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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

    Summary
    EudraCT number
    2020-003373-21
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 Feb 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Aug 2020
    First version publication date
    26 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B7471003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03512288
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-002330-PIP01-18
    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
    09 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety profile of 20-valent pneumococcal conjugate vaccine (20vPnC) in healthy infants.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (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
    16 Apr 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: 460
    Worldwide total number of subjects
    460
    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)
    460
    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
    Subjects were enrolled from 16 April 2018 to 11 February 2020 in the United States.

    Pre-assignment
    Screening details
    A total of 460 subjects of age greater than or equal to (>=) 42 to less than or equal to (<=) 98 days at baseline, were enrolled into the study. Out of these 460 subjects, 458 subjects received study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    20vPnC
    Arm description
    Subjects were randomised to receive a single 0.5 millilitre (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
    Arm type
    Experimental

    Investigational medicinal product name
    20-valent pneumococcal conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose (0.5 mL) of 20vPnC vaccine intramuscularly into the anterolateral thigh muscle of the left leg at 2, 4, 6, and 12 months of age.

    Arm title
    13vPnC
    Arm description
    Subjects were randomised to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
    Arm type
    Active comparator

    Investigational medicinal product name
    13-valent pneumococcal conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose (0.5 mL) of 13vPnC vaccine intramuscularly into the anterolateral thigh muscle of the left leg at 2, 4, 6, and 12 months of age.

    Number of subjects in period 1
    20vPnC 13vPnC
    Started
    232
    228
    Vaccination 1
    231
    227
    Vaccination 2
    222
    213
    Vaccination 3
    210
    206
    Vaccination 4
    197
    194
    Completed
    191
    185
    Not completed
    41
    43
         Withdrawal by parent/guardian
    14
    18
         Protocol deviation
    6
    4
         Physician decision
    -
    2
         Adverse event
    1
    -
         No longer met eligibility criteria
    5
    2
         Unspecified
    1
    1
         Randomised but not treated
    1
    1
         Medication error without associated adverse event
    1
    -
         Lost to follow-up
    12
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    20vPnC
    Reporting group description
    Subjects were randomised to receive a single 0.5 millilitre (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).

    Reporting group title
    13vPnC
    Reporting group description
    Subjects were randomised to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).

    Reporting group values
    20vPnC 13vPnC Total
    Number of subjects
    232 228 460
    Age Categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    232 228 460
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age Continuous
    Units: days
        arithmetic mean (standard deviation)
    64.5 ± 8.07 64.5 ± 6.68 -
    Gender Categorical
    Units: Subjects
        Female
    112 115 227
        Male
    120 113 233
    Race
    Units: Subjects
        American Indian or Alaska Native
    4 3 7
        Asian
    9 5 14
        Native Hawaiian or Other Pacific Islander
    1 3 4
        Black or African American
    35 29 64
        White
    161 171 332
        More than one race
    22 15 37
        Unknown or Not Reported
    0 2 2
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    41 40 81
        Non-Hispanic/non-Latino
    191 188 379

    End points

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    End points reporting groups
    Reporting group title
    20vPnC
    Reporting group description
    Subjects were randomised to receive a single 0.5 millilitre (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).

    Reporting group title
    13vPnC
    Reporting group description
    Subjects were randomised to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).

