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    Clinical Trial Results:
    A Phase 2, Randomized, Partially Double-Blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine Administered in Healthy Toddlers 12 Through 15 Months of age

    Summary
    EudraCT number
    		 2025-000101-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Feb 2026

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Aug 2026
    First version publication date
    22 Aug 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C4931010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT06531538
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    66 Hudson Boulevard East, New York, United States, NY 10001
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 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-000023-PIP39-67
    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
    08 May 2026
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2026
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability profile of fourth-generation multivalent pneumococcal conjugate vaccine (PG4) administered to toddlers greater than or equal to (>=)12 to less than or equal to (<=)15 months of age.
    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 Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jul 2024
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 191
    Country: Number of subjects enrolled
    Puerto Rico: 32
    Worldwide total number of subjects
    223
    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)
    223
    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
    		 A total of 225 participants were enrolled and randomized in this study, of whom 223 participants received study vaccination.

    Pre-assignment
    Screening details
    		 Participants were randomized to receive either 1 or 2 doses of PG4 or 1 dose of the control vaccine 20-valent pneumococcal conjugate vaccine (20vPnC).

    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, Monitor, Assessor
    Blinding implementation details
    Study is partially blinded as 2 of the 3 groups are blinded and 1 is unblinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 2-Dose PG4
    Arm description
    		 Participants aged >=12 to <=15 months received 2 doses of PG4 0.5 milliliter (mL) each intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]) and Dose 2 was administered 56 to 70 days after Dose 1 (Dose 2 Visit [Vaccination 2]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    PG4
    Investigational medicinal product code
    PF-07872412
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received 2 doses of PG4 0.5 mL intramuscularly each at Dose 1 visit and Dose 2 visit.

    Arm title
    		 1-Dose PG4
    Arm description
    		 Participants aged >=12 to <=15 months received 1 dose of PG4 0.5 mL intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    PG4
    Investigational medicinal product code
    PF-07872412
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received 1 dose of PG4 0.5 mL intramuscularly at Dose 1 visit.

    Arm title
    		 1-Dose 20vPnC
    Arm description
    		 Participants aged >=12 to <=15 months received 1 dose of 20vPnC 0.5 mL intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    20vPnC
    Investigational medicinal product code
    PF-06482077
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received 1 dose of 20vPnC 0.5 mL intramuscularly at Dose 1 visit.

    Number of subjects in period 1
    		2-Dose PG4 1-Dose PG4 1-Dose 20vPnC
    Started
    89
    89
    45
    Completed
    79
    88
    41
    Not completed
    10
    1
    4
         Withdrawal by Parent/Guardian
    7
    -
    2
         Lost to follow-up
    2
    -
    2
         Protocol deviation
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    2-Dose PG4
    Reporting group description
    		 Participants aged >=12 to <=15 months received 2 doses of PG4 0.5 milliliter (mL) each intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]) and Dose 2 was administered 56 to 70 days after Dose 1 (Dose 2 Visit [Vaccination 2]).

    Reporting group title
    1-Dose PG4
    Reporting group description
    		 Participants aged >=12 to <=15 months received 1 dose of PG4 0.5 mL intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]).

    Reporting group title
    1-Dose 20vPnC
    Reporting group description
    		 Participants aged >=12 to <=15 months received 1 dose of 20vPnC 0.5 mL intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]).

    Reporting group values
    		 2-Dose PG4 1-Dose PG4 1-Dose 20vPnC Total
    Number of subjects
    		 89 89 45 223
    Age categorical
    Units: Subjects
        In Utero
    		 0 0 0 0
        Preterm newborn infants (gestional age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days - 23 months)
    		 89 89 45 223
        Children (2 - 11 years)
    		 0 0 0 0
        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: months
        arithmetic mean (standard deviation)
    		 12.7 ( 1.09 ) 12.7 ( 1.02 ) 12.9 ( 1.24 ) -
    Gender categorical
    Units: Subjects
        Male
    		 50 53 24 127
        Female
    		 39 36 21 96
    Race
    Units: Subjects
        White
    		 68 70 33 171
        Black or African American
    		 8 11 5 24
        Asian
    		 2 0 1 3
        American Indian or Alaska Native
    		 1 0 0 1
        Multiracial
    		 6 5 2 13
        Not reported
    		 4 3 4 11
    Ethnicity
    Units: Subjects
        Hispanic/Latino/Spanish origin
    		 45 52 26 123
        Non-Hispanic/non-Latino/non-Spanish origin
    		 44 37 19 100

    End points

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    End points reporting groups
    Reporting group title
    2-Dose PG4
    Reporting group description
    		 Participants aged >=12 to <=15 months received 2 doses of PG4 0.5 milliliter (mL) each intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]) and Dose 2 was administered 56 to 70 days after Dose 1 (Dose 2 Visit [Vaccination 2]).

