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    Clinical Trial Results:
    A Phase 3, Randomized, Placebo-Controlled, Observer-Blinded Trial to Evaluate the Safety of a 6-Valent OspA -Based Lyme Disease Vaccine (VLA15) in Healthy Children 5 Through 17 Years of Age

    Summary
    EudraCT number
    		 2025-000441-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Jul 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2026
    First version publication date
    01 Mar 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C4601012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05634811
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    66 Hudson Boulevard East, New York, United States, NY 10001
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-003130-PIP02-23
    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
    08 Dec 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jul 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety profile of VLA15 as measured by the percentage of participants reporting local reactions, systemic events, adverse events (AEs), newly diagnosed chronic medical conditions (NDCMCs), and serious adverse event (SAEs).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Dec 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 3533
    Worldwide total number of subjects
    3533
    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)
    0
    Children (2-11 years)
    1896
    Adolescents (12-17 years)
    1637
    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
    		 A total of 3646 participants were enrolled, of which 3547 participants were randomised (2653 to PF-07307405 [VLA15] and 894 to placebo) and 3533 were vaccinated (2645 to PF-07307405 [VLA15] and 888 to placebo).

    Pre-assignment
    Screening details
    		 This study was conducted across 57 sites across the United States of America (USA).

    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
    Blinding implementation details
    Double blind study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VLA15: 5 to 11 Years
    Arm description
    		 Participants aged 5 to 11 years were randomised to receive VLA15, 180 micrograms (ug), 0.5 millilter (mL) intramuscular (IM) injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-07307405
    Investigational medicinal product code
    Other name
    VLA15
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received VLA15 0.5mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose at Month 18 if there was no protocol violation.

    Arm title
    		 Placebo: 5 to 11 Years
    Arm description
    		 Participants aged 5 to 11 years were randomised to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received normal saline 0.5mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose at Month 18 if there was no protocol violation.

    Arm title
    		 VLA15: 12 to 17 Years
    Arm description
    		 Participants aged 12 to 17 years were randomised to receive VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-07307405
    Investigational medicinal product code
    Other name
    VLA15
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received VLA15 0.5mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose at Month 18 if there was no protocol violation.

    Arm title
    		 Placebo: 12 to 17 Years
    Arm description
    		 Participants aged 12 to17 years were randomised to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received normal saline 0.5mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose at Month 18 if there was no protocol violation.

    Number of subjects in period 1
    		VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years
    Started
    1429
    467
    1219
    418
    Completed
    1209
    389
    997
    350
    Not completed
    220
    78
    222
    68
         Physician decision
    9
    3
    5
    2
         Consent withdrawn by subject
    45
    12
    49
    16
         Withdrawal by parent or guardian
    50
    18
    42
    11
         No longer met eligibility criteria
    3
    -
    7
    1
         Medication error without associated adverse event
    2
    -
    -
    -
         Unspecified
    5
    1
    3
    -
         Lost to follow-up
    96
    43
    106
    34
         Adverse Event, Not serious
    7
    1
    4
    2
         Adverse Event, Serious non-fatal
    3
    -
    6
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VLA15: 5 to 11 Years
    Reporting group description
    		 Participants aged 5 to 11 years were randomised to receive VLA15, 180 micrograms (ug), 0.5 millilter (mL) intramuscular (IM) injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.

    Reporting group title
    Placebo: 5 to 11 Years
    Reporting group description
    		 Participants aged 5 to 11 years were randomised to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.

    Reporting group title
    VLA15: 12 to 17 Years
    Reporting group description
    		 Participants aged 12 to 17 years were randomised to receive VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.

    Reporting group title
    Placebo: 12 to 17 Years
    Reporting group description
    		 Participants aged 12 to17 years were randomised to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.

