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    Clinical Trial Results:
    A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)

    Summary
    EudraCT number
    		 2023-001146-11
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Dec 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jul 2026
    First version publication date
    02 Jul 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V114-032
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04193215
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@msd.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@msd.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
    22 Dec 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Dec 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion of the study. The primary hypothesis is that V114 is superior to no V114 in preventing VT-AOM as assessed by the incidence of VT-AOM.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Sep 2020
    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
    Thailand: 7119
    Worldwide total number of subjects
    7119
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    7119
    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
    		 This study recruited healthy infants approximately 2 months (42 to 90 days, inclusive) of age, without a history of invasive pneumococcal disease or prior administration of any pneumococcal vaccine.

    Pre-assignment
    Screening details
    		 A total of 7119 participants were randomized in a 1:1 ratio to receive either, the 4-dose V114 vaccine regimen (V114), or no V114 vaccine (Control Group), concomitantly alongside other licensed paediatric vaccines.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V114 Group
    Arm description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 administered as a 4‑dose series on Visits 1,2,3, and 4, at approximately 2,4, 6, and 12 months of age respectively. V114 was administered concomitantly with routine licensed pediatric vaccines: INFANRIX™ hexa and RotaTeq™ on Visits 1, 2, and 3; and M M R™ II and VARIVAX™ (Dose 1) on Visit 4. On Visit 5 (approximately 18 months of age), participants received unblinded VAQTA™ (Dose 1), VARIVAX™ (Dose 2), and Pentavac™. For participants 19 to 35 months of age who have completed Visit 5 by the time the efficacy or futility criterion is met, Visit 6 will be a safety follow-up visit which and no study vaccines will be administered. For these participants, licensed VAQTA™ may be offered outside of the study. For participants who reached Visit 6 (approximately 36 months of age) before the efficacy or futility criterion was met, Visit 6 was the final study visit and VAQTA™ (Dose 2) was administered in a blinded manner.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V114
    Investigational medicinal product code
    Other name
    VAXNEUVANCE™ Pneumococcal 15-Valent Conjugate Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    15-valent pneumococcal conjugate vaccine containing 15 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 22F, 33F) given as a single 0.5 mL intramuscular injection at approximately 2, 4, 6,and 12 months of age on study Visit 1,2,3, and 4, respectively.

    Investigational medicinal product name
    INFANRIX™ hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Licensed pediatric vaccine for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and disease caused by Haemophilus influenzae type b given as a single 0.5 mL intramuscular injection at approximately 2, 4, and 6 months of age on study Visit 1, 2, and 3, respectively.

    Investigational medicinal product name
    RotaTeq™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Licensed pediatric oral pentavalent vaccine for the prevention of rotavirus gastroenteritis given as a single 2 mL oral solution at approximately 2, 4, and 6 months of age on study Visit 1, 2, and 3, respectively.

    Investigational medicinal product name
    Pentavac™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Licensed pediatric vaccine for the prevention of diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b given as a single 0.5 mL intramuscular injection at approximately 18 months of age on study Visit 5.

    Investigational medicinal product name
    M-M-R™II
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Licensed pediatric vaccine for the prevention of measles, mumps, and rubella given as a single 0.5 mL subcutaneous injection at approximately 12 months of age on study Visit 4.

    Investigational medicinal product name
    VARIVAX™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Licensed pediatric vaccine for the prevention of varicella given as a single 0.5 mL subcutaneous injection at approximately 12 and 18 months of age on study Visit 4 and 5, respectively.

    Investigational medicinal product name
    VAQTA™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Licensed pediatric vaccine for the prevention of disease caused by hepatitis A virus given as a single 0.5 mL intramuscular injection at approximately 18 and 36 months of age on study Visit 5 and 6, respectively.

    Arm title
    		 Control Group
    Arm description
    		 Participants received routine licensed pediatric vaccines, as follows: On Visits 1,2, and 3, at approximately 2, 4, and 6 months of age respectively participants received RECOMBIVAX HB™, Pentavac™, and RotaTeq™. On Visit 4 (~12 months of age) participants received VAQTA™ (Dose 1), M-MR™II, and VARIVAX™ (Dose 1). On Visit 5 (~18 months of age), participants received unblinded VAQTA™ (Dose 1), VARIVAX™ (Dose 2), and Pentavac™. For participants 19 to 35 months of age who have completed Visit 5 by the time the efficacy or futility criterion is met, Visit 6 will be a safety follow-up visit and no study vaccines will be administered. For these participants, licensed Prevenar 13™ may be offered outside of the study. For participants who reached Visit 6 (approximately 36 months of age) before the efficacy or futility criterion was met, Visit 6 was the final study visit and Prevenar 13™ was administered in a blinded manner.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pentavac™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Licensed pediatric vaccine for the prevention of diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b given as a single 0.5 mL intramuscular injection at approximately 2, 4, 6, and 18 months of age on study Visit 1,2,3, and 5, respectively.

