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    Clinical Trial Results:
    Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination

    Summary
    EudraCT number
    		 2017-001529-41
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    01 Aug 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Aug 2017
    First version publication date
    17 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0887X1-4596
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01207583
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 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)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Dec 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to estimate the incidence of febrile reactions of greater than or equal to (>=) 38 degrees Celsius (C) to less than or equal to (<=) 39 degrees C; greater than (>) 39 degrees C to <=40 degrees C; > 40 degrees C occurring within 2 days following vaccination with Prevenar (7-valent pneumococcal conjugate vaccine [PCV7]) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation within the licensed indication
    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 subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jan 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 100
    Worldwide total number of subjects
    100
    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)
    100
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study was conducted at 4 sites in Russia. Study was started on 28 January 2010 and completed on 01 August 2011.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Primary Cohort (3-6 Months)
    Arm description
    		 Subjects in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 as standard care as per the summary of product characteristics (SmPC).
    Arm type
    		 Experimental

    Investigational medicinal product name
    PCV7
    Investigational medicinal product code
    Other name
    Prevenar
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    PCV7 was administered intramuscularly as standard care as per the SmPC.

    Arm title
    		 Catch-up Cohort (7-11 Months)
    Arm description
    		 Subjects in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 as standard care as per the SmPC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PCV7
    Investigational medicinal product code
    Other name
    Prevenar
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    PCV7 was administered intramuscularly as standard care as per the SmPC.

    Arm title
    		 Catch-up Cohort (12-23 Months)
    Arm description
    		 Subjects in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 as standard care as per the SmPC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PCV7
    Investigational medicinal product code
    Other name
    Prevenar
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    PCV7 was administered intramuscularly as standard care as per the SmPC.

    Number of subjects in period 1
    		Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months) Catch-up Cohort (12-23 Months)
    Started
    14
    31
    55
    Dose 1
    14
    31
    55
    Dose 2
    13
    29
    54
    Dose 3
    13
    27
    0 [1]
    Dose 4
    7 [2]
    0 [3]
    0 [4]
    Completed
    13
    26
    54
    Not completed
    1
    5
    1
         Withdrawal by Subject
    -
    3
    1
         Lost to follow-up
    -
    2
    -
         Subject failed to return
    1
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Out of 54 subjects who received Dose 2, none of the subjects received Dose 3 and 4 as Dose 2 was last dose for those subjects in Catch-up Cohort (12-23 Months). However, all 54 subjects completed the study till follow-up visit.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Out of 13 subjects who received Dose 3, only 7 subjects received Dose 4. However, all 13 subjects completed the study till follow-up visit.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Out of 27 subjects who received Dose 3, none of the subjects received Dose 4 as Dose 3 was last dose for those subjects in Catch-up Cohort (7-11 Months). However, 26 subjects completed the study till follow-up visit.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Out of 54 subjects who received Dose 2, none of the subjects received Dose 3 and 4 as Dose 2 was last dose for those subjects in Catch-up Cohort (12-23 Months). However, all 54 subjects completed the study till follow-up visit.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Primary Cohort (3-6 Months)
    Reporting group description
    		 Subjects in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 as standard care as per the summary of product characteristics (SmPC).

    Reporting group title
    Catch-up Cohort (7-11 Months)
    Reporting group description
    		 Subjects in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 as standard care as per the SmPC.

    Reporting group title
    Catch-up Cohort (12-23 Months)
    Reporting group description
    		 Subjects in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 as standard care as per the SmPC.

    Reporting group values
    		 Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months) Catch-up Cohort (12-23 Months) Total
    Number of subjects
    		 14 31 55 100
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 14 31 55 100
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 5.42 ( 1.27 ) 9.33 ( 1.26 ) 17.37 ( 3.03 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 5 13 19 37
        Male
    		 9 18 36 63

    End points

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    End points reporting groups
    Reporting group title
    Primary Cohort (3-6 Months)
    Reporting group description
    		 Subjects in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 as standard care as per the summary of product characteristics (SmPC).

    Reporting group title
    Catch-up Cohort (7-11 Months)
    Reporting group description
    		 Subjects in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 as standard care as per the SmPC.

    Reporting group title
    Catch-up Cohort (12-23 Months)
    Reporting group description
    		 Subjects in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 as standard care as per the SmPC.