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

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    End point title
    Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 [1]
    End point description
    Local reactions were recorded using an electronic diary. 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 centimetre [cm]), moderate (greater than [>] 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). Dose 1 to Dose 3 safety population included subjects who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, “number of subjects analysed ” signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 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 analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    229
    224
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any
    24.9 (19.4 to 31.0)
    25.4 (19.9 to 31.7)
        Redness: Mild
    22.3 (17.1 to 28.2)
    23.7 (18.3 to 29.8)
        Redness: Moderate
    2.6 (1.0 to 5.6)
    1.8 (0.5 to 4.5)
        Redness: Severe
    0 (0.0 to 1.6)
    0 (0.0 to 1.6)
        Swelling: Any
    12.7 (8.6 to 17.7)
    14.3 (10.0 to 19.6)
        Swelling: Mild
    10.0 (6.5 to 14.7)
    12.9 (8.8 to 18.1)
        Swelling: Moderate
    2.2 (0.7 to 5.0)
    1.3 (0.3 to 3.9)
        Swelling: Severe
    0.4 (0.0 to 2.4)
    0 (0.0 to 1.6)
        Pain at the injection site: Any
    51.1 (44.4 to 57.7)
    53.6 (46.8 to 60.2)
        Pain at the injection site: Mild
    32.3 (26.3 to 38.8)
    35.7 (29.4 to 42.4)
        Pain at the injection site: Moderate
    18.3 (13.5 to 24.0)
    17.9 (13.1 to 23.5)
        Pain at the injection site: Severe
    0.4 (0.0 to 2.4)
    0 (0.0 to 1.6)
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 [2]
    End point description
    Local reactions were recorded using an electronic diary. 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 (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). Dose 1 to Dose 3 safety population included subjects who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, “number of subjects analysed” signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 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 analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    215
    204
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any
    24.7 (19.0 to 31.0)
    28.4 (22.4 to 35.2)
        Redness: Mild
    21.9 (16.5 to 28.0)
    24.0 (18.3 to 30.5)
        Redness: Moderate
    2.8 (1.0 to 6.0)
    4.4 (2.0 to 8.2)
        Redness: Severe
    0 (0.0 to 1.7)
    0 (0.0 to 1.8)
        Swelling: Any
    16.3 (11.6 to 21.9)
    18.6 (13.5 to 24.7)
        Swelling: Mild
    12.6 (8.4 to 17.7)
    13.2 (8.9 to 18.7)
        Swelling: Moderate
    3.7 (1.6 to 7.2)
    5.4 (2.7 to 9.4)
        Swelling: Severe
    0 (0.0 to 1.7)
    0 (0.0 to 1.8)
        Pain at the injection site: Any
    42.8 (36.1 to 49.7)
    48.5 (41.5 to 55.6)
        Pain at the injection site: Mild
    26.0 (20.3 to 32.5)
    28.9 (22.8 to 35.7)
        Pain at the injection site: Moderate
    15.8 (11.2 to 21.4)
    19.6 (14.4 to 25.7)
        Pain at the injection site: Severe
    0.9 (0.1 to 3.3)
    0 (0.0 to 1.8)
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 3 [3]
    End point description
    Local reactions were recorded using an electronic diary. 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 (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). Dose 1 to Dose 3 safety population included subjects who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, “number of subjects analysed” signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 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 analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    201
    204
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any
    26.9 (20.9 to 33.6)
    26.5 (20.6 to 33.1)
        Redness: Mild
    26.4 (20.4 to 33.0)
    23.0 (17.4 to 29.4)
        Redness: Moderate
    0.5 (0.0 to 2.7)
    3.4 (1.4 to 6.9)
        Redness: Severe
    0 (0.0 to 1.8)
    0 (0.0 to 1.8)
        Swelling: Any
    17.9 (12.9 to 23.9)
    19.6 (14.4 to 25.7)
        Swelling: Mild
    16.9 (12.0 to 22.8)
    15.7 (11.0 to 21.4)
        Swelling: Moderate
    1.0 (0.1 to 3.5)
    3.4 (1.4 to 6.9)
        Swelling: Severe
    0 (0.0 to 1.8)
    0.5 (0.0 to 2.7)
        Pain at the injection site: Any
    44.3 (37.3 to 51.4)
    40.7 (33.9 to 47.8)
        Pain at the injection site: Mild
    28.9 (22.7 to 35.6)
    27.9 (21.9 to 34.6)
        Pain at the injection site: Moderate
    14.9 (10.3 to 20.6)
    12.7 (8.5 to 18.1)
        Pain at the injection site: Severe
    0.5 (0.0 to 2.7)
    0 (0.0 to 1.8)
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 4 [4]
    End point description
    Local reactions were recorded using an electronic diary. 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 (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). Dose 4 safety population included subjects who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4. Here, “number of subjects analyzed” signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 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 analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    186
    185
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any
    25.8 (19.7 to 32.7)
    30.3 (23.7 to 37.4)
        Redness: Mild
    24.2 (18.2 to 31.0)
    25.4 (19.3 to 32.3)
        Redness: Moderate
    1.6 (0.3 to 4.6)
    4.9 (2.2 to 9.0)
        Redness: Severe
    0 (0.0 to 2.0)
    0 (0.0 to 2.0)
        Swelling: Any
    17.2 (12.1 to 23.4)
    14.1 (9.4 to 19.9)
        Swelling: Mild
    15.1 (10.2 to 21.0)
    12.4 (8.0 to 18.1)
        Swelling: Moderate
    2.2 (0.6 to 5.4)
    1.6 (0.3 to 4.7)
        Swelling: Severe
    0 (0.0 to 2.0)
    0 (0.0 to 2.0)
        Pain at the injection site: Any
    35.5 (28.6 to 42.8)
    35.7 (28.8 to 43.0)
        Pain at the injection site: Mild
    26.9 (20.7 to 33.9)
    28.6 (22.3 to 35.7)
        Pain at the injection site: Moderate
    8.6 (5.0 to 13.6)
    7.0 (3.8 to 11.7)
        Pain at the injection site: Severe
    0 (0.0 to 2.0)
    0 (0.0 to 2.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1