    Reporting group values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years Total
    Number of subjects
    		 1429 467 1219 418
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.2 ( 2.0 ) 8.2 ( 2.0 ) 14.3 ( 1.7 ) 14.3 ( 1.7 ) -
    Gender categorical
    Units: Subjects
        Male
    		 776 253 623 236 1888
        Female
    		 653 214 596 182 1645
    Race
    Units: Subjects
        White
    		 1081 342 947 320 2690
        Black or African American
    		 262 99 208 72 641
        American Indian or Alaska Native
    		 2 2 5 0 9
        Native Hawaiian or other Pacific Islander
    		 2 0 2 0 4
        Asian
    		 32 12 27 12 83
        Multiracial
    		 37 8 20 9 74
        Not reported
    		 13 4 10 5 32
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 240 75 268 90 673
        Non-Hispanic or non-Latino
    		 1181 391 944 327 2843
        Not reported
    		 8 1 7 1 17

    End points

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    End points reporting groups
    Reporting group title
    VLA15: 5 to 11 Years
    Reporting group description
    		 Participants aged 5 to 11 years were randomised to receive VLA15, 180 micrograms (ug), 0.5 millilter (mL) intramuscular (IM) injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.

    Reporting group title
    Placebo: 5 to 11 Years
    Reporting group description
    		 Participants aged 5 to 11 years were randomised to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.

    Reporting group title
    VLA15: 12 to 17 Years
    Reporting group description
    		 Participants aged 12 to 17 years were randomised to receive VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.

    Reporting group title
    Placebo: 12 to 17 Years
    Reporting group description
    		 Participants aged 12 to17 years were randomised to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.

    Subject analysis set title
    VLA15: Overall
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants were randomised to receive VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.

    Subject analysis set title
    Placebo: Overall
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants were randomised to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.

    Primary: Percentage of Participants With Local Reactions for up to 7 Days Following Study Vaccination 1

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    End point title
    		 Percentage of Participants With Local Reactions for up to 7 Days Following Study Vaccination 1 [1]
    End point description
    Local reactions included pain at injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 7 after Study Vaccination 1 [Vaccination on Day 1, Month 0]
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1408
    457
    1206
    410
    2614
    867
    Units: Percentage of participants
        number (confidence interval 95%)
    80.8 (78.6 to 82.8)
    34.8 (30.4 to 39.4)
    80.6 (78.3 to 82.8)
    14.6 (11.4 to 18.4)
    80.7 (79.1 to 82.2)
    25.3 (22.4 to 28.3)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Local Reactions for up to 7 Days Following Study Vaccination 2

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    End point title
    		 Percentage of Participants With Local Reactions for up to 7 Days Following Study Vaccination 2 [2]
    End point description
    Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 7 after Study Vaccination 2 [Vaccination on Day 1, Month 2]
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1297
    431
    1112
    386
    2409
    817
    Units: Percentage of participants
        number (confidence interval 95%)
    72.6 (70.0 to 75.0)
    29.0 (24.8 to 33.5)
    71.4 (68.6 to 74.0)
    11.7 (8.6 to 15.3)
    72.0 (70.2 to 73.8)
    20.8 (18.1 to 23.8)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Local Reactions for up to 7 Days Following Study Vaccination 3

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    End point title
    		 Percentage of Participants With Local Reactions for up to 7 Days Following Study Vaccination 3 [3]
    End point description
    Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 7 after Study Vaccination 3 [Vaccination on Day 1, Month 6]
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1225
    391
    1054
    372
    2279
    763
    Units: Percentage of participants
        number (confidence interval 95%)
    73.5 (70.9 to 75.9)
    25.1 (20.8 to 29.7)
    69.6 (66.8 to 72.4)
    9.7 (6.9 to 13.1)
    71.7 (69.8 to 73.5)
    17.6 (14.9 to 20.5)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Local Reactions for up to 7 Days Following Study Vaccination 4