    Primary: Percentage of Subjects With Febrile Reactions Post-dose 1

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    End point title
    		 Percentage of Subjects With Febrile Reactions Post-dose 1 [1]
    End point description
    Febrile reactions were defined as reactions which caused a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of subjects with febrile reaction of >=38 degrees C to <=39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed. Safety set (post-dose 1) population included all subjects who received Dose 1 and who had safety follow-up data following Dose 1.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 3 post-dose 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint
    End point values
    		 Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months) Catch-up Cohort (12-23 Months)
    Number of subjects analysed
    14
    31
    55
    Units: percentage of subjects
    number (confidence interval 95%)
        38 to 39 degrees C
    14.3 (4 to 39.9)
    16.1 (7.1 to 32.6)
    1.8 (0.3 to 9.6)
        >39 to 40 degrees C
    0 (0 to 21.5)
    3.2 (0.6 to 16.2)
    3.6 (1 to 12.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Febrile Reactions Post-dose 2

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    End point title
    		 Percentage of Subjects With Febrile Reactions Post-dose 2 [2]
    End point description
    Febrile reactions were defined as reactions which caused a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of subjects with febrile reaction of >=38 degrees C to <=39 degrees C was observed. Safety set (post-dose 2) population included all subjects who received Dose 2 and who had safety follow-up data following Dose 2.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 3 post-dose 2
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint
    End point values
    		 Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months) Catch-up Cohort (12-23 Months)
    Number of subjects analysed
    13
    29
    54
    Units: percentage of subjects
        number (confidence interval 95%)
    23.1 (8.2 to 50.3)
    10.3 (3.6 to 26.4)
    0 (0 to 6.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Febrile Reactions Post-dose 3

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    End point title
    		 Percentage of Subjects With Febrile Reactions Post-dose 3 [3] [4]
    End point description
    Febrile reactions were defined as reactions which caused a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of subjects with febrile reaction of >=38 degrees C to <=39 degrees C was observed. Safety set (post-dose 3) population included all subjects who received Dose 3 and who had safety follow-up data following Dose 3.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 3 post-dose 3
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned not to be analyzed for reporting arm Catch-up Cohort (12-23 Months).
    End point values
    		 Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months)
    Number of subjects analysed
    13
    26
    Units: percentage of subjects
        number (confidence interval 95%)
    15.4 (4.3 to 42.2)
    0 (0 to 12.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Febrile Reactions Post-dose 4

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    End point title
    		 Percentage of Subjects With Febrile Reactions Post-dose 4 [5] [6]
    End point description
    Febrile reactions were defined as reactions which caused a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of subjects with febrile reaction of >=38 degrees C was observed. Safety set (post-dose 4) population included all subjects who received Dose 4 and who had safety follow-up data following Dose 4.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 3 post-dose 4
    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
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned not to be analyzed for reporting arms Catch-up Cohort (7-11 Months) and Catch-up Cohort (12-23 Months).
    End point values
    		 Primary Cohort (3-6 Months)
    Number of subjects analysed
    7
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 35.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Pre-Specified Local Reactions Post-dose 1

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    End point title
    		 Percentage of Subjects With Pre-Specified Local Reactions Post-dose 1
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Subjects may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. Safety set (post-dose 1) population included all subjects who received Dose 1 and who had safety follow-up data following Dose 1.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 3 post-dose 1
    End point values
    		 Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months) Catch-up Cohort (12-23 Months)
    Number of subjects analysed
    14
    31
    55
    Units: percentage of subjects
    number (not applicable)
        Redness
    7.1
    19.4
    27.3
        Swelling
    0
    6.5
    25.5
        Tenderness
    7.1
    29
    23.6
        Injection site hematoma
    0
    0
    1.8
        Injection site hemorrhage
    0
    3.2
    1.8
        Injection site induration
    7.1
    0
    0
        Injection site warmth
    0
    0
    1.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Pre-Specified Local Reactions Post-dose 2

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    End point title
    		 Percentage of Subjects With Pre-Specified Local Reactions Post-dose 2
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Subjects may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. Safety set (post-dose 2) population included all subjects who received Dose 2 and who had safety follow-up data following Dose 2.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 3 post-dose 2
    End point values
    		 Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months) Catch-up Cohort (12-23 Months)
    Number of subjects analysed
    13
    29
    54
    Units: percentage of subjects
    number (not applicable)
        Redness
    23.1
    13.8
    20.4
        Swelling
    0
    0
    11.1
        Tenderness
    0
    6.9
    16.7
        Injection site hemorrhage
    0
    0
    3.7
        Injection site induration
    0
    0
    1.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Pre-Specified Local Reactions Post-dose 3