    Reporting group title
    1-Dose PG4
    Reporting group description
    		 Participants aged >=12 to <=15 months received 1 dose of PG4 0.5 mL intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]).

    Reporting group title
    1-Dose 20vPnC
    Reporting group description
    		 Participants aged >=12 to <=15 months received 1 dose of 20vPnC 0.5 mL intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]).

    Primary: Percentage of Participants With Any Local Reactions Within 7 Days After the Last Vaccination

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    End point title
    		 Percentage of Participants With Any Local Reactions Within 7 Days After the Last Vaccination [1]
    End point description
    Local reactions included redness, swelling and pain at injection site, reported in the electronic diary (e-diary) and/or case report form (CRF) after vaccination. Redness and swelling were measured and recorded in measuring device (caliper) units, where 1 measuring device unit=0.5 centimeter (cm) and graded as mild: >0 to 2.0 cm, moderate: >2.0 to 7.0 cm, severe: >7 cm, Grade 4: necrosis (redness and swelling) or exfoliative dermatitis (redness). Pain at injection site was graded as mild: hurts if gently touched, moderate: hurts if gently touched with crying, severe: causes limitation of limb movement, Grade 4: emergency room visit or hospitalization for severe injection site pain. Percentage of participants with any local reactions of any severity were reported. Safety analysis set included all participants who received at least 1 dose of the study intervention. Here, “Subjects Analyzed” signifies number of participants who received last vaccination in the specified arms.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 7 after last vaccination (last vaccination = vaccination on Day 1 for "1-Dose PG4" and "1-Dose 20vPnC" arms, and Dose 2 for "2-Dose PG4" arm)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 2-Dose PG4 1-Dose PG4 1-Dose 20vPnC
    Number of subjects analysed
    75
    89
    45
    Units: Percentage of participants
        number (confidence interval 95%)
    57.3 (45.4 to 68.7)
    59.6 (48.6 to 69.8)
    48.9 (33.7 to 64.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Any Local Reactions Within 7 Days After Dose 1: 2-Dose PG4

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    End point title
    		 Percentage of Participants With Any Local Reactions Within 7 Days After Dose 1: 2-Dose PG4 [2] [3]
    End point description
    Local reactions included redness, swelling and pain at injection site, reported in the e-diary and/or CRF after vaccination. Redness and swelling were measured and recorded in measuring device (caliper) units, where 1 measuring device unit= 0.5 cm and graded as mild: >0 to 2.0 cm, moderate: >2.0 to 7.0 cm, severe: >7 cm, Grade 4: necrosis (redness and swelling) or exfoliative dermatitis (redness). Pain at injection site was graded as mild: hurts if gently touched, moderate: hurts if gently touched with crying, severe: causes limitation of limb movement, Grade 4: emergency room visit or hospitalization for severe injection site pain. In this outcome measure, percentage of participants with any local reactions of any severity were reported. Safety analysis set included all participants who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 7 after Dose 1
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    [3] - 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: The end point is reporting statistics for the arms specified
    End point values
    		 2-Dose PG4
    Number of subjects analysed
    89
    Units: Percentage of participants
        number (confidence interval 95%)
    51.7 (40.8 to 62.4)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Any Systemic Events Within 7 Days After the Last Vaccination

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    End point title
    		 Percentage of Participants With Any Systemic Events Within 7 Days After the Last Vaccination [4]
    End point description
    Systemic events: fever, decreased appetite, drowsiness, and irritability, reported in e-diary and/or CRF after vaccination. Fever measured in degree Celsius and ranged: mild (>=38.0-38.4), moderate (>38.4-38.9), severe (>38.9-40.0), Grade 4: >40.0. Decreased appetite graded as: mild (decreased interest in eating), moderate (decreased oral intake), severe (refusal to feed); drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity), severe (disabling, not interested in usual daily activity); irritability graded as: mild (easily consolable), moderate (required increased attention), severe (inconsolable; crying could be comforted). Grade 4: emergency room visit or hospitalization. Percentage of participants with any systemic events of any severity were reported. Safety analysis set was used. Here, “Subjects Analyzed” signifies number of participants who received last vaccination in the specified arms.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 7 after last vaccination (last vaccination = vaccination on Day 1 for "1-Dose PG4" and "1-Dose 20vPnC" arms, and Dose 2 for "2-Dose PG4" arm)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 2-Dose PG4 1-Dose PG4 1-Dose 20vPnC
    Number of subjects analysed
    76
    89
    45
    Units: Percentage of participants
        number (confidence interval 95%)
    52.6 (40.8 to 64.2)
    66.3 (55.5 to 76.0)
    55.6 (40.0 to 70.4)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Any Systemic Events Within 7 Days After Dose 1: 2-Dose PG4

