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    Clinical Trial Results:
    A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine Given With, or Separately From, 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

    Summary
    EudraCT number
    		 2020-005039-59
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    05 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 May 2021
    First version publication date
    19 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C3571002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Nov 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To describe the safety profile of c7vPnC in healthy infants
    Protection of trial subjects
    The study was conducted in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 484
    Worldwide total number of subjects
    484
    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)
    484
    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
    		 A total of 565 subjects were randomized in 3 reporting groups– 512 subjects from 39 sites and 53 from 2 terminated sites (terminated due to serious quality issues). Study includes and reports valid data only from 512 subjects. Out of these 512 subjects, 484 received at least 1 vaccination.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: c7vPnC and Prevenar 13 Co-administration
    Arm description
    		 Subjects who received a dose of c7vPnC in one leg and Prevenar 13 and other vaccines in the other leg at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively).
    Arm type
    		 Experimental

    Investigational medicinal product name
    c7vPnC and Prevenar 13
    Investigational medicinal product code
    c7vPnC, Prevenar 13
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received c7vPnC 0.5 mL IM and Prevenar 13 IM.

    Arm title
    		 Group 2: c7vPnC and Prevenar 13 Staggered Administration
    Arm description
    		 Subjects who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevenar 13 in the other leg at 2, 4, 6, and 12 month of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    c7vPnC and Prevenar 13
    Investigational medicinal product code
    c7vPnC, Prevenar 13
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received c7vPnC 0.5 mL IM and Prevenar 13 IM.

    Arm title
    		 Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Arm description
    		 Subjects who received a dose of Prevenar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months (Supplemental Dose).
    Arm type
    		 Experimental

    Investigational medicinal product name
    c7vPnC and Prevenar 13
    Investigational medicinal product code
    c7vPnC and Prevenar 13
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received supplemental dose of c7vPnC and Prevenar 13 IM.

    Number of subjects in period 1
    		Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Started
    171
    147
    166
    Completed
    95
    77
    72
    Not completed
    76
    70
    94
         No longer meets eligibility criteria
    3
    5
    6
         Adverse event, non-fatal
    -
    1
    -
         Study terminated by sponsor
    44
    37
    48
         Unspecified
    4
    2
    2
         Lost to follow-up
    5
    7
    12
         Withdrawal by parent/guardian
    20
    18
    26

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: c7vPnC and Prevenar 13 Co-administration
    Reporting group description
    		 Subjects who received a dose of c7vPnC in one leg and Prevenar 13 and other vaccines in the other leg at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively).

    Reporting group title
    Group 2: c7vPnC and Prevenar 13 Staggered Administration
    Reporting group description
    		 Subjects who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevenar 13 in the other leg at 2, 4, 6, and 12 month of age.

    Reporting group title
    Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Reporting group description
    		 Subjects who received a dose of Prevenar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months (Supplemental Dose).

    Reporting group values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose Total
    Number of subjects
    		 171 147 166 484
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 171 147 166 484
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 65.9 ± 9.53 95.1 ± 10.40 64.9 ± 8.22 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 85 80 75 240
        Male
    		 86 67 91 244
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 4 8 3 15
        Asian
    		 7 5 3 15
        Native Hawaiian or Other Pacific Islander
    		 0 0 1 1
        Black or African American
    		 35 26 31 92
        White
    		 102 90 105 297
        More than one race
    		 6 4 6 16
        Unknown or Not Reported
    		 17 14 17 48
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 89 70 85 244
        Not Hispanic or Latino
    		 81 77 80 238
        Unknown or Not Reported
    		 1 0 1 2

    End points

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    End points reporting groups
    Reporting group title
    Group 1: c7vPnC and Prevenar 13 Co-administration
    Reporting group description
    		 Subjects who received a dose of c7vPnC in one leg and Prevenar 13 and other vaccines in the other leg at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively).

    Reporting group title
    Group 2: c7vPnC and Prevenar 13 Staggered Administration
    Reporting group description
    		 Subjects who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevenar 13 in the other leg at 2, 4, 6, and 12 month of age.

    Reporting group title
    Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Reporting group description
    		 Subjects who received a dose of Prevenar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months (Supplemental Dose).

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 1

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 1 [1]
    End point description
    Local reactions were recorded using an electronic diary by subject's legally acceptable representative (LAR). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). The overall safety population included all subjects who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevenar 13 (in Group 3) and had safety data reported in the study. Here, "Number of Subjects Analysed" signifies number of subjects with any e-diary data reported after Dose 1 in the overall safety population. Dose 1 was first dose of c7vPnC in Group 1 and Groups 2, and first dose of Prevenar 13 in Group 3.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    166
    144
    165
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Redness: Any
    25.9 (19.4 to 33.3)
    26.4 (19.4 to 34.4)
    21.8 (15.8 to 28.9)
        Redness: Mild
    16.3 (11.0 to 22.8)
    21.5 (15.1 to 29.1)
    18.2 (12.6 to 24.9)
        Redness: Moderate
    9.6 (5.6 to 15.2)
    4.9 (2.0 to 9.8)
    3.6 (1.3 to 7.7)
        Redness: Severe
    0 (0.0 to 2.2)
    0 (0.0 to 2.5)
    0 (0.0 to 2.2)
        Swelling: Any
    27.1 (20.5 to 34.5)
    22.2 (15.7 to 29.9)
    23.6 (17.4 to 30.9)
        Swelling: Mild
    16.3 (11.0 to 22.8)
    13.9 (8.7 to 20.6)
    17.0 (11.6 to 23.6)
        Swelling: Moderate
    10.2 (6.1 to 15.9)
    8.3 (4.4 to 14.1)
    5.5 (2.5 to 10.1)
        Swelling: Severe
    0.6 (0.0 to 3.3)
    0 (0.0 to 2.5)
    1.2 (0.1 to 4.3)
        Pain at Injection Site: Any
    59.6 (51.8 to 67.2)
    40.3 (32.2 to 48.8)
    50.3 (42.4 to 58.2)
        Pain at Injection Site: Mild
    28.9 (22.2 to 36.4)
    28.5 (21.3 to 36.6)
    26.1 (19.5 to 33.5)
        Pain at Injection Site: Moderate
    27.7 (21.1 to 35.2)
    11.1 (6.5 to 17.4)
    22.4 (16.3 to 29.6)
        Pain at Injection Site: Severe
    3.0 (1.0 to 6.9)
    0.7 (0.0 to 3.8)
    1.8 (0.4 to 5.2)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 2 [2]
    End point description
    Local reactions were recorded using an electronic diary by subject's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).The overall safety population included all subjects who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevenar 13 (in Group 3) and had safety data reported in the study. Here, "Number of Subjects Analysed" signifies number of subjects with any e-diary data reported after Dose 2 in the overall safety population. Dose 2 was second dose of c7vPnC in Group 1 and Groups 2, and second dose of Prevenar 13 in Group 3.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 2
    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: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    152
    126
    147
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Redness: Any
    28.9 (21.9 to 36.8)
    20.6 (13.9 to 28.8)
    23.8 (17.2 to 31.5)
        Redness: Mild
    22.4 (16.0 to 29.8)
    18.3 (11.9 to 26.1)
    21.1 (14.8 to 28.6)
        Redness: Moderate
    6.6 (3.2 to 11.8)
    2.4 (0.5 to 6.8)
    2.7 (0.7 to 6.8)
        Redness: Severe
    0 (0.0 to 2.4)
    0 (0.0 to 2.9)
    0 (0.0 to 2.5)
        Swelling: Any
    21.1 (14.9 to 28.4)
    16.7 (10.6 to 24.3)
    22.4 (16.0 to 30.1)
        Swelling: Mild
    14.5 (9.3 to 21.1)
    14.3 (8.7 to 21.6)
    16.3 (10.7 to 23.3)
        Swelling: Moderate
    6.6 (3.2 to 11.8)
    2.4 (0.5 to 6.8)
    6.1 (2.8 to 11.3)
        Swelling: Severe
    0 (0.0 to 2.4)
    0 (0.0 to 2.9)
    0 (0.0 to 2.5)
        Pain at Injection Site: Any
    55.3 (47.0 to 63.3)
    23.8 (16.7 to 32.2)
    46.9 (38.7 to 55.3)
        Pain at Injection Site: Mild
    31.6 (24.3 to 39.6)
    19.0 (12.6 to 27.0)
    27.9 (20.8 to 35.9)
        Pain at Injection Site: Moderate
    21.7 (15.4 to 29.1)
    4.8 (1.8 to 10.1)
    18.4 (12.5 to 25.6)
        Pain at Injection Site: Severe
    2.0 (0.4 to 5.7)
    0 (0.0 to 2.9)
    0.7 (0.0 to 3.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 3

