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    Clinical Trial Results:
    A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar.

    Summary
    EudraCT number
    		 2008-003631-21
    Trial protocol
    		 SE  
    Global end of trial date
    23 Jun 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Jan 2017
    First version publication date
    29 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    reporting periods and duplicate AEs in their data

    Trial information

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    Trial identification
    Sponsor protocol code
    6096A1-3012-EU
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00824655
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias ID: B1851011
    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., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, 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
    06 Dec 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the pneumococcal immune response induced by 13-valent pneumococcal conjugate vaccine (13vPnC) when measured 1 month after the infant dose of 13vPnC in Group 1.
    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 Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2009
    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
    Sweden: 234
    Worldwide total number of subjects
    234
    EEA total number of subjects
    234
    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)
    234
    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
    		 Total 234 subjects were enrolled from Sweden. The study started on 26 March 2009 and completed on 6 December 2010. Group 1 (13vPnC/13vPnC) subjects received 1 dose of Prevenar at least 42 days prior to study enrollment. Group 2 (13vPnC) subjects received 2 doses of Prevenar with the last dose at least 140 days prior to study enrollment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC/13vPnC
    Arm description
    		 Subjects received 13vPnC at 5 months (Infant dose) and at 12 months (Toddler dose).
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single dose of 0.5 milliliter (mL) 13vPnC intramuscularly (IM) at 5 months (Infant dose) at 12 months (Toddler dose).

    Arm title
    		 13vPnC
    Arm description
    		 Subjects received 13vPnC at 12 months (Toddler dose) of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC/ 13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single dose of 0.5 mL 13vPnC IM at 12 months (Toddler dose).

    Number of subjects in period 1
    		13vPnC/13vPnC 13vPnC
    Started
    118
    116
    Vaccinated infant dose
    118
    0 [1]
    Vaccinated toddler dose
    118
    116
    Completed
    116
    116
    Not completed
    2
    0
         Adverse Event
    1
    -
         Parent/legal guardian request
    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: No infant dose was administered to the subjects in this reporting group.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC/13vPnC
    Reporting group description
    		 Subjects received 13vPnC at 5 months (Infant dose) and at 12 months (Toddler dose).

    Reporting group title
    13vPnC
    Reporting group description
    		 Subjects received 13vPnC at 12 months (Toddler dose) of age.

    Reporting group values
    		 13vPnC/13vPnC 13vPnC Total
    Number of subjects
    		 118 116 234
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 5.1 ± 0.37 11.9 ± 0.52 -
    Gender categorical
    Units: Subjects
        Female
    		 50 60 110
        Male
    		 68 56 124

    End points

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    End points reporting groups
    Reporting group title
    13vPnC/13vPnC
    Reporting group description
    		 Subjects received 13vPnC at 5 months (Infant dose) and at 12 months (Toddler dose).

    Reporting group title
    13vPnC
    Reporting group description
    		 Subjects received 13vPnC at 12 months (Toddler dose) of age.

    Primary: Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose

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    End point title
    		 Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose [1]
    End point description
    Antibody geometric mean concentration (GMC) as measured by microgram (mcg) per mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence intervals (CI) were evaluated. GMCs were calculated using all Subjects with available data for the specified blood draw. Evaluable Toddler Immunogenicity Population: eligible subjects who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
    End point type
    Primary
    End point timeframe
    One month after the toddler dose (13 months of age)
    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 reported for this endpoint. 
    End point values
    		 13vPnC/13vPnC 13vPnC
    Number of subjects analysed
    114
    115
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common Serotype 4
    5.27 (4.43 to 6.26)
    5.06 (4.22 to 6.06)
        Common Serotype 6B
    9.63 (8.01 to 11.57)
    8.75 (6.76 to 11.32)
        Common Serotype 9V
    3.5 (3.01 to 4.07)
    3.33 (2.88 to 3.84)
        Common Serotype 14
    9.22 (7.66 to 11.09)
    9.3 (7.9 to 10.95)
        Common Serotype 18C
    2.93 (2.5 to 3.44)
    3.87 (3.3 to 4.53)
        Common Serotype 19F
    7.7 (6.12 to 9.69)
    8.31 (6.39 to 10.81)
        Common Serotype 23F
    3.27 (2.68 to 3.99)
    4.4 (3.7 to 5.22)
        Additional Serotype 1
    14.65 (12.5 to 17.17)
    1.58 (1.3 to 1.93)
        Additional Serotype 3
    1.85 (1.59 to 2.15)
    1.34 (1.13 to 1.58)
        Additional Serotype 5
    7.02 (5.98 to 8.25)
    1.44 (1.21 to 1.72)
        Additional Serotype 6A
    6.14 (5.08 to 7.43)
    2.48 (1.89 to 3.26)
        Additional Serotype 7F
    5.86 (5.11 to 6.72)
    3.55 (3.09 to 4.08)
        Additional Serotype 19A
    7.25 (6.14 to 8.57)
    13.16 (11.26 to 15.38)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose

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    End point title
    		 Percentage of Subjects Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose [2]
    End point description
    Percentage of Subjects achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of subjects. Evaluable Infant Immunogenicity Population: eligible subjects who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 Month after the infant series (6 months of age)
    Notes
    [2] - 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 endpoint was planned to be assessed for subjects who received infant dose
    End point values
    		 13vPnC/13vPnC
    Number of subjects analysed
    115
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotype 4
    99.1 (95.3 to 100)
        Common Serotype 6B
    53 (43.5 to 62.4)
        Common Serotype 9V
    99.1 (95.3 to 100)
        Common Serotype 14
    96.5 (91.3 to 99)
        Common Serotype 18C
    95.7 (90.1 to 98.6)
        Common Serotype 19F
    92.2 (85.7 to 96.4)
        Common Serotype 23F
    62.6 (53.1 to 71.5)
        Additional Serotype 1
    80.9 (72.5 to 87.6)
        Additional Serotype 3
    100 (96.8 to 100)
        Additional Serotype 5
    83.5 (75.4 to 89.7)
        Additional Serotype 6A
    36.8 (28 to 46.4)
        Additional Serotype 7F
    93 (86.8 to 96.9)
        Additional Serotype 19A
    87.8 (80.4 to 93.2)
    No statistical analyses for this end point

    Secondary: GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose

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    End point title
    		 GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose [3]
    End point description
    Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all Subjects with available data for the specified blood draw. Evaluable Infant Immunogenicity Population.
    End point type
    Secondary
    End point timeframe
    One Month after the infant series (6 months of age)
    Notes
    [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 endpoint was planned to be assessed for subjects who received infant dose
    End point values
    		 13vPnC/13vPnC
    Number of subjects analysed
    115
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common Serotype 4
    2.9 (2.48 to 3.4)
        Common Serotype 6B
    0.4 (0.32 to 0.5)
        Common Serotype 9V
    1.73 (1.5 to 1.99)
        Common Serotype 14
    4.7 (3.72 to 5.92)
        Common Serotype 18C
    1.56 (1.29 to 1.89)
        Common Serotype 19F
    3.01 (2.34 to 3.88)
        Common Serotype 23F
    0.57 (0.46 to 0.7)
        Additional Serotype 1
    0.89 (0.73 to 1.08)
        Additional Serotype 3
    1.88 (1.65 to 2.14)
        Additional Serotype 5
    0.72 (0.62 to 0.84)
        Additional Serotype 6A
    0.28 (0.23 to 0.34)
        Additional Serotype 7F
    1.78 (1.48 to 2.15)
        Additional Serotype 19A
    0.85 (0.73 to 0.99)
    No statistical analyses for this end point