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    End point title
    Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 [5]
    End point description
    Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was categorised as >=38.0 degree Celsius (C), >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was 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 (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). Dose 1 to Dose 3 safety population included subjects who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, “number of subjects analysed” signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 1
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    229
    224
    Units: percentage of subjects
    number (confidence interval 95%)
        Fever: >=38.0 degree C
    14.4 (10.1 to 19.6)
    9.8 (6.3 to 14.5)
        Fever: >=38.0 degree C to 38.4 degree C
    10.0 (6.5 to 14.7)
    6.3 (3.5 to 10.3)
        Fever: >38.4 degree C to 38.9 degree C
    3.9 (1.8 to 7.3)
    2.2 (0.7 to 5.1)
        Fever: >38.9 degree C to 40.0 degree C
    0.4 (0.0 to 2.4)
    1.3 (0.3 to 3.9)
        Fever: >40.0 degree C
    0 (0.0 to 1.6)
    0 (0.0 to 1.6)
        Decreased appetite: Any
    25.3 (19.8 to 31.5)
    30.4 (24.4 to 36.8)
        Decreased appetite: Mild
    16.2 (11.6 to 21.6)
    19.2 (14.3 to 25.0)
        Decreased appetite: Moderate
    9.2 (5.8 to 13.7)
    10.7 (7.0 to 15.5)
        Decreased appetite: Severe
    0 (0.0 to 1.6)
    0.4 (0.0 to 2.5)
        Drowsiness: Any
    68.1 (61.7 to 74.1)
    71.0 (64.6 to 76.8)
        Drowsiness: Mild
    51.1 (44.4 to 57.7)
    54.9 (48.1 to 61.5)
        Drowsiness: Moderate
    16.6 (12.0 to 22.1)
    14.3 (10.0 to 19.6)
        Drowsiness: Severe
    0.4 (0.0 to 2.4)
    1.8 (0.5 to 4.5)
        Irritability: Any
    79.5 (73.7 to 84.5)
    77.7 (71.7 to 83.0)
        Irritability: Mild
    23.6 (18.2 to 29.6)
    25.9 (20.3 to 32.1)
        Irritability: Moderate
    50.7 (44.0 to 57.3)
    47.3 (40.6 to 54.1)
        Irritability: Severe
    5.2 (2.7 to 9.0)
    4.5 (2.2 to 8.1)
        Use of antipyretic or pain medication
    38.0 (31.7 to 44.6)
    44.2 (37.6 to 51.0)
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 [6]
    End point description
    Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was categorised as >=38.0 degree C, >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was 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 (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). Dose 1 to Dose 3 safety population included subjects who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, “number of subjects analysed” signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 2
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    215
    204
    Units: percentage of subjects
    number (confidence interval 95%)
        Fever: >= 38.0 degree C
    17.2 (12.4 to 22.9)
    23.0 (17.4 to 29.4)
        Fever: >=38.0 degree C to 38.4 degree C
    10.2 (6.5 to 15.1)
    12.7 (8.5 to 18.1)
        Fever: >38.4 degree C to 38.9 degree C
    4.2 (1.9 to 7.8)
    7.8 (4.5 to 12.4)
        Fever: >38.9 degree C to 40.0 degree C
    2.8 (1.0 to 6.0)
    2.5 (0.8 to 5.6)
        Fever: >40.0 degree C
    0 (0.0 to 1.7)
    0 (0.0 to 1.8)
        Decreased appetite: Any
    23.3 (17.8 to 29.5)
    27.0 (21.0 to 33.6)
        Decreased appetite: Mild
    14.4 (10.0 to 19.8)
    14.7 (10.1 to 20.3)
        Decreased appetite: Moderate
    7.9 (4.7 to 12.4)
    11.8 (7.7 to 17.0)
        Decreased appetite: Severe
    0.9 (0.1 to 3.3)
    0.5 (0.0 to 2.7)
        Drowsiness: Any
    57.2 (50.3 to 63.9)
    56.4 (49.3 to 63.3)
        Drowsiness: Mild
    37.2 (30.7 to 44.0)
    37.7 (31.1 to 44.8)
        Drowsiness: Moderate
    17.7 (12.8 to 23.4)
    16.7 (11.8 to 22.5)
        Drowsiness: Severe
    2.3 (0.8 to 5.3)
    2.0 (0.5 to 4.9)
        Irritability: Any
    71.2 (64.6 to 77.1)
    79.9 (73.7 to 85.2)
        Irritability: Mild
    20.0 (14.9 to 26.0)
    22.5 (17.0 to 28.9)
        Irritability: Moderate
    48.8 (42.0 to 55.7)
    52.5 (45.4 to 59.5)
        Irritability: Severe
    2.3 (0.8 to 5.3)
    4.9 (2.4 to 8.8)
        Use of antipyretic/pain medication
    39.5 (33.0 to 46.4)
    48.5 (41.5 to 55.6)
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 3 [7]
    End point description
    Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was categorised as >=38.0 degree C, >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was 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 (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). Dose 1 to Dose 3 safety population included subjects who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, “number of subjects analysed” signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 3
