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    Clinical Trial Results:
    Immunogenicity and Safety of Sanofi Pasteur’s AVAXIM 80U Pediatric Vaccine Administered in Healthy Adolescents, Children and Toddlers in People’s Republic of China Followed by a Booster Dose 6 Months after the Initial Dose Versus HAVRIX 720 Vaccine

    Summary
    EudraCT number
    2015-005191-18
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    08 Mar 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Mar 2016
    First version publication date
    26 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HAF78
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00483470
    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
    Responsible Medical Officer, Sanofi Pasteur SA, 33 4 37 37 73 84, Eric.desauziers@sanofipasteur.com
    Scientific contact
    Responsible Medical Officer, Sanofi Pasteur SA, 33 4 37 37 73 84, Eric.desauziers@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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jun 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To demonstrate the non-inferiority in terms of seroprotection rate of AVAXIM 80U Pediatric vaccine versus HAVRIX 720 vaccine 1 month after booster vaccination.
    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
    30 May 2007
    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
    China: 720
    Worldwide total number of subjects
    720
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    78
    Children (2-11 years)
    376
    Adolescents (12-17 years)
    266
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study subjects were enrolled from 06 June 2007 to 15 August 2007 at 1 clinic center in China.

    Pre-assignment
    Screening details
    A total of 720 subjects who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.

    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
    Group A; AVAXIM 80U Pediatric
    Arm description
    Subjects received AVAXIM 80U Pediatric vaccine at baseline and a booster dose 6 months after the primary injection.
    Arm type
    Experimental

    Investigational medicinal product name
    Hepatitis A vaccine (AVAXIM 80U Pediatric)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the left deltoid muscle, 1 injection on Day 0 and as a booster dose 6 months after the primary injection.

    Arm title
    Group B; HAVRIX 720
    Arm description
    Subjects received HAVRIX 720 vaccine at baseline and a booster dose 6 months after the primary injection.
    Arm type
    Active comparator

    Investigational medicinal product name
    Hepatitis A vaccine (HAVRIX 720)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0 and as a booster dose 6 months after the primary injection.

    Number of subjects in period 1
    Group A; AVAXIM 80U Pediatric Group B; HAVRIX 720
    Started
    480
    240
    Completed
    457
    229
    Not completed
    23
    11
         Protocol deviation
             6
             1
         Consent withdrawn by subject
             13
             8
         Lost to follow-up
             4
             2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A; AVAXIM 80U Pediatric
    Reporting group description
    Subjects received AVAXIM 80U Pediatric vaccine at baseline and a booster dose 6 months after the primary injection.

    Reporting group title
    Group B; HAVRIX 720
    Reporting group description
    Subjects received HAVRIX 720 vaccine at baseline and a booster dose 6 months after the primary injection.

    Reporting group values
    Group A; AVAXIM 80U Pediatric Group B; HAVRIX 720 Total
    Number of subjects
    480 240 720
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    54 24 78
        Children (2-11 years)
    247 129 376
        Adolescents (12-17 years)
    179 87 266
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    8.78 ± 4.5 8.81 ± 4.43 -
    Gender categorical
    Units: Subjects
        Female
    246 118 364
        Male
    234 122 356

    End points

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    End points reporting groups
    Reporting group title
    Group A; AVAXIM 80U Pediatric
    Reporting group description
    Subjects received AVAXIM 80U Pediatric vaccine at baseline and a booster dose 6 months after the primary injection.

    Reporting group title
    Group B; HAVRIX 720
    Reporting group description
    Subjects received HAVRIX 720 vaccine at baseline and a booster dose 6 months after the primary injection.

    Primary: Percentage of Subjects With Seroprotection Against Inactivated Hepatitis A Antigen After Primary and Booster Vaccinations with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine

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    End point title
    Percentage of Subjects With Seroprotection Against Inactivated Hepatitis A Antigen After Primary and Booster Vaccinations with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine
    End point description
    Anti-Hepatitis A antibody titers were measured by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as Anti-Hepatitis A virus antibody titers ≥ 20 mIU/mL on Day 210, 1 month after booster vaccination with study vaccines. Seroprotection is reported based on age group: Toddlers (12 to 23 months), Children (2 to 11 years), and Adolescents (12 to 15 years).
    End point type
    Primary
    End point timeframe
    Day 210 (1 month post booster vaccination)
    End point values
    Group A; AVAXIM 80U Pediatric Group B; HAVRIX 720
    Number of subjects analysed
    454
    226
    Units: Percentage of subjects
    number (not applicable)
        All Subjects; Anti-Hepatitis A antibody titers
    99.8
    100
        Toddlers; Anti-Hepatitis A antibody titers
    100
    100
        Children; Anti-Hepatitis A antibody titers
    100
    100
        Adolescents; Anti-Hepatitis A antibody titers
    99.4
    100
    Statistical analysis title
    Non-inferiority (Group A - Group B); All Subjects
    Statistical analysis description
    Non-inferiority analysis of AVAXIM 80U Pediatric on HAVRIX 720 in all subjects assessed 1 month after booster vaccination.
    Comparison groups
    Group A; AVAXIM 80U Pediatric v Group B; HAVRIX 720
    Number of subjects included in analysis
    680
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Difference in AVAXIM 80U Ped.-HAVRIX 720
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.24
         upper limit
    1.46
    Notes
    [1] - The non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference was greater than -10%. The 95% CI was calculated with the Wilson score method without continuity correction. AVAXIM 80U Pediatric was non-inferior to HAVRIX 720.
    Statistical analysis title
    Non-inferiority (Group A - Group B); Toddlers
    Statistical analysis description
    Non-inferiority analysis of AVAXIM 80U Pediatric on HAVRIX 720 in toddlers (12 to 23 months) assessed 1 month after booster vaccination.
    Comparison groups
    Group A; AVAXIM 80U Pediatric v Group B; HAVRIX 720
    Number of subjects included in analysis
    680
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    Difference in AVAXIM 80U Ped.-HAVRIX 720
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.41
         upper limit
    15.46
    Notes
    [2] - The non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference was greater than -10%. The 95% CI was calculated with the Wilson score method without continuity correction. AVAXIM 80U Pediatric was non-inferior to HAVRIX 720.
    Statistical analysis title
    Non-inferiority (Group A - Group B); Children
    Statistical analysis description
    Non-inferiority analysis of AVAXIM 80U Pediatric on HAVRIX 720 in children (2 to 11 years) assessed 1 month after booster vaccination.
    Comparison groups
    Group A; AVAXIM 80U Pediatric v Group B; HAVRIX 720
    Number of subjects included in analysis
    680
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    Parameter type
    Difference in AVAXIM 80U Ped.-HAVRIX 720
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.61
         upper limit
    2.98
    Notes
    [3] - The non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference was greater than -10%. The 95% CI was calculated with the Wilson score method without continuity correction. AVAXIM 80U Pediatric was non-inferior to HAVRIX 720.
    Statistical analysis title
    Non-inferiority (Group A - Group B); Adolescents
    Statistical analysis description
    Non-inferiority analysis of AVAXIM 80U Pediatric on HAVRIX 720 in adolescents (12 to 15 years) assessed 1 month after booster vaccination.
    Comparison groups
    Group A; AVAXIM 80U Pediatric v Group B; HAVRIX 720
    Number of subjects included in analysis
    680
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    Method
    Parameter type
    Difference in AVAXIM 80U Ped.-HAVRIX 720
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.24
         upper limit
    4.02
    Notes
    [4] - The non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference was greater than -10%. The 95% CI was calculated with the Wilson score method without continuity correction. AVAXIM 80U Pediatric was non-inferior to HAVRIX 720.

    Secondary: Geometric Mean Titers (GMTs) of Hepatitis A Antibodies After Primary and Booster Vaccinations with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine

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    End point title
    Geometric Mean Titers (GMTs) of Hepatitis A Antibodies After Primary and Booster Vaccinations with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine
    End point description
    Anti-Hepatitis A antibody titers were measured by enzyme-linked immunosorbent assay (ELISA). Geometric mean titers are reported based on age group: Toddlers (12 to 23 months), Children (2 to 11 years), and Adolescents (12 to 15 years).
    End point type
    Secondary
    End point timeframe
    Day 210 (1 month after booster vaccination)
    End point values
    Group A; AVAXIM 80U Pediatric Group B; HAVRIX 720
    Number of subjects analysed
    455
    227
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        All Subjects; Anti-Hepatitis A antibody titer
    2694 (2529.4 to 2869.4)
    1525.6 (1369.3 to 1699.7)
        Toddlers; Anti-Hepatitis A antibody titer
    3398.6 (2834.7 to 4074.6)
    2405.7 (1710.6 to 3383.2)
        Children; Anti-Hepatitis A antibody titer
    3029.3 (2750.5 to 3336.4)
    1501.4 (1273.6 to 1770)
        Adolescents; Anti-Hepatitis A antibody titer
    2142.4 (1984.1 to 2313.3)
    1388.2 (1220.8 to 1578.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection-site Reaction After Any and Each Vaccination with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site Reaction After Any and Each Vaccination with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine
    End point description
    Solicited injection site reactions: Tenderness (Toddlers), Pain (Children and Adolescents), Erythema, and Swelling. Grade 3 solicited injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Pain, Incapacitating unable to perform usual activities; Erythema and Swelling > 3 cm.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-any and each injection
    End point values
    Group A; AVAXIM 80U Pediatric Group B; HAVRIX 720
    Number of subjects analysed
    479
    239
    Units: Percentage of subjects
    number (not applicable)
        Injection site Tenderness; Post-Any Injection
    36.5
    40.9
        Grade 3 Injection site Tenderness; Post-Any Inj.
    0
    0
        Injection site Pain; Post-Any Injection
    41.9
    41
        Grade 3 Injection site Pain; Post-Any Injection
    0
    0
        Injection site Erythema; Post-Any Injection
    12.1
    9.6
        Grade 3 Injection site Erythema; Post-Any Inj.
    0
    0
        Injection site Swelling; Post-Any Injection
    8.8
    7.1
        Grade 3 Injection site Swelling; Post-Any Inj.
    0
    0
        Injection site Tenderness; Post-Injection 1
    23.1
    31.8
        Grade 3 Injection site Tenderness; Post-Inj. 1
    0
    0
        Injection site Pain; Post-Injection 1
    32.8
    29.5
        Grade 3 Injection site Pain; Post-Injection 1
    0
    0
        Injection site Erythema; Post-Injection 1
    6.5
    6.3
        Grade 3 Injection site Erythema; Post-Injection 1
    0
    0
        Injection site Swelling; Post-Injection 1
    4.6
    5
        Grade 3 Injection site Swelling; Post-Injection 1
    0
    0
        Injection site Tenderness; Post-Injection 2
    23.9
    33.3
        Grade 3 Injection site Tenderness; Post-Inj. 2
    0
    0
        Injection site Pain; Post-Injection 2
    23.4
    26.4
        Grade 3 Injection site Pain; Post-Injection 2
    0
    0
        Injection site Erythema; Post-Injection 2
    7.4
    6.6
        Grade 3 Injection site Erythema; Post-Injection 2
    0
    0
        Injection site Swelling; Post-Injection 2
    5.5
    5.2
        Grade 3 Injection site Swelling; Post-Injection 2
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Systemic Reaction After Any and Each Vaccination with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine

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    End point title
    Percentage of Subjects Reporting Solicited Systemic Reaction After Any and Each Vaccination with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine
    End point description
    Solicited systemic reactions (Toddlers; 12 to 23 months of age): Pyrexia (Fever), Vomiting, Abnormal crying, Somnolence (Drowsiness), Anorexia (Loss of appetite), and Irritability. Solicited systemic reactions (Children and Adolescents; 2 to 15 years of age): Pyrexia (Fever), Headache, Malaise, Myalgia. Grade 3 solicited systemic reactions (Toddlers): Pyrexia, > 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying, > 3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable. Grade 3 solicited systemic reactions (Children and Adolescents): Pyrexia, > 39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-any and each injection
    End point values
    Group A; AVAXIM 80U Pediatric Group B; HAVRIX 720
    Number of subjects analysed
    479
    239
    Units: Percentage of subjects
    number (not applicable)
        Fever; Post-Any Injection
    27.3
    27.6
        Grade 3 Fever; Post-Any Injection
    1.3
    0.4
        Headache; Post-Any Injection
    15
    16.1
        Grade 3 Headache; Post-Any Injection
    0
    0
        Malaise; Post-Any Injection
    16.9
    18.4
        Grade 3 Malaise; Post-Any Injection
    0
    0
        Myalgia; Post-Any Injection
    25.1
    23.5
        Grade 3 Myalgia; Post-Any Injection
    0
    0
        Vomiting; Post-Any Injection
    17.3
    9.1
        Grade 3 Vomiting; Post-Any Injection
    0
    0
        Crying abnormal; Post-Any Injection
    26.9
    27.3
        Grade 3 Crying abnormal; Post-Any Injection
    0
    0
        Drowsiness; Post-Any Injection
    9.6
    4.5
        Grade 3 Drowsiness; Post-Any Injection
    0
    0
        Appetite lost; Post-Any Injection
    25
    31.8
        Grade 3 Appetite lost; Post-Any Injection
    0
    0
        Irritability; Post-Any Injection
    25
    36.4
        Grade 3 Irritability; Post-Any Injection
    0
    0
        Fever; Post-Injection 1
    18.2
    18
        Grade 3 Fever; Post-Injection 1
    1
    0
        Headache; Post-Injection 1
    10.3
    13.4
        Grade 3 Headache; Post-Injection 1
    0
    0
        Malaise; Post-Injection 1
    9.6
    13.4
        Grade 3 Malaise; Post-Injection 1
    0
    0
        Myalgia; Post-Injection 1
    17.3
    16.1
        Grade 3 Myalgia; Post-Injection 1
    0
    0
        Vomiting; Post-Injection 1
    13.5
    4.5
        Grade 3 Vomiting; Post-Injection 1
    0
    0
        Crying abnormal; Post-Injection 1
    25
    22.7
        Grade 3 Crying abnormal; Post-Injection 1
    0
    0
        Drowsiness; Post-Injection 1
    7.7
    0
        Grade 3 Drowsiness; Post-Injection 1
    0
    0
        Appetite lost; Post-Injection 1
    21.2
    22.7
        Grade 3 Appetite lost; Post-Injection 1
    0
    0
        Irritability; Post-Injection 1
    23.1
    22.7
        Grade 3 Irritability; Post-Injection 1
    0
    0
        Fever; Post-Injection 2
    13.8
    13.1
        Grade 3 Fever; Post-Injection 2
    0.2
    0.4
        Headache; Post-Injection 2
    7.1
    5.8
        Grade 3 Headache; Post-Injection 2
    0
    0
        Malaise; Post-Injection 2
    8.3
    7.7
        Grade 3 Malaise; Post-Injection 2
    0
    0
        Myalgia; Post-Injection 2
    15.6
    12
        Grade 3 Myalgia; Post-Injection 2
    0
    0
        Vomiting; Post-Injection 2
    4.3
    4.8
        Grade 3 Vomiting; Post-Injection 2
    0
    0
        Crying abnormal; Post-Injection 2
    4.3
    9.5
        Grade 3 Crying abnormal; Post-Injection 2
    0
    0
        Drowsiness; Post-Injection 2
    2.2
    4.8
        Grade 3 Drowsiness; Post-Injection 2
    0
    0
        Appetite lost; Post-Injection 2
    8.7
    9.5
        Grade 3 Appetite lost; Post-Injection 2
    0
    0
        Irritability; Post-Injection 2
    8.7
    14.3
        Grade 3 Irritability; Post-Injection 2
    0
    0
    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 up to Day 210 (1 month after booster vaccination).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Group A; AVAXIM 80U Pediatric
    Reporting group description
    Subjects received AVAXIM 80U Pediatric vaccine at baseline and a booster dose 6 months after the primary injection.

