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    Clinical Trial Results:
    A Phase II, observer-blind, randomized, controlled study to evaluate the immunogenicity and safety of a varicella vaccine at various potencies compared with Varivax, as a first dose, administered in healthy children in their second year of life

    Summary
    EudraCT number
    		 2022-001910-21
    Trial protocol
    		 EE   PL   Outside EU/EEA  
    Global end of trial date
    13 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Dec 2024
    First version publication date
    26 Dec 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    217212
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05084508
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut, 89,, Rixensart, Belgium, 1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 044 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 8664357343, 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 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immune response of VNS vaccine (formulated with different potencies) and VV vaccine in terms of geometric mean concentration at Day 43
    Protection of trial subjects
    All participants were observed for 30 min after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible participants that have no contraindications to any components of the vaccines. Participants were followed-up for 180 days after the vaccination. The burden of the study for the participant were minimized as much as possible. For taking blood samples, 3 attempts at most should be performed. If the investigator/designee was not successful after the third attempt, the investigator/designee made no further attempts. A local numbing cream or patch were offered at the discretion of the investigator prior to blood sampling, to minimize pain when blood samples were drawn.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Estonia: 100
    Country: Number of subjects enrolled
    Poland: 38
    Country: Number of subjects enrolled
    Taiwan: 10
    Country: Number of subjects enrolled
    United States: 652
    Worldwide total number of subjects
    800
    EEA total number of subjects
    138
    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)
    800
    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
    		 Out of 800 participants enrolled, 9 participants discontinued before receiving the vaccination and therefore only 791 participants were included in the Exposed Set and started the study.

    Pre-assignment
    Screening details
    		 The Prevnar 13 vaccine was administered only to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12- 15 months as per national immunization schedule.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Data analyst, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VNS_Low Group
    Arm description
    		 Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Investigational Varicella Vaccine (VNS vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose VNS vaccine (low potency) received on Day 1.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of 13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of a hepatitis A vaccine (Havrix) on Day 1.

    Investigational medicinal product name
    MMR (M-M-R II or M-M-RVaxPro) vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose of a measles, mumps, and rubella (MMR) vaccine on Day 1.

    Arm title
    		 VNS_Med Group
    Arm description
    		 Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Investigational Varicella Vaccine (VNS vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose VNS vaccine (medium potency) received on Day 1.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of 13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of a hepatitis A vaccine (Havrix) on Day 1.

    Investigational medicinal product name
    MMR (M-M-R II or M-M-RVaxPro) vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose of a measles, mumps, and rubella (MMR) vaccine on Day 1.

    Arm title
    		 VNS_High Group
    Arm description
    		 Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Investigational Varicella Vaccine (VNS vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose VNS vaccine (high potency) received on Day 1.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of 13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of a hepatitis A vaccine (Havrix) on Day 1.

    Investigational medicinal product name
    MMR (M-M-R II or M-M-RVaxPro) vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose of a measles, mumps, and rubella (MMR) vaccine on Day 1.

    Arm title
    		 VV_Lot1 and Lot2 Pooled Group
    Arm description
    		 Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    VV Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose of VV (comparator vaccine) received on Day 1.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of 13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of a hepatitis A vaccine (Havrix) on Day 1.

    Investigational medicinal product name
    MMR (M-M-R II or M-M-RVaxPro) vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose of a measles, mumps, and rubella (MMR) vaccine on Day 1.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This is an Observer-blind study.
    Number of subjects in period 1 [2]
    		VNS_Low Group VNS_Med Group VNS_High Group VV_Lot1 and Lot2 Pooled Group
    Started
    203
    195
    203
    190
    Completed
    197
    190
    193
    185
    Not completed
    6
    5
    10
    5
         Consent withdrawn by subject
    -
    2
    3
    1
         Not specified
    -
    -
    -
    1
         Lost to follow-up
    6
    3
    7
    3
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 800 participants enrolled, 9 participants discontinued before receiving the vaccination and therefore only 791 participants were included in the Exposed Set and started the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VNS_Low Group
    Reporting group description
    		 Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1.

    Reporting group title
    VNS_Med Group
    Reporting group description
    		 Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Reporting group title
    VNS_High Group
    Reporting group description
    		 Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Reporting group title
    VV_Lot1 and Lot2 Pooled Group
    Reporting group description
    		 Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Reporting group values
    		 VNS_Low Group VNS_Med Group VNS_High Group VV_Lot1 and Lot2 Pooled Group Total
    Number of subjects
    		 203 195 203 190 791
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 203 195 203 190 791
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 12.4 ( 0.7 ) 12.4 ( 0.7 ) 12.3 ( 0.7 ) 12.4 ( 0.7 ) -
    Sex: Female, Male
    Units: Participants
        Male
    		 89 93 102 83 367
        Female
    		 114 102 101 107 424
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 75 71 74 73 293
        Not Hispanic nor Latino
    		 128 124 128 117 497
        Missing
    		 0 0 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    VNS_Low Group
    Reporting group description
    		 Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1.