    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 analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    201
    204
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38.0 degree C
    17.9 (12.9 to 23.9)
    18.1 (13.1 to 24.1)
        Fever: >=38.0 degree C to 38.4 degree C
    10.0 (6.2 to 14.9)
    9.8 (6.1 to 14.7)
        Fever: >38.4 degree C to 38.9 degree C
    4.5 (2.1 to 8.3)
    4.9 (2.4 to 8.8)
        Fever: >38.9 degree C to 40.0 degree C
    3.5 (1.4 to 7.0)
    3.4 (1.4 to 6.9)
        Fever: >40.0 degree C
    0 (0.0 to 1.8)
    0 (0.0 to 1.8)
        Decreased appetite: Any
    30.8 (24.5 to 37.7)
    33.3 (26.9 to 40.3)
        Decreased appetite: Mild
    20.9 (15.5 to 27.2)
    19.1 (14.0 to 25.2)
        Decreased appetite: Moderate
    9.5 (5.8 to 14.4)
    13.7 (9.3 to 19.2)
        Decreased appetite: Severe
    0.5 (0.0 to 2.7)
    0.5 (0.0 to 2.7)
        Drowsiness: Any
    41.3 (34.4 to 48.4)
    45.6 (38.6 to 52.7)
        Drowsiness: Mild
    28.9 (22.7 to 35.6)
    29.9 (23.7 to 36.7)
        Drowsiness: Moderate
    11.4 (7.4 to 16.7)
    15.7 (11.0 to 21.4)
        Drowsiness: Severe
    1.0 (0.1 to 3.5)
    0 (0.0 to 1.8)
        Irritability: Any
    72.6 (65.9 to 78.7)
    69.6 (62.8 to 75.8)
        Irritability: Mild
    28.9 (22.7 to 35.6)
    27.5 (21.5 to 34.1)
        Irritability: Moderate
    40.8 (33.9 to 47.9)
    37.7 (31.1 to 44.8)
        Irritability: Severe
    3.0 (1.1 to 6.4)
    4.4 (2.0 to 8.2)
        Use of antipyretic/pain medication
    42.8 (35.8 to 49.9)
    47.1 (40.1 to 54.2)
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 4 [8]
    End point description
    Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was categorised as >=38.0 degree C, >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was 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 (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). Dose 4 safety population included subjects who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4. Here, “number of subjects analysed” signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 4
    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 analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    186
    185
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38.0°C
    12.4 (8.0 to 18.0)
    14.6 (9.8 to 20.5)
        Fever: >=38.0°C to 38.4°C
    5.9 (3.0 to 10.3)
    4.3 (1.9 to 8.3)
        Fever: >38.4°C to 38.9°C
    3.2 (1.2 to 6.9)
    7.0 (3.8 to 11.7)
        Fever: >38.9°C to 40.0°C
    3.2 (1.2 to 6.9)
    3.2 (1.2 to 6.9)
        Fever: >40.0°C
    0 (0.0 to 2.0)
    0 (0.0 to 2.0)
        Decreased appetite: Any
    23.7 (17.7 to 30.4)
    29.2 (22.8 to 36.3)
        Decreased appetite: Mild
    13.4 (8.9 to 19.2)
    15.7 (10.8 to 21.7)
        Decreased appetite: Moderate
    10.2 (6.3 to 15.5)
    13.5 (8.9 to 19.3)
        Decreased appetite: Severe
    0 (0.0 to 2.0)
    0 (0.0 to 2.0)
        Drowsiness: Any
    32.8 (26.1 to 40.0)
    37.3 (30.3 to 44.7)
        Drowsiness: Mild
    26.9 (20.7 to 33.9)
    25.4 (19.3 to 32.3)
        Drowsiness: Moderate
    4.8 (2.2 to 9.0)
    11.9 (7.6 to 17.4)
        Drowsiness: Severe
    1.1 (0.1 to 3.8)
    0 (0.0 to 2.0)
        Irritability: Any
    62.4 (55.0 to 69.3)
    62.7 (55.3 to 69.7)
        Irritability: Mild
    23.7 (17.7 to 30.4)
    19.5 (14.0 to 25.9)
        Irritability: Moderate
    36.0 (29.1 to 43.4)
    40.0 (32.9 to 47.4)
        Irritability: Severe
    2.7 (0.9 to 6.2)
    3.2 (1.2 to 6.9)
        Use of antipyretic/pain medication
    37.1 (30.1 to 44.5)
    44.3 (37.0 to 51.8)
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3 [9]
    End point description
    An AE was any untoward medical occurrence in study subjects who received study vaccine without regard to possibility of causal relationship. Dose 1 to Dose 3 safety population included subjects who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3.
    End point type
    Primary
    End point timeframe
    From Vaccination 1 to 1 month after Vaccination 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 analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    231
    227
    Units: percentage of subjects
        number (confidence interval 95%)
    61.0 (54.4 to 67.4)
    56.4 (49.7 to 62.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Adverse Events (AEs) 1 Month After Vaccination 4

