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    Clinical Trial Results:
    A Phase 2/3 Protocol to Investigate the Safety, Tolerability, and Immunogenicity of BNT162b2 RNA - Based Vaccine Candidates for SARS-Cov-2 New Variants in Healthy Individuals

    Summary
    EudraCT number
    		 2024-000361-24
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date

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

    Trial information

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    Trial identification
    Sponsor protocol code
    C4591054
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05997290
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BioNTech SE
    Sponsor organisation address
    An der Goldgrube 12, Mainz, Germany, 55131
    Public contact
    BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de
    Scientific contact
    BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    25 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Mar 2024
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    SSA: Describe the safety & tolerability profile of BNT162b2 (Omi XBB.1.5) 30 micrograms (mcg) in messenger ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine-experienced participants >=12 years of age & describe immune response to BNT162b2 (Omi XBB.1.5) 30 mcg & to bivalent BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg in mRNA COVID-19 vaccine–experienced participants =>12 years of age. SSB: Describe the safety & tolerability profile of BNT162b2 (Omi XBB.1.5) 30 mcg given as a single dose to COVID-19 vaccine-naïve participants who were previously SARS-CoV-2 exposed, >=12 years of age & demonstrate the noninferiority with respect to level of neutralizing titer & with respect to seroresponse rate of the anti-XBB.1.5 immune response elicited by BNT162b2 (Omi XBB.1.5) 30 mcg given as a single dose to COVID-19 vaccine–naïve participants, who were previously SARS-CoV-2 exposed, >=12 years of age compared to BNT162b2 (Omi XBB.1.5) 30 mcg given to vaccine-experienced participants in SSA.
    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
    10 Aug 2023
    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: 723
    Worldwide total number of subjects
    723
    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)
    0
    Adolescents (12-17 years)
    39
    Adults (18-64 years)
    517
    From 65 to 84 years
    165
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 SSA: A total of 417 participants were screened in sub-study A out of which 412 were vaccinated. SSB: A total of 311 participants were screened and vaccinated in sub-study B.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SSA: Group 1: 12-17 years
    Arm description
    		 Participants aged 12 to 17 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via intramuscular (IM) route on Day 1 of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2 (Omi XBB.1.5)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

    Arm title
    		 SSA: Group 2: 18-55 years
    Arm description
    		 Participants aged 18 to 55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2 (Omi XBB.1.5)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

    Arm title
    		 SSA: Group 3: >55 years
    Arm description
    		 Participants aged greater than (>) 55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2 (Omi XBB.1.5)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

    Arm title
    		 SSB: Group 1: 12-17 years
    Arm description
    		 Participants aged 12-17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2 (Omi XBB.1.5)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

    Arm title
    		 SSB: Group 2: 18-55 years
    Arm description
    		 Participants aged 18-55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2 (Omi XBB.1.5)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

    Arm title
    		 SSB: Group 3: >55 years
    Arm description
    		 Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2 (Omi XBB.1.5)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

    Number of subjects in period 1
    		SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSB: Group 1: 12-17 years SSB: Group 2: 18-55 years SSB: Group 3: >55 years
    Started
    30
    174
    208
    9
    253
    49
    Safety Population
    30
    174
    208
    9
    253
    49
    Evaluable Immunogenicity Population
    27 [1]
    167 [2]
    188 [3]
    9
    243
    47
    Completed
    29
    172
    203
    9
    225
    44
    Not completed
    1
    2
    5
    0
    28
    5
         Consent withdrawn by subject
    1
    -
    2
    -
    6
    1
         Death
    -
    -
    1
    -
    -
    -
         Lost to follow-up
    -
    2
    -
    -
    22
    4
         Protocol deviation
    -
    -
    2
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SSA: Group 1: 12-17 years
    Reporting group description
    		 Participants aged 12 to 17 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via intramuscular (IM) route on Day 1 of this study.

    Reporting group title
    SSA: Group 2: 18-55 years
    Reporting group description
    		 Participants aged 18 to 55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSA: Group 3: >55 years
    Reporting group description
    		 Participants aged greater than (>) 55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSB: Group 1: 12-17 years
    Reporting group description
    		 Participants aged 12-17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSB: Group 2: 18-55 years
    Reporting group description
    		 Participants aged 18-55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSB: Group 3: >55 years
    Reporting group description
    		 Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSB: Group 1: 12-17 years SSB: Group 2: 18-55 years SSB: Group 3: >55 years Total
    Number of subjects
    		 30 174 208 9 253 49 723
    Age Categorical
    Units: Participants
        Adolescents (12-17 years)
    		 30 0 0 9 0 0 39
        Adults (18-64 years)
    		 0 174 63 0 253 27 517
        From 65-84 years
    		 0 0 143 0 0 22 165
        85 years and over
    		 0 0 2 0 0 0 2
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.0 ( 1.74 ) 40.4 ( 9.82 ) 68.6 ( 6.74 ) 14.6 ( 1.67 ) 34.5 ( 10.43 ) 64.0 ( 6.35 ) -
    Gender Categorical
    Units: Participants
        Female
    		 19 100 123 5 138 23 408
        Male
    		 11 74 85 4 115 26 315
    Race
    Units: Subjects
        White
    		 26 135 164 2 162 30 519
        Black or African American
    		 3 23 27 7 87 16 163
        American Indian or Alaska Native
    		 0 0 1 0 0 1 2
        Asian
    		 1 11 10 0 4 2 28
        Native Hawaiian or other Pacific Islander
    		 0 0 2 0 0 0 2
        Multiracial
    		 0 5 3 0 0 0 8
        Unknown
    		 0 0 1 0 0 0 1
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 6 35 34 3 136 19 233
        Non-Hispanic/non-Latino
    		 24 138 173 6 117 30 488
        Not reported
    		 0 1 1 0 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    SSA: Group 1: 12-17 years
    Reporting group description
    		 Participants aged 12 to 17 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via intramuscular (IM) route on Day 1 of this study.

