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    Clinical Trial Results:
    A phase III open-label randomised study, to evaluate the immunogenicity and safety of the concomitant administration of V419 (PR5I) given at 2, 3 and 4 months of age with two types of meningococcal serogroup C conjugate (MCC) vaccines given at 3 and 4 months of age, and followed by the administration at 12 months of age of a combined Haemophilus influenzae type b-MCC vaccine.

    Summary
    EudraCT number
    		 2011-002413-11
    Trial protocol
    		 GB  
    Global end of trial date
    27 Sep 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    16 Nov 2019
    First version publication date
    02 Aug 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    V419-011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01553279
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 PRI01C: Sanofi Protocol Pasteur MSD Protocol Number
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Senior Vice President, Global Clinical Development, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Senior Vice President, Global Clinical Development, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Mar 2012
    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 Kingdom: 284
    Worldwide total number of subjects
    284
    EEA total number of subjects
    284
    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)
    284
    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
    		 -

    Pre-assignment
    Screening details
    		 Infant participants were enrolled at 11 study sites in the United Kingdom.

    Period 1
    Period 1 title
    Part 1: Infant Vaccinations
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V419 and MCC-TT
    Arm description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 3 doses of Prevnar 13® (at 2, 4, and 12 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
    Arm type
    		 Experimental

    Investigational medicinal product name
    V419
    Investigational medicinal product code
    Other name
    PR51; VAXELIS®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate [meningococcal outer membrane protein complex], and Hepatitis B [recombinant] vaccine administered via 0.5 mL intramuscular injection.

    Investigational medicinal product name
    PREVNAR 13®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).

    Investigational medicinal product name
    MCC-TT
    Investigational medicinal product code
    Other name
    NEISVAC-C®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age.

    Investigational medicinal product name
    Hib-MCC
    Investigational medicinal product code
    Other name
    MENITORIX®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.

    Arm title
    		 V419 and MCC-CRM
    Arm description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 3 doses of Prevnar 13® (at 2, 4, and 12 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
    Arm type
    		 Experimental

    Investigational medicinal product name
    V419
    Investigational medicinal product code
    Other name
    PR51; VAXELIS®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate [meningococcal outer membrane protein complex], and Hepatitis B [recombinant] vaccine administered via 0.5 mL intramuscular injection.

    Investigational medicinal product name
    MCC-CRM
    Investigational medicinal product code
    Other name
    MENJUGATE®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age.

    Investigational medicinal product name
    Hib-MCC
    Investigational medicinal product code
    Other name
    MENITORIX®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.

    Investigational medicinal product name
    PREVNAR 13®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).

    Number of subjects in period 1
    		V419 and MCC-TT V419 and MCC-CRM
    Started
    142
    142
    Completed
    140
    141
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    1
         Lost to follow-up
    1
    -
    Period 2
    Period 2 title
    Interim Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No study drug was administered during the Interim Period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V419 and MCC-TT
    Arm description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 V419 and MCC-CRM
    Arm description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		V419 and MCC-TT V419 and MCC-CRM
    Started
    140
    141
    Completed
    137
    139
    Not completed
    3
    2
         Consent withdrawn by subject
    2
    2
         Lost to follow-up
    1
    -
    Period 3
    Period 3 title
    Period 2: Toddler Vaccinations
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V419 and MCC-TT
    Arm description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hib-MCC
    Investigational medicinal product code
    Other name
    MENITORIX®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.

    Investigational medicinal product name
    MMR Vaccine
    Investigational medicinal product code
    Other name
    M-M-RVAXPRO®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).

    Arm title
    		 V419 and MCC-CRM
    Arm description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
    Arm type
    		 Experimental

    Investigational medicinal product name
    MMR Vaccine
    Investigational medicinal product code
    Other name
    M-M-RVAXPRO®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).

    Investigational medicinal product name
    Hib-MCC
    Investigational medicinal product code
    Other name
    MENITORIX®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.

