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    Clinical Trial Results:
    Phase II, double blind, randomized, comparative study of the immunogenicity and safety of GlaxoSmithKline Biologicals’ modified formulation varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life

    Summary
    EudraCT number
    		 2007-000683-24
    Trial protocol
    		 CZ   HU  
    Global end of trial date
    29 Apr 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    31 Mar 2021
    First version publication date
    31 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections in safety section.

    Trial information

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    Trial identification
    Sponsor protocol code
    109705
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00568334
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Oct 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Mar 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of Varilrix HSA-free vaccine as compared to Varilrix vaccine in terms of geometric mean titer (GMT) of varicella zoster virus (VZV) antibodies 43-57 days after the first dose vaccination. Criterion for non-inferiority: The lower limit of the 95% confidence interval (CI) for the GMT ratio (derived from immunofluorescence assay [IFA]) between Group Varilrix HSA free and (divided by) Group Varilrix is equal to or above the pre-defined clinical limit of 0.5. If this first criterion was met, an additional criterion was to be tested. Additional criterion of non-inferiority: The lower limit of the 95% CI for the GMC ratio (derived from ELISA) between Group Varilrix HSA-free and (divided by) Group Varilrix is equal to or above the pre-defined clinical limit of 0.67
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of vaccines, with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Nov 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
    Czech Republic: 114
    Country: Number of subjects enrolled
    Hungary: 130
    Worldwide total number of subjects
    244
    EEA total number of subjects
    244
    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)
    244
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

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

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Varilrix HSA-Free Group
    Arm description
    		 Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Varilrix HSA-free
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two doses of OKAH HSA-free vaccine administered subcutaneously into the left upper arm (deltoid region) on Day 0 and Week 6 (Day 43-57).

    Arm title
    		 Varilrix Group
    Arm description
    		 Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Varilrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two doses of OKAH vaccine administered subcutaneously into the left upper arm (deltoid region) on Day 0 and Week 6 (Day 43-57).

    Number of subjects in period 1
    		Varilrix HSA-Free Group Varilrix Group
    Started
    122
    122
    Completed
    121
    121
    Not completed
    1
    1
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Varilrix HSA-Free Group
    Reporting group description
    		 Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).

    Reporting group title
    Varilrix Group
    Reporting group description
    		 Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).

    Reporting group values
    		 Varilrix HSA-Free Group Varilrix Group Total
    Number of subjects
    		 122 122 244
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 15.6 ( 3.34 ) 14.8 ( 3.08 ) -
    Gender categorical
    Units: Subjects
        Female
    		 59 60 119
        Male
    		 63 62 125

    End points

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    End points reporting groups
    Reporting group title
    Varilrix HSA-Free Group
    Reporting group description
    		 Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).

    Reporting group title
    Varilrix Group
    Reporting group description
    		 Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).

    Primary: Antibody Titers Against Varicella Zoster Virus (VZV)

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    End point title
    		 Antibody Titers Against Varicella Zoster Virus (VZV)
    End point description
    Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].
    End point type
    Primary
    End point timeframe
    At 43-57 days after the first vaccination dose (Week 6).
    End point values
    		 Varilrix HSA-Free Group Varilrix Group
    Number of subjects analysed
    116
    115
    Units: Titer
    geometric mean (confidence interval 95%)
        anti-VZV
    172.6 (141.6 to 210.3)
    154.3 (128.7 to 185)
    Statistical analysis title
    		 Non-inferiority of HSAFREEcompared to OKAH vaccine
    Statistical analysis description
    Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean titers (GMTs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.
    Comparison groups
    Varilrix HSA-Free Group v Varilrix Group
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.46
    Notes
    [1] - The lower limit (LL) of the 95% confidence interval (CI) for the GMT ratio (derived from IFA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.5.

    Primary: Antibody Concentrations Against Varicella Zoster Virus (VZV)

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    End point title
    		 Antibody Concentrations Against Varicella Zoster Virus (VZV)
    End point description
    Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].
    End point type
    Primary
    End point timeframe
    At 43-57 days after the first vaccine dose (Week 6)
    End point values
    		 Varilrix HSA-Free Group Varilrix Group
    Number of subjects analysed
    116
    115
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        anti-VZV
    123.5 (107.9 to 141.4)
    110.7 (98.4 to 124.6)
    Statistical analysis title
    		 Non-inferiority of HSAFREEcompared to OKAH vaccine
    Statistical analysis description
    Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean concentrations (GMCs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.
    Comparison groups
    Varilrix HSA-Free Group v Varilrix Group
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.33
    Notes
    [2] - The lower limit (LL) of the 95% confidence interval (CI) for the GMC ratio (derived from ELISA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.67.

