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    Clinical Trial Results:
    A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine

    Summary
    EudraCT number
    		 2006-006779-19
    Trial protocol
    		 PL  
    Global end of trial date
    31 Mar 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2016
    First version publication date
    01 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    6096A1-3002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00452452
    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., 1-800- 718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 1-800- 718-1021, 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-000036-PIP01-07
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Sep 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: To assess the pneumococcal immune responses induced by 13vPnC when measured 1 month after last scheduled dose of 13vPnC in each age group.
    Protection of trial subjects
    The study was in compliance with with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jul 2007
    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
    Poland: 355
    Worldwide total number of subjects
    355
    EEA total number of subjects
    355
    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)
    202
    Children (2-11 years)
    153
    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
    		 The study started on 12 July 2007 and ended on 31 March 2008. Overall, 355 subjects were enrolled in Poland.

    Period 1
    Period 1 title
    Overall (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 7 to <12 Months of Age
    Arm description
    		 Subjects 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant 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
    Three single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.

    Arm title
    		 13vPnC 12 to <24 Months of Age
    Arm description
    		 Subjects 12 to <24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single doses of 13vPnC at least 56 days apart.
    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
    Two single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); at least 56 days after the first dose.

    Arm title
    		 13vPnC 24 to <72 Months of Age
    Arm description
    		 Subjects 24 to <72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single dose of 13vPnC.
    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
    A single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC).

    Number of subjects in period 1
    		13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to <72 Months of Age
    Started
    90
    112
    153
    Vaccinated Dose 1
    90
    112
    152
    Vaccinated Dose 2
    90
    112
    0 [1]
    Vaccinated Dose 3
    89
    0 [2]
    0 [3]
    Completed
    88
    112
    152
    Not completed
    2
    0
    1
         Consent withdrawn by subject
    1
    -
    -
         Protocol Violation
    -
    -
    1
         Lost to follow-up
    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 subject was administered dose 2 for this arm.
    [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: No subject was administered dose 3 for this arm.
    [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: No subject was administered dose 3 for this arm.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC 7 to <12 Months of Age
    Reporting group description
    		 Subjects 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.

    Reporting group title
    13vPnC 12 to <24 Months of Age
    Reporting group description
    		 Subjects 12 to <24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single doses of 13vPnC at least 56 days apart.

    Reporting group title
    13vPnC 24 to <72 Months of Age
    Reporting group description
    		 Subjects 24 to <72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single dose of 13vPnC.

    Reporting group values
    		 13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to <72 Months of Age Total
    Number of subjects
    		 90 112 153 355
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 8.7 ( 1.6 ) 17.6 ( 3.5 ) 42 ( 13.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 47 58 74 179
        Male
    		 43 54 79 176

    End points

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    End points reporting groups
    Reporting group title
    13vPnC 7 to <12 Months of Age
    Reporting group description
    		 Subjects 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.

    Reporting group title
    13vPnC 12 to <24 Months of Age
    Reporting group description
    		 Subjects 12 to <24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single doses of 13vPnC at least 56 days apart.

    Reporting group title
    13vPnC 24 to <72 Months of Age
    Reporting group description
    		 Subjects 24 to <72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single dose of 13vPnC.

    Subject analysis set title
    13vPnC Group 1 - Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects 7 to <12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) dose of vaccine 13vPnC in the infant series.

    Subject analysis set title
    13vPnC Group 2 - Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects 12 to <24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC in the infant series.

    Subject analysis set title
    13vPnC Group 3 - Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects 24 to <72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC in the infant series.

    Subject analysis set title
    13vPnC Group 1 - Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects 7 to less than (<) 12 months of age received a second single IM 0.5 milliliter (mL) dose of 13vPnC at least 28 days after the first in the infant series.

    Subject analysis set title
    13vPnC Group 2 - Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects 12 to <24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).

    Subject analysis set title
    13vPnC Group 1 - Dose 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.

