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    Clinical Trial Results:
    A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lots and a High Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults

    Summary
    EudraCT number
    		 2015-001658-14
    Trial protocol
    		 ES  
    Global end of trial date
    29 Sep 2017

    Results information
    Results version number
    		 v1
    This version publication date
    26 Sep 2018
    First version publication date
    26 Sep 2018
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V920-012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02503202
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.
    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
    17 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 24
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    United States: 1133
    Worldwide total number of subjects
    1197
    EEA total number of subjects
    40
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1186
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study enrolled healthy male and female adults.

    Pre-assignment
    Screening details
    		 A total of 1261 participants were screened and 1197 were randomized.

    Period 1
    Period 1 title
    Base Study: Up to Month 6
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V920 Consistency Lot A
    Arm description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Consistency Lot A
    Investigational medicinal product code
    Other name
    V920 (rVSVZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nominal ≥2 x 10^7 plaque-forming units in 1 mL for intramuscular injection

    Arm title
    		 V920 Consistency Lot B
    Arm description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Consistency Lot B
    Investigational medicinal product code
    Other name
    V920 (rVSVZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nominal ≥2 x 10^7 plaque-forming units in 1 mL for intramuscular injection

    Arm title
    		 V920 Consistency Lot C
    Arm description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Consistency Lot C
    Investigational medicinal product code
    Other name
    V920 (rVSVZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nominal ≥2 x 10^7 plaque-forming units in 1 mL for intramuscular injection

    Arm title
    		 V920 High-dose Lot
    Arm description
    		 Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 High-dose Lot
    Investigational medicinal product code
    Other name
    V920 (rVSVZEBOV-GP) Ebola Zaire vaccine consistency high-dose lot, live, attenuated, sterile solution for intramuscular injection
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nominal ≥1 x 10^8 plaque-forming units in 1 mL for intramuscular injection

    Arm title
    		 Placebo
    Arm description
    		 Participants received a 1.0-mL intramuscular injection of placebo on Day 1
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Normal saline (0.9%)
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 mL for intramuscular injection

    Number of subjects in period 1
    		V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
    Started
    266
    265
    267
    266
    133
    Vaccinated
    266
    265
    266
    264
    133
    Completed
    248
    253
    252
    255
    130
    Not completed
    18
    12
    15
    11
    3
         Adverse event, serious fatal
    1
    1
    -
    -
    -
         Consent withdrawn by subject
    6
    3
    4
    4
    1
         Physician decision
    -
    -
    -
    -
    1
         Randomized not vaccinated
    -
    -
    1
    2
    -
         Lost to follow-up
    11
    8
    10
    5
    1
    Period 2
    Period 2 title
    Extension: Month 6 to 24
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V920 Consistency Lot A
    Arm description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Consistency Lot A
    Investigational medicinal product code
    Other name
    V920 (rVSVZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nominal ≥2 x 10^7 plaque-forming units in 1 mL for intramuscular injection on Day 1 in the Base Study. No vaccine was administered in the study extension.

    Arm title
    		 V920 Consistency Lot B
    Arm description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Consistency Lot B
    Investigational medicinal product code
    Other name
    V920 (rVSVZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nominal ≥2 x 10^7 plaque-forming units in 1 mL for intramuscular injection on Day 1 in the Base Study. No vaccine was administered in the study extension.

    Arm title
    		 V920 Consistency Lot C
    Arm description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Consistency Lot C
    Investigational medicinal product code
    Other name
    V920 (rVSVZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nominal ≥2 x 10^7 plaque-forming units in 1 mL for intramuscular injection on Day 1 in the Base Study. No vaccine was administered in the study extension.

    Arm title
    		 V920 High-dose Lot
    Arm description
    		 Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 High-dose Lot
    Investigational medicinal product code
    Other name
    V920 (rVSVZEBOV-GP) Ebola Zaire vaccine consistency high-dose lot, live, attenuated, sterile solution for intramuscular injection
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nominal ≥1 x 10^8 plaque-forming units in 1 mL for intramuscular injection on Day 1 in the Base Study. No vaccine was administered in the study extension.