    Reporting group title
    VNS_Med Group
    Reporting group description
    		 Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Reporting group title
    VNS_High Group
    Reporting group description
    		 Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Reporting group title
    VV_Lot1 and Lot2 Pooled Group
    Reporting group description
    		 Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Primary: Concentrations of anti-varicella zoster virus (VZV) glycoprotein E (gE) antibodies

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    End point title
    		 Concentrations of anti-varicella zoster virus (VZV) glycoprotein E (gE) antibodies [1]
    End point description
    Concentrations of anti-VZV gE antibodies were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group. The analysis was performed on the Per Protocol Set (PPS), which included participants who received all study interventions as per protocol, were not unblinded, had immunogenicity results post-dose, complied with blood draw intervals, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.
    End point type
    Primary
    End point timeframe
    At Day 43
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of this primary endpoint was descriptive i.e. No statistical hypothesis test was performed.
    End point values
    		 VNS_Low Group VNS_Med Group VNS_High Group VV_Lot1 and Lot2 Pooled Group
    Number of subjects analysed
    171
    159
    158
    161
    Units: mlU/ml
        geometric mean (confidence interval 95%)
    960 (843 to 1093)
    1071 (952 to 1204)
    1555 (1407 to 1718)
    1284 (1136 to 1453)
    No statistical analyses for this end point

    Secondary: Percentage of participants with seroresponse to VZV gE

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    End point title
    		 Percentage of participants with seroresponse to VZV gE
    End point description
    Seroresponse was defined as the percentage of participants for whom the post-dose of anti VZV gE antibody concentration was greater than or equal to (>=) 300 mIU/mL for each group. The analysis was performed on the PPS, which included participants who received all study interventions as per protocol, were not unblinded, had immunogenicity results post-dose, complied with blood draw intervals, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 43
    End point values
    		 VNS_Low Group VNS_Med Group VNS_High Group VV_Lot1 and Lot2 Pooled Group
    Number of subjects analysed
    171
    159
    158
    161
    Units: Percentage of participants
        number (confidence interval 95%)
    93.6 (88.78 to 96.75)
    96.2 (91.97 to 98.60)
    98.7 (95.50 to 99.85)
    98.1 (94.65 to 99.61)
    No statistical analyses for this end point

    Secondary: Number of participants reporting each solicited administration site events

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    End point title
    		 Number of participants reporting each solicited administration site events
    End point description
    Assessed solicited administration site events included injection site redness, pain, and swelling. The analysis was performed on the Exposed set (ES), which included all participants who received a study intervention. Analysis per group was based on the varicella intervention administered.
    End point type
    Secondary
    End point timeframe
    Day 1 (post dose) to Day 4
    End point values
    		 VNS_Low Group VNS_Med Group VNS_High Group VV_Lot1 and Lot2 Pooled Group
    Number of subjects analysed
    203
    195
    203
    190
    Units: Participants
        Injection site pain
    76
    64
    70
    57
        Redness at injection site
    24
    23
    35
    23
        Swelling at injection site
    14
    11
    15
    12
    No statistical analyses for this end point

    Secondary: Number of participants reporting each solicited systemic events from Day 1 to Day 43

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    End point title
    		 Number of participants reporting each solicited systemic events from Day 1 to Day 43
    End point description
    Solicited systemic events included fever, varicella like rash (including injection site varicella-like rash), and general rash (not varicella-like) after the administration of all vaccines for each group. Fever was defined as temperature >= 38.0 °C (100.4°F) by any route (the preferred location for measuring temperature is the axilla). A typical varicella-like rash manifests as a rash/lesion that may appear within several weeks after the varicella vaccination. Lesions may contain spots, bumps, blisters, or crusts. Includes injection site varicella-like rash. The analysis was performed on the ES, which included all participants who received a study intervention. Analysis per group was based on the varicella intervention administered.
    End point type
    Secondary
    End point timeframe
    Day 1 (post dose) to Day 43
    End point values
    		 VNS_Low Group VNS_Med Group VNS_High Group VV_Lot1 and Lot2 Pooled Group
    Number of subjects analysed
    203
    195
    203
    190
    Units: Participants
        Fever
    49
    48
    59
    44
        Any varicella-like rash
    33
    31
    35
    29
        Any general rash
    66
    51
    68
    59
    No statistical analyses for this end point