    Number of subjects in period 3
    		V419 and MCC-TT V419 and MCC-CRM
    Started
    137
    139
    Completed
    134
    132
    Not completed
    3
    7
         Consent withdrawn by subject
    -
    5
         Lost to follow-up
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V419 and MCC-TT
    Reporting group description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 3 doses of Prevnar 13® (at 2, 4, and 12 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

    Reporting group title
    V419 and MCC-CRM
    Reporting group description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 3 doses of Prevnar 13® (at 2, 4, and 12 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

    Reporting group values
    		 V419 and MCC-TT V419 and MCC-CRM Total
    Number of subjects
    		 142 142 284
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 142 142 284
    Age Continuous
    Units: Days
        arithmetic mean (standard deviation)
    		 62.6 ( 6.7 ) 61.6 ( 7.2 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 62 67 129
        Male
    		 80 75 155

    End points

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    End points reporting groups
    Reporting group title
    V419 and MCC-TT
    Reporting group description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 3 doses of Prevnar 13® (at 2, 4, and 12 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

    Reporting group title
    V419 and MCC-CRM
    Reporting group description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 3 doses of Prevnar 13® (at 2, 4, and 12 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
    Reporting group title
    V419 and MCC-TT
    Reporting group description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

    Reporting group title
    V419 and MCC-CRM
    Reporting group description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
    Reporting group title
    V419 and MCC-TT
    Reporting group description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

    Reporting group title
    V419 and MCC-CRM
    Reporting group description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

    Subject analysis set title
    V419 + MCC-TT/MCC-CRM
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pooled population of participants who received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of either MCC-TT or MCC-CRM (at 3 and 4 months of age) in Part 1.

    Primary: Percentage of Participants with Anti-Meningococcal Serogroup C (anti-MCC) Antibody (Ab) Titre ≥1:8 dil One Month After MCC-TT or MCC-CRM (Part 1)

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    End point title
    		 Percentage of Participants with Anti-Meningococcal Serogroup C (anti-MCC) Antibody (Ab) Titre ≥1:8 dil One Month After MCC-TT or MCC-CRM (Part 1) [1]
    End point description
    The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Primary
    End point timeframe
    Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    121
    109
    Units: Percentage of Participants
        number (confidence interval 95%)
    100.0 (97.0 to 100.0)
    99.1 (95.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Polyribosylribitol Phosphate (anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Percentage of Participants with Anti-Polyribosylribitol Phosphate (anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)
    End point description
    The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >80%. Serum Ab levels were determined with radioimmunoassay (RIA). All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 + MCC-TT/MCC-CRM
    Number of subjects analysed
    175
    Units: Percentage of Participants
        number (confidence interval 95%)
    98.9 (95.9 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Meningococcal Serogroup C (anti-MCC) Antibody (Ab) Titre ≥1:8 dil and ≥1:128 dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)

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    End point title
    		 Percentage of Participants with Anti-Meningococcal Serogroup C (anti-MCC) Antibody (Ab) Titre ≥1:8 dil and ≥1:128 dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
    End point description
    The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    121
    109
    Units: Percentage of Participants
    number (confidence interval 95%)
        Post-MCC Dose 1: % with ≥1:8 dil (n=102, 84)
    100.0 (96.4 to 100.0)
    96.4 (89.9 to 99.3)
        Post-MCC Dose 1: % with ≥1:128 dil (n=102, 84)
    98.0 (93.1 to 99.8)
    84.5 (75.0 to 91.5)
        Post-MCC Dose 2: % with ≥1:8 dil (n=121, 109)
    100.0 (97.0 to 100.0)
    99.1 (95.0 to 100.0)
        Post-MCC Dose 2: % with ≥1:128 dil (n=121, 109)
    99.2 (95.5 to 100.0)
    99.1 (95.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)

