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    Clinical Trial Results:
    A Randomized Study to Describe the Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers

    Summary
    EudraCT number
    		 2019-004459-35
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Mar 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 Jan 2024
    First version publication date
    29 Sep 2023
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Safety section updated with no change in conclusions

    Trial information

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    Trial identification
    Sponsor protocol code
    MET41
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03673462
    WHO universal trial number (UTN)
    		 U1111-1183-6261
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001930-PIP01-16
    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
    21 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2023
    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 Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®) when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Sep 2018
    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
    United States: 2751
    Country: Number of subjects enrolled
    Puerto Rico: 46
    Worldwide total number of subjects
    2797
    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)
    2797
    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
    		 Study was conducted at 75 sites in Puerto Rico and the United States from 17 September 2018 to 16 March 2023.

    Pre-assignment
    Screening details
    		 A total of 2797 subjects were enrolled and randomised in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    The meningococcal vaccines (Group 1: MenACYW Conjugate Vaccine and Group 2: MENVEO®) used in the study have different appearances and preparation methods. Hence, the study followed a modified double blind design i.e., with the exception of the personnel administering the vaccine, everyone involved in the study (subjects, care provider, investigator, safety outcomes assessor, Sponsor) was blinded to avoid any bias.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenACYW Conjugate Vaccine
    Arm description
    		 Healthy infants aged greater than equal to (>=) 42 to less than equal to (<=) 89 days (at the time of enrollment) received MenACYW Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib) at 2, 4, and 6 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine; PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Investigational medicinal product code
    Other name
    MenACYW Conjugate vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received MenACYW Conjugate vaccine at 2, 4, 6, and 12 months of age.

    Investigational medicinal product name
    Rotavirus Vaccine
    Investigational medicinal product code
    Other name
    RotaTeq®
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received RotaTeq® vaccine at 2, 4, and 6 months of age.

    Investigational medicinal product name
    Hepatitis B Vaccine
    Investigational medicinal product code
    Other name
    ENGERIX-B®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received ENGERIX-B® vaccine at 2 and 6 months of age.

    Investigational medicinal product name
    Pneumococcal 13-valent Conjugate Vaccine
    Investigational medicinal product code
    Other name
    PREVNAR 13®, PCV13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received PREVNAR 13® vaccine at 2, 4, 6, and 12 months of age.

    Investigational medicinal product name
    Measles, Mumps, and Rubella Virus Vaccine
    Investigational medicinal product code
    Other name
    M-M-R® II
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received M-M-R® II vaccine at 12 months of age.

    Investigational medicinal product name
    Varicella Virus Vaccine
    Investigational medicinal product code
    Other name
    VARIVAX®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received VARIVAX® vaccine at 12 months of age.

    Investigational medicinal product name
    Diphtheria and Tetanus Toxoids and Acellular Pertussis Poliovirus and Haemophilus b Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pentacel®
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Pentacel® vaccine at 2, 4, and 6 months of age.

    Arm title
    		 Group 2: MENVEO® Vaccine
    Arm description
    		 Healthy infants aged >= 42 to <= 89 days (at the time of enrollment) received MENVEO® Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib) at 2, 4, and 6 months of age; PREVNAR 13® (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
    Investigational medicinal product code
    Other name
    MENVEO®
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received MENVEO® vaccine at 2, 4, 6, and 12 months of age.

    Investigational medicinal product name
    Diphtheria and Tetanus Toxoids and Acellular Pertussis Poliovirus and Haemophilus b Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pentacel®
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Pentacel® vaccine at 2, 4 and 6 months of age.

    Investigational medicinal product name
    Pneumococcal 13-valent Conjugate Vaccine
    Investigational medicinal product code
    Other name
    PREVNAR 13®, PCV13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received PREVNAR 13® vaccine at 2, 4, 6, and 12 months of age.

    Investigational medicinal product name
    Varicella Virus Vaccine
    Investigational medicinal product code
    Other name
    VARIVAX®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received VARIVAX® at 12 months of age.

    Investigational medicinal product name
    Hepatitis B Vaccine
    Investigational medicinal product code
    Other name
    ENGERIX-B®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received ENGERIX-B® vaccine at 2 and 6 months of age.

    Investigational medicinal product name
    Measles, Mumps, and Rubella Virus Vaccine
    Investigational medicinal product code
    Other name
    M-M-R® II
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received M-M-R® vaccine II at 12 months of age.

    Investigational medicinal product name
    Rotavirus Vaccine
    Investigational medicinal product code
    Other name
    RotaTeq®
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received RotaTeq® vaccine at 2, 4, and 6 months of age.

