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    Clinical Trial Results:
    Phase I Open-Label, Age De-escalation Safety and Immunogenicity Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents, Children, Toddlers, and Infants in China

    Summary
    EudraCT number
    		 2025-000103-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 May 2025
    First version publication date
    02 May 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MEQ00075
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1256-9026
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    Discovery Drive, Swiftwater, Pennsylvania, United States, 18370-0187
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Mar 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety profile of meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid (MenACYW) conjugate vaccine and the safety profiles of the control vaccines (locally-licensed MenAC conjugate vaccines: Royal or Green Bamboo)
    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 on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Aug 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
    China: 300
    Worldwide total number of subjects
    300
    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)
    180
    Children (2-11 years)
    100
    Adolescents (12-17 years)
    20
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted in China.

    Pre-assignment
    Screening details
    		 A total of 300 participants were randomly assigned to 1 of 10 study groups in 1:1 ratio in 5 Cohorts.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years)
    Arm description
    		 Participants aged 7 to 17 years received a single dose of 0.5 milliliter (mL) MenACYW conjugate vaccine intramuscular (IM) injection on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    MenQuadfi
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACYW conjugate vaccine 0.5 mL IM injection was administered as a single dose in the form of liquid solution on Day 1.

    Arm title
    		 Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years)
    Arm description
    		 Participants aged 7 to 17 years received a single dose of 0.5 mL Green Bamboo’s MenAC conjugate vaccine IM injection on Day 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Green Bamboo’s MenAC Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Mening A Con
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Green Bamboo’s MenAC conjugate vaccine 0.5 mL IM injection was administered as a single dose in the form of suspension on Day 1.

    Arm title
    		 Group 3: MenACYW Conjugate Vaccine (2-6 Years)
    Arm description
    		 Participants aged 2 to 6 years received a single dose of 0.5 mL MenACYW conjugate vaccine IM injection on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    MenQuadfi
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACYW conjugate vaccine 0.5 mL IM injection was administered as a single dose in the form of liquid solution on Day 1.

    Arm title
    		 Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years)
    Arm description
    		 Participants aged 2 to 6 years received a single dose of 0.5 mL Royal’s MenAC conjugate vaccine IM injection on Day 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Royal’s MenAC Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Royal’s MenAC conjugate vaccine 0.5 mL IM injection was administered as a single dose in the form of lyophilized powder on Day 1.

    Arm title
    		 Group 5: MenACYW Conjugate Vaccine (12-23 Months)
    Arm description
    		 Participants aged 12 to 23 months received a single dose of 0.5 mL MenACYW conjugate vaccine IM injection on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    MenQuadfi
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACYW conjugate vaccine 0.5 mL IM injection was administered as a single dose in the form of liquid solution on Day 1.

    Arm title
    		 Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months)
    Arm description
    		 Participants aged 12 to 23 months received a single dose of 0.5 mL Royal’s MenAC conjugate vaccine IM injection on Day 1. An additional dose of Royal’s MenAC conjugate vaccine was offered by the Investigator to participants in Group 6 after the study procedure on the last visit of blood sampling to comply with product’s approved vaccination schedule. This second dose of Royal’s vaccine was not a part of the study assessment and was administered at least 31 days after the study vaccination.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Royal’s MenAC Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Royal’s MenAC conjugate vaccine 0.5 mL IM injection was administered as 2 doses in the form of lyophilized powder on Days 1 and 31.

    Arm title
    		 Group 7: MenACYW Conjugate Vaccine (6-11 Months)
    Arm description
    		 Participants aged 6 to 11 months received 2 doses of 0.5 mL MenACYW conjugate vaccine IM injection each on Days 1 and 31.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    MenQuadfi
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACYW conjugate vaccine 0.5 mL IM injection was administered as 2 doses in the form of liquid solution on Days 1 and 31.