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    End point title
    		 Percentage of Participants With Local Reactions for up to 7 Days Following Study Vaccination 4 [4]
    End point description
    Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 7 after Study Vaccination 4 [Vaccination on Day 1, Month 18]
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1169
    384
    979
    349
    2148
    733
    Units: Percentage of participants
        number (confidence interval 95%)
    77.0 (74.5 to 79.4)
    24.7 (20.5 to 29.4)
    71.6 (68.7 to 74.4)
    11.7 (8.6 to 15.6)
    74.5 (72.6 to 76.4)
    18.6 (15.8 to 21.6)
    No statistical analyses for this end point

    Primary: Percentage of Participants With any Local Reaction for up to 7 Days After any Study Vaccination

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    End point title
    		 Percentage of Participants With any Local Reaction for up to 7 Days After any Study Vaccination [5]
    End point description
    Local reactions included pain at injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 7 after any study vaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1428
    466
    1212
    415
    2640
    881
    Units: Percentage of participants
        number (confidence interval 95%)
    88.3 (86.5 to 89.9)
    56.0 (51.4 to 60.6)
    90.0 (88.2 to 91.6)
    31.6 (27.1 to 36.3)
    89.1 (87.8 to 90.3)
    44.5 (41.2 to 47.8)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Systemic Events for up to 7 Days Following Study Vaccination 1

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    End point title
    		 Percentage of Participants With Systemic Events for up to 7 Days Following Study Vaccination 1 [6]
    End point description
    Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 7 after Study Vaccination 1 [Vaccination on Day 1, Month 0]
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1406
    456
    1205
    410
    2611
    866
    Units: Percentage of participants
        number (confidence interval 95%)
    56.0 (53.3 to 58.6)
    41.0 (36.5 to 45.7)
    62.2 (59.4 to 64.9)
    48.8 (43.8 to 53.7)
    58.8 (56.9 to 60.7)
    44.7 (41.3 to 48.1)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination After Dose 2

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    End point title
    		 Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination After Dose 2 [7]
    End point description
    Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 7 after Study Vaccination 2 [Vaccination on Day 1, Month 2]
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1296
    430
    1111
    386
    2407
    816
    Units: Percentage of participants
        number (confidence interval 95%)
    48.1 (45.3 to 50.8)
    30.2 (25.9 to 34.8)
    55.3 (52.3 to 58.2)
    31.6 (27.0 to 36.5)
    51.4 (49.4 to 53.4)
    30.9 (27.7 to 34.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination After Dose 3

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    End point title
    		 Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination After Dose 3 [8]
    End point description
    Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 7 after Study Vaccination 3 [Vaccination on Day 1, Month 6]
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1224
    391
    1055
    371
    2279
    762
    Units: Percentage of participants
        number (confidence interval 95%)
    47.5 (44.6 to 50.3)
    27.6 (23.2 to 32.3)
    51.6 (48.5 to 54.6)
    26.1 (21.7 to 30.9)
    49.4 (47.3 to 51.4)
    26.9 (23.8 to 30.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination After Dose 4

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    End point title
    		 Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination After Dose 4 [9]
    End point description
    Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 7 after Study Vaccination 4 [Vaccination on Day 1, Month 18]
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1169
    384
    977
    349
    2146
    733
    Units: Percentage of participants
        number (confidence interval 95%)
    53.5 (50.6 to 56.4)
    28.1 (23.7 to 32.9)
    54.8 (51.6 to 57.9)
    28.4 (23.7 to 33.4)
    54.1 (51.9 to 56.2)
    28.2 (25.0 to 31.7)
    No statistical analyses for this end point

    Primary: Percentage of Participants With any Systemic Events for up to 7 Days After any Study Vaccination

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    End point title
    		 Percentage of Participants With any Systemic Events for up to 7 Days After any Study Vaccination [10]
    End point description
    Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 7 after any study vaccination
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1427
    466
    1212
    415
    2639
    881
    Units: Percentage of participants
        number (confidence interval 95%)
    77.8 (75.5 to 79.9)
    60.1 (55.5 to 64.6)
    82.1 (79.8 to 84.2)
    63.1 (58.3 to 67.8)
    79.8 (78.2 to 81.3)
    61.5 (58.2 to 64.7)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Adverse Events (AEs) Through 1 Month Following Study Vaccination 1