    Investigational medicinal product name
    RotaTeq™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Licensed pediatric oral pentavalent vaccine for the prevention of rotavirus gastroenteritis given as a single 2 mL oral solution at approximately 2, 4, and 6 months of age on study Visit 1, 2, and 3, respectively.

    Investigational medicinal product name
    Prevenar 13™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Licensed pediatric Pneumococcal 13-valent Conjugate Vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) for the prevention of pneumococcal disease caused by the serotypes contained in the vaccine given as a single 0.5 mL intramuscular injection at approximately 36 months of age on study Visit 6.

    Investigational medicinal product name
    M-M-R™II
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Licensed pediatric vaccine for the prevention of measles, mumps, and rubella given as a single 0.5 mL subcutaneous injection at approximately 12 months of age on study Visit 4.

    Investigational medicinal product name
    VARIVAX™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Licensed pediatric vaccine for the prevention of varicella given as a single 0.5 mL subcutaneous injection at approximately 12 and 18 months of age on study Visit 4 and 5, respectively.

    Investigational medicinal product name
    RECOMBIVAX HB™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Licensed pediatric vaccine for the prevention of hepatitis B virus infection given as a single 0.5 mL intramuscular injection at approximately 2, 4, and 6 months of age on study Visit 1,2, and 3, respectively.

    Investigational medicinal product name
    VAQTA™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Licensed pediatric vaccine for the prevention of disease caused by hepatitis A virus given as a single 0.5 mL intramuscular injection at approximately 12 and 18 months of age on study Visit 4 and 5, respectively.

    Number of subjects in period 1
    		V114 Group Control Group
    Started
    3560
    3559
    Primary Efficacy Analysis Population
    2901 [1]
    2925 [2]
    Safety Analysis Population
    3557
    3556
    Completed
    3278
    3292
    Not completed
    282
    267
         Physician decision
    10
    17
         Death
    4
    2
         Withdrawal by Parent/Guardian
    205
    186
         Lost to follow-up
    63
    62
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The efficacy analysis population is based on the Per-Protocol (PP) population which consisted of all randomized participants who: received all injectable study vaccinations at 2, 4, and 6 months of age, had at least 1 follow-up visit/phone call for assessment of Vaccine Type-Acute Otitis Media (VT-AOM) ≥14 days after the injectable study vaccinations at 6 months of age; and, did not have any protocol deviations that may substantially affect the results of the efficacy endpoint.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per protocol, the safety analyses population was the All Participants as Treated (APaT) which consisted of all randomized participants who received at least one study vaccination. Participants were included in the treatment group corresponding to the study treatment they actually received. Per the statistical analysis plan, participants who received both V114 and control vaccine were excluded from the safety analysis APaT population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V114 Group
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 administered as a 4‑dose series on Visits 1,2,3, and 4, at approximately 2,4, 6, and 12 months of age respectively. V114 was administered concomitantly with routine licensed pediatric vaccines: INFANRIX™ hexa and RotaTeq™ on Visits 1, 2, and 3; and M M R™ II and VARIVAX™ (Dose 1) on Visit 4. On Visit 5 (approximately 18 months of age), participants received unblinded VAQTA™ (Dose 1), VARIVAX™ (Dose 2), and Pentavac™. For participants 19 to 35 months of age who have completed Visit 5 by the time the efficacy or futility criterion is met, Visit 6 will be a safety follow-up visit which and no study vaccines will be administered. For these participants, licensed VAQTA™ may be offered outside of the study. For participants who reached Visit 6 (approximately 36 months of age) before the efficacy or futility criterion was met, Visit 6 was the final study visit and VAQTA™ (Dose 2) was administered in a blinded manner.