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    End point title
    		 Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
    End point description
    Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay. All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    121
    109
    Units: Titres
    geometric mean (confidence interval 95%)
        Post-MCC Dose 1 anti-MCC GMTs (n=125, 111)
    1353 (1058.4 to 1729.6)
    285.0 (201.5 to 403.1)
        Post-MCC Dose 2 anti-MCC GMTs (n=125, 111)
    2024.7 (1689.8 to 2425.9)
    1077.4 (847.5 to 1369.8)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Response Rates for V419 Antigens One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Antibody (Ab) Response Rates for V419 Antigens One Month After V419 Dose 3 (Part 1)
    End point description
    The percentage of participants meeting Ab response rates for V419 antigens was determined after Dose 3. Response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown below. The percentage of responders to pertussis (pertussis toxoid [PT]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 [FIM]; and pertactin [PRN]) was determined as 1) if pre-vaccination Ab concentration <lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN. Randomized, treated participants with data and no protocol violations are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    125
    105
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-PRP ≥0.15 µg/mL (n=93, 82)
    97.8 (92.4 to 99.7)
    100.0 (95.6 to 100.0)
        Anti-HBsAG ≥10 mIU/mL (n=93, 82)
    96.8 (90.9 to 99.3)
    96.3 (89.7 to 99.2)
        Anti-Diptheria ≥0.01 IU/mL (n=125, 104)
    100.0 (97.1 to 100.0)
    100.0 (96.5 to 100.0)
        Anti-Diptheria ≥0.1 IU/mL (n=125, 104)
    68.0 (59.1 to 76.1)
    74.0 (64.5 to 82.1)
        Anti-Tetanus ≥0.01 IU/mL (n=122, 105)
    100.0 (97.0 to 100.0)
    100.0 (96.5 to 100.0)
        Anti-Tetanus ≥0.1 IU/mL (n=122, 105)
    100.0 (97.0 to 100.0)
    100.0 (96.5 to 100.0)
        Anti-PT seroresponse (n=100, 75)
    99.0 (94.6 to 100.0)
    100.0 (95.2 to 100.0)
        Anti-FHA seroresponse (n=100, 74)
    91.0 (83.6 to 95.8)
    90.5 (81.5 to 96.1)
        Anti-PRN seroresponse (n=100, 73)
    95.0 (88.7 to 98.4)
    90.4 (81.2 to 96.1)
        Anti-FIM seroresponse (n=100, 75)
    96.0 (90.1 to 98.9)
    96.0 (88.8 to 99.2)
        Anti-Polio 1 ≥ 1:8 dil (n=114, 95)
    100.0 (96.8 to 100.0)
    100.0 (96.2 to 100.0)
        Anti-Polio 2 ≥ 1:8 dil (n=106, 89)
    100.0 (96.6 to 100.0)
    100.0 (95.9 to 100.0)
        Anti-Polio 3 ≥ 1:8 dil (n=90, 74)
    100.0 (96.0 to 100.0)
    100.0 (95.1 to 100.0)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V419 Dose 3 (Part 1)
    End point description
    The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA). All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    93
    82
    Units: µg/mL
        geometric mean (confidence interval 95%)
    6.44 (4.7 to 8.83)
    8.21 (6.08 to 11.09)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V419 Dose 3 (Part 1)
    End point description
    The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay. All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    93
    82
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    195.1 (150.7 to 252.7)
    247.7 (186.3 to 329.3)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V419 Dose 3 (Part 1)
    End point description
    The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT). All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    125
    104
    Units: IU/mL
        geometric mean (confidence interval 95%)
    0.198 (0.165 to 0.237)
    0.22 (0.181 to 0.268)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V419 Dose 3 (Part 1)
    End point description
    The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA). All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    122
    105
    Units: IU/mL
        geometric mean (confidence interval 95%)
    1.03 (0.9 to 1.17)
    0.95 (0.82 to 1.1)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V419 Dose 3 (Part 1)
    End point description
    The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA). All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    112
    89
    Units: EU/mL
        geometric mean (confidence interval 95%)
    131.5 (117.2 to 147.6)
    133.3 (118.3 to 150.2)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V419 Dose 3 (Part 1)
    End point description
    The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay. All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    112
    88
    Units: EU/mL
        geometric mean (confidence interval 95%)
    50.4 (44.8 to 56.6)
    50.1 (43.7 to 57.4)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V419 Dose 3 (Part 1)
    End point description
    The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay. All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    112
    87
    Units: EU/mL
        geometric mean (confidence interval 95%)
    90.4 (73.2 to 111.7)
    106.8 (83.7 to 136.3)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V419 Dose 3 (Part 1)
    End point description
    The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay. All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    112
    89
    Units: EU/mL
        geometric mean (confidence interval 95%)
    401.7 (339.4 to 475.5)
    441.7 (363.2 to 537.2)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V419 Dose 3 (Part 1)