    Primary: Percentage of Subjects Achieving Antibody Level Greater Than Equal To (>=) 0.35 Microgram per Mililiter μg/mL After Vaccination

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    End point title
    		 Percentage of Subjects Achieving Antibody Level Greater Than Equal To (>=) 0.35 Microgram per Mililiter μg/mL After Vaccination [1]
    End point description
    Percentages of subjects achieving World Health Organization (WHO) predefined antibody threshold >=0.35μg/mL along with the corresponding 95 percent (%) Confidence Interval (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. Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. (n) = number of subjects with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.
    End point type
    Primary
    End point timeframe
    28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 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: Inferential statistical analysis was not performed since descriptive statistical analysis was planned for this endpoint.
    End point values
    		 13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to <72 Months of Age
    Number of subjects analysed
    84
    110
    152
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotypes - Serotype 4 (n= 84,110,151)
    100 (95.7 to 100)
    100 (96.7 to 100)
    99.3 (96.4 to 100)
        Common Serotypes - Serotype 6B (n=83,110,150)
    98.8 (93.5 to 100)
    100 (96.7 to 100)
    99.3 (96.3 to 100)
        Common Serotypes - Serotype 9V (n= 83,104,148)
    98.8 (93.5 to 100)
    99 (94.8 to 100)
    98.6 (95.2 to 99.8)
        Common Serotypes - Serotype 14 (n= 84,108,135)
    100 (95.7 to 100)
    100 (96.6 to 100)
    88.1 (81.5 to 93.1)
        Common Serotypes - Serotype 18C (n= 83,109,151)
    100 (95.7 to 100)
    100 (96.7 to 100)
    98.7 (95.3 to 99.8)
        Common Serotypes - Serotype 19F (n=84,110,147)
    97.6 (91.7 to 99.7)
    100 (96.7 to 100)
    98 (94.2 to 99.6)
        Common Serotypes - Serotype 23F (n= 84,110,151)
    98.8 (93.5 to 100)
    92.7 (86.2 to 96.8)
    93.4 (88.2 to 96.8)
        Additional Serotypes - Serotype 1 (n= 83,108,149)
    100 (95.7 to 100)
    100 (96.6 to 100)
    96.6 (92.3 to 98.9)
        Additional Serotypes - Serotype 3 (n= 83,108,149)
    98.8 (93.5 to 100)
    100 (96.6 to 100)
    97.3 (93.3 to 99.3)
        Additional Serotypes - Serotype 5 (n= 84,107,152)
    97.6 (91.7 to 99.7)
    99.1 (94.9 to 100)
    98.7 (95.3 to 99.8)
        Additional Serotypes - Serotype 6A (n= 84,110,150)
    100 (95.7 to 100)
    98.2 (93.6 to 99.8)
    100 (97.6 to 100)
        Additional Serotypes - Serotype 7F (n= 84,108,142)
    100 (95.7 to 100)
    100 (96.6 to 100)
    99.3 (96.1 to 100)
        Additional Serotypes - Serotype 19A (n=84,110,150)
    100 (95.7 to 100)
    100 (96.7 to 100)
    100 (97.6 to 100)
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups

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    End point title
    		 Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups [2]
    End point description
    GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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) are presented. The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Primary
    End point timeframe
    28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age)
    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: Inferential statistical analysis was not performed since descriptive statistical analysis was planned for this endpoint.
    End point values
    		 13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to <72 Months of Age
    Number of subjects analysed
    84
    110
    152
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Common Serotypes - Serotype 4
    3.63 (3.11 to 4.23)
    4.28 (3.78 to 4.86)
    3.37 (2.95 to 3.85)
        Common Serotypes - Serotype 6B
    4.77 (3.9 to 5.84)
    3.38 (2.81 to 4.06)
    3.41 (2.8 to 4.16)
        Common Serotypes - Serotype 9V
    2.56 (2.21 to 2.96)
    3.08 (2.69 to 3.53)
    2.67 (2.32 to 3.07)
        Common Serotypes - Serotype 14
    8.04 (6.95 to 9.3)
    6.45 (5.48 to 7.59)
    2.24 (1.71 to 2.93)
        Common Serotypes - Serotype 18C
    2.77 (2.39 to 3.23)
    3.71 (3.29 to 4.19)
    2.56 (2.17 to 3.03)
        Common Serotypes - Serotype 19F
    2.88 (2.35 to 3.54)
    3.07 (2.68 to 3.51)
    2.53 (2.14 to 2.99)
        Common Serotypes - Serotype 23F
    2.16 (1.82 to 2.55)
    1.98 (1.64 to 2.39)
    1.55 (1.31 to 1.85)
        Additional Serotypes - Serotype 1
    2.88 (2.44 to 3.39)
    2.74 (2.37 to 3.16)
    1.78 (1.52 to 2.08)
        Additional Serotypes - Serotype 3
    1.94 (1.68 to 2.24)
    1.86 (1.6 to 2.15)
    1.42 (1.23 to 1.64)
        Additional Serotypes - Serotype 5
    2.85 (2.34 to 3.46)
    2.16 (1.89 to 2.47)
    2.33 (2.05 to 2.64)
        Additional Serotypes - Serotype 6A
    3.72 (3.12 to 4.45)
    2.62 (2.25 to 3.06)
    2.96 (2.52 to 3.47)
        Additional Serotypes - Serotype 7F
    5.3 (4.54 to 6.18)
    5.99 (5.4 to 6.65)
    4.92 (4.26 to 5.68)
        Additional Serotypes - Serotype 19A
    4.77 (4.28 to 5.33)
    4.94 (4.31 to 5.65)
    6.03 (5.22 to 6.97)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Pre-Specified Local Reactions

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Local Reactions
    End point description
    Local reactions were collected 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 be represented in more than 1 category. The safety population included all subjects who received at least 1 dose of vaccine.
    End point type
    Secondary
    End point timeframe
    During the 4-day period after each dose
    End point values
    		 13vPnC Group 1 - Dose 1 13vPnC Group 2 - Dose 1 13vPnC Group 3 - Dose 1 13vPnC Group 1 - Dose 2 13vPnC Group 2 - Dose 2 13vPnC Group 1 - Dose 3
    Number of subjects analysed
    90
    112
    152
    90
    112
    89
    Units: percentage of subjects
    number (not applicable)
        Tenderness - Any
    15.1
    33.3
    42.3
    15.1
    43.7
    15.2
        Tenderness - Significant
    1.2
    0
    4.1
    3.5
    4.1
    6.4
        Swelling - Any
    36
    44.5
    36.9
    32.2
    41
    25
        Swelling - Mild
    32.6
    36.7
    28.2
    28.7
    36.2
    20.5
        Swelling - Moderate
    11.6
    24.8
    20.3
    14
    12.1
    11.3
        Swelling - Severe
    0
    0
    0
    0
    0
    0
        Redness - Any
    48.8
    70
    50
    46
    54.7
    37.8
        Redness - Mild
    41.9
    55.5
    37.4
    40.2
    44.7
    31.3
        Redness - Moderate
    16.3
    38.2
    25.7
    9.3
    25.5
    12.5
        Redness - Severe
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Pre-Specified Systemic Events