    Number of subjects in period 1
    		Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Started
    2099
    698
    Safety Analysis Set (SafAS)
    2080
    697
    Vaccinated at 2 Months
    2080
    695
    Vaccinated at 4 Months
    2005
    663
    Vaccinated at 6 Months
    1951
    648
    Vaccinated at 12 Months
    1838
    623
    Completed
    1799
    611
    Not completed
    300
    87
         Adverse events
    11
    1
         Withdrawal by Parent/Guardian
    162
    56
         Lost to follow-up
    102
    19
         Protocol deviation
    25
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Healthy infants aged greater than equal to (>=) 42 to less than equal to (<=) 89 days (at the time of enrollment) received MenACYW Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib) at 2, 4, and 6 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine; PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.

    Reporting group title
    Group 2: MENVEO® Vaccine
    Reporting group description
    		 Healthy infants aged >= 42 to <= 89 days (at the time of enrollment) received MENVEO® Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib) at 2, 4, and 6 months of age; PREVNAR 13® (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.

    Reporting group values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine Total
    Number of subjects
    		 2099 698 2797
    Age categorical
    Units: Subjects
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 64.7 ± 6.63 64.9 ± 6.77 -
    Gender categorical
    Units: Subjects
        Female
    		 998 336 1334
        Male
    		 1101 362 1463
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 8 0 8
        Asian
    		 28 12 40
        Black or African American
    		 210 67 277
        Native Hawaiian or Other Pacific Islander
    		 10 5 15
        White
    		 1719 580 2299
        Mixed Origin
    		 102 31 133
        Not Reported
    		 10 3 13
        Unknown
    		 12 0 12

    End points

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    End points reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Healthy infants aged greater than equal to (>=) 42 to less than equal to (<=) 89 days (at the time of enrollment) received MenACYW Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib) at 2, 4, and 6 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine; PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.

    Reporting group title
    Group 2: MENVEO® Vaccine
    Reporting group description
    		 Healthy infants aged >= 42 to <= 89 days (at the time of enrollment) received MENVEO® Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib) at 2, 4, and 6 months of age; PREVNAR 13® (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.

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

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    End point title
    		 Number of Subjects With Immediate Unsolicited Systemic Adverse Events (AEs) [1]
    End point description
    An AE was any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Immediate adverse events are unsolicited systemic adverse events occurring in the 30 minutes after injection. Reported AEs for each arm were presented as pre-specified in protocol. Analysis was performed on Safety Analysis Set (SafAS) that included all subjects who have received at least one dose of the study vaccines and have any safety data available.
    End point type
    Primary
    End point timeframe
    Within 30 minutes post-any 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: No statistical analyses
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    2080
    697
    Units: subjects
    7
    2
    No statistical analyses for this end point

    Primary: Number of Subjects With Solicited Injection Site Reactions

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    End point title
    		 Number of Subjects With Solicited Injection Site Reactions [2]
    End point description
    A solicited reaction (SR) was an “expected” adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included Injection site tenderness, Injection site erythema, and Injection site swelling and were planned to be collected and reported for each vaccine separately; and not planned to be collected for Rotavirus vaccine as the vaccine was administered orally, and no injection site reactions were expected to occur. Reported AEs for each arm were presented as pre-specified in protocol. Analysis was performed on SafAS. Here, ‘number of subjects analysed’ = subjects with available data for this endpoint and ‘n’ = subjects with available data for each specified category.
    End point type
    Primary
    End point timeframe
    Within 7 days post any 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: No statistical analyses
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    2021
    676
    Units: subjects
        MenACYW or MENVEO: Tenderness (n = 2021, 676)
    1501
    499
        MenACYW or MENVEO: Erythema (n = 2021, 676)
    826
    257
        MenACYW or MENVEO: Swelling (n = 2019, 676)
    557
    170
        PENTACEL: Tenderness (n = 2017, 676)
    1388
    456
        PENTACEL: Erythema (n = 2017, 676)
    770
    255
        PENTACEL: Swelling (n = 2017, 676)
    562
    178
        PREVNAR 13: Tenderness (n = 2018, 676)
    1464
    496
        PREVNAR 13: Erythema (n = 2017,676)
    889
    298
        PREVNAR 13: Swelling (n = 2017, 676)
    656
    206
        ENGERIX-B: Tenderness (n= 2013, 674)
    1199
    395
        ENGERIX-B: Erythema (n = 2013, 675)
    539
    192
        ENGERIX-B: Swelling (n = 2013, 675)
    347
    115
        M-M-R II: Tenderness (n = 1756, 588)
    786
    268
        M-M-R II: Erythema (n = 1755, 588)
    409
    130
        M-M-R II: Swelling (n = 1754, 588)
    221
    71
        VARIVAX: Tenderness (n = 1758, 588)
    724
    252
        VARIVAX: Erythema (n = 1757, 588)
    364
    129
        VARIVAX: Swelling (n = 1757,588)
    208
    70
    No statistical analyses for this end point