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    End point title
    		 Percentage of Participants With Adverse Events (AEs) Through 1 Month Following Study Vaccination 1 [11]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 1 were included in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Month 1 after Study Vaccination 1 [Vaccination on Day 1, Month 0]
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1426
    467
    1219
    418
    2645
    885
    Units: Percentage of participants
        number (confidence interval 95%)
    3.4 (2.6 to 4.5)
    3.0 (1.6 to 5.0)
    3.1 (2.2 to 4.3)
    4.5 (2.8 to 7.0)
    3.3 (2.6 to 4.0)
    3.7 (2.6 to 5.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Adverse Events (AEs) Through 1 Month Following Study Vaccination 2

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    End point title
    		 Percentage of Participants With Adverse Events (AEs) Through 1 Month Following Study Vaccination 2 [12]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 2 were included in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Month 1 after Study Vaccination 2 [Vaccination on Day 1, Month 2]
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1371
    452
    1173
    406
    2544
    858
    Units: Percentage of participants
        number (confidence interval 95%)
    2.4 (1.7 to 3.4)
    2.2 (1.1 to 4.0)
    1.5 (0.9 to 2.4)
    2.2 (1.0 to 4.2)
    2.0 (1.5 to 2.6)
    2.2 (1.3 to 3.4)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Adverse Events (AEs) Through 1 Month Following Study Vaccination 3

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    End point title
    		 Percentage of Participants With Adverse Events (AEs) Through 1 Month Following Study Vaccination 3 [13]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 3 were included in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Month 1 after Study Vaccination 3 [Vaccination on Day 1, Month 6]
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1313
    428
    1126
    397
    2439
    825
    Units: Percentage of participants
        number (confidence interval 95%)
    4.6 (3.5 to 5.8)
    3.5 (2.0 to 5.7)
    4.6 (3.5 to 6.0)
    4.3 (2.5 to 6.8)
    4.6 (3.8 to 5.5)
    3.9 (2.7 to 5.4)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Adverse Events (AEs) Through 1 Month Following Study Vaccination 4

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    End point title
    		 Percentage of Participants With Adverse Events (AEs) Through 1 Month Following Study Vaccination 4 [14]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 4 were included in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through Month 1 after Study Vaccination 4 [Vaccination on Day 1, Month 18]
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1226
    396
    1019
    360
    2245
    756
    Units: Percentage of participants
        number (confidence interval 95%)
    4.1 (3.0 to 5.3)
    2.5 (1.2 to 4.6)
    4.1 (3.0 to 5.5)
    4.7 (2.8 to 7.5)
    4.1 (3.3 to 5.0)
    3.6 (2.4 to 5.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Adverse Events (AEs) Through 1 Month Following any Study Vaccination

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    End point title
    		 Percentage of Participants With Adverse Events (AEs) Through 1 Month Following any Study Vaccination [15]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after any dose were included in this endpoint. Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "subjects analysed" signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 through 1 Month after any study vaccination
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1429
    467
    1219
    418
    2648
    885
    Units: Percentage of participants
        number (confidence interval 95%)
    11.7 (10.1 to 13.5)
    8.6 (6.2 to 11.5)
    11.2 (9.5 to 13.1)
    12.2 (9.2 to 15.7)
    11.5 (10.3 to 12.8)
    10.3 (8.4 to 12.5)
    No statistical analyses for this end point