    Secondary: Number of participants reporting each solicited systemic events from Day 1 to Day 15

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    End point title
    		 Number of participants reporting each solicited systemic events from Day 1 to Day 15
    End point description
    Solicited systemic events included drowsiness, loss of appetite, and irritability after the administration of all vaccines for each group. The analysis was performed on the ES, which included all participants who received a study intervention. Analysis per group was based on the varicella intervention administered.
    End point type
    Secondary
    End point timeframe
    Day 1 (post dose) to Day 15
    End point values
    		 VNS_Low Group VNS_Med Group VNS_High Group VV_Lot1 and Lot2 Pooled Group
    Number of subjects analysed
    203
    195
    203
    190
    Units: Participants
        Any drowsiness
    86
    68
    93
    80
        Any loss of appetite
    69
    57
    71
    60
        Any irritability
    112
    94
    112
    109
    No statistical analyses for this end point

    Secondary: Number of participants reporting unsolicited adverse events

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    End point title
    		 Number of participants reporting unsolicited adverse events
    End point description
    Unsolicited adverse events (AEs) included any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms; these were assessed for each group after the administration of all vaccines. Unsolicited AEs included both serious and non-serious AEs. The analysis was performed on the ES, which included all participants who received a study intervention. Analysis per group was based on the varicella intervention administered.
    End point type
    Secondary
    End point timeframe
    Day 1 (post dose) to Day 43
    End point values
    		 VNS_Low Group VNS_Med Group VNS_High Group VV_Lot1 and Lot2 Pooled Group
    Number of subjects analysed
    203
    195
    203
    190
    Units: Participants
    67
    53
    64
    61
    No statistical analyses for this end point

    Secondary: Number of participants reporting serious adverse events (SAEs)

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    End point title
    		 Number of participants reporting serious adverse events (SAEs)
    End point description
    A SAE was defined as an AE which was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or other situations that were considered serious per medical or scientific judgment. The analysis was performed on the ES, which included all participants who received a study intervention. Analysis per group was based on the varicella intervention administered.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 181 (Study end)
    End point values
    		 VNS_Low Group VNS_Med Group VNS_High Group VV_Lot1 and Lot2 Pooled Group
    Number of subjects analysed
    203
    195
    203
    190
    Units: Participants
    2
    4
    4
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events from Day 1 to Day 15 & Day 1 to Day 43 and unsolicited AEs and general rash from Day 1 to Day 43
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 v27.0
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    VNS_Low Group
    Reporting group description
    		 Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1.

