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    Clinical Trial Results:
    A Phase 4, Open-Label, Single-Arm Trial to Describe the Safety, Tolerability, And Immunogenicity of Trumenba® When Administered to Immunocompromised Participants ≥10 Years of Age

    Summary
    EudraCT number
    		 2018-002588-24
    Trial protocol
    		 CZ   PL  
    Global end of trial date
    06 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Mar 2024
    First version publication date
    17 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B1971060
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04893811
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235E 42nd Street, New York, United States, NY 10017
    Public contact
    PfizerClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    PfizerClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main immunogenicity objective of the study was to describe the immune response induced by 2 doses of Trumenba in immunocompromised subjects and historical age-matched healthy subjects as measured by serum bactericidal assay using human complement (hSBA) performed with 4 primary Neisseria meningitidis serogroup B (MnB) test strains, 2 expressing an LP2086 subfamily A protein and 2 expressing an LP2086 subfamily B protein. The main safety objective of the study was to evaluate the safety profile of Trumenba in immunocompromised subjects and historical age-matched healthy subjects.
    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 subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Aug 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czechia: 16
    Country: Number of subjects enrolled
    Finland: 5
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Türkiye: 24
    Country: Number of subjects enrolled
    United States: 42
    Worldwide total number of subjects
    104
    EEA total number of subjects
    38
    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)
    4
    Adolescents (12-17 years)
    14
    Adults (18-64 years)
    83
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 53 subjects were enrolled at multiple sites. Study started from 18 August 2021 and completed on 06 September 2023.

    Pre-assignment
    Screening details
    		 Age- and sex-matched healthy subjects from groups 2 or 4 (Trumenba) of previously completed Phase 3 study B1971057 Stage 1 were used as control arm in this study; their historical data was used as reference for safety and immunogenicity analysis.

    Period 1
    Period 1 title
    Vaccination phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Trumenba
    Arm description
    		 Immunocompromised subjects >=10 years of age with asplenia (anatomic or functional) or complement deficiency, received Trumenba 0.5 millilitre (mL), intramuscularly (IM) on Day 1 of Visit 1 (Month 0) and Visit 3 (Month 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trumenba
    Investigational medicinal product code
    PF-05212366
    Other name
    Bivalent rLP2086 and meningococcal serogroup B vaccine
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Immunocompromised subjects >=10 years of age with asplenia (anatomic or functional) or complement deficiency, received Trumenba 0.5 mL, IM on Day 1 of Visit 1 (Month 0) and Visit 3 (Month 6).

    Arm title
    		 Trumenba: From B1971057, Control Arm
    Arm description
    		 Age- and sex-matched healthy subjects from group 2 or 4 (Trumenba groups) from Phase 3 study B1971057 Stage 1(NCT ID: NCT04893811/EudraCT Number: 2016-004421-17) were randomly selected and included in this group. This arm served as a control arm for the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Trumenba
    Investigational medicinal product code
    PF-05212366
    Other name
    Bivalent rLP2086 and meningococcal serogroup B vaccine
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL IM injection at Month 0 (first dose along with Menveo) and at Month 6 (second dose, single) during Stage 1 of the study B1971057.

    Investigational medicinal product name
    Meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM)
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL IM injection at Month 0 (first dose along with Trumenba) during Stage 1 of the study B1971057.

    Number of subjects in period 1
    		Trumenba Trumenba: From B1971057, Control Arm
    Started
    53
    51
    Vaccination 1
    53
    51
    Vaccination 2
    47
    47
    Completed
    47
    47
    Not completed
    6
    4
         Consent withdrawn by subject
    2
    1
         No longer meets eligibility criteria
    -
    1
         Death
    1
    -
         Unspecified
    -
    1
         Lost to follow-up
    1
    1
         Protocol deviation
    2
    -
    Period 2
    Period 2 title
    Follow-up phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Trumenba
    Arm description
    		 Immunocompromised subjects >=10 years of age with asplenia (anatomic or functional) or complement deficiency, received Trumenba 0.5 mL, IM on Day 1 of Visit 1 (Month 0) and Visit 3 (Month 6).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Trumenba: From B1971057, Control Arm
    Arm description
    		 Age- and sex-matched healthy subjects from group 2 or 4 (Trumenba groups) from Phase 3 study B1971057 Stage 1 (NCT ID: NCT04893811/EudraCT Number: 2016-004421-17) were randomly selected and included in this group. This arm served as a control arm for the study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Trumenba Trumenba: From B1971057, Control Arm
    Started
    47
    47
    Completed
    47
    46
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Trumenba
    Reporting group description
    		 Immunocompromised subjects >=10 years of age with asplenia (anatomic or functional) or complement deficiency, received Trumenba 0.5 millilitre (mL), intramuscularly (IM) on Day 1 of Visit 1 (Month 0) and Visit 3 (Month 6).

