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    Clinical Trial Results:
    A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain.

    Summary
    EudraCT number
    2007-000304-32
    Trial protocol
    ES  
    Global end of trial date
    23 Mar 2009

    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
    6096A1-3007
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00474539
    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
    22 Jul 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Mar 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immune response induced by NeisVac-C given with 13vPnC is noninferior to the immune response induced by NeisVac-C given with 7vPnC when measured 1 month after the 2-dose NeisVac-C infant series. To demonstrate that the immune responses induced by Infanrix hexa given with 13vPnC are noninferior to the immune responses induced by Infanrix hexa given with 7vPnC when measured 1 month after the 3-dose infant series.
    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
    04 Jul 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 449
    Worldwide total number of subjects
    449
    EEA total number of subjects
    449
    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)
    449
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited in Spain from 4 July 2007 to 23 July 2007.

    Pre-assignment
    Screening details
    Subjects were enrolled into the study according to the inclusion or exclusion criteria without a screening period.

    Period 1
    Period 1 title
    Infant Series
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    13vPnC Infant Series
    Arm description
    Included subjects who received 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and Hemophilus influenzae type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
    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 one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at the 2-, 4- and 6-month visits.

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single dose of Neisseria meningitidis group C polysaccharide tetanus toxoid conjugated vaccine (NeisVac-C) at the 2- and 4-month visits.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single dose of combined diphtheria-­tetanus­-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2-, 4- and 6-month visits.

    Arm title
    7vPnC Infant Series
    Arm description
    Included subjects who received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). One subject was randomized to 7vPnC, but received 13vPnC.
    Arm type
    Active comparator

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at the 2-, 4- and 6-month visits.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single dose of Infanrix hexa at the 2-, 4- and 6-month visits.

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single dose of NeisVac-C at the 2- and 4-month visits.

    Number of subjects in period 1
    13vPnC Infant Series 7vPnC Infant Series
    Started
    223
    226
    Vaccinated Dose 1
    218
    226
    Vaccinated Dose 3
    214
    221
    Vaccinated Dose 2
    217
    222
    Completed
    213
    220
    Not completed
    10
    6
         'Protocol violation '
    -
    1
         'Randomization error '
    5
    -
         Consent withdrawn by subject
    3
    4
         Lost to follow-up
    2
    1
    Period 2
    Period 2 title
    After Infant Series
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    13vPnC After Infant Series
    Arm description
    Included subjects who received 13vPnC coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits and 13vPnC coadministered with Infanrix hexa at the 6-month visit in infant series.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    7vPnC After Infant Series
    Arm description
    Included subjects who received 7vPnC coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits and 7vPnC coadministered with Infanrix hexa at the 6-month visit in infant series.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    13vPnC After Infant Series 7vPnC After Infant Series
    Started
    213
    220
    Completed
    209
    220
    Not completed
    4
    0
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    3
    -
    Period 3
    Period 3 title
    Toddler Dose
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    13vPnC Toddler Dose
    Arm description
    Subjects received 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and Hib vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
    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 one single 0.5 mL dose of 13vPnC at the 15-month visit (toddler dose).

    Investigational medicinal product name
    Infanrix IPV + Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose of combined DTPa, inactivated poliovirus, and Hib vaccine (Infanrix IPV + Hib) at the 15 month- visit (toddler dose).

    Investigational medicinal product name
    MMR
    Investigational medicinal product code
    Other name
    Priorix
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subject received a single dose of Measles, mumps, and rubella vaccine (MMR) without study vaccine at the 12-month visit.

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose of NeisVac-C at the 15-month visit (toddler dose).

    Arm title
    7vPnC Toddler Dose
    Arm description
    Subjects received 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus and Hib vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
    Arm type
    Active comparator

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of 7vPnC at the 15-month visit (toddler dose).

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose of NeisVac-C at the 15-month visit (toddler dose).

    Investigational medicinal product name
    Infanrix IPV + Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose of Infanrix IPV + Hib at the 15 month- visit (toddler dose).

