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    Clinical Trial Results:
    A Phase III, double blind, randomized, comparative study of the safety and immunogenicity of GSK Biologicals’ Varilrix HSA-free varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life

    Summary
    EudraCT number
    		 2013-003535-30
    Trial protocol
    		 DE   GB   EE  
    Global end of trial date
    17 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 May 2017
    First version publication date
    28 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    200147
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02570126
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, (44)2089 904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, (44)2089 904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the safety profile (i.e. fever above (>) 39°C (> 102.2°F)) of Varilrix HSA-free compared to Varilrix™ post Dose 1 Criterion: For the Varilrix HSA-free vaccine as compared to Varilrix™, the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (VAR_HSA_F minus VAR) in incidence of fever > 39.0°C (> 102.2°F) within 0-14 days after Dose 1 is equal to or below 5%
    Protection of trial subjects
    All subjects were observed closely for at least 30 minutes following the administration of vaccine, with appropriate medical treatment readily available in case of an anaphylactic reaction
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Nov 2015
    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
    Estonia: 164
    Country: Number of subjects enrolled
    Germany: 237
    Country: Number of subjects enrolled
    Mexico: 142
    Country: Number of subjects enrolled
    Thailand: 265
    Country: Number of subjects enrolled
    United Kingdom: 423
    Worldwide total number of subjects
    1231
    EEA total number of subjects
    824
    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)
    1229
    Children (2-11 years)
    2
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 1231
    Number of subjects completed
    		 1231

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The laboratory in charge of the laboratory testing was blinded to the treatment, and codes were used to link the subject and study (without any link to the treatment attributed to the subject) to each sample

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VAR_HSA_F Group
    Arm description
    		 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Varilrix HSA-free
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 doses administered, one at Day 0 and the other at Day 42

    Arm title
    		 VAR Group
    Arm description
    		 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Varilrix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 doses administered, one at Day 0 and the other at Day 42

    Number of subjects in period 1
    		VAR_HSA_F Group VAR Group
    Started
    615
    616
    Completed
    609
    607
    Not completed
    6
    9
         Consent withdrawn by subject
    3
    7
         Violation of Procedures GSK
    -
    1
         Unable to Arrange Visit 3
    1
    -
         Lost to follow-up
    2
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VAR_HSA_F Group
    Reporting group description
    		 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm

    Reporting group title
    VAR Group
    Reporting group description
    		 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm

    Reporting group values
    		 VAR_HSA_F Group VAR Group Total
    Number of subjects
    		 615 616
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 16.7 ± 3.3 16.9 ± 3.4 -
    Gender categorical
    Units: Subjects
        Female
    		 318 312 630
        Male
    		 297 304 601
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage / African American
    		 3 1 4
        Asian - Central/South Asian Heritage
    		 2 2 4
        Asian - East Asian Heritage
    		 3 2 5
        Asian - South East Asian Heritage
    		 133 135 268
        Other
    		 94 94 188
        White - Arabic / North African Heritage
    		 1 1 2
        White - Caucasian / European Heritage
    		 379 381 760

    End points

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    End points reporting groups
    Reporting group title
    VAR_HSA_F Group
    Reporting group description
    		 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm

    Reporting group title
    VAR Group
    Reporting group description
    		 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm

    Primary: Number of subjects reporting fever

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    End point title
    		 Number of subjects reporting fever
    End point description
    Fever was defined as axillary temperature above (>) 39.0 °C (> 102.2°F)
    End point type
    Primary
    End point timeframe
    15-days (Days 0-14) post Dose 1 of varicella vaccination
    End point values
    		 VAR_HSA_F Group VAR Group
    Number of subjects analysed
    612
    614
    Units: Subjects
        Subjects
    24
    32
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    For the Varilrix HSA-free as compared to Varilrix™, the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (VAR_HSA_F minus VAR) in incidence of fever >39.0°C (>102.2°F) within 0-14 days after Dose 1 was to be equal to or below 5%
    Comparison groups
    VAR Group v VAR_HSA_F Group
    Number of subjects included in analysis
    1226
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentage between groups
    Point estimate
    -1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.72
         upper limit
    		 1.08
    Notes
    [1] - Non-inferiority of Varilrix HSA-free vaccine to Varilrix™ vaccine in terms of percentage of subjects reporting fever >39.0°C (>102.2°F) within 15-days (Days 0-14) after Dose 1 (VAR_HSA_F Group minus VAR Group). Power obtained using PASS 2005 (Likelihood Score [Miettinen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=2.5%