    Arm title
    		 Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months)
    Arm description
    		 Participants aged 6 to 11 months received 2 doses of 0.5 mL Royal’s MenAC conjugate vaccine IM injection each on Days 1 and 31.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Royal’s MenAC Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Royal’s MenAC conjugate vaccine 0.5 mL IM injection was administered as 2 doses in the form of lyophilized powder on Days 1 and 31.

    Arm title
    		 Group 9: MenACYW Conjugate Vaccine (3-5 Months)
    Arm description
    		 Participants aged 3 to 5 months received 3 doses of 0.5 mL MenACYW conjugate vaccine IM injection each on Days 1, 31 and 61.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    MenQuadfi
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACYW conjugate vaccine 0.5 mL IM injection was administered as 3 doses in the form of liquid solution on Days 1, 31 and 61.

    Arm title
    		 Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Arm description
    		 Participants aged 3 to 5 months received 3 doses of 0.5 mL Green Bamboo’s MenAC conjugate vaccine IM injection each on Days 1, 31 and 61.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Green Bamboo’s MenAC Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Mening A Con
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Green Bamboo’s MenAC conjugate vaccine 0.5 mL IM injection was administered as 3 doses in the form of suspension on Days 1, 31 and 61.

    Number of subjects in period 1
    		Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Started
    30
    30
    30
    30
    30
    30
    30
    30
    30
    30
    Completed
    30
    30
    30
    30
    30
    30
    30
    28
    30
    30
    Not completed
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
         Randomized but did not receive vaccination
    -
    -
    -
    -
    -
    -
    -
    2
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine (7-17 Years)
    Reporting group description
    		 Participants aged 7 to 17 years received a single dose of 0.5 milliliter (mL) MenACYW conjugate vaccine intramuscular (IM) injection on Day 1.

    Reporting group title
    Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years)
    Reporting group description
    		 Participants aged 7 to 17 years received a single dose of 0.5 mL Green Bamboo’s MenAC conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 3: MenACYW Conjugate Vaccine (2-6 Years)
    Reporting group description
    		 Participants aged 2 to 6 years received a single dose of 0.5 mL MenACYW conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years)
    Reporting group description
    		 Participants aged 2 to 6 years received a single dose of 0.5 mL Royal’s MenAC conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 5: MenACYW Conjugate Vaccine (12-23 Months)
    Reporting group description
    		 Participants aged 12 to 23 months received a single dose of 0.5 mL MenACYW conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months)
    Reporting group description
    		 Participants aged 12 to 23 months received a single dose of 0.5 mL Royal’s MenAC conjugate vaccine IM injection on Day 1. An additional dose of Royal’s MenAC conjugate vaccine was offered by the Investigator to participants in Group 6 after the study procedure on the last visit of blood sampling to comply with product’s approved vaccination schedule. This second dose of Royal’s vaccine was not a part of the study assessment and was administered at least 31 days after the study vaccination.

    Reporting group title
    Group 7: MenACYW Conjugate Vaccine (6-11 Months)
    Reporting group description
    		 Participants aged 6 to 11 months received 2 doses of 0.5 mL MenACYW conjugate vaccine IM injection each on Days 1 and 31.

    Reporting group title
    Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months)
    Reporting group description
    		 Participants aged 6 to 11 months received 2 doses of 0.5 mL Royal’s MenAC conjugate vaccine IM injection each on Days 1 and 31.

    Reporting group title
    Group 9: MenACYW Conjugate Vaccine (3-5 Months)
    Reporting group description
    		 Participants aged 3 to 5 months received 3 doses of 0.5 mL MenACYW conjugate vaccine IM injection each on Days 1, 31 and 61.

    Reporting group title
    Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Reporting group description
    		 Participants aged 3 to 5 months received 3 doses of 0.5 mL Green Bamboo’s MenAC conjugate vaccine IM injection each on Days 1, 31 and 61.