    Secondary: Number of Seroconverted Subjects for Varicella Antibodies

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    End point title
    		 Number of Seroconverted Subjects for Varicella Antibodies
    End point description
    Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies [i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4] in the sera of subjects who were seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)
    End point values
    		 Varilrix HSA-Free Group Varilrix Group
    Number of subjects analysed
    116
    115
    Units: Subjects
        anti-VZV ≥ 1:4 [N=116,115]; Week 6
    114
    114
        anti-VZV ≥ 1:4 [N=115,112]; Week 12
    115
    112
    No statistical analyses for this end point

    Secondary: Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values

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    End point title
    		 Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
    End point description
    Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)
    End point values
    		 Varilrix HSA-Free Group Varilrix Group
    Number of subjects analysed
    116
    115
    Units: Subjects
        anti-VZV ≥ 25 mIU/mL [N=116,115]; Week 6
    114
    113
        anti-VZV ≥ 25 mIU/mL [N=116,114]; Week 12
    116
    114
        anti-VZV ≥ 50 mIU/mL [N=116,115]; Week 6
    105
    103
        anti-VZV ≥ 50 mIU/mL [N=116,114]; Week 12
    116
    114
        anti-VZV ≥ 75 mIU/mL [N=116,115]; Week 6
    89
    89
        anti-VZV ≥ 75 mIU/mL [N=116,114]; Week 12
    116
    114
    No statistical analyses for this end point

    Secondary: Antibody titers against the varicella zoster virus (VZV) by Immunofluorescence Assay [IFA]

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    End point title
    		 Antibody titers against the varicella zoster virus (VZV) by Immunofluorescence Assay [IFA]
    End point description
    Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].
    End point type
    Secondary
    End point timeframe
    At 86-114 days after the second vaccination dose (Week 12).
    End point values
    		 Varilrix HSA-Free Group Varilrix Group
    Number of subjects analysed
    115
    112
    Units: Titers
    geometric mean (confidence interval 95%)
        anti-VZV
    1452.5 (1240.7 to 1700.5)
    1395.4 (1183 to 1645.9)
    No statistical analyses for this end point

    Secondary: Antibody titers against the varicella zoster virus (VZV) by enzyme-linked immunosorbent assay [ELISA]

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    End point title
    		 Antibody titers against the varicella zoster virus (VZV) by enzyme-linked immunosorbent assay [ELISA]
    End point description
    Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].
    End point type
    Secondary
    End point timeframe
    At 86-114 days after the second vaccination dose (Week 12).
    End point values
    		 Varilrix HSA-Free Group Varilrix Group
    Number of subjects analysed
    116
    114
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        anti-VZV
    1013.6 (880.9 to 1166.4)
    999.2 (877.3 to 1138.1)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2)
    End point values
    		 Varilrix HSA-Free Group Varilrix Group
    Number of subjects analysed
    121
    122
    Units: Subjects
        Any Pain; Dose 1
    13
    15
        Grade 3 Pain; Dose 1
    0
    0
        Any Redness; Dose 1
    33
    34
        Grade 3 Redness; Dose 1
    0
    0
        Any Swelling; Dose 1
    5
    7
        Grade 3 Swelling; Dose 1
    0
    0
        Any Pain; Dose 2
    23
    18
        Grade 3 Pain; Dose 2
    0
    0
        Any Redness; Dose 2
    44
    46
        Grade 3 Redness; Dose 2
    6
    3
        Any Swelling; Dose 2
    18
    14
        Grade 3 Swelling; Dose 2
    2
    2
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fever and rash. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Any fever was defined as axillary fever ≥ 37.5°C and grade 3 fever > 39.0°C after vaccination. Grade 3 rash = > 150 lesions. Related = considered by the investigator to be causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)
    End point values
    		 Varilrix HSA-Free Group Varilrix Group
    Number of subjects analysed
    121
    122
    Units: Subjects
        Any temperature; Dose 1
    64
    52
        Grade 3 temperature; Dose 1
    13
    11
        Any rash; Dose 1
    2
    2
        Grade 3 rash; Dose 1
    1
    0
        Any temperature; Dose 2
    54
    53
        Grade 3 temperature; Dose 2
    6
    12
        Any rash; Dose 2
    3
    3
        Grade 3 rash; Dose 2
    1
    0
        Related temperature; Dose 1
    31
    18
        Related rash; Dose 1
    0
    0
        Related temperature; Dose 2
    31
    23
        Related rash; Dose 2
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Any Unsolicited Adverse Event (AE)