    Reporting group title
    Trumenba: From B1971057, Control Arm
    Reporting group description
    		 Age- and sex-matched healthy subjects from group 2 or 4 (Trumenba groups) from Phase 3 study B1971057 Stage 1(NCT ID: NCT04893811/EudraCT Number: 2016-004421-17) were randomly selected and included in this group. This arm served as a control arm for the study.

    Reporting group values
    		 Trumenba Trumenba: From B1971057, Control Arm Total
    Number of subjects
    		 53 51 104
    Age Categorical
    Units: Subjects
        Children (2-11 years)
    		 2 2 4
        Adolescents (12-17 years)
    		 8 6 14
        Adults (18-64 years)
    		 40 43 83
        From 65-84 years
    		 3 0 3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.5 ( 16.55 ) 22.2 ( 4.26 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 23 21 44
        Male
    		 30 30 60
    Race
    Units: Subjects
        White
    		 53 46 99
        Black or African American
    		 0 3 3
        Asian
    		 0 2 2
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 0 7 7
        Not Hispanic/Latino
    		 53 44 97

    End points

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    End points reporting groups
    Reporting group title
    Trumenba
    Reporting group description
    		 Immunocompromised subjects >=10 years of age with asplenia (anatomic or functional) or complement deficiency, received Trumenba 0.5 millilitre (mL), intramuscularly (IM) on Day 1 of Visit 1 (Month 0) and Visit 3 (Month 6).

    Reporting group title
    Trumenba: From B1971057, Control Arm
    Reporting group description
    		 Age- and sex-matched healthy subjects from group 2 or 4 (Trumenba groups) from Phase 3 study B1971057 Stage 1(NCT ID: NCT04893811/EudraCT Number: 2016-004421-17) were randomly selected and included in this group. This arm served as a control arm for the study.
    Reporting group title
    Trumenba
    Reporting group description
    		 Immunocompromised subjects >=10 years of age with asplenia (anatomic or functional) or complement deficiency, received Trumenba 0.5 mL, IM on Day 1 of Visit 1 (Month 0) and Visit 3 (Month 6).

    Reporting group title
    Trumenba: From B1971057, Control Arm
    Reporting group description
    		 Age- and sex-matched healthy subjects from group 2 or 4 (Trumenba groups) from Phase 3 study B1971057 Stage 1 (NCT ID: NCT04893811/EudraCT Number: 2016-004421-17) were randomly selected and included in this group. This arm served as a control arm for the study.

    Subject analysis set title
    Trumenba: From B1971057, Control Arm
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Age- and sex-matched healthy subjects from group 2 or 4 (Trumenba groups) from Phase 3 study B1971057 Stage 1(NCT ID: NCT04893811/EudraCT Number: 2016-004421-17) were randomly selected and included in this group. This arm served as a control arm for the study.

    Primary: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titer => Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains at Baseline

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    End point title
    		 Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titer => Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains at Baseline [1] [2]
    End point description
    The percentage of subjects who achieved an hSBA titer (A22) =>1:16, and hSBA titer (A56, B24, and B44) =>1:8 are reported. Evaluable immunogenicity set included all subjects who were eligible through 1 month after Vaccination 2, received the study vaccination at Visit 1 and Visit 3 as planned, had blood drawn for assay testing within the required time frames at Visit 1 (before vaccination 1) and 1 month after Vaccination 2 (28-42 Days after Visit 3), had at least 1 valid and determinate assay result 1 Month after Vaccination 2, received no prohibited vaccines or medications through visit 4, and had no major protocol deviations through visit 4. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given immunogenicity set. Here, “n” signifies number of subjects evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    Baseline (Before Vaccination 1)
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    43
    44
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) (n =43, 42)
    32.6 (19.1 to 48.5)
    31.0 (17.6 to 47.1)
        PMB2001 (A56) (n =43, 43)
    25.6 (13.5 to 41.2)
    23.3 (11.8 to 38.6)
        PMB2948 (B24) (n =42, 43)
    2.4 (0.1 to 12.6)
    23.3 (11.8 to 38.6)
        PMB2707 (B44) (n =43, 44)
    9.3 (2.6 to 22.1)
    11.4 (3.8 to 24.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2