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 3 [3]
    End point description
    Local reactions were recorded using an electronic diary by subject's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). The overall safety population included all subjects who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevenar 13 (in Group 3) and had safety data reported in the study. Here, "Number of Subjects Analysed" signifies number of subjects with any e-diary data reported after Dose 3 in the overall safety population. Dose 3 was third dose of c7vPnC in Group 1 and Groups 2, and third dose of Prevenar 13 in Group 3.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 3
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    143
    120
    138
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Redness: Any
    25.2 (18.3 to 33.1)
    20.0 (13.3 to 28.3)
    22.5 (15.8 to 30.3)
        Redness: Mild
    23.1 (16.4 to 30.9)
    19.2 (12.6 to 27.4)
    18.1 (12.1 to 25.6)
        Redness: Moderate
    2.1 (0.4 to 6.0)
    0.8 (0.0 to 4.6)
    4.3 (1.6 to 9.2)
        Redness: Severe
    0 (0.0 to 2.5)
    0 (0.0 to 3.0)
    0 (0.0 to 2.6)
        Swelling: Any
    21.7 (15.2 to 29.3)
    14.2 (8.5 to 21.7)
    18.1 (12.1 to 25.6)
        Swelling: Mild
    17.5 (11.6 to 24.7)
    11.7 (6.5 to 18.8)
    13.8 (8.5 to 20.7)
        Swelling: Moderate
    4.2 (1.6 to 8.9)
    2.5 (0.5 to 7.1)
    3.6 (1.2 to 8.3)
        Swelling: Severe
    0 (0.0 to 2.5)
    0 (0.0 to 3.0)
    0.7 (0.0 to 4.0)
        Pain at Injection Site: Any
    39.9 (31.8 to 48.4)
    22.5 (15.4 to 31.0)
    35.5 (27.6 to 44.1)
        Pain at Injection Site: Mild
    23.8 (17.1 to 31.6)
    17.5 (11.2 to 25.5)
    18.8 (12.7 to 26.4)
        Pain at Injection Site: Moderate
    15.4 (9.9 to 22.4)
    5.0 (1.9 to 10.6)
    15.2 (9.7 to 22.3)
        Pain at Injection Site: Severe
    0.7 (0.0 to 3.8)
    0 (0.0 to 3.0)
    1.4 (0.2 to 5.1)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 4

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 4 [4]
    End point description
    Local reactions were recorded using an electronic diary by subject's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). Dose 4 safety analysis set included subjects who received Dose 4 and had safety data between Dose 4 and 1 month after Dose 4 for Groups 1 and 2 and had safety data between Dose 4 and Supplemental Dose for Group 3. Here, "Number of Subjects Analysed" signifies number of subjects with any e-diary data reported after Dose 4 in the Dose 4 safety analysis set. Dose 4 was the fourth dose of c7vPnC in Group 1 and Groups 2, and fourth dose of Prevenar 13 in Group 3.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 4
    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: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    105
    79
    98
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Redness: Any
    22.9 (15.2 to 32.1)
    19.0 (11.0 to 29.4)
    22.4 (14.6 to 32.0)
        Redness: Mild
    21.9 (14.4 to 31.0)
    15.2 (8.1 to 25.0)
    19.4 (12.1 to 28.6)
        Redness: Moderate
    1.0 (0.0 to 5.2)
    3.8 (0.8 to 10.7)
    3.1 (0.6 to 8.7)
        Redness: Severe
    0 (0.0 to 3.5)
    0 (0.0 to 4.6)
    0 (0.0 to 3.7)
        Swelling: Any
    19.0 (12.0 to 27.9)
    13.9 (7.2 to 23.5)
    19.4 (12.1 to 28.6)
        Swelling: Mild
    17.1 (10.5 to 25.7)
    8.9 (3.6 to 17.4)
    13.3 (7.3 to 21.6)
        Swelling: Moderate
    1.9 (0.2 to 6.7)
    5.1 (1.4 to 12.5)
    6.1 (2.3 to 12.9)
        Swelling: Severe
    0 (0.0 to 3.5)
    0 (0.0 to 4.6)
    0 (0.0 to 3.7)
        Pain at Injection Site: Any
    35.2 (26.2 to 45.2)
    22.8 (14.1 to 33.6)
    28.6 (19.9 to 38.6)
        Pain at Injection Site: Mild
    21.9 (14.4 to 31.0)
    16.5 (9.1 to 26.5)
    18.4 (11.3 to 27.5)
        Pain at Injection Site: Moderate
    12.4 (6.8 to 20.2)
    6.3 (2.1 to 14.2)
    10.2 (5.0 to 18.0)
        Pain at Injection Site: Severe
    1.0 (0.0 to 5.2)
    0 (0.0 to 4.6)
    0 (0.0 to 3.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions (LR) Within 7 Days After Supplemental Dose