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    End point title
    Percentage of Subjects With Adverse Events (AEs) 1 Month After Vaccination 4 [10]
    End point description
    An AE was any untoward medical occurrence in study subjects who received study vaccine without regard to possibility of causal relationship. Dose 4 safety population included subjects who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4.
    End point type
    Primary
    End point timeframe
    1 month after Vaccination 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 analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    197
    194
    Units: percentage of subjects
        number (confidence interval 95%)
    18.3 (13.1 to 24.4)
    25.3 (19.3 to 32.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4

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    End point title
    Percentage of Subjects With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4 [11]
    End point description
    An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect. Overall safety analysis set included all subjects who received at least 1 dose of study vaccine (20vPnC or 13vPnC) and had safety follow up in the study.
    End point type
    Primary
    End point timeframe
    Vaccination 1 to 6 months after Vaccination 4
    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 analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    231
    227
    Units: percentage of subjects
        number (confidence interval 95%)
    5.2 (2.7 to 8.9)
    2.2 (0.7 to 5.1)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4

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    End point title
    Percentage of Subjects With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4 [12]
    End point description
    An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Overall safety analysis set included all subjects who received at least 1 dose of study vaccine (20vPnC or 13vPnC) and had safety follow up in the study.
    End point type
    Primary
    End point timeframe
    Vaccination 1 to 6 months after Vaccination 4
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    231
    227
    Units: percentage of subjects
        number (confidence interval 95%)
    5.2 (2.7 to 8.9)
    3.5 (1.5 to 6.8)
    No statistical analyses for this end point

    Secondary: Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3

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    End point title
    Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
    End point description
    Pneumococcal IgG antibody against each of the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F) was measured centrally using direct binding Luminex assay. Results were expressed as IgG concentrations. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding confidence intervals (CIs) based on the Student t distribution. Dose 3 evaluable immunogenicity population: eligible subjects aged 42-98 days on dose 1, received assigned vaccine, had valid determinate IgG concentration for at least 1 serotype 1 month post dose 3, had blood collection within 27-56 days post dose 3, had not received prohibited vaccines before the blood draw at 1 month post dose 3, had no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 3
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    189
    187
    Units: microgram per millilitre
    geometric mean (confidence interval 95%)
        Serotype 1
    0.92 (0.81 to 1.05)
    1.16 (1.00 to 1.33)
        Serotype 3
    0.43 (0.38 to 0.48)
    0.56 (0.49 to 0.64)
        Serotype 4
    1.36 (1.16 to 1.61)
    1.64 (1.39 to 1.93)
        Serotype 5
    0.93 (0.79 to 1.11)
    1.13 (0.96 to 1.34)
        Serotype 6A
    2.28 (1.94 to 2.67)
    2.57 (2.16 to 3.05)
        Serotype 6B
    0.63 (0.49 to 0.80)
    0.99 (0.77 to 1.27)
        Serotype 7F
    2.15 (1.92 to 2.40)
    2.59 (2.28 to 2.93)
        Serotype 9V
    1.22 (1.05 to 1.42)
    1.45 (1.24 to 1.70)
        Serotype 14
    3.15 (2.69 to 3.70)
    3.60 (3.07 to 4.21)
        Serotype 18C
    1.59 (1.37 to 1.84)
    2.05 (1.76 to 2.38)
        Serotype 19A
    0.85 (0.74 to 0.96)
    1.02 (0.89 to 1.17)
        Serotype 19F
    1.98 (1.76 to 2.22)
    2.28 (1.99 to 2.61)
        Serotype 23F
    0.94 (0.78 to 1.14)
    1.26 (1.03 to 1.55)
        Serotype 8
    2.09 (1.90 to 2.30)
    0.04 (0.03 to 0.04)
        Serotype 10A
    1.67 (1.35 to 2.08)
    0.03 (0.03 to 0.03)
        Serotype 11A
    1.94 (1.70 to 2.21)
    0.01 (0.01 to 0.01)
        Serotype 12F
    0.86 (0.72 to 1.01)
    0.02 (0.02 to 0.02)
        Serotype 15B
    5.86 (5.11 to 6.72)
    0.04 (0.04 to 0.05)
        Serotype 22F
    4.62 (3.99 to 5.35)
    0.01 (0.01 to 0.01)
        Serotype 33F
    2.21 (1.87 to 2.61)
    0.05 (0.04 to 0.05)
    No statistical analyses for this end point