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    End point title
    		 Percentage of Subjects With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2 [3] [4]
    End point description
    The percentage of subjects who achieved an hSBA titer (A22) =>1:16, and hSBA titer (A56, B24, and B44) =>1:8 are reported. Evaluable immunogenicity set included all subjects who were eligible through 1 month after Vaccination 2, received the study vaccination at Visit 1 and Visit 3 as planned, had blood drawn for assay testing within the required time frames at Visit 1 (before Vaccination 1) and 1 month after Vaccination 2 (28-42 days after Visit 3), had at least 1 valid and determinate assay result 1 month after Vaccination 2, received no prohibited vaccines or medications through Visit 4, and had no major protocol deviations through Visit 4. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given immunogenicity set. Here, “n” signifies number of subjects evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    1 Month after Vaccination 2
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    44
    44
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) (n =44, 43)
    75.0 (59.7 to 86.8)
    95.3 (84.2 to 99.4)
        PMB2001 (A56) (n =44, 44)
    90.9 (78.3 to 97.5)
    100.0 (92.0 to 100.0)
        PMB2948 (B24) (n =44, 44)
    70.5 (54.8 to 83.2)
    81.8 (67.3 to 91.8)
        PMB2707 (B44) (n =43, 42)
    79.1 (64.0 to 90.0)
    92.9 (80.5 to 98.5)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Local Reactions Within 7 Days After Vaccination 1

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    End point title
    		 Percentage of Subjects Reporting Local Reactions Within 7 Days After Vaccination 1 [5] [6]
    End point description
    Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in electronic diary (e-diary. Redness and swelling measured and recorded in caliper units. Each caliper unit = 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Vaccination 1 safety set = all subjects who received the first dose of study intervention at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” = number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Vaccination 1
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Any
    18.9 (9.4 to 32.0)
    11.8 (4.4 to 23.9)
        Redness: Mild
    5.7 (1.2 to 15.7)
    5.9 (1.2 to 16.2)
        Redness: Moderate
    9.4 (3.1 to 20.7)
    3.9 (0.5 to 13.5)
        Redness: Severe
    3.8 (0.5 to 13.0)
    2.0 (0.0 to 10.4)
        Swelling: Any
    22.6 (12.3 to 36.2)
    11.8 (4.4 to 23.9)
        Swelling: Mild
    7.5 (2.1 to 18.2)
    7.8 (2.2 to 18.9)
        Swelling: Moderate
    15.1 (6.7 to 27.6)
    3.9 (0.5 to 13.5)
        Swelling: Severe
    0 (0.0 to 6.7)
    0 (0.0 to 7.0)
        Pain at injection site: Any
    86.8 (74.7 to 94.5)
    80.4 (66.9 to 90.2)
        Pain at injection site: Mild
    41.5 (28.1 to 55.9)
    47.1 (32.9 to 61.5)
        Pain at injection site: Moderate
    32.1 (19.9 to 46.3)
    33.3 (20.8 to 47.9)
        Pain at injection site: Severe
    13.2 (5.5 to 25.3)
    0 (0.0 to 7.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Local Reactions Within 7 Days After Vaccination 2

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    End point title
    		 Percentage of Subjects Reporting Local Reactions Within 7 Days After Vaccination 2 [7] [8]
    End point description
    Local reactions (redness, swelling, and pain) at the site of investigational product administration recorded in e-diary. Redness and swelling measured and recorded in caliper units. Each caliper unit = 0.5 cm. Redness and swelling graded as mild (>2.0-5.0cm), moderate (>5.0-10.0cm) and severe (>10.0cm). Pain at injection site graded as mild (didn’t interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Vaccination 2 safety set = all subjects who received the second dose of study intervention at Visit 3 and for whom safety information was available from Visit 3 up to and including Visit 4. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. “Number of Subjects Analyzed”: subjects present in the given safety set. All subjects in given safety set are not contributing to data for each specified rows but were evaluable for this endpoint. “n”: subjects analysed for specified rows.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Vaccination 2
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint.
    [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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Any (n =45, 43)
    20.0 (9.6 to 34.6)
    7.0 (1.5 to 19.1)
        Redness: Mild (n =45, 43)
    6.7 (1.4 to 18.3)
    2.3 (0.1 to 12.3)
        Redness: Moderate (n =45, 43)
    11.1 (3.7 to 24.1)
    4.7 (0.6 to 15.8)
        Redness: Severe (n =45, 43)
    2.2 (0.1 to 11.8)
    0 (0.0 to 8.2)
        Swelling: Any (n =45, 43)
    26.7 (14.6 to 41.9)
    4.7 (0.6 to 15.8)
        Swelling: Mild (n =45, 43)
    13.3 (5.1 to 26.8)
    0 (0.0 to 8.2)
        Swelling: Moderate (n =45, 43)
    13.3 (5.1 to 26.8)
    4.7 (0.6 to 15.8)
        Swelling: Severe (n =45, 43)
    0 (0.0 to 7.9)
    0 (0.0 to 8.2)
        Pain at injection site: Any (n =45, 43)
    93.3 (81.7 to 98.6)
    60.5 (44.4 to 75.0)
        Pain at injection site: Mild (n =45, 43)
    44.4 (29.6 to 60.0)
    30.2 (17.2 to 46.1)
        Pain at injection site: Moderate (n =45, 43)
    35.6 (21.9 to 51.2)
    27.9 (15.3 to 43.7)
        Pain at injection site: Severe (n =45, 43)
    13.3 (5.1 to 26.8)
    2.3 (0.1 to 12.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Systemic Events Within 7 Days After Vaccination 1