    Primary: Percentage of Participants With NDCMCs Throughout the Study

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    End point title
    		 Percentage of Participants With NDCMCs Throughout the Study [16]
    End point description
    An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. NDCMCs included conditions that were undiagnosed prior to study entry (diagnosed while in the study and confirmed not to be a preexisting condition) and that were not considered temporary conditions based upon the expected natural history of the condition. Safety population included all enrolled participants who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    From study Vaccination 1 throughout the study [6 months post study Vaccination 4: maximum up to 24 months]
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1429
    467
    1219
    418
    2648
    885
    Units: Percentage of participants
        number (confidence interval 95%)
    2.7 (1.9 to 3.7)
    1.9 (0.9 to 3.6)
    2.1 (1.4 to 3.1)
    3.3 (1.8 to 5.6)
    2.5 (1.9 to 3.1)
    2.6 (1.7 to 3.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants With SAEs Throughout the Study

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    End point title
    		 Percentage of Participants With SAEs Throughout the Study [17]
    End point description
    An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other important medical event. Safety population included all enrolled participants who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    From study Vaccination 1 throughout the study [6 months post study Vaccination 4: maximum up to 24 months]
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: 12 to 17 Years Placebo: 12 to 17 Years VLA15: Overall Placebo: Overall
    Number of subjects analysed
    1429
    467
    1219
    418
    2648
    885
    Units: Percentage of participants
        number (confidence interval 95%)
    1.0 (0.6 to 1.7)
    0.9 (0.2 to 2.2)
    2.2 (1.5 to 3.2)
    2.4 (1.2 to 4.4)
    1.6 (1.1 to 2.1)
    1.6 (0.9 to 2.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: From Day 1 throughout the study (up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination
    Adverse event reporting additional description
    Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v28.0
    Reporting groups
    Reporting group title
    VLA15: 5 to 11 Years
    Reporting group description
    		 Participants aged 5 to 11 years were randomised to receive VLA15, 180 micrograms (ug), 0.5 millilter (mL) intramuscular (IM) injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.

    Reporting group title
    Placebo: 5 to 11 Years
    Reporting group description
    		 Participants aged 5 to 11 years were randomised to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.

    Reporting group title
    VLA15: Overall
    Reporting group description
    		 Participants were randomised to receive VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.

    Reporting group title
    Placebo: 12 to 17 Years
    Reporting group description
    		 Participants aged 12 to17 years were randomised to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.

    Reporting group title
    Placebo: Overall
    Reporting group description
    		 Participants were randomised to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.

    Reporting group title
    VLA15: 12 to 17 Years
    Reporting group description
    		 Participants aged 12 to 17 years were randomised to receive VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.