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    End point title
    		 Percentage of Subjects With Local Reactions (LR) Within 7 Days After Supplemental Dose [5] [6]
    End point description
    Supplemental dose safety analysis set included subjects who received Supplemental Dose and had safety data between Supplemental Dose and 1 month after Supplemental Dose. Data in this endpoint was planned to be collected and analysed only for Prevenar 13 as Control with supplemental c7vPnC dose arm (Group 3) and not planned to be collected and analysed for c7vPnC and Prevenar 13 Co-administration (Group 1) and c7vPnC and Prevenar 13 Staggered Administration (Group 2), as pre-specified in protocol. Number of Subjects Analysed = number of subjects with e-diary data reported after vaccination in supplemental dose safety population.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Supplemental Dose
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed only for the reporting arm specified
    End point values
    		 Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    85
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Redness: Any
    5.9 (1.9 to 13.2)
        Redness: Mild
    4.7 (1.3 to 11.6)
        Redness: Moderate
    1.2 (0.0 to 6.4)
        Redness: Severe
    0 (0.0 to 4.2)
        Swelling: Any
    9.4 (4.2 to 17.7)
        Swelling: Mild
    9.4 (4.2 to 17.7)
        Swelling: Moderate
    0 (0.0 to 4.2)
        Swelling: Severe
    0 (0.0 to 4.2)
        Pain at Injection Site: Any
    12.9 (6.6 to 22.0)
        Pain at Injection Site: Mild
    11.8 (5.8 to 20.6)
        Pain at Injection Site: Moderate
    1.2 (0.0 to 6.4)
        Pain at Injection Site: Severe
    0 (0.0 to 4.2)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events (SE) Within 7 Days After Dose 1

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    End point title
    		 Percentage of Subjects With Systemic Events (SE) Within 7 Days After Dose 1 [7]
    End point description
    SE:using an e-diary by subject's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability.Fever:as rectal temperature of >=38.0 degree(deg) Celsius (C) and categorized to >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite: graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness:graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable),moderate (required increased attention) and severe (inconsolable, crying could not be comforted). Overall safety set analysed.Number of Subjects Analysed=number of subjects with any e-diary data reported after Dose 1 in overall safety population.Dose 1 was first dose of c7vPnC in Group 1 and Groups 2, and first dose of Prevenar 13 in Group 3.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 1
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    166
    144
    165
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Fever: >=38.0 degree C
    12.7 (8.0 to 18.7)
    5.6 (2.4 to 10.7)
    9.1 (5.2 to 14.6)
        Fever: >=38.0 degree C to 38.4 degree C
    7.8 (4.2 to 13.0)
    3.5 (1.1 to 7.9)
    6.1 (2.9 to 10.9)
        Fever: >38.4 degree C to 38.9 degree C
    3.0 (1.0 to 6.9)
    0.7 (0.0 to 3.8)
    2.4 (0.7 to 6.1)
        Fever: >38.9 degree C to 40.0 degree C
    1.8 (0.4 to 5.2)
    1.4 (0.2 to 4.9)
    0.6 (0.0 to 3.3)
        Fever: >40.0 degree C
    0 (0.0 to 2.2)
    0 (0.0 to 2.5)
    0 (0.0 to 2.2)
        Decreased Appetite: Any
    28.9 (22.2 to 36.4)
    15.3 (9.8 to 22.2)
    26.7 (20.1 to 34.1)
        Decreased Appetite: Mild
    19.3 (13.6 to 26.1)
    6.3 (2.9 to 11.5)
    14.5 (9.5 to 20.9)
        Decreased Appetite: Moderate
    7.2 (3.8 to 12.3)
    9.0 (4.9 to 14.9)
    10.3 (6.1 to 16.0)
        Decreased Appetite: Severe
    2.4 (0.7 to 6.1)
    0 (0.0 to 2.5)
    1.8 (0.4 to 5.2)
        Drowsiness: Any
    59.6 (51.8 to 67.2)
    43.1 (34.8 to 51.6)
    53.3 (45.4 to 61.1)
        Drowsiness: Mild
    41.6 (34.0 to 49.5)
    31.9 (24.4 to 40.2)
    38.2 (30.7 to 46.1)
        Drowsiness: Moderate
    16.3 (11.0 to 22.8)
    9.7 (5.4 to 15.8)
    13.3 (8.5 to 19.5)
        Drowsiness: Severe
    1.8 (0.4 to 5.2)
    1.4 (0.2 to 4.9)
    1.8 (0.4 to 5.2)
        Irritability: Any
    70.5 (62.9 to 77.3)
    57.6 (49.1 to 65.8)
    63.6 (55.8 to 71.0)
        Irritability: Mild
    25.3 (18.9 to 32.6)
    29.2 (21.9 to 37.3)
    23.6 (17.4 to 30.9)
        Irritability: Moderate
    38.0 (30.5 to 45.8)
    23.6 (16.9 to 31.4)
    36.4 (29.0 to 44.2)
        Irritability: Severe
    7.2 (3.8 to 12.3)
    4.9 (2.0 to 9.8)
    3.6 (1.3 to 7.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 2 [8]
    End point description
    SE:using an e-diary by subject's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability.Fever:as rectal temperature of >=38.0 degree(deg) Celsius (C) and categorized to >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 degC. Decreased appetite: graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness:graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable),moderate (required increased attention) and severe (inconsolable, crying could not be comforted). Overall safety set analysed.Number of Subjects Analysed=number of subjects with any e-diary data reported after Dose 2 in overall safety population.Dose 2 was second dose of c7vPnC in Group 1 and Groups 2, and second dose of Prevenar 13 in Group 3.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 2
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    152
    126
    147
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Fever: >=38.0 degree C
    25.7 (18.9 to 33.4)
    4.0 (1.3 to 9.0)
    15.6 (10.2 to 22.5)
        Fever: >=38.0 degree C to 38.4 degree C
    12.5 (7.7 to 18.8)
    3.2 (0.9 to 7.9)
    8.2 (4.3 to 13.8)
        Fever: >38.4 degree C to 38.9 degree C
    10.5 (6.1 to 16.5)
    0.8 (0.0 to 4.3)
    2.7 (0.7 to 6.8)
        Fever: >38.9 degree C to 40.0 degree C
    2.6 (0.7 to 6.6)
    0 (0.0 to 2.9)
    4.1 (1.5 to 8.7)
        Fever: >40.0 degree C
    0 (0.0 to 2.4)
    0 (0.0 to 2.9)
    0.7 (0.0 to 3.7)
        Decreased Appetite: Any
    23.0 (16.6 to 30.5)
    12.7 (7.4 to 19.8)
    25.2 (18.4 to 33.0)
        Decreased Appetite: Mild
    11.8 (7.2 to 18.1)
    8.7 (4.4 to 15.1)
    15.6 (10.2 to 22.5)
        Decreased Appetite: Moderate
    9.9 (5.6 to 15.8)
    4.0 (1.3 to 9.0)
    9.5 (5.3 to 15.5)
        Decreased Appetite: Severe
    1.3 (0.2 to 4.7)
    0 (0.0 to 2.9)
    0 (0.0 to 2.5)
        Drowsiness: Any
    48.7 (40.5 to 56.9)
    21.4 (14.6 to 29.6)
    42.9 (34.7 to 51.3)
        Drowsiness: Mild
    32.2 (24.9 to 40.3)
    15.1 (9.3 to 22.5)
    25.9 (19.0 to 33.7)
        Drowsiness: Moderate
    15.1 (9.8 to 21.8)
    6.3 (2.8 to 12.1)
    17.0 (11.3 to 24.1)
        Drowsiness: Severe
    1.3 (0.2 to 4.7)
    0 (0.0 to 2.9)
    0 (0.0 to 2.5)
        Irritability: Any
    64.5 (56.3 to 72.1)
    44.4 (35.6 to 53.6)
    58.5 (50.1 to 66.6)
        Irritability: Mild
    20.4 (14.3 to 27.7)
    21.4 (14.6 to 29.6)
    17.7 (11.9 to 24.8)
        Irritability: Moderate
    40.8 (32.9 to 49.0)
    20.6 (13.9 to 28.8)
    36.1 (28.3 to 44.4)
        Irritability: Severe
    3.3 (1.1 to 7.5)
    2.4 (0.5 to 6.8)
    4.8 (1.9 to 9.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 3