    Investigational medicinal product name
    MMR
    Investigational medicinal product code
    Other name
    Priorix
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subject received a single dose of MMR without study vaccine at the 12-month visit.

    Number of subjects in period 3
    13vPnC Toddler Dose 7vPnC Toddler Dose
    Started
    209
    220
    Completed
    208
    220
    Not completed
    1
    0
         'Protocol violation '
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    Included subjects who received 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and Hemophilus influenzae type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    Included subjects who received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). One subject was randomized to 7vPnC, but received 13vPnC.

    Reporting group values
    13vPnC Infant Series 7vPnC Infant Series Total
    Number of subjects
    223 226 449
    Age categorical
    Units: Subjects
    Age continuous
    Total 449 subjects were randomly assigned to the study, 4 subjects were counted twice and 1 subject was found ineligible for the study and was withdrawn before treatment. Only 444 subjects were evaluable for baseline characteristics measure (age continuous).
    Units: months
        arithmetic mean (standard deviation)
    2.1 ± 0.4 2 ± 0.4 -
    Gender categorical
    Units: Subjects
        Female
    104 116 220
        Male
    115 109 224
        Other
    4 1 5

    End points

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    End points reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    Included subjects who received 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and Hemophilus influenzae type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    Included subjects who received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). One subject was randomized to 7vPnC, but received 13vPnC.
    Reporting group title
    13vPnC After Infant Series
    Reporting group description
    Included subjects who received 13vPnC coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits and 13vPnC coadministered with Infanrix hexa at the 6-month visit in infant series.

    Reporting group title
    7vPnC After Infant Series
    Reporting group description
    Included subjects who received 7vPnC coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits and 7vPnC coadministered with Infanrix hexa at the 6-month visit in infant series.
    Reporting group title
    13vPnC Toddler Dose
    Reporting group description
    Subjects received 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and Hib vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.

    Reporting group title
    7vPnC Toddler Dose
    Reporting group description
    Subjects received 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus and Hib vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.

    Subject analysis set title
    13vPnC After Infant Series Dose 2
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).

    Subject analysis set title
    7vPnC After Infant Series Dose 2
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).

    Subject analysis set title
    13vPnC After Infant Series Dose 3
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).

    Subject analysis set title
    7vPnC After Infant Series Dose 3
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).

    Subject analysis set title
    7vPnC Dose 1
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.

    Subject analysis set title
    13vPnC Dose 1
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.

    Subject analysis set title
    13vPnC Dose 2
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.

    Subject analysis set title
    7vPnC Dose 2
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.

    Subject analysis set title
    13vPnC Dose 3
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.

    Subject analysis set title
    7vPnC Dose 3
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.

    Subject analysis set title
    13vPnC Toddler Dose
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.

    Subject analysis set title
    7vPnC Toddler Dose
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.

    Subject analysis set title
    13vPnC After Toddler Dose
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).

    Subject analysis set title
    7vPnC After Toddler Dose
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).

    Primary: Percentage of Subjects Achieving a Serum Bactericidal Assay (SBA) Titer Greater than or Equal to (>=) 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series

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    End point title
    Percentage of Subjects Achieving a Serum Bactericidal Assay (SBA) Titer Greater than or Equal to (>=) 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
    End point description
    Percentage of subjects achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented. Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Primary
    End point timeframe
    One month after infant series dose (at 5 months of age)
    End point values
    13vPnC After Infant Series Dose 2 7vPnC After Infant Series Dose 2
    Number of subjects analysed
    206
    218
    Units: percentage of subjects
        number (confidence interval 95%)
    98.5 (95.8 to 99.7)
    99.1 (96.7 to 99.9)
    Statistical analysis title
    SBA titer >=1:8 after Infant Series Dose 2
    Statistical analysis description
    For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at >=1:8 titer was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 7vPnC After Infant Series Dose 2
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Difference
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.3
         upper limit
    2
    Notes
    [1] - Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (>) -10%.

