months): Tenderness, Erythema, Swelling, and Induration. Solicited systemic reactions (infants 6–35 months): Fever, Vomiting, Abnormal crying, Drowsiness, Appetite loss, and Irritability.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) up to 7 days post-second vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 ID Group (Age 3–8 years) IM Group (Age 3–8 years) ID Group (Age 6-35 months) IM Group (Age 6-35 months)
    Number of subjects analysed
    30
    20
    30
    20
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    53.3
    45
    0
    0
        Injection site Erythema
    80
    25
    80
    20
        Injection site Edema
    43.3
    5
    0
    0
        Injection site Induration
    40
    20
    50
    10
        Fever
    0
    10
    13.3
    30
        Headache
    3.3
    0
    0
    0
        Malaise
    6.7
    5
    0
    0
        Myalgia
    0
    5
    0
    0
        Injection site Tenderness
    0
    0
    43.3
    10
        Injection site Swelling
    0
    0
    23.3
    15
        Vomiting
    0
    0
    13.3
    5
        Abnormal crying
    0
    0
    26.7
    15
        Drowsiness
    0
    0
    23.3
    5
        Appetite loss
    0
    0
    26.7
    25
        Irritability
    0
    0
    40
    45
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of influenza Vaccine Antibodies Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route

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    End point title
    		 Geometric Mean Titers (GMTs) of influenza Vaccine Antibodies Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route
    End point description
    Antibody titers were evaluated using the hemagglutination inhibition technique.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination), Day 28 and Day 56 post-vaccination.
    End point values
    		 ID Group (Age 3–8 years) IM Group (Age 3–8 years) ID Group (Age 6-35 months) IM Group (Age 6-35 months)
    Number of subjects analysed
    30
    20
    30
    20
    Units: Titers
    geometric mean (confidence interval 95%)
        A/New Caledonia/20/99 (Day 0)
    9.77 (6.11 to 15.63)
    6.95 (4.32 to 11.18)
    6.3 (4.54 to 8.75)
    6.83 (4.21 to 11.09)
        A/Wellington/1/2004 (Day 0)
    80 (39 to 164.2)
    113.1 (50.3 to 254.4)
    6.91 (4.66 to 10.24)
    10 (4.74 to 21.11)
        B/Jiangsu/10/2003 (Day 0)
    5.95 (4.99 to 7.09)
    5.74 (4.74 to 6.96)
    5 (5 to 5)
    5 (5 to 5)
        A/New Caledonia/20/99 (Day 28)
    40.5 (20.2 to 81)
    38.6 (19.6 to 75.7)
    19.3 (10.2 to 36.3)
    18.59 (9.56 to 36.15)
        A/Wellington/1/2004 (Day 28)
    775 (321 to 1869)
    1428 (648 to 3145)
    57.3 (33 to 99.3)
    104.8 (44.7 to 245.5)
        B/Jiangsu/10/2003 (Day 28)
    15.69 (8.73 to 28.22)
    16.97 (8.99 to 32.05)
    6.73 (5.46 to 8.3)
    7.07 (5.58 to 8.96)
        A/New Caledonia/20/99 (Day 56)
    134.5 (79.9 to 226.5)
    169 (106 to 268)
    87 (48.3 to 156.6)
    115.1 (72.7 to 182.4)
        A/Wellington/1/2004 (Day 56)
    1594 (984 to 2583)
    1328 (765 to 2303)
    261 (150 to 455)
    413 (240 to 710)
        B/Jiangsu/10/2003 (Day 56)
    50.4 (32.1 to 79.1)
    58.6 (39.1 to 87.7)
    26.3 (16.9 to 40.9)
    23.8 (15.5 to 36.4)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios (GMTRs) of Influenza vaccine Antibodies After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route