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 3 [9]
    End point description
    SE:using an e-diary by subject's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability.Fever:as rectal temperature of >=38.0 degree(deg) Celsius (C) and categorized to >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite: graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness:graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable),moderate (required increased attention) and severe (inconsolable, crying could not be comforted). Overall safety set analysed.Number of Subjects Analysed=number of subjects with any e-diary data reported after Dose 3 in overall safety population.Dose 3 was third dose of c7vPnC in Group 1 and Groups 2, and third dose of Prevenar 13 in Group 3.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 3
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    143
    120
    138
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Fever: >=38.0 degree C
    14.0 (8.8 to 20.8)
    5.8 (2.4 to 11.6)
    14.5 (9.1 to 21.5)
        Fever: >=38.0 degree C to 38.4 degree C
    6.3 (2.9 to 11.6)
    3.3 (0.9 to 8.3)
    8.0 (4.0 to 13.8)
        Fever: >38.4 degree C to 38.9 degree C
    5.6 (2.4 to 10.7)
    1.7 (0.2 to 5.9)
    2.9 (0.8 to 7.3)
        Fever: >38.9 degree C to 40.0 degree C
    1.4 (0.2 to 5.0)
    0.8 (0.0 to 4.6)
    3.6 (1.2 to 8.3)
        Fever: >40.0 degree C
    0.7 (0.0 to 3.8)
    0 (0.0 to 3.0)
    0 (0.0 to 2.6)
        Decreased Appetite: Any
    19.6 (13.4 to 27.0)
    18.3 (11.9 to 26.4)
    21.0 (14.5 to 28.8)
        Decreased Appetite: Mild
    12.6 (7.6 to 19.2)
    12.5 (7.2 to 19.8)
    10.1 (5.7 to 16.4)
        Decreased Appetite: Moderate
    7.0 (3.4 to 12.5)
    5.8 (2.4 to 11.6)
    10.1 (5.7 to 16.4)
        Decreased Appetite: Severe
    0 (0.0 to 2.5)
    0 (0.0 to 3.0)
    0.7 (0.0 to 4.0)
        Drowsiness: Any
    43.4 (35.1 to 51.9)
    21.7 (14.7 to 30.1)
    45.7 (37.2 to 54.3)
        Drowsiness: Mild
    29.4 (22.1 to 37.6)
    16.7 (10.5 to 24.6)
    32.6 (24.9 to 41.1)
        Drowsiness: Moderate
    13.3 (8.2 to 20.0)
    3.3 (0.9 to 8.3)
    12.3 (7.3 to 19.0)
        Drowsiness: Severe
    0.7 (0.0 to 3.8)
    1.7 (0.2 to 5.9)
    0.7 (0.0 to 4.0)
        Irritability: Any
    57.3 (48.8 to 65.6)
    50.8 (41.6 to 60.1)
    53.6 (44.9 to 62.1)
        Irritability: Mild
    25.2 (18.3 to 33.1)
    26.7 (19.0 to 35.5)
    23.9 (17.1 to 31.9)
        Irritability: Moderate
    31.5 (24.0 to 39.8)
    21.7 (14.7 to 30.1)
    26.8 (19.6 to 35.0)
        Irritability: Severe
    0.7 (0.0 to 3.8)
    2.5 (0.5 to 7.1)
    2.9 (0.8 to 7.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 4