    Arm title
    		 Placebo
    Arm description
    		 Participants received a 1.0-mL intramuscular injection of placebo on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Normal saline (0.9%)
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 mL for intramuscular injection on Day 1 in the Base Study. No placebo was administered in the study extension.

    Number of subjects in period 2 [1]
    		V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
    Started
    119
    130
    112
    137
    68
    Completed
    108
    114
    103
    119
    67
    Not completed
    11
    16
    9
    18
    1
         Adverse event, serious fatal
    1
    -
    -
    -
    -
         Physician decision
    1
    -
    1
    3
    -
         Consent withdrawn by subject
    5
    8
    2
    4
    -
         Lost to follow-up
    4
    8
    6
    10
    1
         Protocol deviation
    -
    -
    -
    1
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants from selected US sites were invited to enroll in the study extension. Participation in the study extension was voluntary.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V920 Consistency Lot A
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1

    Reporting group title
    V920 Consistency Lot B
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1

    Reporting group title
    V920 Consistency Lot C
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1

    Reporting group title
    V920 High-dose Lot
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of placebo on Day 1

    Reporting group values
    		 V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo Total
    Number of subjects
    		 266 265 267 266 133 1197
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 263 263 263 265 132 1186
        From 65-84 years
    		 3 2 4 1 1 11
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 41.3 ( 13.4 ) 41.5 ( 12.4 ) 40.9 ( 13.1 ) 41.7 ( 13.4 ) 41.1 ( 13.7 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 143 135 138 149 72 637
        Male
    		 123 130 129 117 61 560

    End points

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    End points reporting groups
    Reporting group title
    V920 Consistency Lot A
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1

    Reporting group title
    V920 Consistency Lot B
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1

    Reporting group title
    V920 Consistency Lot C
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1

    Reporting group title
    V920 High-dose Lot
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of placebo on Day 1
    Reporting group title
    V920 Consistency Lot A
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.

    Reporting group title
    V920 Consistency Lot B
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.

    Reporting group title
    V920 Consistency Lot C
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.

    Reporting group title
    V920 High-dose Lot
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of placebo on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.

    Primary: Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody

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    End point title
    		 Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody
    End point description
    Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL. A value of 36.11 in the table means that the geometric mean and CIs were <36.11 EU/mL. The population analyzed was participants who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample collected within the acceptable day range.
    End point type
    Primary
    End point timeframe
    Day 28 postvaccination
    End point values
    		 V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
    Number of subjects analysed
    239
    231
    226
    219
    124
    Units: EU/mL
        geometric mean (confidence interval 95%)
    1183.9 (1038.7 to 1349.4)
    1266.0 (1108.2 to 1446.2)
    1346.0 (1176.6 to 1539.9)
    1291.9 (1126.9 to 1481.2)
    36.11 (36.11 to 36.11)
    Statistical analysis title
    		 Equivalence
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot B
    Number of subjects included in analysis
    470
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 < 0.001 [2]
    Method
    		 ANOVA
    Parameter type
    		 GMT ratio (Lot A / Lot B)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.14
    Notes
    [1] - Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis.
    [2] - Primary analysis: a p-value <0.025 supported the conclusion of equivalence. As equivalence was established for the 3 pairwise comparisons, the lots were considered to be consistent.
    Statistical analysis title
    		 Equivalence
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot C
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    P-value
    		 < 0.001 [4]
    Method
    		 ANOVA
    Parameter type
    		 GMT ratio (Lot A / Lot C)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.09
    Notes
    [3] - Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis.
    [4] - Primary analysis: a p-value <0.025 supported the conclusion of equivalence. As equivalence was established for the 3 pairwise comparisons, the lots were considered to be consistent.
    Statistical analysis title
    		 Equivalence
    Comparison groups
    V920 Consistency Lot B v V920 Consistency Lot C
    Number of subjects included in analysis
    457
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 < 0.001 [6]
    Method
    		 ANOVA
    Parameter type
    		 GMT ratio (Lot B / Lot C)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.15
    Notes
    [5] - Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis.
    [6] - Primary analysis: a p-value <0.025 supported the conclusion of equivalence. As equivalence was established for the 3 pairwise comparisons, the lots were considered to be consistent.