    Secondary: Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 4

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    End point title
    Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 4
    End point description
    Pneumococcal IgG antibody against each of the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F) was measured centrally using direct binding Luminex assay. Results were expressed as IgG concentrations. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student t distribution. Dose 4 evaluable immunogenicity population: eligible subjects aged 42-98 days on dose 1, received assigned vaccine as randomized for all 4 doses, with Dose 4 received in the 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, had not received prohibited vaccines before the blood draw at 1 month post dose 4, had no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    1 Month after Vaccination 4
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    168
    166
    Units: microgram per millilitre
    geometric mean (confidence interval 95%)
        Serotype 1
    2.65 (2.33 to 3.02)
    3.63 (3.20 to 4.11)
        Serotype 3
    1.15 (0.97 to 1.35)
    1.49 (1.28 to 1.74)
        Serotype 4
    7.16 (6.22 to 8.24)
    9.45 (8.16 to 10.95)
        Serotype 5
    3.41 (2.95 to 3.93)
    4.95 (4.29 to 5.71)
        Serotype 6A
    13.77 (12.16 to 15.59)
    18.83 (16.39 to 21.63)
        Serotype 6B
    6.37 (5.42 to 7.50)
    9.73 (8.13 to 11.65)
        Serotype 7F
    6.14 (5.51 to 6.83)
    9.32 (8.26 to 10.52)
        Serotype 9V
    5.52 (4.82 to 6.31)
    7.78 (6.77 to 8.95)
        Serotype 14
    8.61 (7.32 to 10.12)
    11.04 (9.44 to 12.90)
        Serotype 18C
    5.58 (4.89 to 6.36)
    8.46 (7.25 to 9.88)
        Serotype 19A
    5.71 (4.91 to 6.64)
    7.05 (6.04 to 8.24)
        Serotype 19F
    7.79 (6.73 to 9.01)
    9.30 (7.99 to 10.83)
        Serotype 23F
    6.06 (5.16 to 7.12)
    9.81 (8.10 to 11.88)
        Serotype 8
    3.12 (2.78 to 3.49)
    0.05 (0.04 to 0.06)
        Serotype 10A
    9.93 (8.58 to 11.50)
    0.03 (0.03 to 0.04)
        Serotype 11A
    5.70 (4.96 to 6.54)
    0.01 (0.01 to 0.02)
        Serotype 12F
    1.92 (1.68 to 2.20)
    0.02 (0.02 to 0.03)
        Serotype 15B
    18.45 (16.43 to 20.72)
    0.04 (0.04 to 0.05)
        Serotype 22F
    14.68 (12.62 to 17.08)
    0.01 (0.01 to 0.01)
        Serotype 33F
    4.70 (4.20 to 5.27)
    0.05 (0.04 to 0.05)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month after Vaccination 3

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    End point title
    Percentage of Subjects who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month after Vaccination 3
    End point description
    Subjects who achieved pre-specified level of serotypes were reported. Pre-specified levels of serotypes were- for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per millilitre, for serotype 5: >=0.23 microgram per millilitre, for serotype 6B: >=0.10 microgram per milliliter and for serotype 19A: >=0.12 microgram per millilitre. Dose 3 evaluable immunogenicity population: eligible subjects aged 42-98 days on dose 1, received assigned vaccine, had valid determinate IgG concentration for at least 1 serotype 1 month post dose 3, had blood collection within 27-56 days post dose 3, had not received prohibited vaccines before the blood draw at 1 month post dose 3, had no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    1 Month after Vaccination 3
    End point values
    20vPnC 13vPnC
    Number of subjects analysed
    189
    187
    Units: percentage of subjects
    number (confidence interval 95%)
        Serotype 1
    87.8 (82.3 to 92.1)
    87.7 (82.1 to 92.0)
        Serotype 3
    65.1 (57.8 to 71.9)
    75.4 (68.6 to 81.4)
        Serotype 4
    87.8 (82.3 to 92.1)
    91.4 (86.5 to 95.0)
        Serotype 5
    87.8 (82.3 to 92.1)
    89.8 (84.6 to 93.8)
        Serotype 6A
    93.7 (89.2 to 96.7)
    92.5 (87.8 to 95.8)
        Serotype 6B
    86.8 (81.1 to 91.3)
    90.4 (85.2 to 94.2)
        Serotype 7F
    98.9 (96.2 to 99.9)
    97.9 (94.6 to 99.4)
        Serotype 9V
    89.4 (84.1 to 93.4)
    89.3 (84.0 to 93.3)
        Serotype 14
    94.2 (89.8 to 97.1)
    95.7 (91.7 to 98.1)
        Serotype 18C
    92.6 (87.9 to 95.9)
    95.2 (91.1 to 97.8)
        Serotype 19A
    98.4 (95.4 to 99.7)
    97.9 (94.6 to 99.4)
        Serotype 19F
    98.4 (95.4 to 99.7)
    96.8 (93.1 to 98.8)
        Serotype 23F
    79.9 (73.5 to 85.4)
    81.8 (75.5 to 87.1)
        Serotype 8
    99.5 (97.1 to 100.0)
    3.7 (1.5 to 7.6)
        Serotype 10A
    87.8 (82.3 to 92.1)
    1.1 (0.1 to 3.8)
        Serotype 11A
    97.4 (93.9 to 99.1)
    1.6 (0.3 to 4.6)
        Serotype 12F
    82.5 (76.4 to 87.7)
    0.5 (0.0 to 2.9)
        Serotype 15B
    98.9 (96.2 to 99.9)
    4.3 (1.9 to 8.3)
        Serotype 22F
    98.9 (96.2 to 99.9)
    1.1 (0.1 to 3.8)
        Serotype 33F
    92.1 (87.2 to 95.5)
    1.6 (0.3 to 4.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
    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
    22.1
    Reporting groups
    Reporting group title
    20vPnC
    Reporting group description
    Subjects were randomised to receive a single 0.5 mL intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).