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 4 [10]
    End point description
    SE:using an e-diary by subject's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever: rectal temperature of >=38.0 deg C and categorized to >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite: graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). Dose 4 safety analysis set analysed.Number of Subjects Analysed=number of subjects with any e-diary data reported after Dose 4 in Dose 4 safety analysis set. Dose 4 was fourth dose of c7vPnC in Group 1 and Groups 2, and fourth dose of Prevenar 13 in Group 3.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 4
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    105
    79
    98
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Fever: >=38.0 degree C
    12.4 (6.8 to 20.2)
    0 (0.0 to 4.6)
    11.2 (5.7 to 19.2)
        Fever: >=38.0 degree C to 38.4 degree C
    7.6 (3.3 to 14.5)
    0 (0.0 to 4.6)
    4.1 (1.1 to 10.1)
        Fever: >38.4 degree C to 38.9 degree C
    1.9 (0.2 to 6.7)
    0 (0.0 to 4.6)
    4.1 (1.1 to 10.1)
        Fever: >38.9 degree C to 40.0 degree C
    1.9 (0.2 to 6.7)
    0 (0.0 to 4.6)
    3.1 (0.6 to 8.7)
        Fever: >40.0 degree C
    1.0 (0.0 to 5.2)
    0 (0.0 to 4.6)
    0 (0.0 to 3.7)
        Decreased Appetite: Any
    20.0 (12.8 to 28.9)
    13.9 (7.2 to 23.5)
    23.5 (15.5 to 33.1)
        Decreased Appetite: Mild
    14.3 (8.2 to 22.5)
    10.1 (4.5 to 19.0)
    13.3 (7.3 to 21.6)
        Decreased Appetite: Moderate
    4.8 (1.6 to 10.8)
    3.8 (0.8 to 10.7)
    9.2 (4.3 to 16.7)
        Decreased Appetite: Severe
    1.0 (0.0 to 5.2)
    0 (0.0 to 4.6)
    1.0 (0.0 to 5.6)
        Drowsiness: Any
    33.3 (24.4 to 43.2)
    20.3 (12.0 to 30.8)
    29.6 (20.8 to 39.7)
        Drowsiness: Mild
    25.7 (17.7 to 35.2)
    17.7 (10.0 to 27.9)
    20.4 (12.9 to 29.7)
        Drowsiness: Moderate
    7.6 (3.3 to 14.5)
    2.5 (0.3 to 8.8)
    8.2 (3.6 to 15.5)
        Drowsiness: Severe
    0 (0.0 to 3.5)
    0 (0.0 to 4.6)
    1.0 (0.0 to 5.6)
        Irritability: Any
    60.0 (50.0 to 69.4)
    53.2 (41.6 to 64.5)
    46.9 (36.8 to 57.3)
        Irritability: Mild
    24.8 (16.9 to 34.1)
    31.6 (21.6 to 43.1)
    21.4 (13.8 to 30.9)
        Irritability: Moderate
    34.3 (25.3 to 44.2)
    20.3 (12.0 to 30.8)
    23.5 (15.5 to 33.1)
        Irritability: Severe
    1.0 (0.0 to 5.2)
    1.3 (0.0 to 6.9)
    2.0 (0.2 to 7.2)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Supplemental Dose

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Supplemental Dose [11] [12]
    End point description
    Supplemental dose safety analysis set included subjects who received Supplemental Dose and had safety data between Supplemental Dose and 1 month after Supplemental Dose. Data in this endpoint was planned to be collected and analysed only for Prevenar 13 as Control with supplemental c7vPnC dose arm (Group 3) and not planned to be collected and analysed for c7vPnC and Prevenar 13 Co-administration (Group 1) and c7vPnC and Prevenar 13 Staggered Administration (Group 2), as pre-specified in protocol. Number of Subjects Analysed = number of subjects with e-diary data reported after vaccination in supplemental dose safety population.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Supplemental Dose
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed only for the reporting arm specified
    End point values
    		 Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    85
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Fever: >=38.0 degree C
    5.9 (1.9 to 13.2)
        Fever: >=38.0 degree C to 38.4 degree C
    3.5 (0.7 to 10.0)
        Fever: >38.4 degree C to 38.9 degree C
    1.2 (0.0 to 6.4)
        Fever: >38.9 degree C to 40.0 degree C
    1.2 (0.0 to 6.4)
        Fever: >40.0 degree C
    0 (0.0 to 4.2)
        Decreased Appetite: Any
    11.8 (5.8 to 20.6)
        Decreased Appetite: Mild
    8.2 (3.4 to 16.2)
        Decreased Appetite: Moderate
    1.2 (0.0 to 6.4)
        Decreased Appetite: Severe
    2.4 (0.3 to 8.2)
        Drowsiness: Any
    21.2 (13.1 to 31.4)
        Drowsiness: Mild
    17.6 (10.2 to 27.4)
        Drowsiness: Moderate
    2.4 (0.3 to 8.2)
        Drowsiness: Severe
    1.2 (0.0 to 6.4)
        Irritability: Any
    30.6 (21.0 to 41.5)
        Irritability: Mild
    15.3 (8.4 to 24.7)
        Irritability: Moderate
    12.9 (6.6 to 22.0)
        Irritability: Severe
    2.4 (0.3 to 8.2)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 [13]
    End point description
    An AE was any untoward medical occurrence in study subjects who received study vaccine without regard to possibility of causal relationship with the treatment. The overall safety population included all subjects who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevenar 13 (in Group 3) and had safety data reported in the study.
    End point type
    Primary
    End point timeframe
    From Dose 1 to 1 Month After Dose 3 (up to 5 months)
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    171
    147
    166
    Units: Percentage of Subjects
        number (confidence interval 95%)
    57.9 (50.1 to 65.4)
    65.3 (57.0 to 73.0)
    56.6 (48.7 to 64.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4 [14]
    End point description
    An AE was any untoward medical occurrence in study subjects who received study vaccine without regard to possibility of causal relationship with the treatment. Dose 4 safety analysis set included subjects who received Dose 4 and had safety data between Dose 4 and 1 month after Dose 4 for Groups 1 and 2 and had safety data between Dose 4 and Supplemental Dose for Group 3.
    End point type
    Primary
    End point timeframe
    From Dose 4 to 1 Month After Dose 4 (up to 1 month)
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    110
    85
    101
    Units: Percentage of Subjects
        number (confidence interval 95%)
    23.6 (16.1 to 32.7)
    15.3 (8.4 to 24.7)
    25.7 (17.6 to 35.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose [15] [16]
    End point description
    An AE was any untoward medical occurrence in study subjects who received study vaccine without regard to possibility of causal relationship with the treatment. Supplemental dose safety analysis set included subjects who received Supplemental Dose and had safety data between Supplemental Dose and 1 month after Supplemental Dose. Data for this endpoint was planned to be collected and analyzed only for Prevenar 13 as control with supplemental c7vPnC dose arm and not planned to be collected and analyzed for c7vPnC and Prevenar 13 co-administration and c7vPnC and Prevenar 13 staggered administration, as pre-specified in protocol.
    End point type
    Primary
    End point timeframe
    From Supplemental Dose to 1 Month After Supplemental Dose (up to 1 month)
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed only for the reporting arm specified
    End point values
    		 Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    88
    Units: Percentage of Subjects
        number (confidence interval 95%)
    18.2 (10.8 to 27.8)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Serious Adverse Events (SAEs) From Dose 1 to End of the Study

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    End point title
    		 Percentage of Subjects With Serious Adverse Events (SAEs) From Dose 1 to End of the Study [17]
    End point description
    An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. The overall safety population included all subjects who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevenar 13 (in Group 3) and had safety data reported in the study.
    End point type
    Primary
    End point timeframe
    From Dose 1 to End of the Study (up to 17 months)
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    171
    147
    166
    Units: Percentage of Subjects
        number (confidence interval 95%)
    4.1 (1.7 to 8.3)
    2.7 (0.7 to 6.8)
    5.4 (2.5 to 10.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study