    Secondary: Number of subjects reporting fever

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    End point title
    		 Number of subjects reporting fever
    End point description
    Fever was defined as axillary temperature greater than or equal to (≥) 38.0°C (≥ 100.4°F)
    End point type
    Secondary
    End point timeframe
    15 days post each dose of varicella vaccination
    End point values
    		 VAR_HSA_F Group VAR Group
    Number of subjects analysed
    612
    614
    Units: Subjects
        Fever ≥ 38 °C following Dose 1
    83
    92
        Fever ≥ 38 °C following Dose 2
    83
    86
    No statistical analyses for this end point

    Secondary: Evaluation of immune response to varicella vaccine with respect to Anti Varicella Zoster Virus (Anti-VZV) antibody concentrations (immuno-sub cohort)

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    End point title
    		 Evaluation of immune response to varicella vaccine with respect to Anti Varicella Zoster Virus (Anti-VZV) antibody concentrations (immuno-sub cohort)
    End point description
    Anti-VZY antibody concentrations were expressed in terms of Geometric Mean Concentrations (GMCs)
    End point type
    Secondary
    End point timeframe
    At Day 42 and Day 84 post vaccination
    End point values
    		 VAR_HSA_F Group VAR Group
    Number of subjects analysed
    185
    173
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Post Dose 1 blood sample at Day 42
    139.9 (126.7 to 154.5)
    146 (132.5 to 160.7)
        Post Dose 2 blood sample at Day 84
    931.8 (841.1 to 1032.3)
    1102.4 (996.1 to 1220.2)
    No statistical analyses for this end point

    Secondary: Number of subjects with a seroresponse to VZV (immuno sub cohort)

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    End point title
    		 Number of subjects with a seroresponse to VZV (immuno sub cohort)
    End point description
    For VZV, seroresponse was defined as, post-vaccination anti-VZV antibody concentration ≥ 50 mIU/mL among subjects who were seronegative (antibody concentration below (< ) 25 mIU/mL) before vaccination
    End point type
    Secondary
    End point timeframe
    At Day 42 and Day 84 post vaccination
    End point values
    		 VAR_HSA_F Group VAR Group
    Number of subjects analysed
    185
    173
    Units: Subjects
        ≥ 25 mIU/mL (At Day 42)
    184
    168
        ≥ 50 mIU/mL (At Day 42)
    174
    166
        ≥ 25 mIU/mL (At Day 84)
    180
    173
        ≥ 50 mIU/mL (At Day 84)
    180
    173
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local symptoms

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    End point title
    		 Number of subjects reporting solicited local symptoms
    End point description
    Solicited local symptoms assessed were pain, injection site redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = subject crying when limb was moved or as spontaneously painful. Grade 3 redness and swelling = above (>) 20 mm
    End point type
    Secondary
    End point timeframe
    4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
    End point values
    		 VAR_HSA_F Group VAR Group
    Number of subjects analysed
    612
    614
    Units: Subjects
        Any Pain, Dose 1
    75
    86
        Grade 3 Pain, Dose 1
    2
    4
        Any Redness, Dose 1
    149
    150
        Grade 3 Redness, Dose 1
    3
    2
        Any Swelling, Dose 1
    43
    42
        Grade 3 Swelling, Dose 1
    2
    1
        Any Pain, Dose 2
    63
    80
        Grade 3 Pain, Dose 2
    1
    1
        Any Redness, Dose 2
    168
    185
        Grade 3 Redness, Dose 2
    10
    8
        Any Swelling, Dose 2
    69
    71
        Grade 3 Swelling, Dose 2
    1
    4
        Any Pain, Across Doses
    101
    126
        Grade 3 Pain, Across Doses
    3
    5
        Any Redness, Across Doses
    224
    234
        Grade 3 Redness, Across Doses
    13
    10
        Any Swelling, Across Doses
    92
    94
        Grade 3 Swelling, Across Doses
    3
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting fever