    Reporting group title
    13vPnC
    Reporting group description
    Subjects were randomised to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).

    Serious adverse events
    20vPnC 13vPnC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 231 (5.19%)
    5 / 227 (2.20%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure like phenomena
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Oliguria
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (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
    Failure to thrive
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 231 (0.43%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (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
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 227 (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: 1%
    Non-serious adverse events
    20vPnC 13vPnC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    225 / 231 (97.40%)
    224 / 227 (98.68%)
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 231 (0.00%)
    3 / 227 (1.32%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Injection site erythema (REDNESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    112 / 231 (48.48%)
    120 / 227 (52.86%)
         occurrences all number
    212
    225
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    163 / 231 (70.56%)
    167 / 227 (73.57%)
         occurrences all number
    364
    368
    Injection site swelling (SWELLING)
    alternative assessment type: Systematic
         subjects affected / exposed
    76 / 231 (32.90%)
    81 / 227 (35.68%)
         occurrences all number
    132
    137
    Pyrexia
         subjects affected / exposed
    12 / 231 (5.19%)
    10 / 227 (4.41%)
         occurrences all number
    13
    12
    Pyrexia (FEVER)
    alternative assessment type: Systematic
         subjects affected / exposed
    90 / 231 (38.96%)
    90 / 227 (39.65%)
         occurrences all number
    129
    133
    Psychiatric disorders
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    214 / 231 (92.64%)
    206 / 227 (90.75%)
         occurrences all number
    597
    595
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    6 / 231 (2.60%)
    2 / 227 (0.88%)
         occurrences all number
    6
    2
    Congenital, familial and genetic disorders
    Plagiocephaly
         subjects affected / exposed
    2 / 231 (0.87%)
    4 / 227 (1.76%)
         occurrences all number
    2
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 231 (3.90%)
    8 / 227 (3.52%)
         occurrences all number
    10
    9
    Nasal congestion
         subjects affected / exposed
    12 / 231 (5.19%)
    7 / 227 (3.08%)
         occurrences all number
    12
    7
    Nervous system disorders
    Agitation neonatal
         subjects affected / exposed
    2 / 231 (0.87%)
    4 / 227 (1.76%)
         occurrences all number
    3
    5
    Hypersomnia (INCREASED SLEEP)
    alternative assessment type: Systematic
         subjects affected / exposed
    188 / 231 (81.39%)
    189 / 227 (83.26%)
         occurrences all number
    423
    436
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    3 / 231 (1.30%)
    2 / 227 (0.88%)
         occurrences all number
    3
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    10 / 231 (4.33%)
    6 / 227 (2.64%)
         occurrences all number
    10
    6
    Diarrhoea
         subjects affected / exposed
    10 / 231 (4.33%)
    10 / 227 (4.41%)
         occurrences all number
    11
    11
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 231 (2.60%)
    10 / 227 (4.41%)
         occurrences all number
    6
    10
    Haematochezia
         subjects affected / exposed
    0 / 231 (0.00%)
    3 / 227 (1.32%)
         occurrences all number
    0
    3
    Teething
         subjects affected / exposed
    10 / 231 (4.33%)
    16 / 227 (7.05%)
         occurrences all number
    11
    17
    Vomiting
         subjects affected / exposed
    8 / 231 (3.46%)
    9 / 227 (3.96%)
         occurrences all number
    10
    9
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    6 / 231 (2.60%)
    5 / 227 (2.20%)
         occurrences all number
    6
    5
    Dermatitis contact
         subjects affected / exposed
    3 / 231 (1.30%)
    0 / 227 (0.00%)
         occurrences all number
    3
    0
    Dermatitis diaper
         subjects affected / exposed
    11 / 231 (4.76%)
    8 / 227 (3.52%)
         occurrences all number
    12
    8
    Drug eruption
         subjects affected / exposed
    1 / 231 (0.43%)
    3 / 227 (1.32%)
         occurrences all number
    1
    3
    Eczema
         subjects affected / exposed
    5 / 231 (2.16%)
    3 / 227 (1.32%)
         occurrences all number
    5
    3
    Eczema infantile
         subjects affected / exposed
    1 / 231 (0.43%)
    3 / 227 (1.32%)
         occurrences all number
    1
    3
    Rash
         subjects affected / exposed
    5 / 231 (2.16%)
    5 / 227 (2.20%)