    Primary: Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose

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    End point title
    Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
    End point description
    The evaluable 2-dose 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
    One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
    End point values
    13vPnC After Infant Series Dose 2 7vPnC After Infant Series Dose 2 13vPnC After Toddler Dose 7vPnC After Toddler Dose
    Number of subjects analysed
    206
    218
    164 [2]
    172
    Units: titer
        geometric mean (confidence interval 95%)
    654.55 (557.75 to 768.16)
    757.04 (648.45 to 883.81)
    2573.06 (2176.29 to 3042.16)
    2098.12 (1779.65 to 2473.58)
    Notes
    [2] - Subjects with determinate immunoglobulin G (IgG) antibody concentration to given vaccine component.
    Statistical analysis title
    GMT ratio after Infant Series Dose 2
    Statistical analysis description
    For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated after the infant series dose 2.
    Comparison groups
    7vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 2
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    Parameter type
    Ratio
    Point estimate
    0.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.69
         upper limit
    1.08
    Notes
    [3] - Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
    Statistical analysis title
    GMT ratio after Toddler Dose
    Statistical analysis description
    For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated after the toddler dose.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    336
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    Method
    Parameter type
    Ratio
    Point estimate
    1.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.97
         upper limit
    1.55
    Notes
    [4] - Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

    Primary: Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose

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    End point title
    Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
    End point description
    Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL). The evaluable 3-dose 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
    One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
    End point values
    13vPnC After Infant Series Dose 3 7vPnC After Infant Series Dose 3 13vPnC After Toddler Dose 7vPnC After Toddler Dose
    Number of subjects analysed
    197
    212
    164
    172
    Units: percentage of subjects
    number (confidence interval 95%)
        Diphtheria ≥0.10 IU/mL
    98.5 (95.6 to 99.7)
    99.1 (96.6 to 99.9)
    100 (97.8 to 100)
    100 (97.9 to 100)
        Diphtheria ≥0.01 IU/mL
    100 (98.1 to 100)
    100 (98.3 to 100)
    100 (97.8 to 100)
    100 (97.9 to 100)
        Tetanus ≥0.10 IU/mL
    96.6 (92.6 to 98.7)
    96.7 (93 to 98.8)
    100 (97.8 to 100)
    100 (97.9 to 100)
        Tetanus ≥0.01 IU/mL
    100 (97.9 to 100)
    100 (98 to 100)
    100 (97.8 to 100)
    100 (97.9 to 100)
    Statistical analysis title
    Diphtheria >=0.10 IU/mL:After Infant Series Dose 3
    Statistical analysis description
    For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [5]
    Method
    Parameter type
    Difference
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.5
         upper limit
    2
    Notes
    [5] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    Diphtheria >=0.01 IU/mL:After Infant Series Dose 3
    Statistical analysis description
    For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.010 IU/mL threshold was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [6]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.9
         upper limit
    1.7
    Notes
    [6] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    Tetanus >=0.10 IU/mL: After Infant Series Dose 3
    Statistical analysis description
    For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [7]
    Method
    Parameter type
    Difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.4
         upper limit
    4
    Notes
    [7] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    Tetanus >=0.01 IU/mL: After Infant Series Dose 3
    Statistical analysis description
    For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.010 IU/mL threshold was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [8]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.1
         upper limit
    2
    Notes
    [8] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    Diphtheria >=0.10 IU/mL: After Toddler Dose
    Statistical analysis description
    For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    336
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [9]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    2.2
    Notes
    [9] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    Diphtheria >=0.01 IU/mL: After Toddler Dose
    Statistical analysis description
    For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.010 IU/mL threshold was calculated.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    336
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [10]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    2.2
    Notes
    [10] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    Tetanus >=0.10 IU/mL: After Toddler Dose
    Statistical analysis description
    For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    336
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [11]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    2.2
    Notes
    [11] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    Tetanus >=0.01 IU/mL: After Toddler Dose
    Statistical analysis description
    For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated.
    Comparison groups
    7vPnC After Toddler Dose v 13vPnC After Toddler Dose
    Number of subjects included in analysis
    336
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [12]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    2.2
    Notes
    [12] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