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    End point title
    		 Number of subjects reporting fever
    End point description
    Any fever (≥ 38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade 3 fever = temperature > 39.5°C. Related fever = assessed by the investigator as causally related to study vaccination
    End point type
    Secondary
    End point timeframe
    43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
    End point values
    		 VAR_HSA_F Group VAR Group
    Number of subjects analysed
    612
    614
    Units: Subjects
        Fever (Axillary), Dose 1 : ≥ 38 °C
    205
    188
        Fever (Axillary), Dose 1 : > 39.5 °C
    40
    27
        Fever (Axillary), Dose 1 : Related
    72
    51
        Fever (Axillary), Dose 2 : ≥ 38 °C
    172
    177
        Fever (Axillary), Dose 2 : > 39.5 °C
    23
    31
        Fever (Axillary), Dose 2 : Related
    51
    57
        Fever (Axillary), Across Doses : ≥ 38 °C
    301
    290
        Fever (Axillary), Across Doses : > 39.5 °C
    57
    53
        Fever (Axillary), Across Doses : Related
    111
    95
    No statistical analyses for this end point

    Secondary: Number of subjects reporting rash

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    End point title
    		 Number of subjects reporting rash
    End point description
    Any rash = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 rash = rash which prevented normal, everyday activities. Related rash = assessed by the investigator as causally related to study vaccination
    End point type
    Secondary
    End point timeframe
    43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
    End point values
    		 VAR_HSA_F Group VAR Group
    Number of subjects analysed
    612
    614
    Units: Subjects
        Any, Dose 1 : Localised or generalised
    89
    104
        Any, Dose 1 : With fever
    32
    27
        Any, Dose 1 : Varicella like
    7
    9
        Any, Dose 1 : Grade 3
    2
    4
        Any, Dose 1 : Related
    16
    23
        Localised, Dose 1 : Any
    65
    74
        Localised, Dose 1 : Administration site
    4
    2
        Localised, Dose 1 : Other site
    63
    72
        Localised, Dose 1 : With fever
    18
    12
        Localised, Dose 1 : Varicella like
    5
    4
        Localised, Dose 1 : Grade 3
    2
    1
        Localised, Dose 1 : Related
    11
    13
        Generalised, Dose 1 : Any
    29
    35
        Generalised, Dose 1 : With fever
    14
    15
        Generalised, Dose 1 : Varicella like
    2
    6
        Generalised, Dose 1 : Grade 3
    0
    3
        Generalised, Dose 1 : Related
    5
    11
        Any, Dose 2 : Localised or generalised
    76
    78
        Any, Dose 2 : With fever
    27
    34
        Any, Dose 2 : Varicella like
    4
    5
        Any, Dose 2 : Grade 3
    2
    5
        Any, Dose 2 : Related
    15
    16
        Localised, Dose 2 : Any
    52
    57
        Localised, Dose 2 : Administration site
    1
    4
        Localised, Dose 2 : Other site
    51
    53
        Localised, Dose 2 : With fever
    16
    23
        Localised, Dose 2 : Varicella like
    3
    2
        Localised, Dose 2 : Grade 3
    1
    1
        Localised, Dose 2 : Related
    12
    9
        Generalised, Dose 2 : Any
    25
    26
        Generalised, Dose 2 : With fever
    11
    12
        Generalised, Dose 2 : Varicella like
    1
    3
        Generalised, Dose 2 : Grade 3
    1
    4
        Generalised, Dose 2 : Related
    3
    8
        Any, Across Doses : Localised or generalised
    144
    152
        Any, Across Doses : With fever
    55
    59
        Any, Across Doses : Varicella like
    11
    14
        Any, Across Doses : Grade 3
    4
    9
        Any, Across Doses : Related
    28
    37
        Localised, Across Doses : Any
    106
    112
        Localised, Across Doses : Administration site
    5
    6
        Localised, Across Doses : Other site
    103
    107
        Localised, Across Doses : With fever
    32
    34
        Localised, Across Doses : Varicella like
    8
    6
        Localised, Across Doses : Grade 3
    3
    2
        Localised, Across Doses : Related
    20
    21
        Generalised, Across Doses : Any
    49
    57
        Generalised, Across Doses : With fever
    24
    27
        Generalised, Across Doses : Varicella like
    3
    9
        Generalised, Across Doses : Grade 3
    1
    7
        Generalised, Across Doses : Related
    8
    19
    No statistical analyses for this end point