    Reporting group values
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months) Total
    Number of subjects
    		 30 30 30 30 30 30 30 30 30 30
    Age Categorical
    Units: Participants
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 124.8 ( 1.7 ) 136.8 ( 2.4 ) 61.2 ( 1.2 ) 61.2 ( 1.1 ) 20.7 ( 2.3 ) 19.4 ( 2.9 ) 7.0 ( 1.4 ) 6.9 ( 1.3 ) 4.0 ( 0.8 ) 4.1 ( 0.8 ) -
    Gender Categorical
    Units: Participants
        Female
    		 22 17 13 16 14 14 14 13 17 18 158
        Male
    		 8 13 17 14 16 16 16 17 13 12 142

    End points

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    End points reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine (7-17 Years)
    Reporting group description
    		 Participants aged 7 to 17 years received a single dose of 0.5 milliliter (mL) MenACYW conjugate vaccine intramuscular (IM) injection on Day 1.

    Reporting group title
    Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years)
    Reporting group description
    		 Participants aged 7 to 17 years received a single dose of 0.5 mL Green Bamboo’s MenAC conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 3: MenACYW Conjugate Vaccine (2-6 Years)
    Reporting group description
    		 Participants aged 2 to 6 years received a single dose of 0.5 mL MenACYW conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years)
    Reporting group description
    		 Participants aged 2 to 6 years received a single dose of 0.5 mL Royal’s MenAC conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 5: MenACYW Conjugate Vaccine (12-23 Months)
    Reporting group description
    		 Participants aged 12 to 23 months received a single dose of 0.5 mL MenACYW conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months)
    Reporting group description
    		 Participants aged 12 to 23 months received a single dose of 0.5 mL Royal’s MenAC conjugate vaccine IM injection on Day 1. An additional dose of Royal’s MenAC conjugate vaccine was offered by the Investigator to participants in Group 6 after the study procedure on the last visit of blood sampling to comply with product’s approved vaccination schedule. This second dose of Royal’s vaccine was not a part of the study assessment and was administered at least 31 days after the study vaccination.

    Reporting group title
    Group 7: MenACYW Conjugate Vaccine (6-11 Months)
    Reporting group description
    		 Participants aged 6 to 11 months received 2 doses of 0.5 mL MenACYW conjugate vaccine IM injection each on Days 1 and 31.

    Reporting group title
    Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months)
    Reporting group description
    		 Participants aged 6 to 11 months received 2 doses of 0.5 mL Royal’s MenAC conjugate vaccine IM injection each on Days 1 and 31.

    Reporting group title
    Group 9: MenACYW Conjugate Vaccine (3-5 Months)
    Reporting group description
    		 Participants aged 3 to 5 months received 3 doses of 0.5 mL MenACYW conjugate vaccine IM injection each on Days 1, 31 and 61.

    Reporting group title
    Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Reporting group description
    		 Participants aged 3 to 5 months received 3 doses of 0.5 mL Green Bamboo’s MenAC conjugate vaccine IM injection each on Days 1, 31 and 61.

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

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    End point title
    		 Number of Participants With Immediate Unsolicited Adverse Events (AEs) [1]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that was, pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs. Analysis was performed on the safety analysis set which included participants who received at least 1 dose of the study vaccine and had any safety data available.
    End point type
    Primary
    End point timeframe
    Up to 30 minutes after each and any study vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, statistical analysis is not presented.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Number of subjects analysed
    30
    30
    30
    30
    30
    30
    30
    28
    30
    30
    Units: participants
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    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 [2]
    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 and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology. Analysis was performed on the safety analysis set which included participants who received at least 1 dose of the study vaccine and had any safety data available.
    End point type
    Primary
    End point timeframe
    Up to 7 days after each and any study vaccination
    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, statistical analysis is not presented.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Number of subjects analysed
    30
    30
    30
    30
    30
    30
    30
    28
    30
    30
    Units: participants
        Injection site reactions
    7
    9
    9
    5
    2
    2
    3
    1
    1
    3
        Systemic reactions
    3
    2
    5
    2
    7
    6
    17
    8
    19
    12
    No statistical analyses for this end point