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    End point title
    		 Geometric Mean Titer Ratios (GMTRs) of Influenza vaccine Antibodies After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route
    End point description
    Antibodies were evaluated using the hemagglutination inhibition technique. Geometric mean titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer of antibodies to three vaccine strains evaluated at Day 28/Day 0, Day 56/Day 0, and Day 56/Day 28.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 and Day 56 post-vaccination
    End point values
    		 ID Group (Age 3–8 years) IM Group (Age 3–8 years) ID Group (Age 6-35 months) IM Group (Age 6-35 months)
    Number of subjects analysed
    30
    20
    30
    20
    Units: Titer ratios
    geometric mean (confidence interval 95%)
        A/New Caledonia/20/99 (Day 28/Day 0)
    4.14 (2.87 to 5.98)
    5.45 (3.89 to 7.65)
    3.01 (2.08 to 4.35)
    2.68 (1.87 to 3.83)
        A/Wellington/1/2004 (Day 28/Day 0)
    10.41 (6.66 to 16.26)
    10.71 (6.37 to 18.02)
    8.1 (5.34 to 12.28)
    10.08 (6.55 to 15.5)
        B/Jiangsu/10/2003 (Day 28/Day 0)
    2.64 (1.68 to 4.15)
    2.93 (1.82 to 4.73)
    1.35 (1.09 to 1.66)
    1.41 (1.12 to 1.79)
        A/New Caledonia/20/99 (Day 56/Day 0)
    13.8 (10.3 to 18.5)
    24.3 (16.3 to 36)
    13.7 (8.58 to 21.88)
    16.9 (10.5 to 27)
        A/Wellington/1/2004 (Day 56/Day 0)
    19.9 (13.1 to 30.4)
    12.62 (7.08 to 22.52)
    37.4 (21.6 to 64.6)
    41.3 (26.1 to 65.3)
        B/Jiangsu/10/2003 (Day 56/Day 0)
    8.48 (5.91 to 12.15)
    10.2 (7.22 to 14.4)
    5.27 (3.39 to 8.18)
    4.76 (3.11 to 7.28)
        A/New Caledonia/20/99 (Day 56/Day 28)
    3.32 (2.36 to 4.68)
    4.46 (2.88 to 6.92)
    4.32 (2.77 to 6.74)
    5.76 (3.75 to 8.85)
        A/Wellington/1/2004 (Day 56/Day 28)
    1.95 (1.21 to 3.16)
    1.039 (0.712 to 1.517)
    4.55 (3.13 to 6.62)
    3.86 (2.8 to 5.31)
        B/Jiangsu/10/2003 (Day 56/Day 28)
    3.21 (2.2 to 4.69)
    3.46 (2.13 to 5.62)
    3.66 (2.55 to 5.24)
    3.04 (2.39 to 3.87)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Seroconversion or Significant Increase in Influenza Vaccine Antibodies Following Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route

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    End point title
    		 Percentage of Subjects Achieving Seroconversion or Significant Increase in Influenza Vaccine Antibodies Following Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route
    End point description
    Antibodies were evaluated using the hemagglutination inhibition technique. Seroconversion was defined as the following: for subjects with a pre-vaccination titer <10 (1/dil), post-injection titer ≥40 (1/dil) on Day 28 and Day 56 or significant increase and for subjects with a pre-vaccination titer ≥10 (1/dil), ≥ four-fold increase from pre- to post-injection titer on Day 28 and Day 56.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination), Day 28 and Day 56 post-vaccination
    End point values
    		 ID Group (Age 3–8 years) IM Group (Age 3–8 years) ID Group (Age 6-35 months) IM Group (Age 6-35 months)
    Number of subjects analysed
    30
    20
    30
    20
    Units: Percentage of subjects
    number (not applicable)
        A/New Caledonia/20/99 (Day 28/Day 0)
    33.3
    36.8
    17.9
    21.1
        A/Wellington/1/2004 (Day 28/Day 0)
    75.9
    84.2
    53.6
    88.9
        B/Jiangsu/10/2003 (Day 28/Day 0)
    20
    21.1
    0
    0
        A/New Caledonia/20/99 (Day 56/Day 0)
    83.3
    95
    72.4
    85
        A/Wellington/1/2004 (Day 56/Day 0)
    96.7
    89.5
    89.7
    100
        B/Jiangsu/10/2003 (Day 56/Day 0)
    56.7
    75
    37.9
    35
        A/New Caledonia/20/99 (Day 56/Day 28)
    50
    73.7
    55.6
    78.9
        A/Wellington/1/2004 (Day 56/Day 28)
    34.5
    11.1
    66.7
    73.7
        B/Jiangsu/10/2003 (Day 56/Day 28)
    33.3
    47.4
    33.3
    21.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Seroprotection Against Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route

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    End point title
    		 Percentage of Subjects with Seroprotection Against Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or Intramuscular Route
    End point description
    Antibodies were evaluated using the hemagglutination inhibition technique. Seroprotection was defined as antibody titers of ≥40 [1/dil] on Day 28 and Day 56.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination), Day 28 and Day 56 post-vaccination
    End point values
    		 ID Group (Age 3–8 years) IM Group (Age 3–8 years) ID Group (Age 6-35 months) IM Group (Age 6-35 months)
    Number of subjects analysed
    30
    20
    30
    20
    Units: Percentage of subjects
    number (not applicable)
        A/New Caledonia/20/99 (Day 0)
    23.3
    10
    6.7
    5
        A/Wellington/1/2004 (Day 0)
    70
    80
    6.7
    15.8
        B/Jiangsu/10/2003 (Day 0)
    0
    0
    0
    0
        A/New Caledonia/20/99 (Day 28)
    40
    36.8
    17.9
    21.1
        A/Wellington/1/2004 (Day 28)
    82.8
    94.7
    57.1
    88.9
        B/Jiangsu/10/2003 (Day 28)
    20
    21.1
    0
    0
        A/New Caledonia/20/99 (Day 56)
    86.7
    95
    72.4
    95
        A/Wellington/1/2004 (Day 56)
    100
    100
    93.1
    100
        B/Jiangsu/10/2003 (Day 56)
    56.7
    75
    37.9
    35
    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 Day 28 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    ID 9 µg (3–8 years)
    Reporting group description
    		 Subjects received 2 intradermal doses of the 9 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28 in children aged 3–8 years.