    Serious adverse events
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: Overall Placebo: 12 to 17 Years Placebo: Overall VLA15: 12 to 17 Years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 1429 (1.05%)
    4 / 467 (0.86%)
    42 / 2648 (1.59%)
    10 / 418 (2.39%)
    14 / 885 (1.58%)
    27 / 1219 (2.21%)
         number of deaths (all causes)
    0
    0
    0
    1
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    1
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hodgkin's disease nodular sclerosis stage IV
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Forearm fracture
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal injury
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    1 / 418 (0.24%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arnold-Chiari malformation
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Central nervous system lesion
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    0 / 2648 (0.00%)
    1 / 418 (0.24%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tethered cord syndrome
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 1429 (0.07%)
    1 / 467 (0.21%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    0 / 2648 (0.00%)
    1 / 418 (0.24%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal oedema
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheal stenosis
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    0 / 2648 (0.00%)
    1 / 418 (0.24%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    0 / 2648 (0.00%)
    1 / 418 (0.24%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    3 / 2648 (0.11%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    2 / 1219 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disruptive mood dysregulation disorder
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    0 / 2648 (0.00%)
    1 / 418 (0.24%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oppositional defiant disorder
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 467 (0.21%)
    3 / 2648 (0.11%)
    0 / 418 (0.00%)
    1 / 885 (0.11%)
    3 / 1219 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    0 / 0
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance-induced psychotic disorder
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    2 / 2648 (0.08%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    2 / 1219 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Chronic recurrent multifocal osteomyelitis
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 1429 (0.07%)
    1 / 467 (0.21%)
    3 / 2648 (0.11%)
    0 / 418 (0.00%)
    1 / 885 (0.11%)
    2 / 1219 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    2 / 2648 (0.08%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    2 / 1219 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis orbital
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza myocarditis
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mycoplasma infection
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    0 / 2648 (0.00%)
    1 / 418 (0.24%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    0 / 2648 (0.00%)
    1 / 418 (0.24%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital abscess
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 467 (0.21%)
    0 / 2648 (0.00%)
    0 / 418 (0.00%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    0 / 2648 (0.00%)
    1 / 418 (0.24%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    2 / 2648 (0.08%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    1 / 1219 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    0 / 2648 (0.00%)
    1 / 418 (0.24%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subperiosteal abscess
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 467 (0.00%)
    1 / 2648 (0.04%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 467 (0.00%)
    0 / 2648 (0.00%)
    2 / 418 (0.48%)
    2 / 885 (0.23%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    2 / 1429 (0.14%)
    0 / 467 (0.00%)
    2 / 2648 (0.08%)
    1 / 418 (0.24%)
    1 / 885 (0.11%)
    0 / 1219 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 VLA15: 5 to 11 Years Placebo: 5 to 11 Years VLA15: Overall Placebo: 12 to 17 Years Placebo: Overall VLA15: 12 to 17 Years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1290 / 1429 (90.27%)
    341 / 467 (73.02%)
    2411 / 2648 (91.05%)
    295 / 418 (70.57%)
    636 / 885 (71.86%)
    1121 / 1219 (91.96%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 1429 (0.14%)
    5 / 467 (1.07%)
    7 / 2648 (0.26%)
    3 / 418 (0.72%)
    8 / 885 (0.90%)
    5 / 1219 (0.41%)
         occurrences all number
    2
    5
    7
    3
    8
    5
    Nervous system disorders
    Headache (HEADACHE)
    alternative assessment type: Systematic
         subjects affected / exposed
    750 / 1429 (52.48%)
    192 / 467 (41.11%)
    1484 / 2648 (56.04%)
    180 / 418 (43.06%)