    Reporting group title
    Control Group
    Reporting group description
    		 Participants received routine licensed pediatric vaccines, as follows: On Visits 1,2, and 3, at approximately 2, 4, and 6 months of age respectively participants received RECOMBIVAX HB™, Pentavac™, and RotaTeq™. On Visit 4 (~12 months of age) participants received VAQTA™ (Dose 1), M-MR™II, and VARIVAX™ (Dose 1). On Visit 5 (~18 months of age), participants received unblinded VAQTA™ (Dose 1), VARIVAX™ (Dose 2), and Pentavac™. For participants 19 to 35 months of age who have completed Visit 5 by the time the efficacy or futility criterion is met, Visit 6 will be a safety follow-up visit and no study vaccines will be administered. For these participants, licensed Prevenar 13™ may be offered outside of the study. For participants who reached Visit 6 (approximately 36 months of age) before the efficacy or futility criterion was met, Visit 6 was the final study visit and Prevenar 13™ was administered in a blinded manner.

    Reporting group values
    		 V114 Group Control Group Total
    Number of subjects
    		 3560 3559 7119
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 3560 3559 7119
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 8.6 ( 1.5 ) 8.6 ( 1.5 ) -
    Gender Categorical
    Units: Participants
        Female
    		 1723 1726 3449
        Male
    		 1837 1833 3670
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 3558 3557 7115
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 0 0 0
        More than one race
    		 2 2 4
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 3560 3559 7119
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    V114 Group
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 administered as a 4‑dose series on Visits 1,2,3, and 4, at approximately 2,4, 6, and 12 months of age respectively. V114 was administered concomitantly with routine licensed pediatric vaccines: INFANRIX™ hexa and RotaTeq™ on Visits 1, 2, and 3; and M M R™ II and VARIVAX™ (Dose 1) on Visit 4. On Visit 5 (approximately 18 months of age), participants received unblinded VAQTA™ (Dose 1), VARIVAX™ (Dose 2), and Pentavac™. For participants 19 to 35 months of age who have completed Visit 5 by the time the efficacy or futility criterion is met, Visit 6 will be a safety follow-up visit which and no study vaccines will be administered. For these participants, licensed VAQTA™ may be offered outside of the study. For participants who reached Visit 6 (approximately 36 months of age) before the efficacy or futility criterion was met, Visit 6 was the final study visit and VAQTA™ (Dose 2) was administered in a blinded manner.

    Reporting group title
    Control Group
    Reporting group description
    		 Participants received routine licensed pediatric vaccines, as follows: On Visits 1,2, and 3, at approximately 2, 4, and 6 months of age respectively participants received RECOMBIVAX HB™, Pentavac™, and RotaTeq™. On Visit 4 (~12 months of age) participants received VAQTA™ (Dose 1), M-MR™II, and VARIVAX™ (Dose 1). On Visit 5 (~18 months of age), participants received unblinded VAQTA™ (Dose 1), VARIVAX™ (Dose 2), and Pentavac™. For participants 19 to 35 months of age who have completed Visit 5 by the time the efficacy or futility criterion is met, Visit 6 will be a safety follow-up visit and no study vaccines will be administered. For these participants, licensed Prevenar 13™ may be offered outside of the study. For participants who reached Visit 6 (approximately 36 months of age) before the efficacy or futility criterion was met, Visit 6 was the final study visit and Prevenar 13™ was administered in a blinded manner.

    Primary: Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114

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    End point title
    		 Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114
    End point description
    The number of participants with a first episode of VT-AOM caused by the pneumococcal stereotypes contained in the V114 is presented. Per protocol, cases were defined as the first episode of VT-AOM diagnosed ≥14 days after the participant received study vaccinations at approximately 6 months of age (following Visit 3). Per protocol, the final analysis was conducted after at least 120 cases were accrued. Per protocol, the primary efficacy analysis population (Per-Protocol population) consisted of all randomized participants who: received all injectable study vaccinations at 2, 4, and 6 months of age; had at least 1 follow-up visit/phone call for assessment of VT-AOM ≥14 days after the injectable study vaccinations at 6 months of age; excluded perforated middle ear fluid samples; and did not have any protocol deviations that may substantially affect the results of the endpoint.
    End point type
    Primary
    End point timeframe
    Up to approximately 30 months after Visit 3
    End point values
    		 V114 Group Control Group
    Number of subjects analysed
    2901 [1]
    2925 [2]
    Units: Participants
    47
    84
    Notes
    [1] - Subjects analyzed reflect the V114 Per Protocol (PP) population
    [2] - Subjects analyzed reflect the Control Per Protocol (PP) population
    Statistical analysis title
    		 Observed Efficacy (%) of V114 versus Control
    Statistical analysis description
    Primary efficacy hypothesis used a two-sided multiplicity-adjusted exact 95% CI for vaccine efficacy based on the group-sequential methodology of Jennison & Turnbull (2000). The statistical criterion for success requires the lower bound of multiplicity-adjusted 95% CI of the vaccine efficacy to be >20%. Per protocol, cases are defined as first episode of VT-AOM diagnosed ≥14 days after the participant receives injectable study vaccinations at approximately 6 months of age (following Visit 3).
    Comparison groups
    V114 Group v Control Group
    Number of subjects included in analysis
    5826
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Observed Efficacy (%)
    Point estimate
    43.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.87
         upper limit
    		 62.26