    Reporting group title
    SSA: Group 2: 18-55 years
    Reporting group description
    		 Participants aged 18 to 55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSA: Group 3: >55 years
    Reporting group description
    		 Participants aged greater than (>) 55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSB: Group 1: 12-17 years
    Reporting group description
    		 Participants aged 12-17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSB: Group 2: 18-55 years
    Reporting group description
    		 Participants aged 18-55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSB: Group 3: >55 years
    Reporting group description
    		 Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Subject analysis set title
    SSA Total Study Participants: C4591054
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study. This analysis set is created for safety analysis.

    Subject analysis set title
    SSA Historical Control: C4591044 BNT162b2 12-17 years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 12 to 17 years from study C4591044 (NCT05472038) Cohort 2/Cohort 3 who received bivalent BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as a fourth dose were used as historical control for immunogenicity. This analysis set is created for immunogenicity analysis.

    Subject analysis set title
    SSA Historical Control: C4591044 BNT162b2 18-55 years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 18 to 55 years from study C4591044 (NCT05472038) Cohort 2/Cohort 3 who received bivalent BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as a fourth dose were used as historical control for immunogenicity. This analysis set is created for immunogenicity analysis.

    Subject analysis set title
    SSA Historical Control: C4591044 BNT162b2 >55 years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged >55 years from study C4591044 (NCT05472038) Cohort 2/Cohort 3 who received bivalent BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as a fourth dose were used as historical control for immunogenicity. This analysis set is created for immunogenicity analysis.

    Subject analysis set title
    SSA Total Study Participants: C4591054
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study. This analysis set is created for immunogenicity analysis.

    Subject analysis set title
    SSA Total Historical Control: C4591044 BNT162b2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants from study C4591044 (NCT05472038) Cohort 2/Cohort 3 who received bivalent BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as a fourth dose were used as historical control for immunogenicity. This analysis set is created for immunogenicity analysis.

    Subject analysis set title
    SSB Total Study Participants
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged >=12 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in SSB. This analysis set is created for safety analysis.

    Subject analysis set title
    SSB: Vaccine-Naïve Substudy B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged >=12 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in SSB. This analysis set is created for immunogenicity analysis.

    Subject analysis set title
    SSB Control: Vaccine-Experienced Substudy A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in SSA were included. This analysis set is created for immunogenicity analysis.

    Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA

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    End point title
    		 Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA [1] [2]
    End point description
    Local reactions: pain at injection site, redness and swelling recorded by participants in an electronic diary (e-diary) or as adverse events (AEs) in the case report form (CRF). Redness & swelling measured & recorded in measuring device units (mdu)(range:1 to 21),1mdu=0.5 cm &were graded as mild (greater than[>] 2.0 to 5.0 cm),moderate(>5.0 to 10.0 cm),severe(>10.0 cm)&Grade 4(necrosis [swelling]&necrosis or exfoliative dermatitis[redness]).Pain at injection site graded as mild(did not interfere with activity),moderate(interfered with activity),severe(prevented daily activity)&Grade(G)4(emergency room [ER]visit or hospitalisation for severe pain at injection site).G4 LR classified by investigator or medically qualified person.Exact 2-sided confidence interval(CI)based on Clopper and Pearson method. Safety population: all participants who received study intervention.Number of Participants Analysed=Participants evaluable.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 7 after vaccination
    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.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSA Total Study Participants: C4591054
    Number of subjects analysed
    30
    174
    206
    410
    Units: Percentage of Participants
    number (confidence interval 95%)
        Redness: Any
    10.0 (2.1 to 26.5)
    4.0 (1.6 to 8.1)
    5.8 (3.0 to 10.0)
    5.4 (3.4 to 8.0)
        Redness: Mild
    6.7 (0.8 to 22.1)
    3.4 (1.3 to 7.4)
    3.9 (1.7 to 7.5)
    3.9 (2.2 to 6.3)
        Redness: Moderate
    3.3 (0.1 to 17.2)
    0.6 (0.0 to 3.2)
    1.9 (0.5 to 4.9)
    1.5 (0.5 to 3.2)
        Redness: Severe
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Redness: Grade 4
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Swelling: Any
    16.7 (5.6 to 34.7)
    7.5 (4.0 to 12.4)
    5.8 (3.0 to 10.0)
    7.3 (5.0 to 10.3)
        Swelling: Mild
    13.3 (3.8 to 30.7)
    5.7 (2.8 to 10.3)
    3.9 (1.7 to 7.5)
    5.4 (3.4 to 8.0)
        Swelling: Moderate
    3.3 (0.1 to 17.2)
    1.7 (0.4 to 5.0)
    1.9 (0.5 to 4.9)
    2.0 (0.8 to 3.8)
        Swelling: Severe
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Swelling: Grade 4
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Pain at the injection site: Any
    80.0 (61.4 to 92.3)
    75.9 (68.8 to 82.0)
    52.4 (45.4 to 59.4)
    64.4 (59.5 to 69.0)
        Pain at the injection site: Mild
    50.0 (31.3 to 68.7)
    59.8 (52.1 to 67.1)
    46.6 (39.6 to 53.7)
    52.4 (47.5 to 57.4)
        Pain at the injection site: Moderate
    30.0 (14.7 to 49.4)
    16.1 (11.0 to 22.4)
    5.8 (3.0 to 10.0)
    12.0 (9.0 to 15.5)
        Pain at the injection site: Severe
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Pain at the injection site: Grade 4
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA

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    End point title
    		 Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA [3] [4]
    End point description
    Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 degree Celsius (deg C) and categorised as >= 38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and joint pain: mild (didn’t interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous (IV) hydration. Diarrhoea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 events were classified by investigator or medically qualified person. Exact 2-sided CI was based on Clopper and Pearson method. Safety population: All participants who received the study intervention. Number of Participants Analysed= Participants evaluable.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 7 after vaccination
    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.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSA Total Study Participants: C4591054
    Number of subjects analysed
    30
    174
    206
    410
    Units: Percentage of participants
    number (confidence interval 95%)
        Fever: Any
    16.7 (5.6 to 34.7)
    4.0 (1.6 to 8.1)
    3.9 (1.7 to 7.5)
    4.9 (3.0 to 7.4)
        Fever: >=38.0 degree C to 38.4 degree C
    10.0 (2.1 to 26.5)
    3.4 (1.3 to 7.4)
    2.4 (0.8 to 5.6)
    3.4 (1.9 to 5.7)
        Fever: >38.4 degree C to 38.9 degree C
    3.3 (0.1 to 17.2)
    0.6 (0.0 to 3.2)
    1.0 (0.1 to 3.5)
    1.0 (0.3 to 2.5)
        Fever: >38.9 degree C to 40.0 degree C
    3.3 (0.1 to 17.2)
    0 (0.0 to 2.1)
    0.5 (0.0 to 2.7)
    0.5 (0.1 to 1.8)
        Fever: >40.0 degree C
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Fatigue: Any
    56.7 (37.4 to 74.5)
    56.9 (49.2 to 64.4)
    35.4 (28.9 to 42.4)
    46.1 (41.2 to 51.1)
        Fatigue: Mild
    30.0 (14.7 to 49.4)
    31.6 (24.8 to 39.1)
    18.4 (13.4 to 24.4)
    24.9 (20.8 to 29.4)
        Fatigue: Moderate
    26.7 (12.3 to 45.9)
    24.1 (18.0 to 31.2)
    17.0 (12.1 to 22.8)
    20.7 (16.9 to 25.0)
        Fatigue: Severe
    0 (0.0 to 11.6)
    1.1 (0.1 to 4.1)
    0 (0.0 to 1.8)
    0.5 (0.1 to 1.8)
        Fatigue: Grade 4
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Headache: Any
    36.7 (19.9 to 56.1)
    43.7 (36.2 to 51.4)
    26.2 (20.3 to 32.8)
    34.4 (29.8 to 39.2)
        Headache: Mild
    30.0 (14.7 to 49.4)
    31.0 (24.3 to 38.5)
    20.4 (15.1 to 26.5)
    25.6 (21.5 to 30.1)
        Headache: Moderate
    6.7 (0.8 to 22.1)
    12.6 (8.1 to 18.5)
    5.8 (3.0 to 10.0)
    8.8 (6.2 to 11.9)
        Headache: Severe
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Headache: Grade 4
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Chills: Any
    20.0 (7.7 to 38.6)
    9.2 (5.3 to 14.5)
    9.2 (5.6 to 14.0)
    10.0 (7.3 to 13.3)
        Chills: Mild
    10.0 (2.1 to 26.5)
    6.9 (3.6 to 11.7)
    6.3 (3.4 to 10.5)
    6.8 (4.6 to 9.7)
        Chills: Moderate
    10.0 (2.1 to 26.5)
    2.3 (0.6 to 5.8)
    2.9 (1.1 to 6.2)
    3.2 (1.7 to 5.4)
        Chills: Severe
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Chills: Grade 4
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Vomiting: Any
    0 (0.0 to 11.6)
    2.3 (0.6 to 5.8)
    0 (0.0 to 1.8)
    1.0 (0.3 to 2.5)
        Vomiting: Mild
    0 (0.0 to 11.6)
    2.3 (0.6 to 5.8)
    0 (0.0 to 1.8)
    1.0 (0.3 to 2.5)
        Vomiting: Moderate
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Vomiting: Severe
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Vomiting: Grade 4
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        Diarrhea: Any
    0 (0.0 to 11.6)
    13.2 (8.6 to 19.2)
    8.7 (5.3 to 13.5)
    10.0 (7.3 to 13.3)
        Diarrhea: Mild
    0 (0.0 to 11.6)
    11.5 (7.2 to 17.2)
    7.3 (4.1 to 11.7)
    8.5 (6.0 to 11.7)
        Diarrhea: Moderate
    0 (0.0 to 11.6)
    1.1 (0.1 to 4.1)
    1.5 (0.3 to 4.2)
    1.2 (0.4 to 2.8)
        Diarrhea: Severe
    0 (0.0 to 11.6)
    0.6 (0.0 to 3.2)
    0 (0.0 to 1.8)
    0.2 (0.0 to 1.4)
        Diarrhea: Grade 4
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        New or worsened muscle pain: Any
    23.3 (9.9 to 42.3)
    21.8 (15.9 to 28.7)
    12.1 (8.0 to 17.4)
    17.1 (13.6 to 21.1)
        New or worsened muscle pain: Mild
    3.3 (0.1 to 17.2)
    12.1 (7.6 to 17.9)
    5.3 (2.7 to 9.4)
    8.0 (5.6 to 11.1)
        New or worsened muscle pain: Moderate
    20.0 (7.7 to 38.6)
    9.8 (5.8 to 15.2)
    6.8 (3.8 to 11.1)
    9.0 (6.4 to 12.2)
        New or worsened muscle pain: Severe
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        New or worsened joint pain: Any
    16.7 (5.6 to 34.7)
    14.4 (9.5 to 20.5)
    7.8 (4.5 to 12.3)
    11.2 (8.3 to 14.7)
        New or worsened joint pain: Mild
    6.7 (0.8 to 22.1)
    8.6 (4.9 to 13.8)
    5.3 (2.7 to 9.4)
    6.8 (4.6 to 9.7)
        New or worsened joint pain: Moderate
    10.0 (2.1 to 26.5)
    5.7 (2.8 to 10.3)
    2.4 (0.8 to 5.6)
    4.4 (2.6 to 6.8)
        New or worsened joint pain: Severe
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
        New or worsened joint pain: Grade 4
    0 (0.0 to 11.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.8)
    0 (0.0 to 0.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA

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    End point title
    		 Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA [5] [6]
    End point description
    An AE was defined as 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. Percentage of participants reporting AEs from study vaccination on Day 1 up to 1 month after the study vaccination were reported in this endpoint. Exact 2-sided CI was based on Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received the study intervention.
    End point type
    Primary
    End point timeframe
    From vaccination on Day 1 up to 1 month after 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.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSA Total Study Participants: C4591054
    Number of subjects analysed
    30
    174
    208
    412
    Units: Percentage of participants
        number (confidence interval 95%)
    16.7 (5.6 to 34.7)
    7.5 (4.0 to 12.4)
    8.2 (4.8 to 12.8)
    8.5 (6.0 to 11.6)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination Through 6 Months After the Study Vaccination: SSA

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    End point title
    		 Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination Through 6 Months After the Study Vaccination: SSA [7] [8]
    End point description
    An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; or considered as an important medical event. Percentage of participants reporting SAEs from study vaccination on Day 1 up to 6 months after the study vaccination were reported in this endpoint. Exact 2-sided CI was based on Clopper and Pearson method. Safety population included all participants who received the study intervention.
    End point type
    Primary
    End point timeframe
    From vaccination on Day 1 up to 6 months after vaccination
    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.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSA Total Study Participants: C4591054
    Number of subjects analysed
    30
    174
    208
    412
    Units: Percentage of Participants
        number (confidence interval 95%)
    3.3 (0.1 to 17.2)
    0 (0.0 to 2.1)
    1.9 (0.5 to 4.9)
    1.2 (0.4 to 2.8)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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    End point title
    		 Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 [9] [10]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination
    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.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSA Historical Control: C4591044 BNT162b2 12-17 years SSA Historical Control: C4591044 BNT162b2 18-55 years SSA Historical Control: C4591044 BNT162b2 >55 years SSA Total Study Participants: C4591054 SSA Total Historical Control: C4591044 BNT162b2
    Number of subjects analysed
    27
    166
    185
    15
    85
    100
    378
    200
    Units: Titer
        geometric mean (confidence interval 95%)
    3632.1 (2043.8 to 6454.7)
    2503.6 (2003.0 to 3129.3)
    2606.8 (2065.5 to 3289.9)
    837.1 (459.5 to 1524.9)
    615.5 (459.0 to 825.2)
    560.4 (430.0 to 730.2)
    2622.3 (2246.6 to 3060.9)
    601.0 (499.5 to 723.1)
    No statistical analyses for this end point

    Primary: GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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    End point title
    		 GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 [11] [12]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination
    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.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSA Historical Control: C4591044 BNT162b2 12-17 years SSA Historical Control: C4591044 BNT162b2 18-55 years SSA Historical Control: C4591044 BNT162b2 >55 years SSA Total Study Participants: C4591054 SSA Total Historical Control: C4591044 BNT162b2
    Number of subjects analysed
    26
    167
    187
    15
    85
    100
    380
    200
    Units: Titer
        geometric mean (confidence interval 95%)
    7903.6 (4961.5 to 12590.4)
    4831.8 (4044.5 to 5772.3)
    5046.1 (4123.3 to 6175.3)
    6376.3 (3568.4 to 11393.8)
    3868.2 (2974.8 to 5029.9)
    4122.7 (3261.2 to 5211.6)
    5105.1 (4483.4 to 5813.0)
    4146.0 (3512.6 to 4893.5)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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    End point title
    		 Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 [13] [14]
    End point description
    GMFR and 2-sided 95% CI were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From before vaccination on Day 1 up to 1 month after vaccination
    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.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSA Historical Control: C4591044 BNT162b2 12-17 years SSA Historical Control: C4591044 BNT162b2 18-55 years SSA Historical Control: C4591044 BNT162b2 >55 years SSA Total Study Participants: C4591054 SSA Total Historical Control: C4591044 BNT162b2
    Number of subjects analysed
    27
    165
    184
    15
    82
    100
    376
    197
    Units: Fold rise
        geometric mean (confidence interval 95%)
    11.8 (6.3 to 22.2)
    10.7 (8.7 to 13.1)
    13.5 (10.7 to 17.1)
    7.1 (3.9 to 12.8)
    6.1 (4.5 to 8.3)
    5.2 (4.1 to 6.5)
    12.1 (10.4 to 14.0)
    5.7 (4.8 to 6.8)
    No statistical analyses for this end point