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    End point title
    		 Percentage of Participants With Any Systemic Events Within 7 Days After Dose 1: 2-Dose PG4 [5] [6]
    End point description
    Systemic events: fever, decreased appetite, drowsiness, and irritability, reported in e-diary and/or CRF after vaccination. Fever measured in degree Celsius and ranged: mild (>=38.0-38.4), moderate (>38.4-38.9), severe (>38.9-40.0), Grade 4: >40.0. Decreased appetite graded as: mild (decreased interest in eating), moderate (decreased oral intake), severe (refusal to feed); drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity), severe (disabling, not interested in usual daily activity); irritability graded as: mild (easily consolable), moderate (required increased attention), severe (inconsolable; crying could be comforted). Grade 4: emergency room visit or hospitalization. Percentage of participants with any systemic events of any severity were reported. Safety analysis set included all participants who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 7 after dose 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: No statistical analysis was planned 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: The end point is not reporting statistics for all the arms
    End point values
    		 2-Dose PG4
    Number of subjects analysed
    89
    Units: Percentage of participants
        number (confidence interval 95%)
    60.7 (49.7 to 70.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Adverse Events (AEs) From the Last Vaccination to 1 Month After the Last Vaccination

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    End point title
    		 Percentage of Participants With Adverse Events (AEs) From the Last Vaccination to 1 Month After the Last Vaccination [7]
    End point description
    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study. AEs included both serious AEs (SAEs) and all other AEs (non-SAEs). An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other important medical events per protocol of the study. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation. Safety analysis set included all participants who had received at least 1 dose of the study intervention. Here, “Subjects Analyzed” signifies number of participants who received last vaccination in the specified arms.
    End point type
    Primary
    End point timeframe
    From the last vaccination to 1 Month after the last vaccination (last vaccination = vaccination on Day 1 for "1-Dose PG4" and "1-Dose 20vPnC" arms, and Dose 2 for "2-Dose PG4" arm)
    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: No statistical analysis was planned for this endpoint
    End point values
    		 2-Dose PG4 1-Dose PG4 1-Dose 20vPnC
    Number of subjects analysed
    79
    89
    45
    Units: Percentage of participants
        number (confidence interval 95%)
    19.0 (11.0 to 29.4)
    25.8 (17.1 to 36.2)
    28.9 (16.4 to 44.3)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 6 Months After the Last Vaccination

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    End point title
    		 Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 6 Months After the Last Vaccination [8]
    End point description
    An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other important medical events per protocol of the study. Safety analysis set included all participants who had received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    From Dose 1 on Day 1 through 6 months after the last vaccination (6 months after Dose 1 for 1-Dose PG4 and 1-Dose 20vPnC, and 6 months after Dose 2 for 2-Dose PG4)
    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: No statistical analysis was planned for this endpoint
    End point values
    		 2-Dose PG4 1-Dose PG4 1-Dose 20vPnC
    Number of subjects analysed
    89
    89
    45
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 4.1)
    3.4 (0.7 to 9.5)
    0 (0.0 to 7.9)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) at 1 Month After the Last Vaccination