    Primary: Number of Participants with Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants with Serious Adverse Events (SAEs)
    End point description
    A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Per protocol, the safety analyses APaT population consisted of all randomized participants who had ≥1 study vaccination. Participants were included in the treatment group corresponding to the study treatment they actually received. Per the statistical analysis plan, participants who received both V114 and control vaccine were excluded from the safety analysis APaT population. The number of participants who experienced at least one SAE is reported. Per protocol, reported serious adverse events occurred from approximately 2 months of age (following Visit 1) through the completion of study participation.
    End point type
    Primary
    End point timeframe
    Up to approximately 34 months
    End point values
    		 V114 Group Control Group
    Number of subjects analysed
    3557 [3]
    3556 [4]
    Units: Participants
    963
    1011
    Notes
    [3] - Subjects analyzed reflect the V114 All Participants as Treated (APaT) population
    [4] - Subjects analyzed reflect the Control All Participants as Treated (APaT) population
    Statistical analysis title
    		 Difference in percent: V114 minus Control
    Statistical analysis description
    Estimated differences and confidence intervals (CIs) are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 Group v Control Group
    Number of subjects included in analysis
    7113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in % versus Control
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 0.7

    Primary: Number of Participants with Vaccine-Related Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants with Vaccine-Related Serious Adverse Events (SAEs)
    End point description
    A SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed by medical or scientific judgment. A SAE defined by the investigator to be related to the study vaccine is considered vaccine-related. Per protocol, the safety analyses APaT population consisted of all randomized participants who had ≥1 study vaccination. Participants were included in the treatment group corresponding to the study treatment they actually received. Per the statistical analysis plan, participants who received both V114 and control vaccine were excluded from the safety analysis APaT population. The number of participants who experienced at ≥1 vaccine-related SAE is reported. Per protocol, reported SAEs occurred from approximately 2 months of age (following Visit 1) through the completion of study participation.
    End point type
    Primary
    End point timeframe
    Up to approximately 34 months
    End point values
    		 V114 Group Control Group
    Number of subjects analysed
    3557 [5]
    3556 [6]
    Units: Participants
    3
    2
    Notes
    [5] - Subjects analyzed reflect the V114 All Participants as Treated (APaT) population
    [6] - Subjects analyzed reflect the Control All Participants as Treated (APaT) population
    Statistical analysis title
    		 Difference in percent: V114 minus Control
    Statistical analysis description
    Estimated differences and CIs are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 Group v Control Group
    Number of subjects included in analysis
    7113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in % versus Control
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.2

    Primary: Number of Participants Who Discontinued the Study Vaccine Due to Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants Who Discontinued the Study Vaccine Due to Serious Adverse Events (SAEs)
    End point description
    A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Per protocol, the safety analyses APaT population consisted of all randomized participants who had ≥1 study vaccination. Participants were included in the treatment group corresponding to the study treatment they actually received. Per the statistical analysis plan, participants who received both V114 and control vaccine were excluded from the safety analysis APaT population. The number of participants who discontinued the study vaccine due to an SAE is reported. Per protocol, reported serious adverse events occurred from approximately 2 months of age (following Visit 1) through the completion of study participation.
    End point type
    Primary
    End point timeframe
    Up to approximately 34 months
    End point values
    		 V114 Group Control Group
    Number of subjects analysed
    3557 [7]
    3556 [8]
    Units: Participants
    2
    1
    Notes
    [7] - Subjects analyzed reflect the V114 All Participants as Treated (APaT) population
    [8] - Subjects analyzed reflect the Control All Participants as Treated (APaT) population
    Statistical analysis title
    		 Difference in percent: V114 minus Control
    Statistical analysis description
    Estimated differences and CIs are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    Control Group v V114 Group
    Number of subjects included in analysis
    7113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in % versus Control
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.2