    Reporting group title
    IM 15 µg (3–8 years)
    Reporting group description
    		 Subjects received 2 intramuscular (IM) doses of the 15 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28 in children aged 3–8 years.

    Reporting group title
    ID 9 µg (6-35 months)
    Reporting group description
    		 Subjects received 2 intradermal (ID) doses of the 9 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28 in infants aged 6–35 months.

    Reporting group title
    IM 7.5 µg (6-35 months)
    Reporting group description
    		 Subjects received 2 intramuscular (IM) doses of the 7.5 µg formulation of inactivated, split-virion influenza vaccine administered on Day 0 and Day 28 in infants aged 6–35 months.

    Serious adverse events
    		 ID 9 µg (3–8 years) IM 15 µg (3–8 years) ID 9 µg (6-35 months) IM 7.5 µg (6-35 months)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Infections and infestations
    Bronchiolitis
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ID 9 µg (3–8 years) IM 15 µg (3–8 years) ID 9 µg (6-35 months) IM 7.5 µg (6-35 months)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 30 (90.00%)
    13 / 20 (65.00%)
    24 / 30 (80.00%)
    12 / 20 (60.00%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 20 (10.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    13 / 30 (43.33%)
    3 / 20 (15.00%)
         occurrences all number
    0
    0
    13
    3
    General disorders and administration site conditions
    Injection site haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    5 / 30 (16.67%)
    2 / 20 (10.00%)
    10 / 30 (33.33%)
    5 / 20 (25.00%)
         occurrences all number
    5
    2
    10
    5
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 30 (63.33%)
    13 / 20 (65.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    19
    13
    0
    0
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    27 / 30 (90.00%)
    7 / 20 (35.00%)
    24 / 30 (80.00%)
    5 / 20 (25.00%)
         occurrences all number
    27
    7
    24
    5
    Injection site edema
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 30 (56.67%)
    2 / 20 (10.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    17
    2
    0
    0
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 30 (46.67%)
    6 / 20 (30.00%)
    16 / 30 (53.33%)
    3 / 20 (15.00%)
         occurrences all number
    14
    6
    16
    3
    Injection site tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    13 / 30 (43.33%)
    4 / 20 (20.00%)
         occurrences all number
    0
    0
    13
    4
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 30 (3.33%)
    4 / 20 (20.00%)
    8 / 30 (26.67%)
    10 / 20 (50.00%)
         occurrences all number
    1
    4
    8
    10
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 30 (13.33%)
    4 / 20 (20.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    4
    4
    0
    0
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    7 / 30 (23.33%)
    3 / 20 (15.00%)
         occurrences all number
    0
    0
    7
    3
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 20 (10.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 20 (5.00%)
    2 / 30 (6.67%)
    5 / 20 (25.00%)
         occurrences all number
    3
    1
    2
    5
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Stomatitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Teething
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    4 / 30 (13.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    4 / 30 (13.33%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    4
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    8 / 30 (26.67%)
    6 / 20 (30.00%)
    11 / 30 (36.67%)
    4 / 20 (20.00%)
         occurrences all number
    8
    6
    11
    4
    Pharyngolaryngeal pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Rash papular
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 30 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    0
    0
    3
    Abnormal crying
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    16 / 30 (53.33%)
    6 / 20 (30.00%)
         occurrences all number
    0
    0
    16
    6
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    19 / 30 (63.33%)
    12 / 20 (60.00%)
         occurrences all number
    0
    0
    19
    12
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 20 (10.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Eye infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 20 (10.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    2
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 20 (10.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
         occurrences all number
    4
    2
    1
    0
    Otitis media
         subjects affected / exposed
    5 / 30 (16.67%)
    4 / 20 (20.00%)
    10 / 30 (33.33%)
    7 / 20 (35.00%)
         occurrences all number
    5
    4
    10
    7
    Rhinitis
         subjects affected / exposed
    4 / 30 (13.33%)
    5 / 20 (25.00%)
    13 / 30 (43.33%)
    12 / 20 (60.00%)
         occurrences all number
    4
    5
    13
    12
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 20 (5.00%)
    1 / 30 (3.33%)
    4 / 20 (20.00%)
         occurrences all number
    2
    1
    1
    4
    Bronchiolitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    15 / 30 (50.00%)
    7 / 20 (35.00%)
         occurrences all number
    0
    0
    15
    7

    More information

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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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