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    End point title
    		 Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V419 Dose 3 (Part 1)
    End point description
    The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT). All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 5 (1 month after V419 Dose 3)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    114
    95
    Units: titre (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Polio 1 GMT (n=114,95)
    214 (164.9 to 277.7)
    257.9 (193.8 to 343.1)
        Anti-Polio 2 GMT (n=106, 89)
    385.2 (288.2 to 514.9)
    400.6 (290.6 to 552.3)
        Anti-Polio 3 GMT (n=90, 74)
    502.2 (370.2 to 681.4)
    405.1 (284.9 to 576)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Meningococcal Serogroup C (anti-MCC) Antibody (Ab) Titre ≥1:8 (1/dil) and Titre ≥1:28 (1/dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)

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    End point title
    		 Percentage of Participants with Anti-Meningococcal Serogroup C (anti-MCC) Antibody (Ab) Titre ≥1:8 (1/dil) and Titre ≥1:28 (1/dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)
    End point description
    The percentage of participants with anti-MCC Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included.
    End point type
    Secondary
    End point timeframe
    Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    111
    111
    Units: Percentage of Participants
    number (confidence interval 95%)
        Pre-Hib anti-MCC % titre ≥1:8 (1/dil) [n=89, 94]
    83.1 (73.7 to 90.2)
    40.4 (30.4 to 51.0)
        Pre-Hib anti-MCC % titre ≥1:28 (1/dil) [n=89, 94]
    40.4 (30.2 to 51.4)
    16.0 (9.2 to 25.0)
        Post-Hib anti-MCC % titre ≥1:8 (1/dil)[n=109, 110]
    100.0 (96.7 to 100.0)
    97.3 (92.2 to 99.4)
        Post-Hib anti-MCC % titre ≥1:28 (1/dil)[n=109,110]
    99.1 (95.0 to 100.0)
    95.5 (89.7 to 98.5)
    No statistical analyses for this end point

    Secondary: Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)

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    End point title
    		 Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)
    End point description
    Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included.
    End point type
    Secondary
    End point timeframe
    Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    111
    111
    Units: tire (1/dil)
    geometric mean (confidence interval 95%)
        Pre-Hib anti-MCC GMT (n=89, 94)
    50.3 (34.4 to 73.4)
    8.7 (5.9 to 12.9)
        Post-Hib anti-MCC GMT (n=109, 110)
    3257.9 (2597.4 to 4086.3)
    580.8 (432.7 to 779.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)

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    End point title
    		 Percentage of Participants with Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)
    End point description
    The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA). All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    111
    111
    Units: Percentage of Participants
    number (confidence interval 95%)
        Pre-Hib-MCC anti-PRP ≥0.15 µg/mL (n=82, 87)
    93.9 (86.3 to 98.0)
    95.4 (88.6 to 98.7)
        Pre-Hib-MCC anti-PRP ≥1.0 µg/mL (n=82, 87)
    54.9 (43.5 to 65.9)
    56.3 (45.3 to 66.9)
        Post-Hib-MCC anti-PRP ≥0.15 µg/mL (n=110, 106)
    100.0 (96.7 to 100.0)
    100.0 (96.6 to 100.0)
        Post-Hib-MCC anti-PRP ≥1.0 µg/mL (n=110, 106)
    99.1 (95.0 to 100.0)
    100.0 (96.6 to 100.0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)

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    End point title
    		 Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)
    End point description
    Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL. All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
    End point type
    Secondary
    End point timeframe
    Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    111
    111
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Pre-Hib-MCC anti-PRP ≥0.15 µg/mL (n=82, 87)
    1.09 (0.81 to 1.45)
    1.18 (0.90 to 1.55)
        Post-Hib-MCC anti-PRP ≥1.0 µg/mL (n=110, 106)
    100.19 (81.05 to 123.86)
    121.00 (101.11 to 144.80)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]

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    End point title
    		 Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. All randomized participants who received ≥1 dose of study medication in Part 1 are included.
    End point type
    Secondary
    End point timeframe
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    142
    142
    Units: Percentage of Participants
        number (confidence interval 95%)
    98.6 (95.0 to 99.8)
    97.2 (92.9 to 99.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing a Vaccine-Related Systemic Adverse Event (AE) [Part 1]