    Primary: Percentage of Participants Reporting Serious Adverse Events

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    End point title
    		 Percentage of Participants Reporting Serious Adverse Events
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose. The population analyzed was randomized participants who received vaccination and had follow-up data for the outcome measure.
    End point type
    Primary
    End point timeframe
    Up to Month 6 postvaccination
    End point values
    		 V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
    Number of subjects analysed
    265
    263
    263
    260
    133
    Units: Percentage of participants
        number (not applicable)
    2.6
    1.5
    2.7
    1.2
    0.0
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot B
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    P-value
    		 = 0.368
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 4
    Notes
    [7] - Risk difference is Lot A - Lot B
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot C
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    P-value
    		 = 0.989
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 3
    Notes
    [8] - Risk difference is Lot A - Lot C
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot B v V920 Consistency Lot C
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    P-value
    		 = 0.361
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 1.5
    Notes
    [9] - Risk difference is Lot B - Lot C
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 High-dose Lot v Placebo
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    P-value
    		 = 0.214
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 3.3
    Notes
    [10] - Risk difference is High-dose Lot - Placebo

    Primary: Percentage of Participants with Injection-site Adverse Events Prompted on the Vaccination Report Card

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    End point title
    		 Percentage of Participants with Injection-site Adverse Events Prompted on the Vaccination Report Card
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. The population analyzed was randomized participants who received vaccination and had follow-up data for the outcome measure.
    End point type
    Primary
    End point timeframe
    Up to Day 5 postvaccination
    End point values
    		 V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
    Number of subjects analysed
    265
    263
    263
    260
    133
    Units: Percentage of participants
    number (not applicable)
        Injection-site erythema|
    14.7
    10.6
    14.8
    7.3
    1.5
        Injection-site pain|
    66.8
    73.0
    70.3
    67.7
    12.8
        Injection-site swelling|
    17.7
    13.7
    18.3
    16.2
    3.0
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site erythema
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot B
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    P-value
    		 = 0.16
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 9.9
    Notes
    [11] - Risk difference is Lot A - Lot B
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site erythema
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot C
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [12]
    P-value
    		 = 0.971
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.2
         upper limit
    		 6
    Notes
    [12] - Risk difference is Lot A - Lot C
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site erythema
    Comparison groups
    V920 Consistency Lot B v V920 Consistency Lot C
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    P-value
    		 = 0.151
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 1.5
    Notes
    [13] - Risk difference is Lot B - Lot C
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site erythema
    Comparison groups
    V920 High-dose Lot v Placebo
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 [14]
    P-value
    		 = 0.016
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 9.9
    Notes
    [14] - Risk difference is High-dose Lot - Placebo
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site pain
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot B
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [15]
    P-value
    		 = 0.12
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14
         upper limit
    		 1.6
    Notes
    [15] - Risk difference is Lot A - Lot B
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site pain
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot C
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [16]
    P-value
    		 = 0.38
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -3.5
    Confidence interval
         level
    		 94%
         sides
    2-sided
         lower limit
    		 -11.4
         upper limit
    		 4.4
    Notes
    [16] - Risk difference is Lot A - Lot C
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site pain
    Comparison groups
    V920 Consistency Lot B v V920 Consistency Lot C
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 [17]
    P-value
    		 = 0.499
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 10.4
    Notes
    [17] - Risk difference is Lot B - Lot C
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site pain
    Comparison groups
    V920 High-dose Lot v Placebo
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 [18]
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    54.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 46.2
         upper limit
    		 62.3
    Notes
    [18] - Risk difference is High-dose Lot - Placebo
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site swelling
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot B
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [19]
    P-value
    		 = 0.202
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 10.3
    Notes
    [19] - Risk difference is Lot A - Lot B
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site swelling
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot C
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [20]
    P-value
    		 = 0.878
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 6.1
    Notes
    [20] - Risk difference is Lot A - Lot C
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site swelling
    Comparison groups
    V920 Consistency Lot B v V920 Consistency Lot C
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 [21]
    P-value
    		 = 0.154
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.9
         upper limit
    		 1.7
    Notes
    [21] - Risk difference is Lot B - Lot C
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Injection site swelling
    Comparison groups
    V920 High-dose Lot v Placebo
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 [22]
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    13.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.4
         upper limit
    		 18.6
    Notes
    [22] - Risk difference is High-dose Lot - Placebo