    Secondary: GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose

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    End point title
    		 GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose
    End point description
    Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all subjects with available data for the specified blood draw. Evaluable Toddler Immunogenicity Population.
    End point type
    Secondary
    End point timeframe
    Twelve months of age (prior to toddler dose)
    End point values
    		 13vPnC/13vPnC 13vPnC
    Number of subjects analysed
    114
    115
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common Serotype 4
    0.66 (0.57 to 0.77)
    0.62 (0.53 to 0.72)
        Common Serotype 6B
    0.83 (0.67 to 1.02)
    0.65 (0.51 to 0.82)
        Common Serotype 9V
    0.74 (0.65 to 0.85)
    0.7 (0.6 to 0.82)
        Common Serotype 14
    1.99 (1.63 to 2.42)
    2.23 (1.85 to 2.69)
        Common Serotype 18C
    0.35 (0.3 to 0.41)
    0.44 (0.38 to 0.51)
        Common Serotype 19F
    0.85 (0.7 to 1.03)
    0.81 (0.66 to 1)
        Common Serotype 23F
    0.33 (0.27 to 0.39)
    0.41 (0.34 to 0.49)
        Additional Serotype 1
    0.46 (0.4 to 0.53)
    0.01 (0.01 to 0.02)
        Additional Serotype 3
    0.4 (0.34 to 0.47)
    0.05 (0.04 to 0.07)
        Additional Serotype 5
    1.18 (1.02 to 1.36)
    0.33 (0.26 to 0.42)
        Additional Serotype 6A
    0.71 (0.6 to 0.85)
    0.24 (0.19 to 0.31)
        Additional Serotype 7F
    1.08 (0.95 to 1.23)
    0.02 (0.02 to 0.02)
        Additional Serotype 19A
    1.06 (0.88 to 1.28)
    1.55 (1.32 to 1.81)
    No statistical analyses for this end point

    Other pre-specified: Percentage of subjects Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age)

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    End point title
    		 Percentage of subjects Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) [4]
    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). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe greater than [>] 7.0 cm). Subjects may have been represented in more than 1 category. Safety Population: all subjects who received at least 1 dose of the study vaccine; n = number of subjects reporting yes for at least 1 day or no for all days for the specific characteristic.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 through Day 7 after vaccination
    Notes
    [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:  The endpoint was planned to be assessed for subjects who received infant dose
    End point values
    		 13vPnC/13vPnC
    Number of subjects analysed
    113
    Units: Percentage of Subjects
    number (not applicable)
        Tenderness: Any (n=108)
    36.1
        Tenderness: Significant (n=99)
    3
        Swelling: Any (n=104)
    33.7
        Swelling: Mild (n=104)
    31.7
        Swelling: Moderate (n=101)
    9.9
        Swelling: Severe (n=99)
    0
        Redness: Any (n=107)
    40.2
        Redness: Mild (n=107)
    36.4
        Redness: Moderate (n=99)
    4
        Redness: Severe (n=99)
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)
    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). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may have been represented in more than 1 category. Safety Population; n = number of subjects reporting yes for at least 1 day or no for all days for the specific characteristic.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 through Day 7 after vaccination
    End point values
    		 13vPnC/13vPnC 13vPnC
    Number of subjects analysed
    108
    115
    Units: percentage of subjects
    number (not applicable)
        Tenderness: Any (n=104,110)
    59.6
    52.7
        Tenderness: Significant (n=96,103)
    5.2
    7.8
        Swelling: Any (n=104,110)
    53.8
    54.5
        Swelling: Mild (n=104,109)
    50
    52.3
        Swelling: Moderate (n=100,105)
    24
    29.5
        Swelling: Severe (n=95,101)
    0
    0
        Redness: Any (n=104,113)
    62.5
    59.3
        Redness: Mild (n=103,113)
    52.4
    51.3
        Redness: Moderate (n=98,106)
    20.4
    26.4
        Redness: Severe (n=95,101)
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) [5]
    End point description
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Subjects may have been represented in more than 1 category. Safety Population; n = number of subjects reporting yes for at least 1 day or no for all days for the specific characteristic.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 through 7 after vaccination
    Notes
    [5] - 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 endpoint was planned to be assessed for subjects who received infant dose
    End point values
    		 13vPnC/13vPnC
    Number of subjects analysed
    117
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38 degrees C but ≤39 degrees C (n=103)
    26.2
        Fever >39 degrees C but ≤40 degrees C (n=99)
    2
        Fever >40 degrees C (n=99)
    0
        Decreased appetite (n=107)
    36.4
        Irritability (n=114)
    80.7
        Increased sleep (n=106)
    50.9
        Decreased sleep (n=112)
    39.3
    No statistical analyses for this end point