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Systemic Events
    End point description
    Systemic events (fever >=37.5 degrees Celsius [C], fever >=38 C but less than equal to <=39 C, fever >39 C but <=40 C, fever >40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Subjects may be represented in more than 1 category. The safety population included all subjects who received at least 1 dose of vaccine.
    End point type
    Secondary
    End point timeframe
    During the 4-day period after each dose
    End point values
    		 13vPnC Group 1 - Dose 1 13vPnC Group 2 - Dose 1 13vPnC Group 3 - Dose 1 13vPnC Group 1 - Dose 2 13vPnC Group 2 - Dose 2 13vPnC Group 1 - Dose 3
    Number of subjects analysed
    90
    112
    152
    90
    112
    89
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38°C but ≤39°C
    3.4
    3.7
    0.7
    8.1
    5.1
    5.1
        Fever >39°C but ≤40°C
    1.2
    0.9
    0.7
    2.3
    0
    1.3
        Fever >40°C
    0
    0
    0
    0
    0
    0
        Decreased appetite
    19.5
    22.2
    16.3
    17.2
    25.5
    17.5
        Irritability
    24.1
    30.6
    14.3
    34.5
    34
    24.7
        Increased sleep
    9.2
    13
    11.6
    9.3
    10.1
    2.6
        Decreased sleep
    24.1
    19.4
    6.8
    18.4
    20.4
    15
        Use of antipyretic medication to treat symptoms
    9.2
    10.1
    2.7
    9.3
    13.3
    7.6
        Use of antipyretic medication to prevent symptoms
    8
    13.8
    4.8
    4.7
    14.3
    5.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Signing of the informed consent form (ICF) to the subject’s last visit (28 to 42 days after the last dose of 13vPnC)
    Adverse event reporting additional description
    An 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 AE and SAE event during the study. MedDra version was not captured hence 0.0 has been mentioned for dictionary version.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    13vPnC 7 to <12 Months of Age
    Reporting group description
    		 Subjects 7 to <12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.

    Reporting group title
    13vPnC 12 to <24 Months of Age
    Reporting group description
    		 Subjects 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 doses of 13vPnC at least 56 days apart.

    Reporting group title
    13vPnC 24 to < 72 Months of Age
    Reporting group description
    		 Subjects 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single dose of 13vPnC.