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    End point title
    		 Percentage of Participants Experiencing a Vaccine-Related Systemic Adverse Event (AE) [Part 1]
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. All randomized participants who received ≥1 dose of study medication in Part 1 are included. As per protocol, all injection site AEs were considered vaccine-related.
    End point type
    Secondary
    End point timeframe
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    142
    142
    Units: Percentage of Participants
        number (confidence interval 95%)
    98.6 (95.0 to 99.8)
    96.5 (92.0 to 98.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)

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    End point title
    		 Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
    End point description
    The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling. All randomized participants who received ≥1 dose of study medication in Part 1 are included.
    End point type
    Secondary
    End point timeframe
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    142
    142
    Units: Percentage of Participants
    number (confidence interval 95%)
        Erythema (n=142, 142)
    71.1 (62.9 to 78.4)
    64.8 (56.3 to 72.6)
        Pain (n=142, 142)
    63.4 (54.9 to 71.3)
    66.2 (57.8 to 73.9)
        Swelling (n=142, 142)
    51.4 (42.9 to 59.9)
    47.2 (38.8 to 55.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)

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    End point title
    		 Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
    End point description
    The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited. All randomized participants who received ≥1 dose of study medication in Part 1 are included.
    End point type
    Secondary
    End point timeframe
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    142
    142
    Units: Percentage of Participants
        number (confidence interval 95%)
    6.3 (2.9 to 11.7)
    11.3 (6.6 to 17.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)

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    End point title
    		 Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
    End point description
    The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling. All randomized participants who received ≥1 dose of study medication in Part 1 are included.
    End point type
    Secondary
    End point timeframe
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    142
    142
    Units: Percentage of Participants
    number (confidence interval 95%)
        Erythema (n=142, 142)
    56.3 (47.8 to 64.6)
    45.8 (37.4 to 54.3)
        Pain (n=142, 142)
    41.5 (33.3 to 50.1)
    45.8 (37.4 to 54.3)
        Swelling (n=142, 142)
    35.9 (28.0 to 44.4)
    28.2 (20.9 to 36.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)

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    End point title
    		 Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
    End point description
    The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth. All randomized participants who received ≥1 dose of study medication in Part 1 are included.
    End point type
    Secondary
    End point timeframe
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    142
    142
    Units: Percentage of Participants
    number (not applicable)
        Bruising (n=142, 142)
    1.4
    4.2
        Dermatitis (n=142, 142)
    0
    0.7
        Erythema (n=142, 142)
    0
    0.7
        Induration (n=142, 142)
    1.4
    0.7
        Mass (n=142, 142)
    3.5
    2.1
        Pain (n=142, 142)
    0
    0.7
        Rash (n=142, 142)
    1.4
    0.7
        Warmth (n=142, 142)
    0
    2.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]

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    End point title
    		 Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
    End point description
    The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting. All randomized participants who received ≥1 dose of study medication in Part 1 are included.
    End point type
    Secondary
    End point timeframe
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    142
    142
    Units: Percentage of Participants
    number (not applicable)
        Crying (n=142, 142)
    85.9
    81.0
        Decreased appetite (n=142, 142)
    63.4
    64.8
        Irritability (n=142, 142)
    88.0
    81.0
        Pyrexia (n=142, 142)
    11.3
    10.6
        Somnolence (n=142, 142)
    81.7
    78.9
        Vomiting (n=142, 142)
    40.1
    49.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Increased Temperature [Part 1]

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    End point title
    		 Percentage of Participants Experiencing Increased Temperature [Part 1]
    End point description
    The percentage of participants experiencing temperatures ≥38.0° Celsius (C), >38.5° C, and >39.5° C following any Part 1 vaccination was determined. All randomized participants who received ≥1 dose of study medication in Part 1 are included.
    End point type
    Secondary
    End point timeframe
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    141
    140
    Units: Percentage of Participants
    number (not applicable)
        % ≥38.0° C (n=141, 140)
    11.3
    10.6
        % >38.5° C (n=141, 140)
    1.4
    2.1
        % >39.5° C (n=141, 140)
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]