    Primary: Number of Participants With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Serious Adverse Events (SAEs) [3]
    End point description
    An SAE was defined as 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. Analysis was performed on the safety analysis set which included participants who received at least 1 dose of the study vaccine and had any safety data available.
    End point type
    Primary
    End point timeframe
    From date of first vaccination (Day 1) up to 6 months after the last study vaccination, approximately 180 days for Groups 1 to 6, 210 days for Groups 7, 8 and 240 days for Groups 9, 10
    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, statistical analysis is not presented.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Number of subjects analysed
    30
    30
    30
    30
    30
    30
    30
    28
    30
    30
    Units: participants
    0
    1
    4
    3
    7
    8
    13
    14
    15
    14
    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 [4]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that was, pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on the safety analysis set which included participants who received at least 1 dose of the study vaccine and had any safety data available.
    End point type
    Primary
    End point timeframe
    Up to 30 days after each and any study vaccination
    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, statistical analysis is not presented.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Number of subjects analysed
    30
    30
    30
    30
    30
    30
    30
    28
    30
    30
    Units: participants
    6
    7
    11
    10
    15
    15
    26
    23
    28
    25
    No statistical analyses for this end point

    Secondary: All Groups: Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Rabbit Complement (rSBA)

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    End point title
    		 All Groups: Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
    End point description
    The rSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine and to serogroups A and C for comparators was defined as follows: 30 days post-vaccination rSBA titers >=1:8 for participants with pre-vaccination rSBA titers <1:8 OR at least 4-fold increase in rSBA titers from pre to 30 days post-vaccination for participants with pre vaccination rSBA titers >=1:8. Analysis was performed on the per-protocol analysis set which was the subset of full analysis set (FAS: participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result). Here, n=0 indicates that response to only serogroups A and C were determined for the comparators and not Y and W. Hence the corresponding data is reported as 9999 indicating 'not applicable'. Percentages are rounded off to the tenth decimal place.
    End point type
    Secondary
    End point timeframe
    Day 1 (all Groups) and Day 31 for Groups 1 to 6, Day 61 for Groups 7 and 8 and Day 91 for Groups 9 and 10
    End point values
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Number of subjects analysed
    28
    26
    25
    29
    29
    27
    25
    21
    19
    18
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=28,26,25,29,29,27,25,21,19,18)
    82.1 (63.1 to 93.9)
    19.2 (6.6 to 39.4)
    88.0 (68.8 to 97.5)
    82.8 (64.2 to 94.2)
    96.6 (82.2 to 99.9)
    88.9 (70.8 to 97.6)
    96.0 (79.6 to 99.9)
    76.2 (52.8 to 91.8)
    94.7 (74.0 to 99.9)
    11.1 (1.4 to 34.7)
        Serogroup C (n=28,26,25,29,29,27,25,21,19,18)
    96.4 (81.7 to 99.9)
    30.8 (14.3 to 51.8)
    100 (86.3 to 100)
    100 (88.1 to 100)
    100 (88.1 to 100)
    100 (87.2 to 100)
    100 (86.3 to 100)
    100 (83.9 to 100)
    100 (82.4 to 100)
    38.9 (17.3 to 64.3)
        Serogroup Y (n=28,0,25,0,29,0,25,0,19,0)
    89.3 (71.8 to 97.7)
    9999 (9999 to 9999)
    92.0 (74.0 to 99.0)
    9999 (9999 to 9999)
    89.7 (72.6 to 97.8)
    9999 (9999 to 9999)
    88.0 (68.8 to 97.5)
    9999 (9999 to 9999)
    100 (82.4 to 100)
    9999 (9999 to 9999)
        Serogroup W (n=28,0,25,0,29,0,25,0,19,0)
    96.4 (81.7 to 99.9)
    9999 (9999 to 9999)
    96.0 (79.6 to 99.9)
    9999 (9999 to 9999)
    93.1 (77.2 to 99.2)
    9999 (9999 to 9999)
    96.0 (79.6 to 99.9)
    9999 (9999 to 9999)
    100 (82.4 to 100)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: All Groups: Geometric Mean Titers Against Meningococcal Serogroups as Measured by rSBA