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    End point title
    		 Percentage of Subjects With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study [18]
    End point description
    An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. The overall safety population included all subjects who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevenar 13 (in Group 3) and had safety data reported in the study.
    End point type
    Primary
    End point timeframe
    From Dose 1 to End of the Study (up to 17 months)
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    171
    147
    166
    Units: Percentage of Subjects
        number (confidence interval 95%)
    7.6 (4.1 to 12.6)
    3.4 (1.1 to 7.8)
    7.2 (3.8 to 12.3)
    No statistical analyses for this end point

    Secondary: Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3

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    End point title
    		 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3
    End point description
    IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F). Dose 3 evaluable immunogenicity population: included all eligible subjects, who were randomly assigned to receive the vaccine, aged 42-98 days on the day of Dose 1 for Groups 1 and 3 or aged 63 to 133 days on the day of Dose 1 for Group 2, received 3 doses of assigned vaccine, had valid determinate IgG concentration for at least 1 serotype from 1 month after Dose 3 visit, had blood collection within 27-56 days, inclusive, after Dose 3, and had no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    1 Month After Dose 3
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    128
    107
    109
    Units: microgram per milliliter
    geometric mean (confidence interval 95%)
        Serotype 8
    2.90 (2.47 to 3.39)
    5.14 (4.41 to 5.99)
    0.03 (0.03 to 0.04)
        Serotype 10A
    2.55 (1.95 to 3.34)
    4.52 (3.59 to 5.69)
    0.03 (0.03 to 0.04)
        Serotype 11A
    4.37 (3.57 to 5.34)
    8.88 (7.25 to 10.87)
    0.01 (0.01 to 0.02)
        Serotype 12F
    1.92 (1.58 to 2.34)
    3.35 (2.75 to 4.07)
    0.02 (0.02 to 0.02)
        Serotype 15B
    9.12 (7.54 to 11.04)
    14.86 (12.65 to 17.44)
    0.05 (0.04 to 0.06)
        Serotype 22F
    9.25 (7.50 to 11.41)
    23.94 (19.88 to 28.82)
    0.01 (0.01 to 0.01)
        Serotype 33F
    3.40 (2.75 to 4.21)
    4.83 (3.99 to 5.84)
    0.06 (0.05 to 0.06)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Prespecified Level of Pnuemococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3

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    End point title
    		 Percentage of Subjects Achieving Prespecified Level of Pnuemococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
    End point description
    Percentage of subjects with pre-specified IgG concentration >=0.35 microgram per milliliter were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F). Dose 3 evaluable immunogenicity population: included all eligible subjects, who were randomly assigned to receive the vaccine, aged 42-98 days on the day of Dose 1 for Groups 1 and 3 or aged 63 to 133 days on the day of Dose 1 for Group 2, received 3 doses of assigned vaccine, had valid determinate IgG concentration for at least 1 serotype from 1 month after Dose 3 visit, had blood collection within 27-56 days, inclusive, after Dose 3, and had no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    1 Month after Dose 3
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    128
    107
    109
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Serotype 8
    98.4 (94.5 to 99.8)
    100.0 (96.6 to 100.0)
    1.8 (0.2 to 6.5)
        Serotype 10A
    89.8 (83.3 to 94.5)
    98.1 (93.4 to 99.8)
    2.8 (0.6 to 7.8)
        Serotype 11A
    96.9 (92.2 to 99.1)
    99.1 (94.9 to 100.0)
    0.9 (0.0 to 5.0)
        Serotype 12F
    95.3 (90.1 to 98.3)
    98.1 (93.4 to 99.8)
    0.0 (0.0 to 3.3)
        Serotype 15B
    96.9 (92.2 to 99.1)
    100.0 (96.6 to 100.0)
    6.4 (2.6 to 12.8)
        Serotype 22F
    96.9 (92.2 to 99.1)
    100.0 (96.6 to 100.0)
    0.0 (0.0 to 3.3)
        Serotype 33F
    96.1 (91.1 to 98.7)
    99.1 (94.9 to 100.0)
    4.6 (1.5 to 10.4)
    No statistical analyses for this end point

    Secondary: Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4

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    End point title
    		 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4
    End point description
    IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F). Dose 4 evaluable immunogenicity population: eligible subjects, randomly assigned to receive vaccine, aged 42-98 days on the day of Dose 1 for Groups 1 and 3 or aged 63 to 133 days on the day of Dose 1 for Group 2, received all 4 doses of assigned vaccine, with Dose 4 received in defined window (365-386 days of age), had valid determinate IgG concentration for at least 1 serotype 1 month post dose 4,had blood collection within 27-56 days post Dose 4, and had no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    1 Month After Dose 4
    End point values
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Number of subjects analysed
    76
    57
    68
    Units: microgram per milliliter
    geometric mean (confidence interval 95%)
        Serotype 8
    3.79 (3.10 to 4.62)
    3.05 (2.46 to 3.78)
    0.08 (0.06 to 0.12)
        Serotype 10A
    12.77 (10.16 to 16.06)
    7.15 (5.26 to 9.72)
    0.04 (0.03 to 0.04)
        Serotype 11A
    8.25 (6.72 to 10.12)
    7.12 (5.53 to 9.15)
    0.02 (0.01 to 0.04)
        Serotype 12F
    3.15 (2.64 to 3.74)
    2.57 (2.08 to 3.19)
    0.03 (0.02 to 0.03)
        Serotype 15B
    24.56 (21.23 to 28.41)
    17.70 (14.31 to 21.89)
    0.06 (0.04 to 0.07)
        Serotype 22F
    25.68 (21.33 to 30.91)
    29.92 (24.21 to 36.98)
    0.01 (0.01 to 0.02)
        Serotype 33F
    5.38 (4.47 to 6.48)
    3.95 (3.16 to 4.93)
    0.06 (0.05 to 0.08)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Local reactions,systemic events:within 7 days after Dose 1,2,3,4,Supplemental Dose(SD);Non-SAEs:from Dose 1 to 1 month after Dose 3,Dose 4 to 1 month after Dose 4,SD to 1 month after SD;SAEs:Dose 1 to 6 months after last dose (Dose 4 or SD)
    Adverse event reporting additional description
    Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 subject and as non-serious in another subject or 1 subject may have experienced both serious and non-serious event during study. Overall safety analysis set was analysed.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Group 1: c7vPnC and Prevenar 13 Co-administration
    Reporting group description
    		 Subjects who received a dose of c7vPnC in one leg and Prevenar 13 and other vaccines in the other leg at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively).