    Primary: Number of Subjects With Solicited Systemic Reactions

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    End point title
    		 Number of Subjects With Solicited Systemic Reactions [3]
    End point description
    A SR was an “expected” AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol. Analysis was performed on SafAS. Here, ‘number of subjects analysed’ = subjects with available data for this endpoint and ‘n’ = subjects with available data for each specified category.
    End point type
    Primary
    End point timeframe
    Within 7 days post-any vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    2019
    676
    Units: subjects
        Fever (n = 2002, 671)
    724
    219
        Vomiting (n = 2018, 676)
    542
    163
        Crying abnormal (n = 2019, 676)
    1437
    478
        Drowsiness (n = 2017, 676)
    1430
    475
        Appetite lost (n = 2018, 676)
    1015
    350
        Irritability (n = 2018, 676)
    1604
    536
    No statistical analyses for this end point

    Primary: Number of Subjects With Unsolicited Adverse Events

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    End point title
    		 Number of Subjects With Unsolicited Adverse Events [4]
    End point description
    An AE was any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious adverse events (SAEs) and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol. Analysis was performed on SafAS.
    End point type
    Primary
    End point timeframe
    Within 30 days post any 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: No statistical analyses
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    2080
    697
    Units: subjects
    1352
    437
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) [5]
    End point description
    A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalisation 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 product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. Reported AEs for each arm were presented as pre-specified in protocol. Analysis was performed on SafAS.
    End point type
    Primary
    End point timeframe
    From day of first vaccination (i.e., at the age of 2 months) up to 6 months after last vaccination (i.e., up to the age of 18 months)
    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: No statistical analyses
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    2080
    697
    Units: subjects
        SAE
    108
    21
        AESI
    19
    1
    No statistical analyses for this end point

    Primary: Number of Subjects With Medically-attended Adverse Event (MAAEs)

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    End point title
    		 Number of Subjects With Medically-attended Adverse Event (MAAEs) [6]
    End point description
    An MAAE was defined as a new onset of a condition that prompts the subject or subject’s parent/guardian to seek unplanned medical advice at a health care provider’s office or Emergency Department. Reported AEs for each arm were presented as pre-specified in protocol. Analysis was performed on SafAS.
    End point type
    Primary
    End point timeframe
    From day of first vaccination (i.e., at the age of 2 months) up to 6 months after last vaccination (i.e., up to the age of 18 months)
    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: No statistical analyses
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    2080
    697
    Units: subjects
    1581
    526
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited AE: within 30 days post-any vaccination. SR: within 7 days post-any vaccination. SAE: from dayof first vaccination (i.e., at the age of 2 months) up to 6 months post last vaccination (i.e., up to the age of18 months)
    Adverse event reporting additional description
    SR: “expected” AR observed & reported under conditions pre-listed in protocol. Unsolicited AE: AE that doesnot fulfill conditions prelisted in CRB. SafAS. Reported AEs for each arm presented as pre-specified. In AEsection, SR fever, crying abnormal, drowsiness & appetite lost are reported under Pyrexia, crying,somnolence & decreased appetite.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    MENVEO® Vaccine
    Reporting group description
    		 Healthy infants aged >= 42 to <= 89 days (at the time of enrollment) received MENVEO® ConjugateVaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib) at 2, 4, and 6 months ofage; PREVNAR 13® (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles,mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.

    Reporting group title
    MenACYW Conjugate Vaccine
    Reporting group description
    		 Healthy infants aged greater than equal to (>=) 42 to less than equal to (<=) 89 days (at the time ofenrollment) received MenACYW Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along withPentacel® (DTaP-IPV/Hib) at 2, 4, and 6 months of age; PREVNAR 13® (pneumococcal 13-valent conjugatevaccine; PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months ofage; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, andrubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.