    372 / 885 (42.03%)
    734 / 1219 (60.21%)
         occurrences all number
    750
    192
    1484
    180
    372
    734
    General disorders and administration site conditions
    Fatigue (FATIGUE)
    alternative assessment type: Systematic
         subjects affected / exposed
    875 / 1429 (61.23%)
    219 / 467 (46.90%)
    1644 / 2648 (62.08%)
    193 / 418 (46.17%)
    412 / 885 (46.55%)
    769 / 1219 (63.08%)
         occurrences all number
    875
    219
    1644
    193
    412
    769
    Injection site pain (PAIN AT INJECTION SITE)
    alternative assessment type: Systematic
         subjects affected / exposed
    1245 / 1429 (87.12%)
    250 / 467 (53.53%)
    2329 / 2648 (87.95%)
    130 / 418 (31.10%)
    380 / 885 (42.94%)
    1084 / 1219 (88.93%)
         occurrences all number
    1245
    250
    2329
    130
    380
    1084
    Injection site swelling
         subjects affected / exposed
    20 / 1429 (1.40%)
    0 / 467 (0.00%)
    27 / 2648 (1.02%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    7 / 1219 (0.57%)
         occurrences all number
    21
    0
    30
    0
    0
    9
    Injection site pain
         subjects affected / exposed
    40 / 1429 (2.80%)
    4 / 467 (0.86%)
    69 / 2648 (2.61%)
    4 / 418 (0.96%)
    8 / 885 (0.90%)
    29 / 1219 (2.38%)
         occurrences all number
    53
    4
    90
    4
    8
    37
    Injection site erythema
         subjects affected / exposed
    20 / 1429 (1.40%)
    0 / 467 (0.00%)
    32 / 2648 (1.21%)
    0 / 418 (0.00%)
    0 / 885 (0.00%)
    12 / 1219 (0.98%)
         occurrences all number
    23
    0
    37
    0
    0
    14
    Swelling (SWELLING)
    alternative assessment type: Systematic
         subjects affected / exposed
    752 / 1429 (52.62%)
    45 / 467 (9.64%)
    1029 / 2648 (38.86%)
    7 / 418 (1.67%)
    52 / 885 (5.88%)
    277 / 1219 (22.72%)
         occurrences all number
    752
    45
    1029
    7
    52
    277
    Pyrexia (FEVER)
    alternative assessment type: Systematic
         subjects affected / exposed
    193 / 1429 (13.51%)
    29 / 467 (6.21%)
    282 / 2648 (10.65%)
    19 / 418 (4.55%)
    48 / 885 (5.42%)
    89 / 1219 (7.30%)
         occurrences all number
    193
    29
    282
    19
    48
    89
    Skin and subcutaneous tissue disorders
    Erythema (REDNESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    891 / 1429 (62.35%)
    76 / 467 (16.27%)
    1196 / 2648 (45.17%)
    12 / 418 (2.87%)
    88 / 885 (9.94%)
    305 / 1219 (25.02%)
         occurrences all number
    891
    76
    1196
    12
    88
    305
    Psychiatric disorders
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    27 / 1429 (1.89%)
    8 / 467 (1.71%)
    34 / 2648 (1.28%)
    5 / 418 (1.20%)
    13 / 885 (1.47%)
    7 / 1219 (0.57%)
         occurrences all number
    27
    8
    34
    5
    13
    7
    Depression
         subjects affected / exposed
    2 / 1429 (0.14%)
    1 / 467 (0.21%)
    11 / 2648 (0.42%)
    7 / 418 (1.67%)
    8 / 885 (0.90%)
    9 / 1219 (0.74%)
         occurrences all number
    2
    1
    11
    7
    8
    9
    Musculoskeletal and connective tissue disorders
    Arthralgia (JOINT PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    375 / 1429 (26.24%)
    64 / 467 (13.70%)
    728 / 2648 (27.49%)
    65 / 418 (15.55%)
    129 / 885 (14.58%)
    353 / 1219 (28.96%)
         occurrences all number
    375
    64
    728
    65
    129
    353
    Myalgia (MUSCLE PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    717 / 1429 (50.17%)
    112 / 467 (23.98%)
    1354 / 2648 (51.13%)
    110 / 418 (26.32%)
    222 / 885 (25.08%)
    637 / 1219 (52.26%)
         occurrences all number
    717
    112
    1354
    110
    222
    637
    Infections and infestations
    COVID-19
         subjects affected / exposed
    18 / 1429 (1.26%)
    2 / 467 (0.43%)
    28 / 2648 (1.06%)
    9 / 418 (2.15%)
    11 / 885 (1.24%)
    10 / 1219 (0.82%)
         occurrences all number
    18
    2
    28
    9
    11
    10
    Pharyngitis streptococcal
         subjects affected / exposed
    47 / 1429 (3.29%)
    14 / 467 (3.00%)
    59 / 2648 (2.23%)
    5 / 418 (1.20%)
    19 / 885 (2.15%)
    12 / 1219 (0.98%)
         occurrences all number
    50
    15
    63
    5
    20
    13
    Upper respiratory tract infection
         subjects affected / exposed
    31 / 1429 (2.17%)
    13 / 467 (2.78%)
    55 / 2648 (2.08%)
    16 / 418 (3.83%)
    29 / 885 (3.28%)
    24 / 1219 (1.97%)
         occurrences all number
    32
    13
    57
    17
    30
    25
    Influenza
         subjects affected / exposed
    12 / 1429 (0.84%)
    6 / 467 (1.28%)
    17 / 2648 (0.64%)
    4 / 418 (0.96%)
    10 / 885 (1.13%)
    5 / 1219 (0.41%)
         occurrences all number
    12
    6
    17
    4
    10
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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