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    End point title
    		 Percentage of Subjects With Pre-Specified Local Reactions Post-dose 3 [7]
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Subjects may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. Safety set (post-dose 3) population included all subjects who received Dose 3 and who had safety follow-up data following Dose 3.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 3 post-dose 3
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned not to be analyzed for reporting arm Catch-up Cohort (12-23 Months).
    End point values
    		 Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months)
    Number of subjects analysed
    13
    26
    Units: percentage of subjects
    number (not applicable)
        Redness
    15.4
    3.8
        Swelling
    7.7
    3.8
        Tenderness
    7.7
    7.7
        Injection site induration
    7.7
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Pre-Specified Local Reactions Post-dose 4

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    End point title
    		 Percentage of Subjects With Pre-Specified Local Reactions Post-dose 4 [8]
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Subjects may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. Safety set (post-dose 4) population included all subjects who received Dose 4 and who had safety follow-up data following Dose 4.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 3 post-dose 4
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned not to be analyzed for reporting arms Catch-up Cohort (7-11 Months) and Catch-up Cohort (12-23 Months).
    End point values
    		 Primary Cohort (3-6 Months)
    Number of subjects analysed
    7
    Units: percentage of subjects
    number (not applicable)
        Redness
    14.3
        Swelling
    14.3
        Injection site induration
    14.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Pre-Specified Systemic Events Post-dose 1

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    End point title
    		 Percentage of Subjects With Pre-Specified Systemic Events Post-dose 1
    End point description
    Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Subjects may be represented in more than 1 categories. Safety set (post-dose 1) population included all subjects who received Dose 1 and who had safety follow-up data following Dose 1.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 3 post-dose 1
    End point values
    		 Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months) Catch-up Cohort (12-23 Months)
    Number of subjects analysed
    14
    31
    55
    Units: percentage of subjects
    number (not applicable)
        Decreased appetite
    7.1
    19.4
    23.6
        Diarrhea
    7.1
    3.2
    9.1
        Fever
    14.3
    19.4
    5.5
        Restless sleep
    7.1
    32.3
    27.3
        Unusual crying
    14.3
    25.8
    30.9
        Unusual fussiness
    7.1
    6.5
    12.7
        Unusual irritability
    21.4
    19.4
    25.5
        Vomiting
    0
    6.5
    3.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Pre-Specified Systemic Events Post-dose 2

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    End point title
    		 Percentage of Subjects With Pre-Specified Systemic Events Post-dose 2
    End point description
    Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety set (post-dose 2) population included all subjects who received Dose 2 and who had safety follow-up data following Dose 2.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 3 post-dose 2
    End point values
    		 Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months) Catch-up Cohort (12-23 Months)
    Number of subjects analysed
    13
    29
    54
    Units: percentage of subjects
    number (not applicable)
        Decreased appetite
    15.4
    10.3
    9.3
        Diarrhea
    15.4
    3.4
    0
        Fever
    23.1
    10.3
    0
        Restless sleep
    23.1
    24.1
    16.7
        Unusual crying
    23.1
    20.7
    13
        Unusual fussiness
    15.4
    6.9
    7.4
        Unusual irritability
    23.1
    6.9
    9.3
        Vomiting
    7.7
    0
    1.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Pre-Specified Systemic Events Post-dose 3

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    End point title
    		 Percentage of Subjects With Pre-Specified Systemic Events Post-dose 3 [9]
    End point description
    Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety set (post-dose 3) population included all subjects who received Dose 3 and who had safety follow-up data following Dose 3.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 3 post-dose 3
    Notes
    [9] - 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: Justification for warning: This endpoint was planned not to be analyzed for reporting arm Catch-up Cohort (12-23 Months).
    End point values
    		 Primary Cohort (3-6 Months) Catch-up Cohort (7-11 Months)
    Number of subjects analysed
    13
    26
    Units: percentage of subjects
    number (not applicable)
        Decreased appetite
    7.7
    0
        Diarrhea
    15.4
    3.8
        Fever
    15.4
    0
        Restless sleep
    46.2
    11.5
        Unusual crying
    15.4
    11.5
        Unusual fussiness
    15.4
    0
        Unusual irritability
    7.7
    7.7
        Vomiting
    15.4
    3.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Pre-Specified Systemic Events Post-dose 4