    Primary: Number of Participants Who Died

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    End point title
    		 Number of Participants Who Died
    End point description
    The number of participants who died from any cause during the study is presented. Per protocol, the safety analyses APaT population consisted of all randomized participants who had ≥1 study vaccination. Participants were included in the treatment group corresponding to the study treatment they actually received. Per the statistical analysis plan, participants who received both V114 and control vaccine were excluded from the safety analysis APaT population. The number of participants who died from any cause during the study is reported. Per protocol, reported serious adverse events occurred from approximately 2 months of age (following Visit 1) through the completion of study participation.
    End point type
    Primary
    End point timeframe
    Up to approximately 34 months
    End point values
    		 V114 Group Control Group
    Number of subjects analysed
    3557 [9]
    3556 [10]
    Units: Participants
    4
    2
    Notes
    [9] - Subjects analyzed reflect the V114 All Participants as Treated (APaT) population
    [10] - Subjects analyzed reflect the Control All Participants as Treated (APaT) population
    Statistical analysis title
    		 Difference in percent: V114 minus Control
    Statistical analysis description
    Estimated differences and CIs are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 Group v Control Group
    Number of subjects included in analysis
    7113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in % versus Control
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.2

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    up to approximately 34 months
    Adverse event reporting additional description
    All-Cause Mortality: all randomized participants SAEs: all randomized participants who had ≥1 study vaccination included in treatment group corresponding to treatment received. Per protocol, Non-Serious AEs not collected. Per statistical analysis plan, participants who had both V114 & Control vaccine were excluded from safety analysis population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.1
    Reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Participants received routine licensed pediatric vaccines, as follows: On Visits 1,2, and 3, at approximately 2, 4, and 6 months of age respectively participants received RECOMBIVAX HB™, Pentavac™, and RotaTeq™. On Visit 4 (~12 months of age) participants received VAQTA™ (Dose 1), M-MR™II, and VARIVAX™ (Dose 1). On Visit 5 (~18 months of age), participants received unblinded VAQTA™ (Dose 1), VARIVAX™ (Dose 2), and Pentavac™. For participants 19 to 35 months of age who have completed Visit 5 by the time the efficacy or futility criterion is met, Visit 6 will be a safety follow-up visit and no study vaccines will be administered. For these participants, licensed Prevenar 13™ may be offered outside of the study. For participants who reached Visit 6 (approximately 36 months of age) before the efficacy or futility criterion was met, Visit 6 was the final study visit and Prevenar 13™ was administered in a blinded manner.