    Primary: Percentage of Participants with Elevated Maximum Temperature

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    End point title
    		 Percentage of Participants with Elevated Maximum Temperature
    End point description
    Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F). The population analyzed was randomized participants who received vaccination and had follow-up data for the outcome measure.
    End point type
    Primary
    End point timeframe
    Up to Day 42 postvaccination
    End point values
    		 V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
    Number of subjects analysed
    262
    263
    263
    258
    132
    Units: Percentage of participants
        number (not applicable)
    21.4
    16.7
    22.4
    32.2
    0.8
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot B
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 [23]
    P-value
    		 = 0.176
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 11.4
    Notes
    [23] - Risk difference is Lot A - Lot B
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot C
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 [24]
    P-value
    		 = 0.769
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.2
         upper limit
    		 6
    Notes
    [24] - Risk difference is Lot A - Lot C
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot B v V920 Consistency Lot C
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 [25]
    P-value
    		 = 0.1
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -5.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.5
         upper limit
    		 1.1
    Notes
    [25] - Risk difference is Lot B - Lot C
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 High-dose Lot v Placebo
    Number of subjects included in analysis
    390
    Analysis specification
    Pre-specified
    Analysis type
    		 [26]
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    31.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.6
         upper limit
    		 37.5
    Notes
    [26] - Risk difference is high-dose lot - placebo

    Primary: Percentage of Participants with Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card

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    End point title
    		 Percentage of Participants with Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC. The population analyzed was randomized participants who received vaccination and had follow-up data for the outcome measure.
    End point type
    Primary
    End point timeframe
    From Day 5 to Day 42 postvaccination
    End point values
    		 V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
    Number of subjects analysed
    265
    263
    263
    260
    133
    Units: Percentage of participants
    number (not applicable)
        Arthralgia AEs|
    5.7
    5.7
    6.5
    7.7
    1.5
        Arthritis AEs|
    4.5
    3.8
    2.7
    3.1
    0.0
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Arthralgia
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot B
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [27]
    P-value
    		 = 0.983
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 4.1
    Notes
    [27] - Risk difference is Lot A - Lot B
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Arthralgia
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot C
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [28]
    P-value
    		 = 0.699
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 3.4
    Notes
    [28] - Risk difference is Lot A - Lot C
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Arthralgia
    Comparison groups
    V920 Consistency Lot B v V920 Consistency Lot C
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 [29]
    P-value
    		 = 0.716
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 3.5
    Notes
    [29] - Risk difference is Lot B - Lot C
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Arthralgia
    Comparison groups
    V920 High-dose Lot v Placebo
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 [30]
    P-value
    		 = 0.012
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 10.4
    Notes
    [30] - Risk difference is high-dose lot - placebo
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Arthritis
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot B
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [31]
    P-value
    		 = 0.677
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 4.4
    Notes
    [31] - Risk difference is Lot A - Lot B
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Arthritis
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot C
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [32]
    P-value
    		 = 0.25
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 5.4
    Notes
    [32] - Risk difference is Lot A - Lot C
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Arthritis
    Comparison groups
    V920 Consistency Lot B v V920 Consistency Lot C
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 [33]
    P-value
    		 = 0.46
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 4.5
    Notes
    [33] - Risk difference is Lot B - Lot C
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Arthritis
    Comparison groups
    V920 High-dose Lot v Placebo
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 [34]
    P-value
    		 = 0.041
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 6
    Notes
    [34] - Risk difference is high-dose lot - placebo