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    End point title
    		 Percentage of Subjects Reporting Systemic Events Within 7 Days After Vaccination 1 [9] [10]
    End point description
    Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomitting, and diarrhea. Fever (>=38.0 degree [deg] Celsius [C]) and classified as 38.0-38.4, 38.5-38.9, 39.0 40.0 and >40.0 deg C. Headache, fatigue, chills, muscle pain and joint pain graded as mild (didn’t interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hrs), moderate (>2 times in 24 hrs) and severe (required intravenous [IV] hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (>=6 in 24 hrs). Vaccination 1 safety set was used. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. “Number of Subjects Analyzed”= number of subjects in the given safety set.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Vaccination 1
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: More than or equal (=>)38.0 deg C
    3.8 (0.5 to 13.0)
    2.0 (0.0 to 10.4)
        Fever: 38.0 to 38.4 deg C
    1.9 (0.0 to 10.1)
    0 (0.0 to 7.0)
        Fever: More than (>)38.4 to 38.9 deg C
    0 (0.0 to 6.7)
    2.0 (0.0 to 10.4)
        Fever: >38.9 to 40.0 deg C
    1.9 (0.0 to 10.1)
    0 (0.0 to 7.0)
        Fever: >40.0 deg C
    0 (0.0 to 6.7)
    0 (0.0 to 7.0)
        Fatigue: Any
    54.7 (40.4 to 68.4)
    51.0 (36.6 to 65.2)
        Fatigue: Mild
    26.4 (15.3 to 40.3)
    39.2 (25.8 to 53.9)
        Fatigue: Moderate
    22.6 (12.3 to 36.2)
    11.8 (4.4 to 23.9)
        Fatigue: Severe
    5.7 (1.2 to 15.7)
    0 (0.0 to 7.0)
        Headache: Any
    41.5 (28.1 to 55.9)
    29.4 (17.5 to 43.8)
        Headache: Mild
    18.9 (9.4 to 32.0)
    25.5 (14.3 to 39.6)
        Headache: Moderate
    18.9 (9.4 to 32.0)
    2.0 (0.0 to 10.4)
        Headache: Severe
    3.8 (0.5 to 13.0)
    2.0 (0.0 to 10.4)
        Chills: Any
    15.1 (6.7 to 27.6)
    19.6 (9.8 to 33.1)
        Chills: Mild
    11.3 (4.3 to 23.0)
    17.6 (8.4 to 30.9)
        Chills: Moderate
    1.9 (0.0 to 10.1)
    2.0 (0.0 to 10.4)
        Chills: Severe
    1.9 (0.0 to 10.1)
    0 (0.0 to 7.0)
        Muscle Pain: Any
    26.4 (15.3 to 40.3)
    23.5 (12.8 to 37.5)
        Muscle Pain: Mild
    15.1 (6.7 to 27.6)
    11.8 (4.4 to 23.9)
        Muscle Pain: Moderate
    9.4 (3.1 to 20.7)
    9.8 (3.3 to 21.4)
        Muscle Pain: Severe
    1.9 (0.0 to 10.1)
    2.0 (0.0 to 10.4)
        Joint Pain: Any
    22.6 (12.3 to 36.2)
    19.6 (9.8 to 33.1)
        Joint Pain: Mild
    9.4 (3.1 to 20.7)
    11.8 (4.4 to 23.9)
        Joint Pain: Moderate
    9.4 (3.1 to 20.7)
    5.9 (1.2 to 16.2)
        Joint Pain: Severe
    3.8 (0.5 to 13.0)
    2.0 (0.0 to 10.4)
        Vomiting: Any
    1.9 (0.0 to 10.1)
    2.0 (0.0 to 10.4)
        Vomiting: Mild
    1.9 (0.0 to 10.1)
    2.0 (0.0 to 10.4)
        Vomiting: Moderate
    0 (0.0 to 6.7)
    0 (0.0 to 7.0)
        Vomiting: Severe
    0 (0.0 to 6.7)
    0 (0.0 to 7.0)
        Diarrhea: Any
    9.4 (3.1 to 20.7)
    11.8 (4.4 to 23.9)
        Diarrhea: Mild
    9.4 (3.1 to 20.7)
    5.9 (1.2 to 16.2)
        Diarrhea: Moderate
    0 (0.0 to 6.7)
    5.9 (1.2 to 16.2)
        Diarrhea: Severe
    0 (0.0 to 6.7)
    0 (0.0 to 7.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Systemic Events Within 7 Days After Vaccination 2