    Reporting group title
    V114 Group
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 administered as a 4‑dose series on Visits 1,2,3, and 4, at approximately 2,4, 6, and 12 months of age respectively. V114 was administered concomitantly with routine licensed pediatric vaccines: INFANRIX™ hexa and RotaTeq™ on Visits 1, 2, and 3; and M M R™ II and VARIVAX™ (Dose 1) on Visit 4. On Visit 5 (approximately 18 months of age), participants received unblinded VAQTA™ (Dose 1), VARIVAX™ (Dose 2), and Pentavac™. For participants 19 to 35 months of age who have completed Visit 5 by the time the efficacy or futility criterion is met, Visit 6 will be a safety follow-up visit which and no study vaccines will be administered. For these participants, licensed VAQTA™ may be offered outside of the study. For participants who reached Visit 6 (approximately 36 months of age) before the efficacy or futility criterion was met, Visit 6 was the final study visit and VAQTA™ (Dose 2) was administered in a blinded manner.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Per protocol, Non-Serious Adverse Events were not collected.
    Serious adverse events
    		 Control Group V114 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1011 / 3556 (28.43%)
    963 / 3557 (27.07%)
         number of deaths (all causes)
    2
    4
         number of deaths resulting from adverse events
    2
    4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoblastoma
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kawasaki's disease
         subjects affected / exposed
    7 / 3556 (0.20%)
    5 / 3557 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphangiectasia
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    0 / 3556 (0.00%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Influenza like illness
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    15 / 3556 (0.42%)
    18 / 3557 (0.51%)
         occurrences causally related to treatment / all
    1 / 15
    2 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden infant death syndrome
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Polyp
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    2 / 3556 (0.06%)
    4 / 3557 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    4 / 3556 (0.11%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Milk allergy
         subjects affected / exposed
    2 / 3556 (0.06%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multisystem inflammatory syndrome in children
         subjects affected / exposed
    0 / 3556 (0.00%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    18 / 3556 (0.51%)
    15 / 3557 (0.42%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brief resolved unexplained event
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    2 / 3556 (0.06%)
    3 / 3557 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal hypertrophy
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rebound nasal congestion
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper airway obstruction
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    10 / 3556 (0.28%)
    8 / 3557 (0.22%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Phagophobia
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breath holding
         subjects affected / exposed
    0 / 3556 (0.00%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Influenza A virus test positive
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARS-CoV-2 test positive
         subjects affected / exposed
    21 / 3556 (0.59%)
    24 / 3557 (0.67%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental exposure to product
         subjects affected / exposed
    2 / 3556 (0.06%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 3556 (0.03%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exposure to communicable disease
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immunisation reaction
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body ingestion
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 3556 (0.00%)
    3 / 3557 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Snake bite
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Buried penis syndrome
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital absence of bile ducts
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital intestinal obstruction
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital megacolon
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid ptosis congenital
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cryptorchism
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 3556 (0.00%)
    6 / 3557 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lennox-Gastaut syndrome
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infantile spasms
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    61 / 3556 (1.72%)
    67 / 3557 (1.88%)
         occurrences causally related to treatment / all
    0 / 71
    0 / 84
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    3 / 3556 (0.08%)
    3 / 3557 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign enlargement of the subarachnoid spaces
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    2 / 3556 (0.06%)
    3 / 3557 (0.08%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 3556 (0.00%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    3 / 3556 (0.08%)
    3 / 3557 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Chalazion
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strabismus
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dacryostenosis acquired
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    13 / 3556 (0.37%)
    9 / 3557 (0.25%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    4 / 3556 (0.11%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eosinophilic colitis
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    6 / 3556 (0.17%)
    4 / 3557 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    12 / 3556 (0.34%)
    15 / 3557 (0.42%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal perforation
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    4 / 3556 (0.11%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary tract disorder
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema multiforme
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    4 / 3556 (0.11%)
    3 / 3557 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal artery stenosis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fistula
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal mass
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    1 / 3556 (0.03%)
    3 / 3557 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoviral conjunctivitis
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    8 / 3556 (0.22%)
    9 / 3557 (0.25%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    3 / 3556 (0.08%)
    4 / 3557 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial diarrhoea
         subjects affected / exposed
    3 / 3556 (0.08%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    2 / 3556 (0.06%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial rhinitis
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    64 / 3556 (1.80%)
    49 / 3557 (1.38%)
         occurrences causally related to treatment / all
    0 / 73
    0 / 55
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    34 / 3556 (0.96%)
    32 / 3557 (0.90%)
         occurrences causally related to treatment / all
    0 / 36
    0 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis mycoplasmal
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burn infection
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis viral
         subjects affected / exposed
    4 / 3556 (0.11%)
    7 / 3557 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    60 / 3556 (1.69%)
    44 / 3557 (1.24%)
         occurrences causally related to treatment / all
    0 / 60
    0 / 44
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    3 / 3556 (0.08%)
    4 / 3557 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    20 / 3556 (0.56%)
    16 / 3557 (0.45%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    9 / 3556 (0.25%)
    6 / 3557 (0.17%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue haemorrhagic fever
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    17 / 3556 (0.48%)
    13 / 3557 (0.37%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    4 / 3556 (0.11%)