    Serious adverse events
    		 13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to < 72 Months of Age
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 90 (4.44%)
    2 / 112 (1.79%)
    2 / 152 (1.32%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Exanthema subitum
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to < 72 Months of Age
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 90 (61.11%)
    83 / 112 (74.11%)
    102 / 152 (67.11%)
    Investigations
    Urological examination abnormal
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    1
    Upper limb fracture
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 90 (4.44%)
    2 / 112 (1.79%)
    1 / 152 (0.66%)
         occurrences all number
    4
    2
    1
    Injection site nodule
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site erythema
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site pain
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    Fever ≥38 degree centigrade (°C) but ≤39°C Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    3 / 87 (3.45%)
    4 / 108 (3.70%)
    1 / 147 (0.68%)
         occurrences all number
    3
    4
    1
    Fever >39°C but ≤40°C Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    1 / 86 (1.16%)
    1 / 108 (0.93%)
    1 / 147 (0.68%)
         occurrences all number
    1
    1
    1
    Decreased appetite Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    17 / 87 (19.54%)
    24 / 108 (22.22%)
    24 / 147 (16.33%)
         occurrences all number
    17
    24
    24
    Irritability Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    21 / 87 (24.14%)
    33 / 108 (30.56%)
    21 / 147 (14.29%)
         occurrences all number
    21
    33
    21
    Increased sleep Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    8 / 87 (9.20%)
    14 / 108 (12.96%)
    17 / 147 (11.56%)
         occurrences all number
    8
    14
    17
    Decreased sleep Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    21 / 87 (24.14%)
    21 / 108 (19.44%)
    10 / 148 (6.76%)
         occurrences all number
    21
    21
    10
    Fever ≥38°C but ≤39°C Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    7 / 86 (8.14%)
    5 / 98 (5.10%)
    0 / 152 (0.00%)
         occurrences all number
    7
    5
    0
    Fever >39°C but ≤40°C Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    2 / 86 (2.33%)
    0 / 98 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    Decreased appetite Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    15 / 87 (17.24%)
    25 / 98 (25.51%)
    0 / 152 (0.00%)
         occurrences all number
    15
    25
    0
    Irritability Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    30 / 87 (34.48%)
    34 / 100 (34.00%)
    0 / 152 (0.00%)
         occurrences all number
    30
    34
    0
    Increased sleep Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    8 / 86 (9.30%)
    10 / 99 (10.10%)
    0 / 152 (0.00%)
         occurrences all number
    8
    10
    0
    Decreased sleep Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    16 / 87 (18.39%)
    20 / 98 (20.41%)
    0 / 152 (0.00%)
         occurrences all number
    16
    20
    0
    Fever ≥38°C but ≤39°C Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    4 / 78 (5.13%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    4
    0
    0
    Fever >39°C but ≤40°C Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    1 / 79 (1.27%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    Decreased appetite Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    14 / 80 (17.50%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    14
    0
    0
    Irritability Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    20 / 81 (24.69%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    20
    0
    0
    Increased sleep Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    2 / 78 (2.56%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    Decreased sleep Dose 3 (Infant Series)
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    12 / 80 (15.00%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    12
    0
    0
    Induration (Mild) Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    16 / 78 (20.51%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    16
    0
    0
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    2
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Chalazion
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 90 (6.67%)
    8 / 112 (7.14%)
    1 / 152 (0.66%)
         occurrences all number
    6
    9
    1
    Dyspepsia
         subjects affected / exposed
    2 / 90 (2.22%)
    2 / 112 (1.79%)
    1 / 152 (0.66%)
         occurrences all number
    2
    2
    1
    Stomatitis
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    1
    Teething
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 112 (0.89%)
    1 / 152 (0.66%)
         occurrences all number
    1
    1
    1
    Constipation
         subjects affected / exposed
    0 / 90 (0.00%)
    2 / 112 (1.79%)
    0 / 152 (0.00%)
         occurrences all number
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    Asthma
         subjects affected / exposed
    1 / 90 (1.11%)
    2 / 112 (1.79%)
    1 / 152 (0.66%)
         occurrences all number
    1
    2
    1
    Cough
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    Dysphonia
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    2 / 90 (2.22%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    2
    1
    0
    Dermatitis diaper
         subjects affected / exposed
    2 / 90 (2.22%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    2
    1
    0
    Rash
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 112 (0.89%)
    1 / 152 (0.66%)
         occurrences all number
    1
    1
    1
    Heat rash
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    0
    0
    2
    Dermatitis
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    1
    Swelling face
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    1
    Tenderness (Any) Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    13 / 86 (15.12%)
    36 / 108 (33.33%)
    63 / 149 (42.28%)
         occurrences all number
    13
    36
    63
    Tenderness (Significant) Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    1 / 86 (1.16%)
    0 / 108 (0.00%)
    6 / 147 (4.08%)
         occurrences all number
    1
    0
    6
    Induration (Any) Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    31 / 86 (36.05%)
    49 / 110 (44.55%)
    55 / 149 (36.91%)
         occurrences all number
    31
    49
    55
    Induration (Mild) Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    28 / 86 (32.56%)
    40 / 109 (36.70%)
    42 / 149 (28.19%)
         occurrences all number
    28
    40
    42
    Induration (Moderate) Dose 1(Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    10 / 86 (11.63%)
    27 / 109 (24.77%)
    30 / 148 (20.27%)
         occurrences all number
    10
    27
    30
    Erythema (Any) Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    42 / 86 (48.84%)
    77 / 110 (70.00%)
    74 / 148 (50.00%)
         occurrences all number
    42
    77
    74