    Primary: GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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    End point title
    		 GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 [15] [16]
    End point description
    GMFR and 2-sided 95% CI were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From before vaccination on Day 1 up to 1 month after 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.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSA Historical Control: C4591044 BNT162b2 12-17 years SSA Historical Control: C4591044 BNT162b2 18-55 years SSA Historical Control: C4591044 BNT162b2 >55 years SSA Total Study Participants: C4591054 SSA Total Historical Control: C4591044 BNT162b2
    Number of subjects analysed
    26
    167
    186
    15
    85
    100
    379
    200
    Units: Fold rise
        geometric mean (confidence interval 95%)
    3.5 (2.2 to 5.8)
    4.3 (3.7 to 5.0)
    5.1 (4.3 to 6.2)
    5.7 (3.4 to 9.4)
    6.2 (4.6 to 8.4)
    7.4 (5.7 to 9.6)
    4.6 (4.1 to 5.2)
    6.8 (5.6 to 8.1)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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    End point title
    		 Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 [17] [18]
    End point description
    Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse. Exact 2-sided CI was based on the Clopper and Pearson method. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination
    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.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSA Historical Control: C4591044 BNT162b2 12-17 years SSA Historical Control: C4591044 BNT162b2 18-55 years SSA Historical Control: C4591044 BNT162b2 >55 years SSA Total Study Participants: C4591054 SSA Total Historical Control: C4591044 BNT162b2
    Number of subjects analysed
    27
    165
    184
    15
    82
    100
    376
    197
    Units: Percentage of Participants
        number (confidence interval 95%)
    74.1 (53.7 to 88.9)
    76.4 (69.1 to 82.6)
    71.7 (64.6 to 78.1)
    66.7 (38.4 to 88.2)
    52.4 (41.1 to 63.6)
    51.0 (40.8 to 61.1)
    73.9 (69.2 to 78.3)
    52.8 (45.6 to 59.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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    End point title
    		 Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 [19] [20]
    End point description
    Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse. Exact 2-sided CI was based on the Clopper and Pearson method. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination
    Notes
    [19] - 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.
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSA Historical Control: C4591044 BNT162b2 12-17 years SSA Historical Control: C4591044 BNT162b2 18-55 years SSA Historical Control: C4591044 BNT162b2 >55 years SSA Total Study Participants: C4591054 SSA Total Historical Control: C4591044 BNT162b2
    Number of subjects analysed
    26
    167
    186
    15
    85
    100
    379
    200
    Units: Percentage of participants
        number (confidence interval 95%)
    46.2 (26.6 to 66.6)
    43.7 (36.1 to 51.6)
    52.7 (45.3 to 60.0)
    73.3 (44.9 to 92.2)
    58.8 (47.6 to 69.4)
    65.0 (54.8 to 74.3)
    48.3 (43.2 to 53.4)
    63.0 (55.9 to 69.7)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB

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    End point title
    		 Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB [21] [22]
    End point description
    Local reactions: pain at injection site, redness and swelling recorded by participants in an e-diary or as AEs in the CRF. Redness & swelling measured & recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm & were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) & Grade 4 (necrosis [swelling] & necrosis or exfoliative dermatitis [redness]). Pain at injection site graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) & G4 (ER visit or hospitalisation for severe pain at injection site). G4 LR classified by investigator or medically qualified person. Exact 2-sided CI based on Clopper and Pearson method. Safety population: all participants who received study intervention. Number of Participants Analysed= Participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 7 after vaccination
    Notes
    [21] - 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.
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSB: Group 1: 12-17 years SSB: Group 2: 18-55 years SSB: Group 3: >55 years SSB Total Study Participants
    Number of subjects analysed
    9
    250
    49
    308
    Units: Percentage of Participants
    number (confidence interval 95%)
        Redness: Any
    0 (0.0 to 33.6)
    8.8 (5.6 to 13.0)
    2.0 (0.1 to 10.9)
    7.5 (4.8 to 11.0)
        Redness: Mild
    0 (0.0 to 33.6)
    5.6 (3.1 to 9.2)
    2.0 (0.1 to 10.9)
    4.9 (2.8 to 7.9)
        Redness: Moderate
    0 (0.0 to 33.6)
    2.8 (1.1 to 5.7)
    0 (0.0 to 7.3)
    2.3 (0.9 to 4.6)
        Redness: Severe
    0 (0.0 to 33.6)
    0.4 (0.0 to 2.2)
    0 (0.0 to 7.3)
    0.3 (0.0 to 1.8)
        Redness: Grade 4
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Swelling: Any
    11.1 (0.3 to 48.2)
    12.0 (8.2 to 16.7)
    10.2 (3.4 to 22.2)
    11.7 (8.3 to 15.8)
        Swelling: Mild
    11.1 (0.3 to 48.2)
    6.8 (4.0 to 10.7)
    8.2 (2.3 to 19.6)
    7.1 (4.5 to 10.6)
        Swelling: Moderate
    0 (0.0 to 33.6)
    5.2 (2.8 to 8.7)
    2.0 (0.1 to 10.9)
    4.5 (2.5 to 7.5)
        Swelling: Severe
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Swelling: Grade 4
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Pain at the injection site: Any
    44.4 (13.7 to 78.8)
    58.0 (51.6 to 64.2)
    36.7 (23.4 to 51.7)
    54.2 (48.5 to 59.9)
        Pain at the injection site: Mild
    44.4 (13.7 to 78.8)
    36.4 (30.4 to 42.7)
    32.7 (19.9 to 47.5)
    36.0 (30.7 to 41.7)
        Pain at the injection site: Moderate
    0 (0.0 to 33.6)
    21.2 (16.3 to 26.8)
    4.1 (0.5 to 14.0)
    17.9 (13.7 to 22.6)
        Pain at the injection site: Severe
    0 (0.0 to 33.6)
    0.4 (0.0 to 2.2)
    0 (0.0 to 7.3)
    0.3 (0.0 to 1.8)
        Pain at the injection site: Grade 4
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB

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    End point title
    		 Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB [23] [24]
    End point description
    Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 deg C and categorised as >= 38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and joint pain: mild (didn’t interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhoea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 events were classified by investigator or medically qualified person. Exact 2-sided CI was based on Clopper and Pearson method. Safety population: All participants who received the study intervention. Number of Participants Analysed= Participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 7 after vaccination
    Notes
    [23] - 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.
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSB: Group 1: 12-17 years SSB: Group 2: 18-55 years SSB: Group 3: >55 years SSB Total Study Participants
    Number of subjects analysed
    9
    250
    49
    308
    Units: Percentage of participants
    number (confidence interval 95%)
        Fever: Any
    11.1 (0.3 to 48.2)
    2.4 (0.9 to 5.2)
    6.1 (1.3 to 16.9)
    3.2 (1.6 to 5.9)
        Fever: >=38.0 degree C to 38.4 degree C
    0 (0.0 to 33.6)
    0.8 (0.1 to 2.9)
    4.1 (0.5 to 14.0)
    1.3 (0.4 to 3.3)
        Fever: >38.4 degree C to 38.9 degree C
    11.1 (0.3 to 48.2)
    1.2 (0.2 to 3.5)
    0 (0.0 to 7.3)
    1.3 (0.4 to 3.3)
        Fever: >38.9 degree C to 40.0 degree C
    0 (0.0 to 33.6)
    0.4 (0.0 to 2.2)
    2.0 (0.1 to 10.9)
    0.6 (0.1 to 2.3)
        Fever: >40.0 degree C
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Fatigue: Any
    11.1 (0.3 to 48.2)
    34.8 (28.9 to 41.1)
    24.5 (13.3 to 38.9)
    32.5 (27.3 to 38.0)
        Fatigue: Mild
    0 (0.0 to 33.6)
    13.6 (9.6 to 18.5)
    8.2 (2.3 to 19.6)
    12.3 (8.9 to 16.5)
        Fatigue: Moderate
    11.1 (0.3 to 48.2)
    21.2 (16.3 to 26.8)
    16.3 (7.3 to 29.7)
    20.1 (15.8 to 25.0)
        Fatigue: Severe
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Fatigue: Grade 4
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Headache: Any
    11.1 (0.3 to 48.2)
    30.8 (25.1 to 36.9)
    16.3 (7.3 to 29.7)
    27.9 (23.0 to 33.3)
        Headache: Mild
    11.1 (0.3 to 48.2)
    12.0 (8.2 to 16.7)
    12.2 (4.6 to 24.8)
    12.0 (8.6 to 16.2)
        Headache: Moderate
    0 (0.0 to 33.6)
    18.0 (13.4 to 23.3)
    4.1 (0.5 to 14.0)
    15.3 (11.4 to 19.8)
        Headache: Severe
    0 (0.0 to 33.6)
    0.8 (0.1 to 2.9)
    0 (0.0 to 7.3)
    0.6 (0.1 to 2.3)
        Headache: Grade 4
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Chills: Any
    11.1 (0.3 to 48.2)
    12.0 (8.2 to 16.7)
    10.2 (3.4 to 22.2)
    11.7 (8.3 to 15.8)
        Chills: Mild
    11.1 (0.3 to 48.2)
    7.2 (4.3 to 11.1)
    4.1 (0.5 to 14.0)
    6.8 (4.3 to 10.2)
        Chills: Moderate
    0 (0.0 to 33.6)
    4.8 (2.5 to 8.2)
    6.1 (1.3 to 16.9)
    4.9 (2.8 to 7.9)
        Chills: Severe
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Chills: Grade 4
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Vomiting: Any
    0 (0.0 to 33.6)
    4.8 (2.5 to 8.2)
    2.0 (0.1 to 10.9)
    4.2 (2.3 to 7.1)
        Vomiting: Mild
    0 (0.0 to 33.6)
    2.4 (0.9 to 5.2)
    2.0 (0.1 to 10.9)
    2.3 (0.9 to 4.6)
        Vomiting: Moderate
    0 (0.0 to 33.6)
    2.4 (0.9 to 5.2)
    0 (0.0 to 7.3)
    1.9 (0.7 to 4.2)
        Vomiting: Severe
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Vomiting: Grade 4
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        Diarrhoea: Any
    11.1 (0.3 to 48.2)
    16.8 (12.4 to 22.0)
    8.2 (2.3 to 19.6)
    15.3 (11.4 to 19.8)
        Diarrhoea: Mild
    11.1 (0.3 to 48.2)
    10.0 (6.6 to 14.4)
    6.1 (1.3 to 16.9)
    9.4 (6.4 to 13.2)
        Diarrhoea: Moderate
    0 (0.0 to 33.6)
    6.4 (3.7 to 10.2)
    2.0 (0.1 to 10.9)
    5.5 (3.2 to 8.7)
        Diarrhoea: Severe
    0 (0.0 to 33.6)
    0.4 (0.0 to 2.2)
    0 (0.0 to 7.3)
    0.3 (0.0 to 1.8)
        Diarrhoea: Grade 4
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        New or worsened muscle pain: Any
    11.1 (0.3 to 48.2)
    18.0 (13.4 to 23.3)
    18.4 (8.8 to 32.0)
    17.9 (13.7 to 22.6)
        New or worsened muscle pain: Mild
    11.1 (0.3 to 48.2)
    8.0 (5.0 to 12.1)
    10.2 (3.4 to 22.2)
    8.4 (5.6 to 12.1)
        New or worsened muscle pain: Moderate
    0 (0.0 to 33.6)
    10.0 (6.6 to 14.4)
    8.2 (2.3 to 19.6)
    9.4 (6.4 to 13.2)
        New or worsened muscle pain: Severe
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        New or worsened joint pain: Any
    11.1 (0.3 to 48.2)
    12.8 (8.9 to 17.6)
    12.2 (4.6 to 24.8)
    12.7 (9.2 to 16.9)
        New or worsened joint pain: Mild
    11.1 (0.3 to 48.2)
    6.4 (3.7 to 10.2)
    6.1 (1.3 to 16.9)
    6.5 (4.0 to 9.9)
        New or worsened joint pain: Moderate
    0 (0.0 to 33.6)
    6.4 (3.7 to 10.2)
    6.1 (1.3 to 16.9)
    6.2 (3.8 to 9.5)
        New or worsened joint pain: Severe
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
        New or worsened joint pain: Grade 4
    0 (0.0 to 33.6)
    0 (0.0 to 1.5)
    0 (0.0 to 7.3)
    0 (0.0 to 1.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB

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    End point title
    		 Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB [25] [26]
    End point description
    An AE was defined as 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. Percentage of participants reporting AEs from study vaccination on Day 1 up to 1 month after the study vaccination were reported in this endpoint. Exact 2-sided CI was based on Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received the study intervention.
    End point type
    Primary
    End point timeframe
    From vaccination on Day 1 up to 1 month after vaccination
    Notes
    [25] - 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.
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSB: Group 1: 12-17 years SSB: Group 2: 18-55 years SSB: Group 3: >55 years SSB Total Study Participants
    Number of subjects analysed
    9
    253
    49
    311
    Units: Percentage of Participants
        number (confidence interval 95%)
    0 (0.0 to 33.6)
    2.4 (0.9 to 5.1)
    2.0 (0.1 to 10.9)
    2.3 (0.9 to 4.6)
    No statistical analyses for this end point

    Primary: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB

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    End point title
    		 Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB [27] [28]
    End point description
    An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; or considered as an important medical event. Percentage of participants reporting SAEs from study vaccination on Day 1 up to 6 months after the study vaccination were reported in this endpoint. Exact 2-sided CI was based on Clopper and Pearson method. Safety population included all participants who received the study intervention.
    End point type
    Primary
    End point timeframe
    From vaccination on Day 1 up to 6 months after vaccination
    Notes
    [27] - 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.
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 SSB: Group 1: 12-17 years SSB: Group 2: 18-55 years SSB: Group 3: >55 years SSB Total Study Participants
    Number of subjects analysed
    9
    253
    49
    311
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 33.6)
    0.8 (0.1 to 2.8)
    2.0 (0.1 to 10.9)
    1.0 (0.2 to 2.8)
    No statistical analyses for this end point

    Primary: Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA

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    End point title
    		 Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the least square (LS) means and the corresponding CIs based on analysis of log-transformed assay results using a linear regression model with baseline assay results (log scale), age and vaccine group as covariates. Assay results below the LLOQ were set to 0.5*LLOQ. GMT is reported in descriptive section and GMR in statistical analysis section. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination
    End point values
    		 SSB: Vaccine-Naïve Substudy B SSB Control: Vaccine-Experienced Substudy A
    Number of subjects analysed
    298
    295
    Units: Titer
        geometric mean (confidence interval 95%)
    4951.6 (4222.8 to 5806.2)
    2566.5 (2186.8 to 3012.1)
    Statistical analysis title
    		 Vaccine-Naïve SSB vs Vaccine-Experienced SSA
    Statistical analysis description
    GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the difference in LS means (Substudy B - Substudy A) and the corresponding CIs based on analysis of log-transformed assay results using a linear regression model with baseline assay results (log scale), age and vaccine group as covariates. Noninferiority of GMR was met if the lower limit of the 95% CI was greater than 0.67.
    Comparison groups
    SSB: Vaccine-Naïve Substudy B v SSB Control: Vaccine-Experienced Substudy A
    Number of subjects included in analysis
    593
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.52
         upper limit
    		 2.44

    Primary: Difference in Percentages of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA

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    End point title
    		 Difference in Percentages of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA
    End point description
    Seroresponse was defined as achieving >= 4-fold rise from baseline. If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse. Percentage of participants with seroresponse is reported in descriptive section and percentage difference in statistical analysis section. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination
    End point values
    		 SSB: Vaccine-Naïve Substudy B SSB Control: Vaccine-Experienced Substudy A
    Number of subjects analysed
    298
    295
    Units: Percentage of participants
        number (confidence interval 95%)
    84.9 (80.3 to 88.8)
    73.9 (68.5 to 78.8)
    Statistical analysis title
    		 Vaccine-Naïve SSB vs Vaccine-Experienced SSA
    Statistical analysis description
    2-Sided CI, based on the Miettinen and Nurminen method stratified by baseline neutralizing titer category (< median, >= median) and age group (< median, >= median). Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages was greater than -10%.
    Comparison groups
    SSB: Vaccine-Naïve Substudy B v SSB Control: Vaccine-Experienced Substudy A
    Number of subjects included in analysis
    593
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    7.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.34
         upper limit
    		 13.28