    Reporting group title
    Group 2: c7vPnC and Prevenar 13 Staggered Administration
    Reporting group description
    		 Subjects who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevenar 13 in the other leg at 2, 4, 6, and 12 month of age.

    Reporting group title
    Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Reporting group description
    		 Subjects who received a dose of Prevenar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months (Supplemental Dose).

    Serious adverse events
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 171 (4.09%)
    4 / 147 (2.72%)
    9 / 166 (5.42%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 147 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 147 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    2 / 171 (1.17%)
    1 / 147 (0.68%)
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 147 (0.68%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parotid abscess
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 147 (0.68%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 147 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 147 (0.68%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 171 (0.58%)
    1 / 147 (0.68%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure to thrive
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 147 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Group 1: c7vPnC and Prevenar 13 Co-administration Group 2: c7vPnC and Prevenar 13 Staggered Administration Group 3: Prevenar 13 as Control With Supplemental c7vPnC Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    163 / 171 (95.32%)
    138 / 147 (93.88%)
    163 / 166 (98.19%)
    General disorders and administration site conditions
    Injection site erythema (REDNESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    82 / 171 (47.95%)
    67 / 147 (45.58%)
    77 / 166 (46.39%)
         occurrences all number
    157
    109
    135
    Injection site pain (PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    131 / 171 (76.61%)
    82 / 147 (55.78%)
    112 / 166 (67.47%)
         occurrences all number
    287
    143
    251
    Injection site swelling (SWELLING)
    alternative assessment type: Systematic
         subjects affected / exposed
    74 / 171 (43.27%)
    49 / 147 (33.33%)
    68 / 166 (40.96%)
         occurrences all number
    143
    93
    136
    Pyrexia
         subjects affected / exposed
    5 / 171 (2.92%)
    8 / 147 (5.44%)
    7 / 166 (4.22%)
         occurrences all number
    5
    8
    8
    Pyrexia (FEVER)
    alternative assessment type: Systematic
         subjects affected / exposed
    62 / 171 (36.26%)
    20 / 147 (13.61%)
    53 / 166 (31.93%)
         occurrences all number
    94
    22
    79
    Immune system disorders
    Food allergy
         subjects affected / exposed
    2 / 171 (1.17%)
    0 / 147 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    2
    0
    0
    Hypersensitivity
         subjects affected / exposed
    3 / 171 (1.75%)
    0 / 147 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    3
    0
    0
    Milk allergy
         subjects affected / exposed
    2 / 171 (1.17%)
    0 / 147 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    2
    0
    0
    Seasonal allergy
         subjects affected / exposed
    2 / 171 (1.17%)
    0 / 147 (0.00%)
    2 / 166 (1.20%)
         occurrences all number
    2
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    4 / 171 (2.34%)
    7 / 147 (4.76%)
    4 / 166 (2.41%)
         occurrences all number
    4
    7
    4
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 147 (0.00%)
    2 / 166 (1.20%)
         occurrences all number
    1
    0
    4
    Cough
         subjects affected / exposed
    9 / 171 (5.26%)
    4 / 147 (2.72%)
    10 / 166 (6.02%)
         occurrences all number
    9
    4
    12
    Nasal congestion
         subjects affected / exposed
    10 / 171 (5.85%)
    5 / 147 (3.40%)
    5 / 166 (3.01%)
         occurrences all number
    10
    5
    6
    Rhinitis allergic
         subjects affected / exposed
    3 / 171 (1.75%)
    5 / 147 (3.40%)
    3 / 166 (1.81%)
         occurrences all number
    3
    5
    3
    Wheezing
         subjects affected / exposed
    3 / 171 (1.75%)
    3 / 147 (2.04%)
    3 / 166 (1.81%)
         occurrences all number
    3
    4
    3
    Psychiatric disorders
    Irritability (IRRITABILITY)
    alternative assessment type: Systematic
         subjects affected / exposed
    141 / 171 (82.46%)
    113 / 147 (76.87%)
    141 / 166 (84.94%)
         occurrences all number
    440
    303
    413
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 171 (0.58%)
    2 / 147 (1.36%)
    2 / 166 (1.20%)
         occurrences all number
    1
    3
    2
    Contusion
         subjects affected / exposed
    2 / 171 (1.17%)
    0 / 147 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    2
    0
    0
    Fall
         subjects affected / exposed
    2 / 171 (1.17%)
    1 / 147 (0.68%)
    0 / 166 (0.00%)
         occurrences all number
    2
    1
    0
    Head injury
         subjects affected / exposed
    2 / 171 (1.17%)
    3 / 147 (2.04%)
    0 / 166 (0.00%)
         occurrences all number
    2
    3
    0
    Congenital, familial and genetic disorders
    Craniosynostosis
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 147 (1.36%)
    0 / 166 (0.00%)
         occurrences all number
    0
    2
    0
    Plagiocephaly
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    4 / 166 (2.41%)
         occurrences all number
    0
    0
    4
    Nervous system disorders
    Somnolence (DROWSINESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    124 / 171 (72.51%)
    80 / 147 (54.42%)
    126 / 166 (75.90%)
         occurrences all number
    312
    156
    294
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 171 (0.58%)
    2 / 147 (1.36%)
    2 / 166 (1.20%)
         occurrences all number
    1
    2
    2
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    2 / 171 (1.17%)
    0 / 147 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    2
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    8 / 171 (4.68%)
    8 / 147 (5.44%)
    3 / 166 (1.81%)
         occurrences all number
    9
    9
    4
    Diarrhoea
         subjects affected / exposed
    5 / 171 (2.92%)
    6 / 147 (4.08%)
    8 / 166 (4.82%)
         occurrences all number
    6
    7
    9
    Gastritis
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    2 / 166 (1.20%)
         occurrences all number
    0
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 171 (3.51%)
    2 / 147 (1.36%)
    4 / 166 (2.41%)
         occurrences all number
    6
    2
    5
    Teething
         subjects affected / exposed
    4 / 171 (2.34%)
    0 / 147 (0.00%)
    5 / 166 (3.01%)
         occurrences all number
    4
    0
    5
    Vomiting
         subjects affected / exposed
    5 / 171 (2.92%)
    1 / 147 (0.68%)
    5 / 166 (3.01%)
         occurrences all number
    5
    1
    6