    Reporting group title
    Group B; HAVRIX 720
    Reporting group description
    Subjects received HAVRIX 720 vaccine at baseline and a booster dose 6 months after the primary injection.

    Serious adverse events
    Group A; AVAXIM 80U Pediatric Group B; HAVRIX 720
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 479 (0.84%)
    1 / 239 (0.42%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Tonsillitis
         subjects affected / exposed
    1 / 479 (0.21%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    1 / 479 (0.21%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scratch by cat
         subjects affected / exposed
    1 / 479 (0.21%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 479 (0.21%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aggravation of bilateral chronic tonsillitis
         subjects affected / exposed
    0 / 479 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group A; AVAXIM 80U Pediatric Group B; HAVRIX 720
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    314 / 479 (65.55%)
    149 / 239 (62.34%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    64 / 427 (14.99%)
    35 / 217 (16.13%)
         occurrences all number
    64
    35
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    5 / 52 (9.62%)
    1 / 22 (4.55%)
         occurrences all number
    5
    1
    General disorders and administration site conditions
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    19 / 52 (36.54%)
    9 / 22 (40.91%)
         occurrences all number
    19
    9
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    179 / 427 (41.92%)
    89 / 217 (41.01%)
         occurrences all number
    179
    89
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    58 / 479 (12.11%)
    23 / 239 (9.62%)
         occurrences all number
    58
    23
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    42 / 479 (8.77%)
    17 / 239 (7.11%)
         occurrences all number
    42
    17
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    131 / 479 (27.35%)
    66 / 239 (27.62%)
         occurrences all number
    131
    66
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    72 / 427 (16.86%)
    40 / 217 (18.43%)
         occurrences all number
    72
    40
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    14 / 52 (26.92%)
    6 / 22 (27.27%)
         occurrences all number
    14
    6
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    13 / 52 (25.00%)
    8 / 22 (36.36%)
         occurrences all number
    13
    8
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    9 / 52 (17.31%)
    2 / 22 (9.09%)
         occurrences all number
    9
    2
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    107 / 427 (25.06%)
    51 / 217 (23.50%)
         occurrences all number
    107
    51
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    13 / 52 (25.00%)
    7 / 22 (31.82%)
         occurrences all number
    13
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    42 / 479 (8.77%)
    25 / 239 (10.46%)
         occurrences all number
    42
    25
    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 a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (children and adolescents) 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 a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) 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 a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) 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 a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (children and adolescents) 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 a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (children and adolescents) 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 a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) 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 a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) 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 a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) 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 a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (children and adolescents) 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 a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) 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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