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    End point title
    		 Percentage of Subjects Reporting Systemic Events Within 7 Days After Vaccination 2 [11] [12]
    End point description
    Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, diarrhea. Fever (>=38.0 deg C) and classified as 38.0-38.4, 38.5-38.9, 39.0 40.0 and >40.0 deg C. Headache, fatigue, chills, muscle pain and joint pain graded as mild (didn’t interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hrs), moderate (>2 times in 24 hrs) and severe (required IV hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (>=6 in 24 hrs). Vaccination 2 safety set was used. Historical data of the age- and sex-matched healthy subjects relevant for endpoint used for control arm. “Number of Subjects Analyzed”= subjects in the given safety set. All subjects in given safety set are not contributing to data for each specified rows but were evaluable for endpoint. “n” = subjects analysed for specified rows.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Vaccination 2
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: =>38.0 deg C (n =45, 43)
    2.2 (0.1 to 11.8)
    2.3 (0.1 to 12.3)
        Fever: 38.0 to 38.4 deg C (n =45, 43)
    2.2 (0.1 to 11.8)
    0 (0.0 to 8.2)
        Fever: >38.4 to 38.9 deg C (n =45, 43)
    0 (0.0 to 7.9)
    2.3 (0.1 to 12.3)
        Fever: >38.9 to 40.0 deg C (n =45, 43)
    0 (0.0 to 7.9)
    0 (0.0 to 8.2)
        Fever: >40.0 deg C (n =45, 43)
    0 (0.0 to 7.9)
    0 (0.0 to 8.2)
        Fatigue: Any (n =45, 43)
    53.3 (37.9 to 68.3)
    41.9 (27.0 to 57.9)
        Fatigue: Mild (n =45, 43)
    24.4 (12.9 to 39.5)
    23.3 (11.8 to 38.6)
        Fatigue: Moderate (n =45, 43)
    24.4 (12.9 to 39.5)
    14.0 (5.3 to 27.9)
        Fatigue: Severe (n =45, 43)
    4.4 (0.5 to 15.1)
    4.7 (0.6 to 15.8)
        Headache: Any (n =45, 43)
    35.6 (21.9 to 51.2)
    30.2 (17.2 to 46.1)
        Headache: Mild (n =45, 43)
    6.7 (1.4 to 18.3)
    23.3 (11.8 to 38.6)
        Headache: Moderate (n =45, 43)
    22.2 (11.2 to 37.1)
    7.0 (1.5 to 19.1)
        Headache: Severe (n =45, 43)
    6.7 (1.4 to 18.3)
    0 (0.0 to 8.2)
        Chills: Any (n =45, 43)
    8.9 (2.5 to 21.2)
    14.0 (5.3 to 27.9)
        Chills: Mild (n =45, 43)
    4.4 (0.5 to 15.1)
    11.6 (3.9 to 25.1)
        Chills: Moderate (n =45, 43)
    2.2 (0.1 to 11.8)
    2.3 (0.1 to 12.3)
        Chills: Severe (n =45, 43)
    2.2 (0.1 to 11.8)
    0 (0.0 to 8.2)
        Muscle Pain: Any (n =45, 43)
    13.3 (5.1 to 26.8)
    11.6 (3.9 to 25.1)
        Muscle Pain: Mild (n =45, 43)
    4.4 (0.5 to 15.1)
    7.0 (1.5 to 19.1)
        Muscle Pain: Moderate (n =45, 43)
    8.9 (2.5 to 21.2)
    2.3 (0.1 to 12.3)
        Muscle Pain: Severe (n =45, 43)
    0 (0.0 to 7.9)
    2.3 (0.1 to 12.3)
        Joint Pain: Any (n =45, 43)
    20.0 (9.6 to 34.6)
    16.3 (6.8 to 30.7)
        Joint Pain: Mild (n =45, 43)
    6.7 (1.4 to 18.3)
    14.0 (5.3 to 27.9)
        Joint Pain: Moderate (n =45, 43)
    11.1 (3.7 to 24.1)
    0 (0.0 to 8.2)
        Joint Pain: Severe (n =45, 43)
    2.2 (0.1 to 11.8)
    2.3 (0.1 to 12.3)
        Vomiting: Any (n =45, 43)
    2.2 (0.1 to 11.8)
    0 (0.0 to 8.2)
        Vomiting: Mild (n =45, 43)
    2.2 (0.1 to 11.8)
    0 (0.0 to 8.2)
        Vomiting: Moderate (n =45, 43)
    0 (0.0 to 7.9)
    0 (0.0 to 8.2)
        Vomiting: Severe (n =45, 43)
    0 (0.0 to 7.9)
    0 (0.0 to 8.2)
        Diarrhea: Any (n =45, 43)
    8.9 (2.5 to 21.2)
    4.7 (0.6 to 15.8)
        Diarrhea: Mild (n =45, 43)
    6.7 (1.4 to 18.3)
    4.7 (0.6 to 15.8)
        Diarrhea: Moderate (n =45, 43)
    2.2 (0.1 to 11.8)
    0 (0.0 to 8.2)
        Diarrhea: Severe (n =45, 43)
    0 (0.0 to 7.9)
    0 (0.0 to 8.2)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 1