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    11 / 171 (6.43%)
    5 / 147 (3.40%)
    12 / 166 (7.23%)
         occurrences all number
    11
    5
    12
    Dermatitis diaper
         subjects affected / exposed
    11 / 171 (6.43%)
    7 / 147 (4.76%)
    5 / 166 (3.01%)
         occurrences all number
    11
    7
    7
    Eczema
         subjects affected / exposed
    5 / 171 (2.92%)
    2 / 147 (1.36%)
    2 / 166 (1.20%)
         occurrences all number
    5
    3
    2
    Rash
         subjects affected / exposed
    4 / 171 (2.34%)
    1 / 147 (0.68%)
    2 / 166 (1.20%)
         occurrences all number
    4
    2
    2
    Seborrhoea
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    3 / 166 (1.81%)
         occurrences all number
    0
    0
    3
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 171 (1.17%)
    0 / 147 (0.00%)
    4 / 166 (2.41%)
         occurrences all number
    2
    0
    4
    Musculoskeletal and connective tissue disorders
    Torticollis
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    2 / 166 (1.20%)
         occurrences all number
    0
    0
    2
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    2 / 171 (1.17%)
    0 / 147 (0.00%)
    2 / 166 (1.20%)
         occurrences all number
    2
    0
    2
    Body tinea
         subjects affected / exposed
    2 / 171 (1.17%)
    1 / 147 (0.68%)
    2 / 166 (1.20%)
         occurrences all number
    2
    1
    2
    Bronchiolitis
         subjects affected / exposed
    13 / 171 (7.60%)
    6 / 147 (4.08%)
    14 / 166 (8.43%)
         occurrences all number
    15
    7
    14
    Bronchitis
         subjects affected / exposed
    5 / 171 (2.92%)
    7 / 147 (4.76%)
    3 / 166 (1.81%)
         occurrences all number
    5
    7
    3
    Candida infection
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 147 (1.36%)
    3 / 166 (1.81%)
         occurrences all number
    0
    2
    3
    Conjunctivitis
         subjects affected / exposed
    13 / 171 (7.60%)
    8 / 147 (5.44%)
    11 / 166 (6.63%)
         occurrences all number
    14
    10
    12
    Conjunctivitis bacterial
         subjects affected / exposed
    2 / 171 (1.17%)
    1 / 147 (0.68%)
    4 / 166 (2.41%)
         occurrences all number
    2
    1
    4
    Croup infectious
         subjects affected / exposed
    3 / 171 (1.75%)
    2 / 147 (1.36%)
    5 / 166 (3.01%)
         occurrences all number
    4
    2
    5
    Exanthema subitum
         subjects affected / exposed
    2 / 171 (1.17%)
    2 / 147 (1.36%)
    0 / 166 (0.00%)
         occurrences all number
    2
    2
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 171 (1.17%)
    2 / 147 (1.36%)
    3 / 166 (1.81%)
         occurrences all number
    2
    2
    3
    Gastroenteritis viral
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 147 (0.68%)
    2 / 166 (1.20%)
         occurrences all number
    0
    1
    3
    Hand-foot-and-mouth disease
         subjects affected / exposed
    3 / 171 (1.75%)
    0 / 147 (0.00%)
    2 / 166 (1.20%)
         occurrences all number
    3
    0
    2
    Impetigo
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 147 (1.36%)
    1 / 166 (0.60%)
         occurrences all number
    0
    2
    1
    Influenza
         subjects affected / exposed
    3 / 171 (1.75%)
    7 / 147 (4.76%)
    5 / 166 (3.01%)
         occurrences all number
    3
    7
    5
    Laryngitis
         subjects affected / exposed
    0 / 171 (0.00%)
    4 / 147 (2.72%)
    0 / 166 (0.00%)
         occurrences all number
    0
    4
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 171 (2.34%)
    1 / 147 (0.68%)
    3 / 166 (1.81%)
         occurrences all number
    4
    1
    3
    Otitis media
         subjects affected / exposed
    11 / 171 (6.43%)
    17 / 147 (11.56%)
    13 / 166 (7.83%)
         occurrences all number
    13
    22
    15
    Oral candidiasis
         subjects affected / exposed
    2 / 171 (1.17%)
    3 / 147 (2.04%)
    2 / 166 (1.20%)
         occurrences all number
    2
    3
    2
    Otitis media acute
         subjects affected / exposed
    6 / 171 (3.51%)
    2 / 147 (1.36%)
    6 / 166 (3.61%)
         occurrences all number
    8
    3
    14
    Pharyngitis
         subjects affected / exposed
    4 / 171 (2.34%)
    6 / 147 (4.08%)
    4 / 166 (2.41%)
         occurrences all number
    5
    7
    5
    Pneumonia
         subjects affected / exposed
    1 / 171 (0.58%)
    1 / 147 (0.68%)
    2 / 166 (1.20%)
         occurrences all number
    1
    1
    2
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 147 (0.68%)
    3 / 166 (1.81%)
         occurrences all number
    0
    1
    3
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 171 (0.58%)
    2 / 147 (1.36%)
    1 / 166 (0.60%)
         occurrences all number
    1
    2
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 171 (0.58%)
    2 / 147 (1.36%)
    1 / 166 (0.60%)
         occurrences all number
    1
    2
    1
    Roseola
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 147 (0.00%)
    2 / 166 (1.20%)
         occurrences all number
    0
    0
    2
    Sinusitis
         subjects affected / exposed
    1 / 171 (0.58%)
    3 / 147 (2.04%)
    0 / 166 (0.00%)
         occurrences all number
    1
    3
    0
    Tonsillitis
         subjects affected / exposed
    3 / 171 (1.75%)
    0 / 147 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    3
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    45 / 171 (26.32%)
    43 / 147 (29.25%)
    35 / 166 (21.08%)
         occurrences all number
    65
    58
    47
    Urinary tract infection
         subjects affected / exposed
    3 / 171 (1.75%)
    1 / 147 (0.68%)
    0 / 166 (0.00%)
         occurrences all number
    3
    2
    0
    Viral infection
         subjects affected / exposed
    5 / 171 (2.92%)
    4 / 147 (2.72%)
    7 / 166 (4.22%)
         occurrences all number
    7
    4
    7
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 171 (2.34%)
    4 / 147 (2.72%)
    4 / 166 (2.41%)
         occurrences all number
    4
    6
    5
    Metabolism and nutrition disorders
    Decreased appetite (DECREASED APPETITE)
    alternative assessment type: Systematic
         subjects affected / exposed
    82 / 171 (47.95%)
    51 / 147 (34.69%)
    84 / 166 (50.60%)
         occurrences all number
    149
    82
    157

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Feb 2020
    Updated the number of subjects per arm and the probabilities of detecting AEs by frequency, and minor modifications were made to the target numbers for the OPA and diphtheria/pertussis subsets.

    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.
    Total 565 subjects were randomized. 512 subjects from 39 sites, and 53 subjects from 2 sites terminated early due to serious quality issues. Data from 2 terminated sites/53 were not included in safety or evaluable immunogenicity populations/analyses.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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