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    End point title
    		 All Groups: Geometric Mean Titers Against Meningococcal Serogroups as Measured by rSBA
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine and serogroups A and C for comparators were measured by rSBA. Analysis was performed on the per-protocol analysis set which was the subset of FAS which included participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Here, n=0 indicates that response to only serogroups A and C were determined for the comparators and not Y and W. Hence the corresponding data is reported as 9999 indicating 'not applicable'.
    End point type
    Secondary
    End point timeframe
    30 days after vaccination (Day 31 for Groups 1 to 6, Day 61 for Groups 7 and 8 and Day 91 for Groups 9 and 10)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Number of subjects analysed
    28
    26
    25
    29
    29
    27
    25
    21
    19
    18
    Units: titer
    geometric mean (confidence interval 95%)
        Serogroup A (n=28,26,25,29,29,27,25,21,19,18)
    742 (517 to 1066)
    60.7 (29.1 to 126)
    572 (400 to 817)
    349 (243 to 502)
    256 (160 to 409)
    91.7 (42.0 to 200)
    89.3 (47.8 to 167)
    40.3 (13.0 to 125)
    82.6 (34.3 to 199)
    1.71 (0.786 to 3.74)
        Serogroup C (n=28,26,25,29,29,27,25,21,19,18)
    565 (370 to 864)
    3.89 (1.89 to 8.03)
    695 (463 to 1042)
    433 (325 to 577)
    550 (407 to 744)
    284 (199 to 404)
    211 (151 to 295)
    47.6 (34.4 to 65.8)
    159 (112 to 227)
    3.30 (1.58 to 6.89)
        Serogroup Y (n=28,0,25,0,29,0,25,0,19,0)
    353 (205 to 609)
    9999 (9999 to 9999)
    294 (209 to 413)
    9999 (9999 to 9999)
    54.1 (36.4 to 80.5)
    9999 (9999 to 9999)
    39.9 (23.4 to 68.1)
    9999 (9999 to 9999)
    128 (91.6 to 179)
    9999 (9999 to 9999)
        Serogroup W (n=28,0,25,0,29,0,25,0,19,0)
    238 (163 to 346)
    9999 (9999 to 9999)
    118 (74.7 to 186)
    9999 (9999 to 9999)
    36.9 (21.5 to 63.6)
    9999 (9999 to 9999)
    45.9 (28.5 to 73.8)
    9999 (9999 to 9999)
    82.6 (55.1 to 124)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: All Groups: Percentage of Participants With rSBA Titers >=1:8 and >=1:128