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    End point title
    		 Percentage of Subjects Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 1 [13] [14]
    End point description
    Vaccination 1 safety set included all subjects who received the first dose of study intervention at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Vaccination 1
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    34.0 (21.5 to 48.3)
    9.8 (3.3 to 21.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 2

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    End point title
    		 Percentage of Subjects Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 2 [15] [16]
    End point description
    Vaccination 2 safety set included all subjects who received the second dose of study intervention at Visit 3 and for whom safety information was available from Visit 3 up to and including Visit 4. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects who were analysed for this endpoint and contributed to the data.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Vaccination 2
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    45
    43
    Units: Percentage of subjects
        number (confidence interval 95%)
    28.9 (16.4 to 44.3)
    7.0 (1.5 to 19.1)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Adverse Events (AEs) During 30 Days After Vaccination 1

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    End point title
    		 Percentage of Subjects Reporting Adverse Events (AEs) During 30 Days After Vaccination 1 [17] [18]
    End point description
    An AE was any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events. Vaccination 1 safety set included all subjects who received the first dose of study intervention at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    30 Days after Vaccination 1
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    26.4 (15.3 to 40.3)
    9.8 (3.3 to 21.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting AEs During 30 Days After Vaccination 2

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    End point title
    		 Percentage of Subjects Reporting AEs During 30 Days After Vaccination 2 [19] [20]
    End point description
    An AE was any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events. Vaccination 2 safety set included all subjects who received the second dose of study intervention at Visit 3 and for whom safety information was available from Visit 3 up to and including Visit 4. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    30 Days after Vaccination 2
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
        number (confidence interval 95%)
    12.8 (4.8 to 25.7)
    12.8 (4.8 to 25.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting AEs During the Vaccination Phase

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    End point title
    		 Percentage of Subjects Reporting AEs During the Vaccination Phase [21] [22]
    End point description
    An AE was any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm.
    End point type
    Primary
    End point timeframe
    Vaccination Phase: From Vaccination 1 through one Month after Vaccination 2 (approximately 7 Months)
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    60.4 (46.0 to 73.5)
    41.2 (27.6 to 55.8)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting AEs During 30 Days After any Vaccination

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    End point title
    		 Percentage of Subjects Reporting AEs During 30 Days After any Vaccination [23] [24]
    End point description
    An AE was any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm.
    End point type
    Primary
    End point timeframe
    30 Days after any 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    34.0 (21.5 to 48.3)
    17.6 (8.4 to 30.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting SAEs During 30 Days After Vaccination 2

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    End point title
    		 Percentage of Subjects Reporting SAEs During 30 Days After Vaccination 2 [25] [26]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event. Vaccination 2 safety set included all subjects who received the second dose of study intervention at Visit 3 and for whom safety information was available from Visit 3 up to and including Visit 4. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    30 Days after Vaccination 2
    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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 7.5)
    0 (0.0 to 7.5)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting SAEs During 30 Days After any Vaccination

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    End point title
    		 Percentage of Subjects Reporting SAEs During 30 Days After any Vaccination [27] [28]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm.
    End point type
    Primary
    End point timeframe
    30 Days after any 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    9.4 (3.1 to 20.7)
    0 (0.0 to 7.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting SAEs During the Vaccination Phase

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    End point title
    		 Percentage of Subjects Reporting SAEs During the Vaccination Phase [29] [30]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm.
    End point type
    Primary
    End point timeframe
    Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
    Notes
    [29] - 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.
    [30] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    17.0 (8.1 to 29.8)
    0 (0.0 to 7.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Serious Adverse Events (SAEs) During 30 Days After Vaccination 1

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    End point title
    		 Percentage of Subjects Reporting Serious Adverse Events (SAEs) During 30 Days After Vaccination 1 [31] [32]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event. Vaccination 1 safety set included all subjects who received the first dose of study intervention at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    30 Days after Vaccination 1
    Notes
    [31] - 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.
    [32] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    9.4 (3.1 to 20.7)
    0 (0.0 to 7.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting SAEs During the Entire Study

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    End point title
    		 Percentage of Subjects Reporting SAEs During the Entire Study [33] [34]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm.
    End point type
    Primary
    End point timeframe
    Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
    Notes
    [33] - 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.
    [34] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    18.9 (9.4 to 32.0)
    2.0 (0.0 to 10.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting MAEs During 30 Days After Vaccination 2