    Primary: Percentage of Participants with Rash Adverse Events Prompted on the Vaccination Report Card

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    End point title
    		 Percentage of Participants with Rash Adverse Events Prompted on the Vaccination Report Card
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash. The analysis population was randomized participants who received vaccination and had follow-up data for the outcome measure.
    End point type
    Primary
    End point timeframe
    Up to Day 42 postvaccination
    End point values
    		 V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
    Number of subjects analysed
    265
    263
    263
    260
    133
    Units: Percentage of participants
        number (not applicable)
    3.0
    4.6
    3.8
    3.8
    1.5
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot B
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [35]
    P-value
    		 = 0.353
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 1.9
    Notes
    [35] - Risk difference is Lot A - Lot B
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot C
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [36]
    P-value
    		 = 0.62
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 2.5
    Notes
    [36] - Risk difference is Lot A - Lot C
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot B v V920 Consistency Lot C
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 [37]
    P-value
    		 = 0.663
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 4.5
    Notes
    [37] - Risk difference is Lot B - Lot C
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 High-dose Lot v Placebo
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 [38]
    P-value
    		 = 0.202
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 5.7
    Notes
    [38] - Risk difference is high-dose lot - placebo

    Primary: Percentage of Participants with Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card

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    End point title
    		 Percentage of Participants with Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular. The population analyzed was randomized participants who received vaccination and had follow-up data for the outcome measure.
    End point type
    Primary
    End point timeframe
    Up to Day 42 postvaccination
    End point values
    		 V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
    Number of subjects analysed
    265
    263
    263
    260
    133
    Units: Percentage of participants
        number (not applicable)
    1.9
    1.1
    1.5
    1.5
    0.0
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot B
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [39]
    P-value
    		 = 0.483
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 3.3
    Notes
    [39] - Risk difference is Lot A - Lot B
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot A v V920 Consistency Lot C
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 [40]
    P-value
    		 = 0.746
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 3
    Notes
    [40] - Risk difference is Lot A - Lot C
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 Consistency Lot B v V920 Consistency Lot C
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 [41]
    P-value
    		 = 0.704
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 2
    Notes
    [41] - Risk difference is Lot B - Lot C
    Statistical analysis title
    		 Risk Difference
    Comparison groups
    V920 High-dose Lot v Placebo
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 [42]
    P-value
    		 = 0.151
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 3.9
    Notes
    [42] - Risk difference is high-dose lot - placebo

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Month 24
    Adverse event reporting additional description
    The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    V920 Lot A
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.

    Reporting group title
    V920 Lot B
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.

    Reporting group title
    V920 High Dose
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.

    Reporting group title
    V920 Lot C
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No vaccine was administered in the study extension.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a 1.0-mL intramuscular injection of placebo A on Day 1. A subset of participants was followed beyond Month 6 through approximately Month 24 to assess long-term safety. No placebo was administered in the study extension.