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    End point title
    		 All Groups: Percentage of Participants With rSBA Titers >=1:8 and >=1:128
    End point description
    Seropositivity (rSBA titers >=1:8) and antibody responses of rSBA titers >=1:128 to meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine and meningococcal serogroups A and C for MenAC conjugate vaccine were determined. Analysis was performed on the per-protocol analysis set which was the subset of FAS which included participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Here, n=0 indicates that response to only serogroups A and C were determined for the comparators and not Y and W. Hence the corresponding data is reported as 9999 indicating 'not applicable'. SG: serogroup. Percentages are rounded off to the tenth decimal place.
    End point type
    Secondary
    End point timeframe
    30 days after vaccination (Day 31 for Groups 1 to 6, Day 61 for Groups 7 and 8 and Day 91 for Groups 9 and 10)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Number of subjects analysed
    28
    26
    25
    29
    29
    27
    25
    21
    19
    18
    Units: percentage of participants
    number (confidence interval 95%)
        SG A, >=1:8 (n=28,26,25,29,29,27,25,21,19,18)
    100 (87.7 to 100)
    84.6 (65.1 to 95.6)
    100 (86.3 to 100)
    100 (88.1 to 100)
    100 (88.1 to 100)
    88.9 (70.8 to 97.6)
    96.0 (79.6 to 99.9)
    76.2 (52.8 to 91.8)
    94.7 (74.0 to 99.9)
    11.1 (1.4 to 34.7)
        SG A, >=1:128 (n=28,26,25,29,29,27,25,21,19,18)
    96.4 (81.7 to 99.9)
    50.0 (29.9 to 70.1)
    96.0 (79.6 to 99.9)
    93.1 (77.2 to 99.2)
    79.3 (60.3 to 92.0)
    63.0 (42.4 to 80.6)
    56.0 (34.9 to 75.6)
    42.9 (21.8 to 66.0)
    47.4 (24.4 to 71.1)
    11.1 (1.4 to 34.7)
        SG C, >=1:8(n=28,26,25,29,29,27,25,21,19,18)
    100 (87.7 to 100)
    38.5 (20.2 to 59.4)
    100 (86.3 to 100)
    100 (88.1 to 100)
    100 (88.1 to 100)
    100 (87.2 to 100)
    100 (86.3 to 100)
    100 (83.9 to 100)
    100 (82.4 to 100)
    38.9 (17.3 to 64.3)
        SG C, >=1:128 (n=28,26,25,29,29,27,25,21,19,18)
    100 (87.7 to 100)
    7.7 (0.9 to 25.1)
    100 (86.3 to 100)
    100 (88.1 to 100)
    100 (88.1 to 100)
    88.9 (70.8 to 97.6)
    84.0 (63.9 to 95.5)
    14.3 (3.0 to 36.3)
    84.2 (60.4 to 96.6)
    0 (0 to 18.5)
        SG Y, >=1:8 (n=28,0,25,0,29,0,25,0,19,0)
    96.4 (81.7 to 99.9)
    9999 (9999 to 9999)
    100 (86.3 to 100)
    9999 (9999 to 9999)
    96.6 (82.2 to 99.9)
    9999 (9999 to 9999)
    92.0 (74.0 to 99.0)
    9999 (9999 to 9999)
    100 (82.4 to 100)
    9999 (9999 to 9999)
        SG Y, >=1:128 (n=28,0,25,0,29,0,25,0,19,0)
    92.9 (76.5 to 99.1)
    9999 (9999 to 9999)
    96.0 (79.6 to 99.9)
    9999 (9999 to 9999)
    34.5 (17.9 to 54.3)
    9999 (9999 to 9999)
    24.0 (9.4 to 45.1)
    9999 (9999 to 9999)
    73.7 (48.8 to 90.9)
    9999 (9999 to 9999)
        SG W, >=1:8 (n=28,0,25,0,29,0,25,0,19,0)
    100 (87.7 to 100)
    9999 (9999 to 9999)
    96.0 (79.6 to 99.9)
    9999 (9999 to 9999)
    93.1 (77.2 to 99.2)
    9999 (9999 to 9999)
    96.0 (79.6 to 99.9)
    9999 (9999 to 9999)
    100 (82.4 to 100)
    9999 (9999 to 9999)
        SG W, >=1:128 (n=28,0,25,0,29,0,25,0,19,0)
    89.3 (71.8 to 97.7)
    9999 (9999 to 9999)
    72.0 (50.6 to 87.9)
    9999 (9999 to 9999)
    27.6 (12.7 to 47.2)
    9999 (9999 to 9999)
    28.0 (12.1 to 49.4)
    9999 (9999 to 9999)
    52.6 (28.9 to 75.6)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From date of first vaccination (Day 1) up to 6 months after the last study vaccination, approximately 180 days for Groups 1 to 6, 210 days for Groups 7, 8 and 240 days for Groups 9, 10
    Adverse event reporting additional description
    Analysis was performed on the safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine (7-17 Years)
    Reporting group description
    		 Participants aged 7 to 17 years received a single dose of 0.5 mL MenACYW conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years)
    Reporting group description
    		 Participants aged 7 to 17 years received a single dose of 0.5 mL Green Bamboo’s MenAC conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 3: MenACYW Conjugate Vaccine (2-6 Years)
    Reporting group description
    		 Participants aged 2 to 6 years received a single dose of 0.5 mL MenACYW conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years)
    Reporting group description
    		 Participants aged 2 to 6 years received a single dose of 0.5 mL Royal’s MenAC conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 5: MenACYW Conjugate Vaccine (12-23 Months)
    Reporting group description
    		 Participants aged 12 to 23 months received a single dose of 0.5 mL MenACYW conjugate vaccine IM injection on Day 1.