    Erythema (Moderate) Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    14 / 86 (16.28%)
    42 / 110 (38.18%)
    38 / 148 (25.68%)
         occurrences all number
    14
    42
    38
    Tenderness (Any) Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    13 / 86 (15.12%)
    45 / 103 (43.69%)
    0 / 152 (0.00%)
         occurrences all number
    13
    45
    0
    Tenderness (Significant) Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    3 / 86 (3.49%)
    4 / 98 (4.08%)
    0 / 152 (0.00%)
         occurrences all number
    3
    4
    0
    Induration (Any) Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    28 / 87 (32.18%)
    43 / 105 (40.95%)
    0 / 152 (0.00%)
         occurrences all number
    28
    43
    0
    Induration (Mild) Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    25 / 87 (28.74%)
    38 / 105 (36.19%)
    0 / 152 (0.00%)
         occurrences all number
    25
    38
    0
    Induration (Moderate) Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    12 / 86 (13.95%)
    12 / 99 (12.12%)
    0 / 152 (0.00%)
         occurrences all number
    12
    12
    0
    Erythema (Any) Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    40 / 87 (45.98%)
    58 / 106 (54.72%)
    0 / 152 (0.00%)
         occurrences all number
    40
    58
    0
    Erythema (Mild) Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    35 / 87 (40.23%)
    46 / 103 (44.66%)
    0 / 152 (0.00%)
         occurrences all number
    35
    46
    0
    Erythema (Moderate) Dose 2 (Infant Series)
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    8 / 86 (9.30%)
    26 / 102 (25.49%)
    0 / 152 (0.00%)
         occurrences all number
    8
    26
    0
    Tenderness (Any) Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    12 / 79 (15.19%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    12
    0
    0
    Tenderness (Significant) Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    5 / 78 (6.41%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    5
    0
    0
    Induration (Any) Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    20 / 80 (25.00%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    20
    0
    0
    Induration (moderate) Dose 3 (infant Series).
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    9 / 80 (11.25%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    9
    0
    0
    Erythema (Any) Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    31 / 82 (37.80%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    31
    0
    0
    Erythema (Mild) Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    25 / 80 (31.25%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    25
    0
    0
    Erythema (Moderate) Dose 3 (Infant Series)
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    10 / 80 (12.50%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    10
    0
    0
    Erythema (Mild) Dose 1 (Infant Series)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    36 / 86 (41.86%)
    61 / 110 (55.45%)
    55 / 147 (37.41%)
         occurrences all number
    36
    61
    55
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    12 / 90 (13.33%)
    13 / 112 (11.61%)
    5 / 152 (3.29%)
         occurrences all number
    12
    13
    5
    Nasopharyngitis
         subjects affected / exposed
    11 / 90 (12.22%)
    12 / 112 (10.71%)
    5 / 152 (3.29%)
         occurrences all number
    11
    14
    5
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 90 (8.89%)
    16 / 112 (14.29%)
    4 / 152 (2.63%)
         occurrences all number
    8
    19
    5
    Bronchitis
         subjects affected / exposed
    6 / 90 (6.67%)
    9 / 112 (8.04%)
    1 / 152 (0.66%)
         occurrences all number
    6
    9
    1
    Respiratory tract infection
         subjects affected / exposed
    6 / 90 (6.67%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    6
    0
    1
    Rhinitis
         subjects affected / exposed
    6 / 90 (6.67%)
    9 / 112 (8.04%)
    4 / 152 (2.63%)
         occurrences all number
    6
    10
    4
    Exanthema subitum
         subjects affected / exposed
    4 / 90 (4.44%)
    2 / 112 (1.79%)
    0 / 152 (0.00%)
         occurrences all number
    4
    2
    0
    Viral infection
         subjects affected / exposed
    4 / 90 (4.44%)
    2 / 112 (1.79%)
    0 / 152 (0.00%)
         occurrences all number
    4
    2
    0
    Otitis media
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    2
    1
    0
    Acute tonsillitis
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    1
    Ear infection
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 90 (1.11%)
    4 / 112 (3.57%)
    2 / 152 (1.32%)
         occurrences all number
    1
    4
    2
    Laryngitis
         subjects affected / exposed
    0 / 90 (0.00%)
    4 / 112 (3.57%)
    1 / 152 (0.66%)
         occurrences all number
    0
    4
    1
    Pneumonia
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    1
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 112 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    1
    Varicella
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 112 (0.89%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    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.
    [15] - 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.
    [16] - 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.
    [17] - 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.
    [18] - 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.
    [19] - 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.
    [20] - 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.
    [21] - 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.
    [22] - 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.
    [23] - 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.
    [24] - 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.
    [25] - 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.
    [26] - 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.
    [27] - 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.
    [28] - 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.
    [29] - 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.
    [30] - 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.
    [31] - 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.
    [32] - 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.
    [33] - 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.
    [34] - 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.
    [35] - 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.
    [36] - 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.
    [37] - 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.
    [38] - 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.
    [39] - 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.
    [40] - 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.
    [41] - 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.
    [42] - 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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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