    Reporting group title
    VV_Lot1 and Lot2 Pooled Group
    Reporting group description
    		 Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Reporting group title
    VNS_High Group
    Reporting group description
    		 Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Reporting group title
    VNS_Med Group
    Reporting group description
    		 Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Serious adverse events
    		 VNS_Low Group VV_Lot1 and Lot2 Pooled Group VNS_High Group VNS_Med Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 203 (0.99%)
    6 / 190 (3.16%)
    4 / 203 (1.97%)
    4 / 195 (2.05%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Dyskinesia
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 203 (0.00%)
    2 / 190 (1.05%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 190 (0.53%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    2 / 195 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 VNS_Low Group VV_Lot1 and Lot2 Pooled Group VNS_High Group VNS_Med Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    173 / 203 (85.22%)
    158 / 190 (83.16%)
    178 / 203 (87.68%)
    165 / 195 (84.62%)
    General disorders and administration site conditions
    Administration site erythema
         subjects affected / exposed
    24 / 203 (11.82%)
    23 / 190 (12.11%)
    35 / 203 (17.24%)
    23 / 195 (11.79%)
         occurrences all number
    40
    31
    44
    33
    Administration site pain
         subjects affected / exposed
    76 / 203 (37.44%)
    57 / 190 (30.00%)
    70 / 203 (34.48%)
    65 / 195 (33.33%)
         occurrences all number
    103
    67
    87
    82
    Administration site swelling
         subjects affected / exposed
    14 / 203 (6.90%)
    12 / 190 (6.32%)
    15 / 203 (7.39%)
    11 / 195 (5.64%)
         occurrences all number
    21
    14
    18
    16
    Injection site bruising
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    49 / 203 (24.14%)
    44 / 190 (23.16%)
    59 / 203 (29.06%)
    48 / 195 (24.62%)
         occurrences all number
    99
    87
    145
    91
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    0
    0
    0
    1
    Milk allergy
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Food allergy
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 203 (0.00%)
    2 / 190 (1.05%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Reproductive system and breast disorders
    Genital rash
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    2 / 195 (1.03%)
         occurrences all number
    1
    0
    1
    2
    Wheezing
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    2 / 203 (0.99%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    3 / 203 (1.48%)
    1 / 190 (0.53%)
    5 / 203 (2.46%)
    0 / 195 (0.00%)
         occurrences all number
    4
    1
    5
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory disorder
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    0
    0
    0
    1
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cough
         subjects affected / exposed
    4 / 203 (1.97%)
    3 / 190 (1.58%)
    2 / 203 (0.99%)
    4 / 195 (2.05%)
         occurrences all number
    5
    3
    2
    4
    Epistaxis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    113 / 203 (55.67%)
    110 / 190 (57.89%)
    112 / 203 (55.17%)
    94 / 195 (48.21%)
         occurrences all number
    397
    336
    417
    278
    Investigations
    Influenza A virus test positive
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    2 / 203 (0.99%)
    1 / 190 (0.53%)
    2 / 203 (0.99%)
    1 / 195 (0.51%)
         occurrences all number
    2
    1
    2
    1
    Contusion
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fall
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Foot fracture
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Head injury
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Torus fracture
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    87 / 203 (42.86%)
    80 / 190 (42.11%)
    93 / 203 (45.81%)
    68 / 195 (34.87%)
         occurrences all number
    217
    174
    264
    170
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    0
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    2 / 195 (1.03%)
         occurrences all number
    1
    0
    1
    2
    Macrocytosis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Excessive cerumen production
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear pain
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerumen impaction
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye disorders
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abnormal faeces
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Constipation
         subjects affected / exposed
    2 / 203 (0.99%)
    4 / 190 (2.11%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Diarrhoea
         subjects affected / exposed
    4 / 203 (1.97%)
    5 / 190 (2.63%)
    2 / 203 (0.99%)
    4 / 195 (2.05%)
         occurrences all number
    5
    5
    2
    4
    Flatulence
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    0
    0
    0
    1
    Regurgitation
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Teething
         subjects affected / exposed
    7 / 203 (3.45%)
    5 / 190 (2.63%)
    8 / 203 (3.94%)
    1 / 195 (0.51%)
         occurrences all number
    7
    5
    9
    1
    Vomiting
         subjects affected / exposed
    2 / 203 (0.99%)
    5 / 190 (2.63%)
    1 / 203 (0.49%)
    3 / 195 (1.54%)
         occurrences all number
    2
    8
    1
    3
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 190 (0.53%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    0
    0
    0
    1
    Idiopathic urticaria
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Eczema
         subjects affected / exposed
    0 / 203 (0.00%)
    2 / 190 (1.05%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    0
    2
    0
    1
    Dermatitis diaper
         subjects affected / exposed
    7 / 203 (3.45%)
    6 / 190 (3.16%)
    5 / 203 (2.46%)
    7 / 195 (3.59%)
         occurrences all number
    8
    7
    5
    7
    Dermatitis contact
         subjects affected / exposed
    2 / 203 (0.99%)
    2 / 190 (1.05%)
    1 / 203 (0.49%)
    2 / 195 (1.03%)
         occurrences all number
    3
    2
    1
    2
    Urticaria
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rashes, eruptions and exanthems NEC
         subjects affected / exposed
    76 / 203 (37.44%)
    72 / 190 (37.89%)
    75 / 203 (36.95%)
    64 / 195 (32.82%)
         occurrences all number
    443
    350
    514
    329
    Rash scarlatiniform
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    3 / 203 (1.48%)
    1 / 190 (0.53%)
    1 / 203 (0.49%)
    2 / 195 (1.03%)
         occurrences all number
    3
    1
    1
    2
    Miliaria
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    1
    0
    0
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    3 / 203 (1.48%)