    Reporting group title
    Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months)
    Reporting group description
    		 Participants aged 12 to 23 months received a single dose of 0.5 mL Royal’s MenAC conjugate vaccine IM injection on Day 1. An additional dose of Royal’s MenAC conjugate vaccine was offered by the Investigator to participants in Group 6 after the study procedure on the last visit of blood sampling to comply with product’s approved vaccination schedule. This second dose of Royal’s vaccine was not a part of the study assessment and was administered at least 31 days after the study vaccination.

    Reporting group title
    Group 7: MenACYW Conjugate Vaccine (6-11 Months)
    Reporting group description
    		 Participants aged 6 to 11 months received 2 doses of 0.5 mL MenACYW conjugate vaccine IM injection each on Days 1 and 31.

    Reporting group title
    Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months)
    Reporting group description
    		 Participants aged 6 to 11 months received 2 doses of 0.5 mL Royal’s MenAC conjugate vaccine IM injection each on Days 1 and 31.

    Reporting group title
    Group 9: MenACYW Conjugate Vaccine (3-5 Months)
    Reporting group description
    		 Participants aged 3 to 5 months received 3 doses of 0.5 mL MenACYW conjugate vaccine IM injection each on Days 1, 31 and 61.

    Reporting group title
    Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Reporting group description
    		 Participants aged 3 to 5 months received 3 doses of 0.5 mL Green Bamboo’s MenAC conjugate vaccine IM injection each on Days 1, 31 and 61.