    Other pre-specified: Percentage of subjects Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)

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    End point title
    		 Percentage of subjects Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)
    End point description
    Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Subjects may have been represented in more than 1 category. Safety Population; n = number of subjects reporting yes for at least 1 day or no for all days for the specific characteristic.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 through 7 after vaccination
    End point values
    		 13vPnC/13vPnC 13vPnC
    Number of subjects analysed
    113
    114
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38 degrees C but ≤39 degrees C (n=99,105)
    31.3
    32.4
        Fever >39 degrees C but ≤40 degrees C (n=96,102)
    5.2
    3.9
        Fever >40 degrees C (n=95,101)
    0
    0
        Decreased appetite (n=103,109)
    46.6
    44
        Irritability (n=111,113)
    82
    76.1
        Increased sleep (n=101,108)
    49.5
    38.9
        Decreased sleep (n=105,106)
    36.2
    33
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs: Recorded from signing of informed consent form to completion of study(28­42 days post 13vPnC). Subjects recorded prespecified AEs in electronic diary:local reactions; systemic events (Day 1 - Day 7 post 13vPnC)
    Adverse event reporting additional description
    The same event may appear as both an adverse event (AE) and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious 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
    0.0
    Reporting groups
    Reporting group title
    13vPnC/13vPnC Infant series
    Reporting group description
    		 13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose)

    Reporting group title
    13vPnC/13vPnC After Infant series
    Reporting group description
    		 13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose); assessment 1 month after the infant series (6 months of age).

    Reporting group title
    13vPnC/13vPnC Toddler dose
    Reporting group description
    		 13vPnC 0.5 mL dose administered IM at 5 months (infant dose) and 12 months of age (toddler dose).

    Reporting group title
    13vPnC Toddler dose
    Reporting group description
    		 13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose).