    0 / 190 (0.00%)
    2 / 203 (0.99%)
    1 / 195 (0.51%)
         occurrences all number
    3
    0
    2
    1
    Cellulitis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    3 / 203 (1.48%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    3
    0
    0
    1
    Bronchiolitis
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    2 / 195 (1.03%)
         occurrences all number
    0
    0
    0
    2
    Acute sinusitis
         subjects affected / exposed
    1 / 203 (0.49%)
    2 / 190 (1.05%)
    2 / 203 (0.99%)
    0 / 195 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Candida nappy rash
         subjects affected / exposed
    3 / 203 (1.48%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Herpangina
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    3 / 195 (1.54%)
         occurrences all number
    1
    0
    1
    3
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    4 / 203 (1.97%)
    1 / 195 (0.51%)
         occurrences all number
    1
    0
    5
    1
    Gastroenteritis viral
         subjects affected / exposed
    2 / 203 (0.99%)
    1 / 190 (0.53%)
    2 / 203 (0.99%)
    0 / 195 (0.00%)
         occurrences all number
    2
    1
    2
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 203 (0.99%)
    2 / 190 (1.05%)
    2 / 203 (0.99%)
    1 / 195 (0.51%)
         occurrences all number
    2
    2
    2
    1
    Exanthema subitum
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Croup infectious
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 190 (0.53%)
    2 / 203 (0.99%)
    0 / 195 (0.00%)
         occurrences all number
    1
    1
    2
    0
    COVID-19
         subjects affected / exposed
    2 / 203 (0.99%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    2 / 195 (1.03%)
         occurrences all number
    2
    0
    1
    2
    Laryngitis
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    2 / 195 (1.03%)
         occurrences all number
    0
    0
    0
    2
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 203 (0.49%)
    3 / 190 (1.58%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Conjunctivitis viral
         subjects affected / exposed
    0 / 203 (0.00%)
    2 / 190 (1.05%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    0
    2
    0
    1
    Laryngotracheitis obstructive
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mastitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mastoiditis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 203 (0.99%)
    9 / 190 (4.74%)
    4 / 203 (1.97%)
    3 / 195 (1.54%)
         occurrences all number
    2
    11
    4
    3
    Otitis externa
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    1 / 195 (0.51%)
         occurrences all number
    0
    0
    0
    1
    Otitis media
         subjects affected / exposed
    7 / 203 (3.45%)
    5 / 190 (2.63%)
    2 / 203 (0.99%)
    1 / 195 (0.51%)
         occurrences all number
    7
    5
    2
    2
    Otitis media acute
         subjects affected / exposed
    9 / 203 (4.43%)
    6 / 190 (3.16%)
    2 / 203 (0.99%)
    6 / 195 (3.08%)
         occurrences all number
    10
    7
    2
    6
    Otitis media chronic
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    4 / 203 (1.97%)
    1 / 190 (0.53%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    4
    1
    1
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    2 / 195 (1.03%)
         occurrences all number
    0
    0
    0
    2
    Pneumonia
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pneumonia viral
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    1 / 195 (0.51%)
         occurrences all number
    0
    0
    1
    1
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 203 (0.99%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    1 / 195 (0.51%)
         occurrences all number
    2
    0
    1
    1
    Rhinitis
         subjects affected / exposed
    1 / 203 (0.49%)
    2 / 190 (1.05%)
    1 / 203 (0.49%)
    1 / 195 (0.51%)
         occurrences all number
    1
    2
    1
    1
    Rhinovirus infection
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin candida
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Scarlet fever
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Roseola
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    1 / 195 (0.51%)
         occurrences all number
    0
    0
    1
    1
    Suspected COVID-19
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 190 (0.53%)
    0 / 203 (0.00%)
    2 / 195 (1.03%)
         occurrences all number
    0
    1
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 203 (5.42%)
    10 / 190 (5.26%)
    13 / 203 (6.40%)
    6 / 195 (3.08%)
         occurrences all number
    12
    11
    14
    6
    Urinary tract infection
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 190 (0.00%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    2 / 203 (0.99%)
    0 / 190 (0.00%)
    3 / 203 (1.48%)
    2 / 195 (1.03%)
         occurrences all number
    2
    0
    3
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 203 (0.99%)
    2 / 190 (1.05%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Sinusitis bacterial
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 190 (0.00%)
    1 / 203 (0.49%)
    0 / 195 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 203 (0.00%)
    2 / 190 (1.05%)
    0 / 203 (0.00%)
    0 / 195 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Decreased appetite
         subjects affected / exposed
    71 / 203 (34.98%)
    60 / 190 (31.58%)
    71 / 203 (34.98%)
    57 / 195 (29.23%)
         occurrences all number
    206
    138
    192
    131

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Oct 2021
    This amendment at the request of CBER to add early safety time point checks, to exclude participants with a history of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection who remain symptomatic, to exclude susceptible high-risk individual members of the potential participant’s household, to clarify that varicella-like-rash includes injection site varicella-like rash, to include holding rules for the first 200 study participants enrolled and to revise the grading to assess the severity of the varicella-like rash.
    15 Nov 2021
    The amendment was primarily to reflect the expansion of the study to the countries other than the United States of America (US). Outside of the US, participants will have the same vaccination schedule but will be co administered Prevnar 13 only if the pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule. Also, the storage conditions for Varivax were updated with the country-specific details, and corrections were made to the temperature excursions for study vaccines. Additionally, this amendment conditionally allowed administration of a second dose of Varivax and/or Havrix in non-US countries (not part of the study procedures).

    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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