    5 / 3557 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    15 / 3556 (0.42%)
    15 / 3557 (0.42%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    32 / 3556 (0.90%)
    32 / 3557 (0.90%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    173 / 3556 (4.87%)
    191 / 3557 (5.37%)
         occurrences causally related to treatment / all
    0 / 174
    0 / 192
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Escherichia coli
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    2 / 3556 (0.06%)
    3 / 3557 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    2 / 3556 (0.06%)
    7 / 3557 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis enteroviral
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    5 / 3556 (0.14%)
    7 / 3557 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 3556 (0.06%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    13 / 3556 (0.37%)
    12 / 3557 (0.34%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis shigella
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    48 / 3556 (1.35%)
    32 / 3557 (0.90%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal bacterial infection
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    2 / 3556 (0.06%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingivitis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HCoV-OC43 infection
         subjects affected / exposed
    0 / 3556 (0.00%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    21 / 3556 (0.59%)
    24 / 3557 (0.67%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    12 / 3556 (0.34%)
    16 / 3557 (0.45%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hordeolum
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    123 / 3556 (3.46%)
    113 / 3557 (3.18%)
         occurrences causally related to treatment / all
    0 / 133
    0 / 121
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Human bocavirus infection
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycoplasma infection
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected cyst
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    2 / 3556 (0.06%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    30 / 3556 (0.84%)
    26 / 3557 (0.73%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella urinary tract infection
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis viral
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ludwig angina
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymph node tuberculosis
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis bacterial
         subjects affected / exposed
    2 / 3556 (0.06%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis pneumococcal
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus bronchiolitis
         subjects affected / exposed
    3 / 3556 (0.08%)
    3 / 3557 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus pneumonia
         subjects affected / exposed
    4 / 3556 (0.11%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    0 / 3556 (0.00%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    19 / 3556 (0.53%)
    19 / 3557 (0.53%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia adenoviral
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    2 / 3556 (0.06%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    2 / 3556 (0.06%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    20 / 3556 (0.56%)
    15 / 3557 (0.42%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae viral bronchitis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 3556 (0.00%)
    4 / 3557 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    3 / 3556 (0.08%)
    4 / 3557 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    19 / 3556 (0.53%)
    8 / 3557 (0.22%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis bacterial
         subjects affected / exposed
    2 / 3556 (0.06%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 3556 (0.06%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (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
    75 / 3556 (2.11%)
    71 / 3557 (2.00%)
         occurrences causally related to treatment / all
    0 / 81
    0 / 79
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Norovirus infection
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia chlamydial
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    4 / 3556 (0.11%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    3 / 3556 (0.08%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia parainfluenzae viral
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    46 / 3556 (1.29%)
    53 / 3557 (1.49%)
         occurrences causally related to treatment / all
    0 / 47
    0 / 54
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    82 / 3556 (2.31%)
    62 / 3557 (1.74%)
         occurrences causally related to treatment / all
    0 / 93
    0 / 75
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    5 / 3556 (0.14%)
    8 / 3557 (0.22%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyomyositis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyuria
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    17 / 3556 (0.48%)
    28 / 3557 (0.79%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    12 / 3556 (0.34%)
    18 / 3557 (0.51%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    21 / 3556 (0.59%)
    11 / 3557 (0.31%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    2 / 3556 (0.06%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    28 / 3556 (0.79%)
    27 / 3557 (0.76%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic viral infection
         subjects affected / exposed
    0 / 3556 (0.00%)
    4 / 3557 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonella bacteraemia
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonella sepsis
         subjects affected / exposed
    3 / 3556 (0.08%)
    4 / 3557 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    3 / 3556 (0.08%)
    8 / 3557 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scabies
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrub typhus
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 3556 (0.00%)
    3 / 3557 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scarlet fever
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    6 / 3556 (0.17%)
    5 / 3557 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    1 / 3556 (0.03%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 3556 (0.00%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 3556 (0.51%)
    7 / 3557 (0.20%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    2 / 3556 (0.06%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    9 / 3556 (0.25%)
    14 / 3557 (0.39%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis viral
         subjects affected / exposed
    0 / 3556 (0.00%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    1 / 3556 (0.03%)
    2 / 3557 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    21 / 3556 (0.59%)
    19 / 3557 (0.53%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral pharyngitis
         subjects affected / exposed
    1 / 3556 (0.03%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    10 / 3556 (0.28%)
    9 / 3557 (0.25%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral tonsillitis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    10 / 3556 (0.28%)
    9 / 3557 (0.25%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    1 / 3556 (0.03%)
    0 / 3557 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 3556 (0.00%)
    1 / 3557 (0.03%)
         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
    		 Control Group V114 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 3556 (0.00%)
    0 / 3557 (0.00%)

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jun 2021
    Amendment 01: The rationale for this amendment is to incorporate changes to the statistical criteria for success of the primary hypothesis to allow for a more stringent assessment of vaccine efficacy.
    01 Jul 2021
    Amendment 02: The rationale for this amendment is to allow flexibility in the sourcing of licensed pediatric vaccines.
    06 Jan 2023
    Amendment 03: The rationale for this amendment is to increase the study sample size to mitigate for challenges posed by the COVID-19 pandemic on VT-AOM case accrual.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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