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    End point title
    		 Percentage of Subjects Reporting MAEs During 30 Days After Vaccination 2 [35] [36]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Vaccination 2 safety set included all subjects who received the second dose of study intervention at Visit 3 and for whom safety information was available from Visit 3 up to and including Visit 4. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    30 Days after Vaccination 2
    Notes
    [35] - 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.
    [36] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
        number (confidence interval 95%)
    12.8 (4.8 to 25.7)
    4.3 (0.5 to 14.5)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting SAEs During the Follow-up Phase

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    End point title
    		 Percentage of Subjects Reporting SAEs During the Follow-up Phase [37] [38]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event. Follow-up safety set included all subjects who received at least 1 dose of study intervention and for whom safety information was available from after Visit 4 up to and including Visit 5 Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
    Notes
    [37] - 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.
    [38] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    44
    48
    Units: Percentage of subjects
        number (confidence interval 95%)
    4.5 (0.6 to 15.5)
    2.1 (0.1 to 11.1)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Medically Attended Adverse Event (MAEs) During 30 Days After Vaccination 1

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    End point title
    		 Percentage of Subjects Reporting Medically Attended Adverse Event (MAEs) During 30 Days After Vaccination 1 [39] [40]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Vaccination 1 safety set included all subjects who received the first dose of study intervention at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    30 Days after Vaccination 1
    Notes
    [39] - 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.
    [40] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    20.8 (10.8 to 34.1)
    5.9 (1.2 to 16.2)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting MAEs During the Follow-up Phase

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    End point title
    		 Percentage of Subjects Reporting MAEs During the Follow-up Phase [41] [42]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Follow-up safety set included all subjects who received at least 1 dose of study intervention and for whom safety information was available from after Visit 4 up to and including Visit 5. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
    Notes
    [41] - 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.
    [42] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    44
    48
    Units: Percentage of subjects
        number (confidence interval 95%)
    15.9 (6.6 to 30.1)
    10.4 (3.5 to 22.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting MAEs During the Vaccination Phase

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    End point title
    		 Percentage of Subjects Reporting MAEs During the Vaccination Phase [43] [44]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm.
    End point type
    Primary
    End point timeframe
    Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
    Notes
    [43] - 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.
    [44] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    54.7 (40.4 to 68.4)
    29.4 (17.5 to 43.8)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting MAEs During 30 days After any Vaccination

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    End point title
    		 Percentage of Subjects Reporting MAEs During 30 days After any Vaccination [45] [46]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm.
    End point type
    Primary
    End point timeframe
    30 Days after any Vaccination
    Notes
    [45] - 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.
    [46] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    30.2 (18.3 to 44.3)
    9.8 (3.3 to 21.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Immediate AEs After Vaccination 1

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    End point title
    		 Percentage of Subjects Reporting Immediate AEs After Vaccination 1 [47] [48]
    End point description
    Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration. Vaccination 1 safety set included all subjects who received the first dose of study intervention at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    30 Minutes post Vaccination 1
    Notes
    [47] - 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.
    [48] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 6.7)
    2.0 (0.0 to 10.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Immediate AEs After Vaccination 2

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    End point title
    		 Percentage of Subjects Reporting Immediate AEs After Vaccination 2 [49] [50]
    End point description
    Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration. Vaccination 2 safety set included all subjects who received the second dose of study intervention at Visit 3 and for whom safety information was available from Visit 3 up to and including Visit 4. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    30 Minutes post Vaccination 2
    Notes
    [49] - 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.
    [50] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 7.5)
    0 (0.0 to 7.5)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting MAEs During the Entire Study

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    End point title
    		 Percentage of Subjects Reporting MAEs During the Entire Study [51] [52]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm.
    End point type
    Primary
    End point timeframe
    Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
    Notes
    [51] - 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.
    [52] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    60.4 (46.0 to 73.5)
    31.4 (19.1 to 45.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase

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    End point title
    		 Percentage of Subjects With Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase [53] [54]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm.
    End point type
    Primary
    End point timeframe
    Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
    Notes
    [53] - 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.
    [54] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    1.9 (0.0 to 10.1)
    0 (0.0 to 7.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With NDCMC During the Follow-up Phase

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    End point title
    		 Percentage of Subjects With NDCMC During the Follow-up Phase [55] [56]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. Follow-up safety set included all subjects who received at least 1 dose of study intervention and for whom safety information was available from after Visit 4 up to and including Visit 5. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects present in the given safety set.
    End point type
    Primary
    End point timeframe
    Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
    Notes
    [55] - 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.
    [56] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    44
    48
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 8.0)
    0 (0.0 to 7.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With NDCMC During the Entire Study

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    End point title
    		 Percentage of Subjects With NDCMC During the Entire Study [57] [58]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm.
    End point type
    Primary
    End point timeframe
    Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
    Notes
    [57] - 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.
    [58] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    53
    51
    Units: Percentage of subjects
        number (confidence interval 95%)
    1.9 (0.0 to 10.1)
    0 (0.0 to 7.0)
    No statistical analyses for this end point