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) at 1 Month After the Last Vaccination
    End point description
    GMCs of pneumococcal IgG were reported for 25 serotypes: 20vPnC (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F) and 5 additional (15A, 23A, 23B, 24F and 35B) serotypes in this outcome measure. GMCs and 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Evaluable immunogenicity population included all randomized participants who were eligible, received the study interventions to which they were randomly assigned, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after the last vaccination, and had no other major protocol deviations as determined by the clinician. Here, “number analyzed” signifies participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    1 Month after the last vaccination (last vaccination = vaccination on Day 1 for "1-Dose PG4" and "1-Dose 20vPnC" arms, and Dose 2 for "2-Dose PG4" arm)
    End point values
    		 2-Dose PG4 1-Dose PG4 1-Dose 20vPnC
    Number of subjects analysed
    73
    78
    40
    Units: Microgram/milliliter (mcg/mL)
    number (confidence interval 95%)
        20vPnC: 1 (n= 72, 77, 40)
    2.22 (1.79 to 2.74)
    2.66 (2.28 to 3.11)
    4.24 (3.31 to 5.44)
        20vPnC: 3 (n= 72, 77, 40)
    6.46 (5.01 to 8.32)
    4.21 (3.32 to 5.34)
    1.21 (0.95 to 1.53)
        20vPnC: 4 (n= 72, 77, 40)
    3.22 (2.56 to 4.04)
    4.97 (4.11 to 6.02)
    5.65 (4.56 to 7.01)
        20vPnC: 5 (n= 72, 77, 40)
    1.92 (1.48 to 2.48)
    2.73 (2.24 to 3.34)
    3.43 (2.66 to 4.41)
        20vPnC: 6A (n= 72, 77, 40)
    8.99 (7.32 to 11.05)
    11.41 (9.50 to 13.69)
    16.11 (12.59 to 20.61)
        20vPnC: 6B (n= 72, 77, 40)
    6.83 (5.48 to 8.51)
    9.48 (7.63 to 11.77)
    9.99 (7.17 to 13.92)
        20vPnC: 7F (n= 72, 77, 40)
    5.07 (4.24 to 6.07)
    5.13 (4.44 to 5.92)
    5.57 (4.49 to 6.90)
        20vPnC: 8 (n= 72, 77, 40)
    3.82 (3.23 to 4.52)
    4.86 (4.06 to 5.81)
    5.89 (4.74 to 7.31)
        20vPnC: 9V (n= 72, 77, 40)
    3.64 (2.90 to 4.56)
    4.54 (3.81 to 5.41)
    6.00 (4.65 to 7.74)
        20vPnC: 10A (n= 72, 77, 40)
    8.68 (6.71 to 11.22)
    9.36 (7.50 to 11.68)
    12.64 (9.24 to 17.29)
        20vPnC: 11A (n= 72, 77, 40)
    2.80 (2.32 to 3.38)
    4.14 (3.37 to 5.09)
    4.31 (3.42 to 5.42)
        20vPnC: 12F (n= 72, 77, 40)
    2.23 (1.76 to 2.84)
    2.37 (1.93 to 2.93)
    3.19 (2.49 to 4.08)
        20vPnC: 14 (n= 72, 77, 40)
    5.40 (4.36 to 6.69)
    7.98 (6.29 to 10.12)
    10.70 (8.05 to 14.22)
        20vPnC: 15B (n= 72, 77, 40)
    23.54 (19.40 to 28.55)
    32.97 (27.58 to 39.40)
    26.80 (20.87 to 34.41)
        20vPnC: 18C (n= 72, 77, 40)
    4.68 (3.50 to 6.26)
    4.96 (4.07 to 6.06)
    6.17 (4.53 to 8.41)
        20vPnC: 19A (n= 72, 77, 40)
    3.65 (3.00 to 4.44)
    4.61 (3.79 to 5.60)
    5.81 (4.46 to 7.57)
        20vPnC: 19F (n= 72, 77, 40)
    6.02 (4.71 to 7.70)
    7.68 (6.19 to 9.54)
    9.32 (7.09 to 12.24)
        20vPnC: 22F (n= 72, 77, 40)
    11.71 (9.27 to 14.78)
    11.04 (9.20 to 13.25)
    16.21 (12.62 to 20.81)
        20vPnC: 23F (n= 72, 77, 40)
    8.16 (6.13 to 10.87)
    7.90 (6.02 to 10.37)
    6.57 (4.72 to 9.15)
        20vPnC: 33F (n= 72, 77, 40)
    10.60 (8.24 to 13.64)
    9.60 (7.82 to 11.80)
    13.35 (10.12 to 17.62)
        5 Additional: 15A (n= 73, 78, 40)
    1.61 (1.24 to 2.08)
    1.84 (1.39 to 2.44)
    0.39 (0.26 to 0.60)
        5 Additional: 23A (n= 73, 78, 39)
    2.35 (1.72 to 3.20)
    0.53 (0.35 to 0.81)
    0.07 (0.03 to 0.14)
        5 Additional: 23B (n= 73, 78, 40)
    6.41 (4.69 to 8.76)
    3.10 (2.02 to 4.75)
    1.05 (0.57 to 1.94)
        5 Additional: 24F (n= 73, 78, 36)
    3.49 (2.42 to 5.03)
    0.21 (0.14 to 0.33)
    0.00 (0.00 to 0.01)
        5 Additional: 35B (n= 72, 75, 40)
    2.09 (1.56 to 2.81)
    0.87 (0.59 to 1.29)
    0.01 (0.01 to 0.02)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Systematic assessment (local reactions, systemic events): D1 through D7 after each vaccination; Non-systematic assessment: serious AEs, all-cause mortality-D1 of vaccination up to 6 months after last vaccination; other AEs-1 month after last vaccination.
    Adverse event reporting additional description
    Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.1
    Reporting groups
    Reporting group title
    2-Dose PG4: Dose 1 to Dose 2
    Reporting group description
    		 Participants aged >=12 to <=15 months received 2 doses of PG4 0.5 mL each intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]) and Dose 2 was administered 56 to 70 days after Dose 1 (Dose 2 Visit [Vaccination 2]).