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    End point title
    		 Percentage of Subjects With Pre-Specified Systemic Events Post-dose 4 [10]
    End point description
    Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety set (post-dose 4) population included all subjects who received Dose 4 and who had safety follow-up data following Dose 4.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 3 post-dose 4
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned not to be analyzed for reporting arms Catch-up Cohort (7-11 Months) and Catch-up Cohort (12-23 Months).
    End point values
    		 Primary Cohort (3-6 Months)
    Number of subjects analysed
    7
    Units: percentage of subjects
    number (not applicable)
        Restless sleep
    28.6
        Unusual crying
    14.3
        Unusual irritability
    14.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious AEs were collected within 30 days after each dose and non-serious AEs were collected within 7 days after each dose.
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject 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
    14.0
    Reporting groups
    Reporting group title
    Dose 1 (Primary Cohort [3-6 Months])
    Reporting group description
    		 Subjects in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.

    Reporting group title
    Dose 2 (Primary Cohort [3-6 Months])
    Reporting group description
    		 Subjects in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.

    Reporting group title
    Dose 3 (Primary Cohort [3-6 Months])
    Reporting group description
    		 Subjects in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.

    Reporting group title
    Dose 4 (Primary Cohort [3-6 Months])
    Reporting group description
    		 Subjects in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.

    Reporting group title
    Dose 1 (Catch-up Cohort [7-11 Months])
    Reporting group description
    		 Subjects in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.

    Reporting group title
    Dose 2 (Catch-up Cohort [7-11 Months])
    Reporting group description
    		 Subjects in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.

    Reporting group title
    Dose 3 (Catch-up Cohort [7-11 Months])
    Reporting group description
    		 Subjects in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.

    Reporting group title
    Dose 1 (Catch-up Cohort [12-23 Months])
    Reporting group description
    		 Subjects in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.

    Reporting group title
    Dose 2 (Catch-up Cohort [12-23 Months])
    Reporting group description
    		 Subjects in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.

    Serious adverse events
    		 Dose 1 (Primary Cohort [3-6 Months]) Dose 2 (Primary Cohort [3-6 Months]) Dose 3 (Primary Cohort [3-6 Months]) Dose 4 (Primary Cohort [3-6 Months]) Dose 1 (Catch-up Cohort [7-11 Months]) Dose 2 (Catch-up Cohort [7-11 Months]) Dose 3 (Catch-up Cohort [7-11 Months]) Dose 1 (Catch-up Cohort [12-23 Months]) Dose 2 (Catch-up Cohort [12-23 Months])
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Dose 1 (Primary Cohort [3-6 Months]) Dose 2 (Primary Cohort [3-6 Months]) Dose 3 (Primary Cohort [3-6 Months]) Dose 4 (Primary Cohort [3-6 Months]) Dose 1 (Catch-up Cohort [7-11 Months]) Dose 2 (Catch-up Cohort [7-11 Months]) Dose 3 (Catch-up Cohort [7-11 Months]) Dose 1 (Catch-up Cohort [12-23 Months]) Dose 2 (Catch-up Cohort [12-23 Months])
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 14 (42.86%)
    6 / 13 (46.15%)
    6 / 13 (46.15%)
    2 / 7 (28.57%)
    17 / 31 (54.84%)
    8 / 29 (27.59%)
    5 / 26 (19.23%)
    27 / 55 (49.09%)
    16 / 54 (29.63%)
    Investigations
    Body temperature increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    1 / 26 (3.85%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    1
    Nervous system disorders
    Crying
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    1 / 13 (7.69%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    0
    0
    Injection site induration
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    Gait disturbance
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    1 / 26 (3.85%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    2 / 26 (7.69%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Disbacteriosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    0 / 26 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    1 / 13 (7.69%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    2 / 55 (3.64%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Rash
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 55 (1.82%)
    2 / 54 (3.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Skin irritation
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Enterovirus infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    2 / 31 (6.45%)
    2 / 29 (6.90%)
    0 / 26 (0.00%)
    0 / 55 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    0
    0
    3
    Rotavirus infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 7 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0

    More information

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

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

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