    Serious adverse events
    		 MENVEO® Vaccine MenACYW Conjugate Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 697 (3.01%)
    108 / 2080 (5.19%)
         number of deaths (all causes)
    0
    3
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenocortical Carcinoma
         subjects affected / exposed
    1 / 697 (0.14%)
    0 / 2080 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden Infant Death Syndrome
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    0 / 697 (0.00%)
    2 / 2080 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Developmental Delay
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory Distress
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial Hyperreactivity
         subjects affected / exposed
    1 / 697 (0.14%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    1 / 697 (0.14%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Stereotypy
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Status Changes
         subjects affected / exposed
    0 / 697 (0.00%)
    2 / 2080 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic Enzyme Increased
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head Injury
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Extradural Haematoma
         subjects affected / exposed
    0 / 697 (0.00%)
    2 / 2080 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental Exposure To Product
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural Haemorrhage
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull Fracture
         subjects affected / exposed
    0 / 697 (0.00%)
    2 / 2080 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    0 / 697 (0.00%)
    2 / 2080 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Laryngomalacia
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniosynostosis
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital Absence Of Bile Ducts
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alagille Syndrome
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 697 (0.00%)
    2 / 2080 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile Convulsion
         subjects affected / exposed
    1 / 697 (0.14%)
    15 / 2080 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fontanelle Bulging
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage Intracranial
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure Like Phenomena
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 697 (0.14%)
    3 / 2080 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss Of Consciousness
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unresponsive To Stimuli
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 697 (0.14%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastroenteritis Eosinophilic
         subjects affected / exposed
    1 / 697 (0.14%)
    0 / 2080 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 697 (0.00%)
    3 / 2080 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated Inguinal Hernia
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising Oesophagitis
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sandifer's Syndrome
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowel Movement Irregularity
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acinetobacter Infection
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoviral Upper Respiratory Infection
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 697 (0.14%)
    9 / 2080 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis Orbital
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup Infectious
         subjects affected / exposed
    2 / 697 (0.29%)
    0 / 2080 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-Barr Virus Infection
         subjects affected / exposed
    1 / 697 (0.14%)
    0 / 2080 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 697 (0.14%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 697 (0.00%)
    4 / 2080 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-Foot-And-Mouth Disease
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus Bronchiolitis
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae Virus Infection
         subjects affected / exposed
    1 / 697 (0.14%)
    0 / 2080 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal Abscess
         subjects affected / exposed
    1 / 697 (0.14%)
    0 / 2080 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal Abscess
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 697 (0.14%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 697 (0.00%)
    3 / 2080 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 697 (0.14%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Scalded Skin Syndrome
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    1 / 697 (0.14%)
    0 / 2080 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus Infection
         subjects affected / exposed
    2 / 697 (0.29%)
    2 / 2080 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    1 / 697 (0.14%)
    11 / 2080 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Syncytial Virus Bronchiolitis
         subjects affected / exposed
    1 / 697 (0.14%)
    7 / 2080 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 697 (0.14%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolic Acidosis
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure To Thrive
         subjects affected / exposed
    0 / 697 (0.00%)
    1 / 2080 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    3 / 697 (0.43%)
    5 / 2080 (0.24%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MENVEO® Vaccine MenACYW Conjugate Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    642 / 697 (92.11%)
    1889 / 2080 (90.82%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    475 / 697 (68.15%)
    1430 / 2080 (68.75%)
         occurrences all number
    1127
    3462
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    479 / 697 (68.72%)
    1439 / 2080 (69.18%)
         occurrences all number
    1125
    3327
    Injection Site Bruising
         subjects affected / exposed
    107 / 697 (15.35%)
    353 / 2080 (16.97%)
         occurrences all number
    223
    742
    Injection Site Erythema
         subjects affected / exposed
    380 / 697 (54.52%)
    1129 / 2080 (54.28%)
         occurrences all number
    2025
    6150
    Injection Site Pain
         subjects affected / exposed
    538 / 697 (77.19%)
    1619 / 2080 (77.84%)
         occurrences all number
    4340
    13051
    Injection Site Swelling
         subjects affected / exposed
    282 / 697 (40.46%)
    871 / 2080 (41.88%)
         occurrences all number
    1196
    3790
    Pyrexia
         subjects affected / exposed
    248 / 697 (35.58%)
    810 / 2080 (38.94%)
         occurrences all number
    360
    1280
    Gastrointestinal disorders
    Teething
         subjects affected / exposed
    60 / 697 (8.61%)
    161 / 2080 (7.74%)
         occurrences all number
    68
    200
    Vomiting
         subjects affected / exposed
    172 / 697 (24.68%)
    579 / 2080 (27.84%)
         occurrences all number
    253
    807
    Diarrhoea
         subjects affected / exposed
    37 / 697 (5.31%)
    85 / 2080 (4.09%)
         occurrences all number
    39
    92
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    30 / 697 (4.30%)
    105 / 2080 (5.05%)
         occurrences all number
    31
    113
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    538 / 697 (77.19%)
    1604 / 2080 (77.12%)
         occurrences all number
    1476
    4314
    Infections and infestations
    Otitis Media
         subjects affected / exposed
    47 / 697 (6.74%)
    148 / 2080 (7.12%)
         occurrences all number
    56
    176
    Otitis Media Acute
         subjects affected / exposed
    30 / 697 (4.30%)
    106 / 2080 (5.10%)
         occurrences all number
    34
    132
    Upper Respiratory Tract Infection
         subjects affected / exposed
    89 / 697 (12.77%)
    297 / 2080 (14.28%)
         occurrences all number
    99
    340
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    351 / 697 (50.36%)
    1017 / 2080 (48.89%)
         occurrences all number
    611
    1857

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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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    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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