    Reporting group title
    2-Dose PG4: After Dose 2
    Reporting group description
    		 Participants aged >=12 to <=15 months received 2 doses of PG4 0.5 mL each intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]) and Dose 2 was administered 56 to 70 days after Dose 1 (Dose 2 Visit [Vaccination 2]). In this arm AEs reported after Dose 2 up to 6 months.

    Reporting group title
    1-Dose PG4
    Reporting group description
    		 Participants aged >=12 to <=15 months received 1 dose of PG4 0.5 mL intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]).

    Reporting group title
    1-Dose 20vPnC
    Reporting group description
    		 Participants aged >=12 to <=15 months received 1 dose of 20vPnC 0.5 mL intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit [Vaccination 1]).

    Serious adverse events
    		 2-Dose PG4: Dose 1 to Dose 2 2-Dose PG4: After Dose 2 1-Dose PG4 1-Dose 20vPnC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 79 (0.00%)
    3 / 89 (3.37%)
    0 / 45 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 79 (0.00%)
    1 / 89 (1.12%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 79 (0.00%)
    2 / 89 (2.25%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 2-Dose PG4: Dose 1 to Dose 2 2-Dose PG4: After Dose 2 1-Dose PG4 1-Dose 20vPnC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 89 (80.90%)
    57 / 79 (72.15%)
    74 / 89 (83.15%)
    33 / 45 (73.33%)
    Nervous system disorders
    Hypersomnia (INCREASED SLEEP)
    alternative assessment type: Systematic
         subjects affected / exposed
    36 / 89 (40.45%)
    24 / 79 (30.38%)
    40 / 89 (44.94%)
    12 / 45 (26.67%)
         occurrences all number
    36
    24
    40
    12
    General disorders and administration site conditions
    Pyrexia (FEVER)
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 89 (8.99%)
    4 / 79 (5.06%)
    7 / 89 (7.87%)
    2 / 45 (4.44%)
         occurrences all number
    8
    4
    7
    2
    Injection site pain (PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    37 / 89 (41.57%)
    30 / 79 (37.97%)
    44 / 89 (49.44%)
    18 / 45 (40.00%)
         occurrences all number
    37
    30
    44
    18
    Injection site erythema (REDNESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    26 / 89 (29.21%)
    23 / 79 (29.11%)
    25 / 89 (28.09%)
    10 / 45 (22.22%)
         occurrences all number
    26
    23
    25
    10
    Injection site swelling (SWELLING)
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 89 (17.98%)
    16 / 79 (20.25%)
    21 / 89 (23.60%)
    7 / 45 (15.56%)
         occurrences all number
    16
    16
    21
    7
    Psychiatric disorders
    Irritability (IRRITABILITY)
    alternative assessment type: Systematic
         subjects affected / exposed
    38 / 89 (42.70%)
    28 / 79 (35.44%)
    42 / 89 (47.19%)
    18 / 45 (40.00%)
         occurrences all number
    38
    28
    42
    18
    Infections and infestations
    Otitis media
         subjects affected / exposed
    6 / 89 (6.74%)
    4 / 79 (5.06%)
    4 / 89 (4.49%)
    1 / 45 (2.22%)
         occurrences all number
    8
    4
    4
    1
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 89 (8.99%)
    3 / 79 (3.80%)
    6 / 89 (6.74%)
    2 / 45 (4.44%)
         occurrences all number
    8
    3
    6
    2
    Metabolism and nutrition disorders
    Decreased appetite (DECREASED APPETITE)
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 89 (24.72%)
    11 / 79 (13.92%)
    20 / 89 (22.47%)
    5 / 45 (11.11%)
         occurrences all number
    22
    11
    20
    5

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    PIP number: EMA/PE/0000233967
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