    Secondary: Number of subjects reporting febrile convulsions

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    End point title
    		 Number of subjects reporting febrile convulsions
    End point description
    Any febrile convulsion = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 febrile convulsion = febrile convulsion which prevented normal, everyday activities. Related febrile convulsion = assessed by the investigator as causally related to study vaccination
    End point type
    Secondary
    End point timeframe
    43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
    End point values
    		 VAR_HSA_F Group VAR Group
    Number of subjects analysed
    612
    614
    Units: Subjects
        Febrile convulsion, Dose 1 : Any
    1
    1
        Febrile convulsion, Dose 1 : Grade 3
    0
    1
        Febrile convulsion, Dose 1 : Related
    0
    0
        Febrile convulsion, Dose 2 : Any
    0
    1
        Febrile convulsion, Dose 2 : Grade 3
    0
    0
        Febrile convulsion, Dose 2 : Related
    0
    0
        Febrile convulsion, Across Doses : Any
    1
    2
        Febrile convulsion, Across Doses : Grade 3
    0
    1
        Febrile convulsion, Across Doses : Related
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting unsolicited adverse events (AEs)
    End point description
    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination
    End point type
    Secondary
    End point timeframe
    43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
    End point values
    		 VAR_HSA_F Group VAR Group
    Number of subjects analysed
    615
    616
    Units: Subjects
        Post Dose 1
    270
    282
        Post Dose 2
    223
    220
    No statistical analyses for this end point

    Secondary: Number of subjects reporting Serious Adverse Events (SAEs)

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    End point title
    		 Number of subjects reporting Serious Adverse Events (SAEs)
    End point description
    SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination
    End point type
    Secondary
    End point timeframe
    From Day 0 through the end of study (Day 84)
    End point values
    		 VAR_HSA_F Group VAR Group
    Number of subjects analysed
    615
    616
    Units: Subjects
        Subjects
    13
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84)
    Adverse event reporting additional description
    For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    VAR_HSA_F Group
    Reporting group description
    		 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm

    Reporting group title
    VAR Group
    Reporting group description
    		 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm

    Serious adverse events
    		 VAR_HSA_F Group VAR Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 615 (2.11%)
    15 / 616 (2.44%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 615 (0.16%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 616 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic crisis
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 616 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 615 (0.16%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 616 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 616 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 616 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 615 (0.98%)
    3 / 616 (0.49%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudocroup
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 616 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 616 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 616 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 616 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 VAR_HSA_F Group VAR Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    489 / 615 (79.51%)
    491 / 616 (79.71%)
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    224 / 615 (36.42%)
    237 / 616 (38.47%)
         occurrences all number
    319
    341
    Injection site swelling
         subjects affected / exposed
    92 / 615 (14.96%)
    95 / 616 (15.42%)
         occurrences all number
    112
    114
    Injection site pain
         subjects affected / exposed
    101 / 615 (16.42%)
    127 / 616 (20.62%)
         occurrences all number
    138
    167
    Pyrexia
         subjects affected / exposed
    301 / 615 (48.94%)
    290 / 616 (47.08%)
         occurrences all number
    377
    365
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    38 / 615 (6.18%)
    39 / 616 (6.33%)
         occurrences all number
    44
    53
    Teething
         subjects affected / exposed
    58 / 615 (9.43%)
    55 / 616 (8.93%)
         occurrences all number
    130
    80
    Vomiting
         subjects affected / exposed
    31 / 615 (5.04%)
    34 / 616 (5.52%)
         occurrences all number
    34
    39
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    57 / 615 (9.27%)
    49 / 616 (7.95%)
         occurrences all number
    71
    59
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    144 / 615 (23.41%)
    152 / 616 (24.68%)
         occurrences all number
    165
    182
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    87 / 615 (14.15%)
    80 / 616 (12.99%)
         occurrences all number
    110
    102
    Rhinitis
         subjects affected / exposed
    33 / 615 (5.37%)
    25 / 616 (4.06%)
         occurrences all number
    40
    32
    Upper respiratory tract infection
         subjects affected / exposed
    28 / 615 (4.55%)
    37 / 616 (6.01%)
         occurrences all number
    35
    42

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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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