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SSA & SSB: Systematic assessment: Local reactions, systemic events: Day 1 to Day 7 after vaccination (vacc.); Non-systematic assessment: SAEs: Day 1 of vacc. up to 6 months after study vacc. & Non-SAEs: Day 1 of vaccination up to 1 month after study vacc.
    Adverse event reporting additional description
    Same event may appear as both AE 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 non-SAE.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    SSA: Group 1: 12-17 years
    Reporting group description
    		 Participants aged 12 to 17 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSA: Group 2: 18-55 years
    Reporting group description
    		 Participants aged 18 to 55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSA: Group 3: >55 years
    Reporting group description
    		 Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSB: Group 1: 12-17 years
    Reporting group description
    		 Participants aged 12-17 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSB: Group 2: 18-55 years
    Reporting group description
    		 Participants aged 18-55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Reporting group title
    SSB: Group 3: >55 years
    Reporting group description
    		 Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

    Serious adverse events
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSB: Group 1: 12-17 years SSB: Group 2: 18-55 years SSB: Group 3: >55 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 174 (0.00%)
    4 / 208 (1.92%)
    0 / 9 (0.00%)
    2 / 253 (0.79%)
    1 / 49 (2.04%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    1
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    1 / 208 (0.48%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    1 / 208 (0.48%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    1 / 208 (0.48%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    Dyspnoea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    1 / 253 (0.40%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    1 / 208 (0.48%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    Paroxysmal nocturnal haemoglobinuria
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    1 / 208 (0.48%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    1 / 253 (0.40%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    1 / 208 (0.48%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 SSA: Group 1: 12-17 years SSA: Group 2: 18-55 years SSA: Group 3: >55 years SSB: Group 1: 12-17 years SSB: Group 2: 18-55 years SSB: Group 3: >55 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 30 (90.00%)
    154 / 174 (88.51%)
    134 / 208 (64.42%)
    4 / 9 (44.44%)
    167 / 253 (66.01%)
    25 / 49 (51.02%)
    Nervous system disorders
    Restless arm syndrome
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Headache (HEADACHE)
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 30 (36.67%)
    76 / 174 (43.68%)
    54 / 208 (25.96%)
    1 / 9 (11.11%)
    76 / 253 (30.04%)
    8 / 49 (16.33%)
         occurrences all number
    11
    76
    54
    1
    76
    8
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 174 (1.15%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    1 / 253 (0.40%)
    0 / 49 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    General disorders and administration site conditions
    Chills (CHILLS)
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 30 (20.00%)
    16 / 174 (9.20%)
    19 / 208 (9.13%)
    1 / 9 (11.11%)
    30 / 253 (11.86%)
    5 / 49 (10.20%)
         occurrences all number
    6
    16
    19
    1
    30
    5
    Fatigue
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 174 (1.15%)
    2 / 208 (0.96%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    Injection site erythema (REDNESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 30 (10.00%)
    7 / 174 (4.02%)
    12 / 208 (5.77%)
    0 / 9 (0.00%)
    22 / 253 (8.70%)
    1 / 49 (2.04%)
         occurrences all number
    3
    7
    12
    0
    22
    1
    Fatigue (FATIGUE)
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 30 (56.67%)
    99 / 174 (56.90%)
    73 / 208 (35.10%)
    1 / 9 (11.11%)
    87 / 253 (34.39%)
    12 / 49 (24.49%)
         occurrences all number
    17
    99
    73
    1
    87
    12
    Injection site pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    4 / 208 (1.92%)
    0 / 9 (0.00%)
    5 / 253 (1.98%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    4
    0
    5
    0
    Injection site pain (PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 30 (80.00%)
    132 / 174 (75.86%)
    107 / 208 (51.44%)
    4 / 9 (44.44%)
    142 / 253 (56.13%)
    18 / 49 (36.73%)
         occurrences all number
    24
    132
    107
    4
    142
    18
    Injection site pruritus
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Injection site swelling (SWELLING)
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 30 (16.67%)
    13 / 174 (7.47%)
    12 / 208 (5.77%)
    1 / 9 (11.11%)
    30 / 253 (11.86%)
    5 / 49 (10.20%)
         occurrences all number
    5
    13
    12
    1
    30
    5
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 174 (1.15%)
    1 / 208 (0.48%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Pyrexia (FEVER)
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 30 (16.67%)
    7 / 174 (4.02%)
    8 / 208 (3.85%)
    1 / 9 (11.11%)
    6 / 253 (2.37%)
    3 / 49 (6.12%)
         occurrences all number
    5
    7
    8
    1
    6
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 174 (1.72%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Vomiting (VOMITING)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    4 / 174 (2.30%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    12 / 253 (4.74%)
    1 / 49 (2.04%)
         occurrences all number
    0
    4
    0
    0
    12
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 174 (1.15%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Diarrhoea (DIARRHEA)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    21 / 174 (12.07%)
    18 / 208 (8.65%)
    1 / 9 (11.11%)
    42 / 253 (16.60%)
    4 / 49 (8.16%)
         occurrences all number
    0
    21
    18
    1
    42
    4
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia (MUSCLE PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 30 (23.33%)
    38 / 174 (21.84%)
    25 / 208 (12.02%)
    1 / 9 (11.11%)
    45 / 253 (17.79%)
    9 / 49 (18.37%)
         occurrences all number
    7
    38
    25
    1
    45
    9
    Arthralgia (JOINT PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 30 (16.67%)
    25 / 174 (14.37%)
    16 / 208 (7.69%)
    1 / 9 (11.11%)
    32 / 253 (12.65%)
    6 / 49 (12.24%)
         occurrences all number
    5
    25
    16
    1
    32
    6
    Pain in extremity
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Sialoadenitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 174 (0.00%)
    0 / 208 (0.00%)
    0 / 9 (0.00%)
    0 / 253 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0

    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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