    Serious adverse events
    		 V920 Lot A V920 Lot B V920 High Dose V920 Lot C Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 265 (4.53%)
    12 / 263 (4.56%)
    8 / 260 (3.08%)
    11 / 263 (4.18%)
    4 / 133 (3.01%)
         number of deaths (all causes)
    2
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    1 / 260 (0.38%)
    1 / 263 (0.38%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Breast cancer
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    1 / 260 (0.38%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer stage III
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ruptured ectopic pregnancy
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    1 / 260 (0.38%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menometrorrhagia
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory failure
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    1 / 260 (0.38%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    1 / 260 (0.38%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Platelet count decreased
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Arthropod bite
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    1 / 260 (0.38%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scapula fracture
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radicular pain
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    1 / 260 (0.38%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Conductive deafness
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal incarcerated hernia
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    1 / 260 (0.38%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Renal failure
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Hyperthyroidism
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Exostosis
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    1 / 263 (0.38%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Meningitis aseptic
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 263 (0.00%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 263 (0.38%)
    0 / 260 (0.00%)
    0 / 263 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V920 Lot A V920 Lot B V920 High Dose V920 Lot C Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    211 / 265 (79.62%)
    211 / 263 (80.23%)
    208 / 260 (80.00%)
    208 / 263 (79.09%)
    35 / 133 (26.32%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    61 / 265 (23.02%)
    51 / 263 (19.39%)
    67 / 260 (25.77%)
    55 / 263 (20.91%)
    15 / 133 (11.28%)
         occurrences all number
    72
    56
    83
    68
    18
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    14 / 265 (5.28%)
    16 / 263 (6.08%)
    27 / 260 (10.38%)
    20 / 263 (7.60%)
    1 / 133 (0.75%)
         occurrences all number
    14
    16
    27
    20
    1
    Fatigue
         subjects affected / exposed
    21 / 265 (7.92%)
    15 / 263 (5.70%)
    20 / 260 (7.69%)
    9 / 263 (3.42%)
    3 / 133 (2.26%)
         occurrences all number
    22
    15
    21
    9
    3
    Influenza like illness
         subjects affected / exposed
    14 / 265 (5.28%)
    12 / 263 (4.56%)
    9 / 260 (3.46%)
    18 / 263 (6.84%)
    1 / 133 (0.75%)
         occurrences all number
    14
    13
    9
    19
    1
    Injection site erythema
         subjects affected / exposed
    39 / 265 (14.72%)
    30 / 263 (11.41%)
    19 / 260 (7.31%)
    39 / 263 (14.83%)
    2 / 133 (1.50%)
         occurrences all number
    43
    30
    23
    42
    2
    Injection site pain
         subjects affected / exposed
    179 / 265 (67.55%)
    192 / 263 (73.00%)
    176 / 260 (67.69%)
    185 / 263 (70.34%)
    18 / 133 (13.53%)
         occurrences all number
    198
    215
    192
    212
    19
    Injection site swelling
         subjects affected / exposed
    47 / 265 (17.74%)
    36 / 263 (13.69%)
    42 / 260 (16.15%)
    49 / 263 (18.63%)
    4 / 133 (3.01%)
         occurrences all number
    51
    40
    42
    52
    4
    Pain
         subjects affected / exposed
    34 / 265 (12.83%)
    23 / 263 (8.75%)
    32 / 260 (12.31%)
    29 / 263 (11.03%)
    2 / 133 (1.50%)
         occurrences all number
    34
    23
    33
    30
    2
    Pyrexia
         subjects affected / exposed
    58 / 265 (21.89%)
    47 / 263 (17.87%)
    76 / 260 (29.23%)
    63 / 263 (23.95%)
    1 / 133 (0.75%)
         occurrences all number
    66
    47
    83
    70
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    12 / 265 (4.53%)
    13 / 263 (4.94%)
    14 / 260 (5.38%)
    15 / 263 (5.70%)
    1 / 133 (0.75%)
         occurrences all number
    12
    13
    15
    16
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    47 / 265 (17.74%)
    41 / 263 (15.59%)
    53 / 260 (20.38%)
    50 / 263 (19.01%)
    4 / 133 (3.01%)
         occurrences all number
    72
    74
    79
    75
    7
    Myalgia
         subjects affected / exposed
    17 / 265 (6.42%)
    11 / 263 (4.18%)
    23 / 260 (8.85%)
    12 / 263 (4.56%)
    1 / 133 (0.75%)
         occurrences all number
    19
    13
    23
    12
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jul 2015
    Amendment 1: Modified Inclusion Criteria to indicate that male subjects of reproductive potential must avoid impregnating a partner for 2 months following study vaccination by complying with the outlined contraception methods.
    28 Jan 2016
    Amendment 2: Modified sections to reflect a subset of approximately 600 subjects who will continue in the study through Month 24 in a study extension.

    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
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