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    Clinical Trial Results:
    A descriptive, Phase IV, open-label, single-arm multi-center study to assess the immunogenicity and safety of MenQuadfi® as a booster vaccine in healthy toddlers 12 to 23 months of age who had been primed with at least 1 dose of another quadrivalent meningococcal conjugate vaccine, ie, Nimenrix® (MCV4-TT) or Menveo® (MCV4-CRM), in infancy

    Summary
    EudraCT number
    		 2025-000002-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    09 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MEQ00086
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05929651
    WHO universal trial number (UTN)
    		 U1111-1277-6838
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    14 Espace Henry Vallée, Lyon, France, 69007
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Mar 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the immune response to a booster dose of meningococcal polysaccharide (serogroups A, C, W, and Y) tetanus toxoid (MenACYW) conjugate vaccine as measured by serum bactericidal assay using human complement (hSBA) in toddlers aged 12 to 23 months, who had been primed with at least 1 dose of another quadrivalent meningococcal conjugate vaccine (MCV4) vaccine during infancy; antibody response as measured by hSBA and serum bactericidal antibody assay using baby rabbit complement (rSBA) in toddlers 12 to 23 months of age who had been primed with at least 1 dose, 2 doses and 1 dose of another MCV4 vaccine during infancy; and antibody responses to tetanus toxoid in toddlers 12 to 23 months of age who had been primed with at least 1 dose of another MCV4 vaccine during infancy.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Participants with allergy to any of the vaccine components were not vaccinated. After vaccination, participants were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available onsite in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Sep 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 71
    Worldwide total number of subjects
    71
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    71
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 2 investigational sites in Argentina between 07 September 2023 to 09 September 2024.

    Pre-assignment
    Screening details
    		 A total of 71 participants were enrolled in this study.

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

    Arms
    Arm title
    		 MenACYW conjugate vaccine
    Arm description
    		 Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 milliliter [mL]) of meningococcal polysaccharide (serogroups A, C, W, and Y) tetanus toxoid (MenACYW conjugate vaccine) as an intramuscular (IM) injection at Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A 0.5 mL dose was administered as an IM injection at Day 1.

    Number of subjects in period 1
    		MenACYW conjugate vaccine
    Started
    71
    Safety analysis set (SafAS)
    69
    Completed
    68
    Not completed
    3
         Protocol Deviation
    1
         Withdrawal by parents/acceptable representatives
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenACYW conjugate vaccine
    Reporting group description
    		 Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 milliliter [mL]) of meningococcal polysaccharide (serogroups A, C, W, and Y) tetanus toxoid (MenACYW conjugate vaccine) as an intramuscular (IM) injection at Day 1.

    Reporting group values
    		 MenACYW conjugate vaccine Total
    Number of subjects
    		 71 71
    Age categorical
    Units: Subjects
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 14.3 ( 1.50 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 34 34
        Male
    		 37 37
    Race and Ethnicity Not Collected
    Units: Subjects
        Not collected
    		 71 71

    End points

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    End points reporting groups
    Reporting group title
    MenACYW conjugate vaccine
    Reporting group description
    		 Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 milliliter [mL]) of meningococcal polysaccharide (serogroups A, C, W, and Y) tetanus toxoid (MenACYW conjugate vaccine) as an intramuscular (IM) injection at Day 1.

    Primary: Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W

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    End point title
    		 Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W [1]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth. The per-protocol analysis set (PPAS) was a subset of the full analysis set (FAS). The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Here, n refers to the number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    64
    Units: Percentage of participants
    number (confidence interval 95%)
        Serogroup A: Day 1 (n= 61)
    72.1 (59.2 to 82.9)
        Serogroup A: Day 31 (n= 58)
    100 (93.8 to 100)
        Serogroup C: Day 1 (n= 63)
    60.3 (47.2 to 72.4)
        Serogroup C: Day 31 (n= 61)
    100 (94.1 to 100)
        Serogroup Y: Day 1 (n= 62)
    67.7 (54.7 to 79.1)
        Serogroup Y: Day 31 (n= 52)
    100 (93.2 to 100)
        Serogroup W: Day 1 (n= 64)
    73.4 (60.9 to 83.7)
        Serogroup W: Day 31 (n= 58)
    100 (93.8 to 100)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement

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    End point title
    		 Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement [2]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Here, n refers to the number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    64
    Units: Titer
    geometric mean (confidence interval 95%)
        Serogroup A: Day 1 (n=61)
    14.0 (10.1 to 19.4)
        Serogroup A: Day 31 (n=58)
    244 (163 to 366)
        Serogroup C: Day 1 (n=63)
    12.3 (8.29 to 18.2)
        Serogroup C: Day 31 (n=61)
    1072 (805 to 1426)
        Serogroup Y: Day 1 (n=62)
    14.0 (9.70 to 20.2)
        Serogroup Y: Day 31 (n=52)
    945 (683 to 1309)
        Serogroup W: Day 1 (n=64)
    16.9 (11.8 to 24.2)
        Serogroup W: Day 31 (n=58)
    953 (712 to 1275)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W

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    End point title
    		 Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W [3]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth. The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Here, n refers to the number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    64
    Units: Percentage of participants
    number (confidence interval 95%)
        Serogroup A: Day 1 (n= 61)
    96.7 (88.7 to 99.6)
        Serogroup A: Day 31 (n= 58)
    100 (93.8 to 100)
        Serogroup C: Day 1 (n= 63)
    76.2 (63.8 to 86.0)
        Serogroup C: Day 31 (n= 61)
    100 (94.1 to 100)
        Serogroup Y: Day 1 (n= 62)
    85.5 (74.2 to 93.1)
        Serogroup Y: Day 31 (n= 52)
    100 (93.2 to 100)
        Serogroup W: Day 1 (n= 64)
    87.5 (76.8 to 94.4)
        Serogroup W: Day 31 (n= 58)
    100 (93.8 to 100)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination

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    End point title
    		 Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination [4]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth. The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Here, n refers to the number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    59
    Units: Percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=56)
    91.1 (80.4 to 97.0)
        Serogroup C (n=59)
    100 (93.9 to 100)
        Serogroup Y (n=51)
    96.1 (86.5 to 99.5)
        Serogroup W (n=57)
    100 (93.7 to 100)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement

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    End point title
    		 Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement [5]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). hSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer <1:8 as a post-vaccination titer of >=1:16 and for a participant with a pre-vaccination titer >=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth. The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Here, n refers to the number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 31 (30 days post vaccination on Day 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    59
    Units: Percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=56)
    91.1 (80.4 to 97.0)
        Serogroup C (n=59)
    100 (93.9 to 100)
        Serogroup Y (n=51)
    96.1 (86.5 to 99.5)
        Serogroup W (n=57)
    100 (93.7 to 100)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement

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    End point title
    		 Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement [6]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Here, n refers to the number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    64
    Units: Titer
    geometric mean (confidence interval 95%)
        Serogroup A: Day 1 (n=55)
    82.3 (33.3 to 203)
        Serogroup A: Day 31 (n=64)
    4715 (3547 to 6268)
        Serogroup C: Day 1 (n=61)
    11.6 (6.54 to 20.7)
        Serogroup C: Day 31 (n=64)
    3676 (2707 to 4990)
        Serogroup Y: Day 1 (n=59)
    30.9 (15.6 to 61.2)
        Serogroup Y: Day 31 (n=64)
    5198 (4091 to 6604)
        Serogroup W: Day 1 (n=63)
    28.0 (14.7 to 53.5)
        Serogroup W: Day 31 (n=64)
    9329 (6627 to 13132)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W

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    End point title
    		 Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W [7]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth. The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Here, n refers to the number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    64
    Units: Percentage of participants
    number (confidence interval 95%)
        Serogroup A: >=1:8: Day 1 (n=55)
    56.4 (42.3 to 69.7)
        Serogroup A: >=1:128: Day 1 (n=55)
    54.5 (40.6 to 68.0)
        Serogroup A: >=1:8: Day 31 (n=64)
    100 (94.4 to 100)
        Serogroup A: >=1:128: Day 31 (n=64)
    100 (94.4 to 100)
        Serogroup C: >=1:8: Day 1 (n=61)
    39.3 (27.1 to 52.7)
        Serogroup C: >=1:128: Day 1 (n=61)
    24.6 (14.5 to 37.3)
        Serogroup C: >=1:8: Day 31 (n=64)
    100 (94.4 to 100)
        Serogroup C: >=1:128: Day 31 (n=64)
    100 (94.4 to 100)
        Serogroup Y: >=1:8: Day 1 (n=59)
    55.9 (42.4 to 68.8)
        Serogroup Y: >=1:128: Day 1 (n=59)
    44.1 (31.2 to 57.6)
        Serogroup Y: >=1:8: Day 31 (n=64)
    100 (94.4 to 100)
        Serogroup Y: >=1:128: Day 31 (n=64)
    100 (94.4 to 100)
        Serogroup W: >=1:8: Day 1 (n=63)
    61.9 (48.8 to 73.9)
        Serogroup W: >=1:128: Day 1 (n=63)
    41.3 (29.0 to 54.4)
        Serogroup W: >=1:8: Day 31 (n=64)
    100 (94.4 to 100)
        Serogroup W: >=1:128: Day 31 (n=64)
    100 (94.4 to 100)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination

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    End point title
    		 Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination [8]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth. The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Here, n refers to the number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    62
    Units: Percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=54)
    83.3 (70.7 to 92.1)
        Serogroup C (n=60)
    98.3 (91.1 to 100)
        Serogroup Y (n=58)
    98.3 (90.8 to 100)
        Serogroup W (n=62)
    100 (94.2 to 100)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement

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    End point title
    		 Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement [9]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). rSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer <1:8 as a post-vaccination titer of >=1:32 and for a participant with a pre-vaccination titer >=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth. The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Here, n refers to the number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    62
    Units: Percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=54)
    83.3 (70.7 to 92.1)
        Serogroup C (n=60)
    98.3 (91.1 to 100)
        Serogroup Y (n=58)
    98.3 (90.8 to 100)
        Serogroup W (n=62)
    100 (94.2 to 100)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid [10]
    End point description
    Geometric Mean Concentrations (GMCs) of anti-tetanus toxoid antibodies was measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent assay. The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Here, n refers to the number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    65
    Units: International units/milliliter
    geometric mean (confidence interval 95%)
        Day 1 (n=65)
    0.642 (0.482 to 0.854)
        Day 31 (n=64)
    8.56 (6.17 to 11.9)
    No statistical analyses for this end point

    Primary: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)

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    End point title
    		 Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) [11]
    End point description
    An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. The SafAS included participants who received the study vaccine.
    End point type
    Primary
    End point timeframe
    Up to 30 minutes post-vaccination on Day 1
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    69
    Units: Participants
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

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    End point title
    		 Number of Participants With Solicited Injection Site Reactions and Systemic Reactions [12]
    End point description
    A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site tenderness, injection site erythema and injection site swelling. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability. The SafAS included participants who received the study vaccine.
    End point type
    Primary
    End point timeframe
    Up to 7 days post-vaccination on Day 1
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    69
    Units: Participants
        Solicited injection site reaction
    24
        Solicited systemic reaction
    35
    No statistical analyses for this end point

    Primary: Number of Participants With Unsolicited Adverse Events

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    End point title
    		 Number of Participants With Unsolicited Adverse Events [13]
    End point description
    An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. The SafAS included participants who received the study vaccine.
    End point type
    Primary
    End point timeframe
    Up to 30 days post-vaccination on Day 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    69
    Units: Participants
    23
    No statistical analyses for this end point

    Primary: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

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    End point title
    		 Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) [14]
    End point description
    An SAE was any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. The SafAS included participants who received the study vaccine.
    End point type
    Primary
    End point timeframe
    From vaccination (Day 1) up to 30 days post vaccination, 31 days
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 MenACYW conjugate vaccine
    Number of subjects analysed
    69
    Units: Participants
        SAEs
    1
        AESIs
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs, SAEs and all-cause mortality (deaths) were collected from vaccination (Day 1) up to 30 days post vaccination, 31 days
    Adverse event reporting additional description
    Analysis was performed on SafAS.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    MenACYW conjugate vaccine
    Reporting group description
    		 Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1.

    Serious adverse events
    		 MenACYW conjugate vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 69 (1.45%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Febrile Convulsion
         subjects affected / exposed
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MenACYW conjugate vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 69 (65.22%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    13 / 69 (18.84%)
         occurrences all number
    13
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    4 / 69 (5.80%)
         occurrences all number
    4
    Injection Site Pain
         subjects affected / exposed
    21 / 69 (30.43%)
         occurrences all number
    21
    Injection Site Swelling
         subjects affected / exposed
    4 / 69 (5.80%)
         occurrences all number
    4
    Pyrexia
         subjects affected / exposed
    14 / 69 (20.29%)
         occurrences all number
    15
    Crying
         subjects affected / exposed
    14 / 69 (20.29%)
         occurrences all number
    14
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    13 / 69 (18.84%)
         occurrences all number
    13
    Diarrhoea
         subjects affected / exposed
    5 / 69 (7.25%)
         occurrences all number
    5
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    22 / 69 (31.88%)
         occurrences all number
    22
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 69 (5.80%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    14 / 69 (20.29%)
         occurrences all number
    14

    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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