    Primary: Number of Days Subjects Missed School or Work Because of AEs During the Vaccination Phase

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    End point title
    		 Number of Days Subjects Missed School or Work Because of AEs During the Vaccination Phase [59] [60]
    End point description
    An AE is any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Safety set included all enrolled subjects who received at least 1 dose of the study intervention and have safety data reported after vaccination. Historical data of the age- and sex-matched healthy subjects relevant for this endpoint used for control arm. Here, “Number of Subjects Analyzed” signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
    Notes
    [59] - 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.
    [60] - 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: Subject analysis set has been created to report data for control arm.
    End point values
    		 Trumenba Trumenba: From B1971057, Control Arm
    Number of subjects analysed
    32
    21
    Units: Days
        arithmetic mean (standard deviation)
    12.7 ( 7.6 )
    2.5 ( 2.3 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Local reactions, systemic events within 7 days of each vaccination; SAEs and Non-SAEs: From Day 1 of vaccination up to 6 months after last study vaccination (approximately 12 months)
    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 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. For study B1971057 MedDRA version 25.1 was used and for study B1971060 MedDRA version 26.0 was used.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Trumenba: From B1971057, Control Arm
    Reporting group description
    		 Age- and sex-matched healthy subjects from group 2 or 4 (Trumenba groups) from Phase 3 study B1971057 Stage 1(NCT ID: NCT04893811/EudraCT Number: 2016-004421-17) were randomly selected and included in this group. This arm served as a control arm for the study.

    Reporting group title
    Trumenba
    Reporting group description
    		 Immunocompromised subjects >=10 years of age with asplenia (anatomic or functional) or complement deficiency, received Trumenba 0.5 mL, IM on Day 1 of Visit 1 (Month 0) and Visit 3 (Month 6).

    Serious adverse events
    		 Trumenba: From B1971057, Control Arm Trumenba
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 51 (1.96%)
    10 / 53 (18.87%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Wrist fracture
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 51 (0.00%)
    4 / 53 (7.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Pancreatitis chronic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Trumenba: From B1971057, Control Arm Trumenba
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 51 (96.08%)
    51 / 53 (96.23%)
    Vascular disorders
    Secondary hypertension
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Chills (CHILLS)
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 51 (21.57%)
    11 / 53 (20.75%)
         occurrences all number
    16
    12
    Fatigue
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Fatigue (FATIGUE)
    alternative assessment type: Systematic
         subjects affected / exposed
    27 / 51 (52.94%)
    31 / 53 (58.49%)
         occurrences all number
    44
    53
    Injection site pain
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Injection site pain (PAIN AT INJECTION SITE)
    alternative assessment type: Systematic
         subjects affected / exposed
    45 / 51 (88.24%)
    48 / 53 (90.57%)
         occurrences all number
    67
    88
    Oedema peripheral
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Pyrexia (FEVER)
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 53 (3.77%)
         occurrences all number
    2
    3
    Swelling (SWELLING)
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 51 (13.73%)
    17 / 53 (32.08%)
         occurrences all number
    8
    24
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Vocal cord polyp
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Pleurisy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Incisional hernia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Limb injury
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Skin laceration
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Soft tissue injury
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Thermal burn
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Headache (HEADACHE)
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 51 (41.18%)
    25 / 53 (47.17%)
         occurrences all number
    28
    38
    Dizziness
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Periorbital swelling
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Eye haemorrhage
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea (DIARRHEA)
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 51 (13.73%)
    8 / 53 (15.09%)
         occurrences all number
    8
    9
    Constipation
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Vomiting (VOMITING)
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Drug eruption
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Erythema (REDNESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 51 (11.76%)
    14 / 53 (26.42%)
         occurrences all number
    9
    19
    Night sweats
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia (JOINT PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 51 (25.49%)
    14 / 53 (26.42%)
         occurrences all number
    17
    21
    Back pain
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Myalgia (MUSCLE PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 51 (27.45%)
    16 / 53 (30.19%)
         occurrences all number
    17
    20
    Pain in extremity
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Soft tissue swelling
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 51 (0.00%)
    5 / 53 (9.43%)
         occurrences all number
    0
    5
    Bronchitis
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Chronic sinusitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Furuncle
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 51 (0.00%)
    5 / 53 (9.43%)
         occurrences all number
    0
    5
    Nasopharyngitis
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Oral herpes
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Otitis media bacterial
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    4 / 51 (7.84%)
    0 / 53 (0.00%)
         occurrences all number
    4
    0
    Tonsillitis
         subjects affected / exposed
    0 / 51 (0.00%)
    4 / 53 (7.55%)
         occurrences all number
    0
    4
    Tonsillitis streptococcal
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Tracheitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 53 (3.77%)
         occurrences all number
    5
    2
    Urethritis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Urethritis mycoplasmal
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Viral pharyngitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    2
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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