    Serious adverse events
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    4 / 30 (13.33%)
    3 / 30 (10.00%)
    7 / 30 (23.33%)
    8 / 30 (26.67%)
    13 / 30 (43.33%)
    14 / 28 (50.00%)
    15 / 30 (50.00%)
    14 / 30 (46.67%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Febrile Convulsion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Incarcerated Inguinal Hernia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Functional Gastrointestinal Disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis Perforated
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    3 / 30 (10.00%)
    2 / 30 (6.67%)
    4 / 30 (13.33%)
    2 / 30 (6.67%)
    4 / 28 (14.29%)
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 2
    0 / 5
    0 / 2
    0 / 4
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complicated Appendicitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile Infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea Infectious
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand-Foot-And-Mouth Disease
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 28 (3.57%)
    3 / 30 (10.00%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes Pharyngitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    3 / 28 (10.71%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 1
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    4 / 30 (13.33%)
    4 / 30 (13.33%)
    7 / 30 (23.33%)
    6 / 28 (21.43%)
    12 / 30 (40.00%)
    9 / 30 (30.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 5
    0 / 5
    0 / 8
    0 / 6
    0 / 17
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection Bacterial
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis Bacterial
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    4 / 30 (13.33%)
    1 / 28 (3.57%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: MenACYW Conjugate Vaccine (7-17 Years) Group 2: Green Bamboo’s MenAC Conjugate Vaccine (7-17 Years) Group 3: MenACYW Conjugate Vaccine (2-6 Years) Group 4: Royal’s MenAC Conjugate Vaccine (2-6 Years) Group 5: MenACYW Conjugate Vaccine (12-23 Months) Group 6: Royal’s MenAC Conjugate Vaccine (12-23 Months) Group 7: MenACYW Conjugate Vaccine (6-11 Months) Group 8: Royal’s MenAC Conjugate Vaccine (6-11 Months) Group 9: MenACYW Conjugate Vaccine (3-5 Months) Group 10: Green Bamboo’s MenAC Conjugate Vaccine (3-5 Months)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 30 (33.33%)
    11 / 30 (36.67%)
    14 / 30 (46.67%)
    10 / 30 (33.33%)
    15 / 30 (50.00%)
    15 / 30 (50.00%)
    26 / 30 (86.67%)
    23 / 28 (82.14%)
    28 / 30 (93.33%)
    27 / 30 (90.00%)
    Investigations
    Myocardial Necrosis Marker Increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 28 (7.14%)
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    2
    2
    3
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    3 / 30 (10.00%)
    4 / 30 (13.33%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    0
    3
    4
    Headache
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    1
    1
    2
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    3 / 30 (10.00%)
    2 / 30 (6.67%)
    4 / 30 (13.33%)
    0 / 28 (0.00%)
    7 / 30 (23.33%)
    3 / 30 (10.00%)
         occurrences all number
    0
    0
    0
    0
    3
    2
    5
    0
    9
    4
    Injection Site Erythema
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 30 (10.00%)
    5 / 30 (16.67%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    3
    3
    5
    2
    0
    1
    2
    0
    1
    2
    Injection Site Pain
         subjects affected / exposed
    7 / 30 (23.33%)
    8 / 30 (26.67%)
    6 / 30 (20.00%)
    3 / 30 (10.00%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    7
    8
    6
    3
    2
    1
    1
    1
    0
    2
    Injection Site Swelling
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
    3 / 30 (10.00%)
    3 / 30 (10.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    2
    3
    3
    3
    0
    0
    1
    0
    0
    1
    Malaise
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    4 / 30 (13.33%)
    1 / 30 (3.33%)
    6 / 30 (20.00%)
    5 / 30 (16.67%)
    19 / 30 (63.33%)
    11 / 28 (39.29%)
    15 / 30 (50.00%)
    14 / 30 (46.67%)
         occurrences all number
    1
    0
    4
    1
    6
    6
    31
    12
    22
    22
    Gastrointestinal disorders
    Functional Gastrointestinal Disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    Diarrhoea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    3 / 30 (10.00%)
    2 / 30 (6.67%)
    3 / 30 (10.00%)
    0 / 28 (0.00%)
    5 / 30 (16.67%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    0
    3
    2
    3
    0
    7
    1
    Vomiting
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    3 / 30 (10.00%)
    3 / 30 (10.00%)
    5 / 30 (16.67%)
    3 / 28 (10.71%)
    3 / 30 (10.00%)
    4 / 30 (13.33%)
         occurrences all number
    1
    0
    0
    1
    3
    3
    5
    3
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    6 / 30 (20.00%)
    4 / 30 (13.33%)
    6 / 30 (20.00%)
    3 / 30 (10.00%)
    10 / 30 (33.33%)
    12 / 28 (42.86%)
    16 / 30 (53.33%)
    18 / 30 (60.00%)
         occurrences all number
    2
    2
    6
    6
    6
    3
    11
    15
    23
    27
    Rhinorrhoea
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    3 / 30 (10.00%)
    3 / 30 (10.00%)
    5 / 30 (16.67%)
    10 / 30 (33.33%)
    12 / 28 (42.86%)
    10 / 30 (33.33%)
    12 / 30 (40.00%)
         occurrences all number
    4
    1
    0
    3
    3
    5
    11
    14
    11
    13
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    2
    2
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    5 / 30 (16.67%)
    4 / 30 (13.33%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    3
    0
    5
    5
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    2 / 28 (7.14%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    2
    0
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    1 / 28 (3.57%)
    4 / 30 (13.33%)
    3 / 30 (10.00%)
         occurrences all number
    0
    1
    3
    0
    2
    2
    0
    1
    4
    3
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    3 / 30 (10.00%)
    4 / 30 (13.33%)
    0 / 28 (0.00%)
    3 / 30 (10.00%)
    3 / 30 (10.00%)
         occurrences all number
    2
    0
    0
    0
    2
    3
    4
    0
    3
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jan 2024
    The main reason for this amendment was to add an interim analysis for Cohorts 1 and 2 (participants from 2 through 17 years of age).

    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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