         occurrences all number
    5
    5
    Urticaria
         subjects affected / exposed
    0 / 231 (0.00%)
    4 / 227 (1.76%)
         occurrences all number
    0
    4
    Musculoskeletal and connective tissue disorders
    Acquired plagiocephaly
         subjects affected / exposed
    1 / 231 (0.43%)
    4 / 227 (1.76%)
         occurrences all number
    1
    4
    Torticollis
         subjects affected / exposed
    3 / 231 (1.30%)
    2 / 227 (0.88%)
         occurrences all number
    3
    2
    Metabolism and nutrition disorders
    Decreased appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    134 / 231 (58.01%)
    136 / 227 (59.91%)
         occurrences all number
    214
    245
    Failure to thrive
         subjects affected / exposed
    2 / 231 (0.87%)
    3 / 227 (1.32%)
         occurrences all number
    2
    3
    Feeding disorder
         subjects affected / exposed
    2 / 231 (0.87%)
    3 / 227 (1.32%)
         occurrences all number
    2
    3
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    11 / 231 (4.76%)
    11 / 227 (4.85%)
         occurrences all number
    11
    11
    Candida infection
         subjects affected / exposed
    4 / 231 (1.73%)
    5 / 227 (2.20%)
         occurrences all number
    4
    6
    Candida nappy rash
         subjects affected / exposed
    0 / 231 (0.00%)
    5 / 227 (2.20%)
         occurrences all number
    0
    5
    Cellulitis
         subjects affected / exposed
    3 / 231 (1.30%)
    1 / 227 (0.44%)
         occurrences all number
    3
    1
    Conjunctivitis
         subjects affected / exposed
    12 / 231 (5.19%)
    11 / 227 (4.85%)
         occurrences all number
    12
    11
    Conjunctivitis bacterial
         subjects affected / exposed
    3 / 231 (1.30%)
    0 / 227 (0.00%)
         occurrences all number
    3
    0
    Croup infectious
         subjects affected / exposed
    4 / 231 (1.73%)
    3 / 227 (1.32%)
         occurrences all number
    4
    3
    Ear infection
         subjects affected / exposed
    2 / 231 (0.87%)
    4 / 227 (1.76%)
         occurrences all number
    2
    4
    Gastroenteritis
         subjects affected / exposed
    2 / 231 (0.87%)
    8 / 227 (3.52%)
         occurrences all number
    2
    9
    Gastroenteritis viral
         subjects affected / exposed
    6 / 231 (2.60%)
    1 / 227 (0.44%)
         occurrences all number
    7
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 231 (0.43%)
    3 / 227 (1.32%)
         occurrences all number
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    15 / 231 (6.49%)
    16 / 227 (7.05%)
         occurrences all number
    17
    18
    Oral candidiasis
         subjects affected / exposed
    3 / 231 (1.30%)
    3 / 227 (1.32%)
         occurrences all number
    3
    4
    Otitis media
         subjects affected / exposed
    25 / 231 (10.82%)
    21 / 227 (9.25%)
         occurrences all number
    35
    27
    Otitis media acute
         subjects affected / exposed
    8 / 231 (3.46%)
    15 / 227 (6.61%)
         occurrences all number
    8
    19
    Pneumonia
         subjects affected / exposed
    3 / 231 (1.30%)
    0 / 227 (0.00%)
         occurrences all number
    3
    0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    2 / 231 (0.87%)
    3 / 227 (1.32%)
         occurrences all number
    2
    3
    Respiratory tract infection viral
         subjects affected / exposed
    6 / 231 (2.60%)
    4 / 227 (1.76%)
         occurrences all number
    7
    5
    Skin candida
         subjects affected / exposed
    0 / 231 (0.00%)
    5 / 227 (2.20%)
         occurrences all number
    0
    5
    Upper respiratory tract infection
         subjects affected / exposed
    40 / 231 (17.32%)
    44 / 227 (19.38%)
         occurrences all number
    51
    55
    Viral infection
         subjects affected / exposed
    10 / 231 (4.33%)
    10 / 227 (4.41%)
         occurrences all number
    11
    11
    Viral upper respiratory tract infection
         subjects affected / exposed
    15 / 231 (6.49%)
    11 / 227 (4.85%)
         occurrences all number
    18
    11

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jun 2018
    1. Revised exclusion criteria to <30 days to ensure subjects received the hepatitis B vaccine at less than 30 days of age. 2. Clarified that Pfizer will provide the diphtheria, tetanus, and acellular pertussis (DTaP)-containing vaccine, as antibody levels are assessed in the study. 3. Revised the lower range for moderate severity of injection site redness and swelling from 2.5 cm to >2 .0 cm
    11 Feb 2020
    1. Exclusion criterion 5 was updated to “Prior receipt of hepatitis B vaccine at age ≥30 days” to clarify the age of administration and to enable the criterion to be answered with a “yes/no” response.

    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
    The status of studies in GB is no longer updated from 1.1.2021
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