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    End point title
    		 Number of Subjects With Any Unsolicited Adverse Event (AE)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    Within the 43-day (Days 0-42) post-vaccination period following each dose
    End point values
    		 Varilrix HSA-Free Group Varilrix Group
    Number of subjects analysed
    122
    122
    Units: Subjects
        Any AE(s), Dose 1 [N=122;122]
    56
    45
        Any AE(s), Dose 2 [N=121;121]
    35
    42
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to study end (Day 86-114)
    End point values
    		 Varilrix HSA-Free Group Varilrix Group
    Number of subjects analysed
    122
    121
    Units: Subjects
        any SAE(s)
    2
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local symptoms were collected during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs during the 43-day (Days 0-42) post each dose. SAEs were collected during the entire study period (Day 0 to Day 86/114).
    Adverse event reporting additional description
    The number of occurrences reported for serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Varilrix HSA-Free Group
    Reporting group description
    		 Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).

    Reporting group title
    Varilrix Group
    Reporting group description
    		 Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).

    Serious adverse events
    		 Varilrix HSA-Free Group Varilrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 122 (1.64%)
    5 / 122 (4.10%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Concussion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Breath holding
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Otitis media
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 122 (0.82%)
         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
    		 Varilrix HSA-Free Group Varilrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    103 / 122 (84.43%)
    100 / 122 (81.97%)
    General disorders and administration site conditions
    Pain; Dose 1
         subjects affected / exposed [1]
    13 / 121 (10.74%)
    15 / 122 (12.30%)
         occurrences all number
    13
    15
    Redness; Dose 1
         subjects affected / exposed [2]
    33 / 121 (27.27%)
    34 / 122 (27.87%)
         occurrences all number
    33
    34
    Swelling; Dose 1
         subjects affected / exposed [3]
    5 / 121 (4.13%)
    7 / 122 (5.74%)
         occurrences all number
    5
    7
    Pain; Dose 2
         subjects affected / exposed [4]
    23 / 121 (19.01%)
    18 / 121 (14.88%)
         occurrences all number
    23
    18
    Redness; Dose 2
         subjects affected / exposed [5]
    44 / 121 (36.36%)
    46 / 121 (38.02%)
         occurrences all number
    44
    46
    Swelling; Dose 2
         subjects affected / exposed [6]
    18 / 121 (14.88%)
    14 / 121 (11.57%)
         occurrences all number
    18
    14
    Fever; Dose 1
         subjects affected / exposed [7]
    64 / 121 (52.89%)
    52 / 122 (42.62%)
         occurrences all number
    64
    52
    Fever; Dose 2
         subjects affected / exposed [8]
    54 / 121 (44.63%)
    53 / 121 (43.80%)
         occurrences all number
    54
    53
    Infections and infestations
    Bronchitis; Dose 1
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 122 (12.30%)
    8 / 122 (6.56%)
         occurrences all number
    15
    8
    Viral infection; Dose 1
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 122 (9.02%)
    11 / 122 (9.02%)
         occurrences all number
    11
    11
    Rhinitis; Dose 1
         subjects affected / exposed
    6 / 122 (4.92%)
    8 / 122 (6.56%)
         occurrences all number
    6
    8
    Bronchitis; Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [9]
    8 / 121 (6.61%)
    11 / 121 (9.09%)
         occurrences all number
    8
    11
    Viral infection; Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [10]
    6 / 121 (4.96%)
    13 / 121 (10.74%)
         occurrences all number
    6
    13
    Rhinitis; Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [11]
    7 / 121 (5.79%)
    1 / 121 (0.83%)
         occurrences all number
    7
    1
    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: For the analysis of solicited symptoms, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the analysis of solicited symptoms, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the analysis of solicited symptoms, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the analysis of solicited symptoms, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the analysis of solicited symptoms, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the analysis of solicited symptoms, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the analysis of solicited symptoms, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
    [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: For the analysis of solicited symptoms, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
    [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: For the analysis of unsolicited adverse events/serious adverse event/concomitant medication, all vaccinated subjects were considered and subjects who did not report an event were considered as subjects without an event.
    [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: For the analysis of unsolicited adverse events/serious adverse event/concomitant medication, all vaccinated subjects were considered and subjects who did not report an event were considered as subjects without an event.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the analysis of unsolicited adverse events/serious adverse event/concomitant medication, all vaccinated subjects were considered and subjects who did not report an event were considered as subjects without an event.

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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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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