    Serious adverse events
    		 13vPnC/13vPnC Infant series 13vPnC/13vPnC After Infant series 13vPnC/13vPnC Toddler dose 13vPnC Toddler dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 118 (0.85%)
    4 / 118 (3.39%)
    1 / 116 (0.86%)
    0 / 116 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Foreign body
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 118 (0.85%)
    0 / 116 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 118 (0.00%)
    1 / 116 (0.86%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 118 (0.85%)
    0 / 116 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 116 (0.86%)
    0 / 116 (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
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 116 (0.86%)
    0 / 116 (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
    Gastroenteritis
         subjects affected / exposed
    0 / 118 (0.00%)
    4 / 118 (3.39%)
    0 / 116 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 116 (0.86%)
    0 / 116 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13vPnC/13vPnC Infant series 13vPnC/13vPnC After Infant series 13vPnC/13vPnC Toddler dose 13vPnC Toddler dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    107 / 118 (90.68%)
    4 / 118 (3.39%)
    98 / 116 (84.48%)
    98 / 116 (84.48%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    2 / 116 (1.72%)
         occurrences all number
    0
    0
    0
    2
    Foreign body
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Thermal burn
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Crying
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 118 (0.00%)
    4 / 116 (3.45%)
    4 / 116 (3.45%)
         occurrences all number
    1
    0
    4
    6
    Injection site swelling
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 116 (0.86%)
    0 / 116 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fever ≥38 degree C but ≤39 degree C (Infant Dose and Toddler Dose)
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    27 / 103 (26.21%)
    0 / 118 (0.00%)
    31 / 99 (31.31%)
    34 / 105 (32.38%)
         occurrences all number
    27
    0
    31
    34
    Decreased appetite (Infant Dose and Toddler Dose)
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    39 / 107 (36.45%)
    0 / 118 (0.00%)
    48 / 103 (46.60%)
    48 / 109 (44.04%)
         occurrences all number
    39
    0
    48
    48
    Irritability
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Increased sleep (Infant Dose and Toddler Dose)
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    54 / 106 (50.94%)
    0 / 118 (0.00%)
    50 / 101 (49.50%)
    42 / 108 (38.89%)
         occurrences all number
    54
    0
    50
    42
    Decreased sleep (Infant Dose and Toddler Dose)
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    44 / 112 (39.29%)
    0 / 118 (0.00%)
    38 / 105 (36.19%)
    35 / 106 (33.02%)
         occurrences all number
    44
    0
    38
    35
    Irritability (Systemic Event) Infant Dose and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    92 / 114 (80.70%)
    0 / 118 (0.00%)
    91 / 111 (81.98%)
    86 / 113 (76.11%)
         occurrences all number
    92
    0
    91
    86
    Fever >39 degree C but ≤40 degree C (Infant Dose and Toddler Dose)
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    2 / 99 (2.02%)
    0 / 118 (0.00%)
    5 / 96 (5.21%)
    4 / 102 (3.92%)
         occurrences all number
    2
    0
    5
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 118 (0.85%)
    1 / 118 (0.85%)
    2 / 116 (1.72%)
    0 / 116 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 118 (0.00%)
    5 / 116 (4.31%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    5
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 118 (0.85%)
    0 / 116 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Teething
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 118 (0.00%)
    1 / 116 (0.86%)
    0 / 116 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash macular
         subjects affected / exposed
    1 / 118 (0.85%)
    1 / 118 (0.85%)
    0 / 116 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    2 / 116 (1.72%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    2
    1
    Erythema
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 116 (0.86%)
    0 / 116 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Tenderness (Any) Infant Dose and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    39 / 108 (36.11%)
    0 / 118 (0.00%)
    62 / 104 (59.62%)
    58 / 110 (52.73%)
         occurrences all number
    39
    0
    62
    58
    Tenderness (Significant) Infant Dose and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    3 / 99 (3.03%)
    0 / 118 (0.00%)
    5 / 96 (5.21%)
    8 / 103 (7.77%)
         occurrences all number
    3
    0
    5
    8
    Swelling (Any) Infant Dose and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    35 / 104 (33.65%)
    0 / 118 (0.00%)
    56 / 104 (53.85%)
    60 / 110 (54.55%)
         occurrences all number
    35
    0
    56
    60
    Swelling (Mild) Infant Dose and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    33 / 104 (31.73%)
    0 / 118 (0.00%)
    52 / 104 (50.00%)
    57 / 109 (52.29%)
         occurrences all number
    33
    0
    52
    57
    Swelling (Moderate) Infant Dose and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    10 / 101 (9.90%)
    0 / 118 (0.00%)
    24 / 100 (24.00%)
    31 / 105 (29.52%)
         occurrences all number
    10
    0
    24
    31
    Redness (Any) Infant Dose and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    43 / 107 (40.19%)
    0 / 118 (0.00%)
    65 / 104 (62.50%)
    67 / 113 (59.29%)
         occurrences all number
    43
    0
    65
    67
    Redness (Mild) Infant Dose and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    39 / 107 (36.45%)
    0 / 118 (0.00%)
    54 / 103 (52.43%)
    58 / 113 (51.33%)
         occurrences all number
    39
    0
    54
    58
    Redness (Moderate) Infant Dose and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    4 / 99 (4.04%)
    0 / 118 (0.00%)
    20 / 98 (20.41%)
    28 / 106 (26.42%)
         occurrences all number
    4
    0
    20
    28
    Musculoskeletal and connective tissue disorders
    Lower extremity mass
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 116 (0.86%)
    0 / 116 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 118 (4.24%)
    0 / 118 (0.00%)
    8 / 116 (6.90%)
    7 / 116 (6.03%)
         occurrences all number
    5
    0
    9
    9
    Exanthema subitum
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    2 / 116 (1.72%)
         occurrences all number
    1
    0
    0
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 118 (0.00%)
    3 / 116 (2.59%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mastitis
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 118 (0.85%)
    0 / 116 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    2 / 116 (1.72%)
    3 / 116 (2.59%)
         occurrences all number
    0
    0
    2
    4
    Otitis media
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    2 / 116 (1.72%)
    2 / 116 (1.72%)
         occurrences all number
    0
    0
    2
    3
    Varicella
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    2 / 116 (1.72%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    2 / 116 (1.72%)
    0 / 116 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Bronchitis
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Croup infectious
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 116 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 118 (0.85%)
    0 / 116 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.

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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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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