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    End point title
    		 Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]
    End point description
    An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant. All randomized participants who received ≥1 dose of study medication in Part 1 are included.
    End point type
    Secondary
    End point timeframe
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    End point values
    		 V419 and MCC-TT V419 and MCC-CRM
    Number of subjects analysed
    142
    142
    Units: Percentage of Participants
        number (confidence interval 95%)
    4.2 (1.6 to 9.0)
    2.8 (0.8 to 7.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12.5 months (up to 14 days after the final dose of study medication)
    Adverse event reporting additional description
    All participants who received ≥1 dose of study medication are included.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    V419 and MCC-TT
    Reporting group description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

    Reporting group title
    V419 and MCC-CRM
    Reporting group description
    		 In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

    Serious adverse events
    		 V419 and MCC-TT V419 and MCC-CRM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 142 (4.23%)
    4 / 142 (2.82%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Crying
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
         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
    Choking
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Croup infectious
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis neonatal
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Weight gain poor
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 V419 and MCC-TT V419 and MCC-CRM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    140 / 142 (98.59%)
    137 / 142 (96.48%)
    Injury, poisoning and procedural complications
    Contusion
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 142 (0.00%)
    3 / 142 (2.11%)
         occurrences all number
    0
    3
    Nervous system disorders
    Somnolence
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    116 / 142 (81.69%)
    112 / 142 (78.87%)
         occurrences all number
    227
    231
    General disorders and administration site conditions
    Crying
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    122 / 142 (85.92%)
    115 / 142 (80.99%)
         occurrences all number
    273
    262
    Injection site bruising
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    4 / 142 (2.82%)
    7 / 142 (4.93%)
         occurrences all number
    4
    12
    Injection site erythema
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    104 / 142 (73.24%)
    96 / 142 (67.61%)
         occurrences all number
    342
    305
    Injection site mass
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    5 / 142 (3.52%)
    3 / 142 (2.11%)
         occurrences all number
    5
    4
    Injection site pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    93 / 142 (65.49%)
    100 / 142 (70.42%)
         occurrences all number
    258
    267
    Injection site swelling
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    78 / 142 (54.93%)
    70 / 142 (49.30%)
         occurrences all number
    211
    177
    Injection site warmth
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 142 (0.00%)
    3 / 142 (2.11%)
         occurrences all number
    0
    4
    Irritability
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    125 / 142 (88.03%)
    115 / 142 (80.99%)
         occurrences all number
    301
    286
    Pyrexia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    19 / 142 (13.38%)
    18 / 142 (12.68%)
         occurrences all number
    22
    23
    Gastrointestinal disorders
    Constipation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    4 / 142 (2.82%)
    3 / 142 (2.11%)
         occurrences all number
    4
    5
    Diarrhoea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    11 / 142 (7.75%)
    8 / 142 (5.63%)
         occurrences all number
    15
    11
    Teething
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 142 (4.93%)
    1 / 142 (0.70%)
         occurrences all number
    8
    1
    Vomiting
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    57 / 142 (40.14%)
    71 / 142 (50.00%)
         occurrences all number
    93
    112
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    12 / 142 (8.45%)
    6 / 142 (4.23%)
         occurrences all number
    13
    6
    Nasal congestion
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    4 / 142 (2.82%)
    2 / 142 (1.41%)
         occurrences all number
    6
    2
    Rhinorrhoea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    4 / 142 (2.82%)
    4 / 142 (2.82%)
         occurrences all number
    4
    4
    Skin and subcutaneous tissue disorders
    Rash
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    8 / 142 (5.63%)
    6 / 142 (4.23%)
         occurrences all number
    8
    7
    Psychiatric disorders
    Insomnia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    4 / 142 (2.82%)
    1 / 142 (0.70%)
         occurrences all number
    4
    1
    Infections and infestations
    Nasopharyngitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    11 / 142 (7.75%)
    12 / 142 (8.45%)
         occurrences all number
    12
    14
    Rhinitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    8 / 142 (5.63%)
    6 / 142 (4.23%)
         occurrences all number
    8
    7
    Metabolism and nutrition disorders
    Decreased appetite
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    91 / 142 (64.08%)
    92 / 142 (64.79%)
         occurrences all number
    164
    167

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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