    Primary: Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose

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    End point title
    Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
    End point description
    The evaluable 3-dose 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
    One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
    End point values
    13vPnC After Infant Series Dose 3 7vPnC After Infant Series Dose 3 13vPnC After Toddler Dose 7vPnC After Toddler Dose
    Number of subjects analysed
    197
    212
    164
    172
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Diphtheria
    0.79 (0.69 to 0.9)
    0.92 (0.81 to 1.04)
    3 (2.63 to 3.41)
    3.23 (2.88 to 3.63)
        Tetanus
    1.1 (0.94 to 1.27)
    1.2 (1.04 to 1.39)
    3.29 (2.83 to 3.83)
    3.28 (2.83 to 3.79)
    Statistical analysis title
    Diphtheria: After Infant Series Dose 3
    Statistical analysis description
    For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated after the infant series dose 3.
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [13]
    Method
    Parameter type
    Ratio
    Point estimate
    0.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    1.03
    Notes
    [13] - Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was > 0.5 (2-fold criterion).
    Statistical analysis title
    Tetanus: After Infant Series Dose 3
    Statistical analysis description
    For tetanus the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [14]
    Method
    Parameter type
    Ratio
    Point estimate
    0.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.74
         upper limit
    1.12
    Notes
    [14] - Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was > 0.5 (2-fold criterion).
    Statistical analysis title
    Diphtheria: After Toddler Dose
    Statistical analysis description
    For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    336
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [15]
    Method
    Parameter type
    Ratio
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.78
         upper limit
    1.1
    Notes
    [15] - Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
    Statistical analysis title
    Tetanus: After Toddler Dose
    Statistical analysis description
    For tetanus the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    336
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [16]
    Method
    Parameter type
    Ratio
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    1.24
    Notes
    [16] - Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

    Primary: Percentage of Subjects Achieving Antibody Level >= 0.35 microgram (μg)/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose

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    End point title
    Percentage of Subjects Achieving Antibody Level >= 0.35 microgram (μg)/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose [17]
    End point description
    Percentages of subjects achieving World Health Organization (WHO) predefined antibody threshold >= 0.35 μg/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. 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
    One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
    Notes
    [17] - 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 After Infant Series Dose 2 13vPnC After Infant Series Dose 3 13vPnC After Toddler Dose
    Number of subjects analysed
    206
    197
    164
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotypes - Serotype 4
    27.9 (87.9 to 95.7)
    98.5 (95.7 to 99.7)
    100 (97.7 to 100)
        Common Serotypes - Serotype 6B
    92.5 (21.8 to 34.7)
    94.9 (90.9 to 97.5)
    100 (97.7 to 100)
        Common Serotypes - Serotype 9V
    89.9 (84.8 to 93.7)
    97 (93.5 to 98.9)
    99.3 (96.3 to 100)
        Common Serotypes - Serotype 14
    91 (86.1 to 94.6)
    97 (93.6 to 98.9)
    99.4 (96.6 to 100)
        Common Serotypes - Serotype 18C
    88.9 (83.7 to 92.9)
    99 (96.4 to 99.9)
    98.8 (95.6 to 99.8)
        Common Serotypes - Serotype 19F
    100 (98.2 to 100)
    99 (96.4 to 99.9)
    98.7 (95.5 to 99.8)
        Common Serotypes - Serotype 23F
    55.8 (48.6 to 62.8)
    93 (88.5 to 96.1)
    98.1 (94.7 to 99.6)
        Additional Serotypes - Serotype 1
    96 (92.2 to 98.2)
    98.5 (95.7 to 99.7)
    98.8 (95.6 to 99.8)
        Additional Serotypes - Serotype 3
    73.8 (67.1 to 79.9)
    86.2 (80.5 to 90.7)
    93.6 (88.6 to 96.9)
        Additional Serotypes - Serotype 5
    86.4 (80.8 to 90.8)
    96 (92.2 to 98.2)
    100 (97.6 to 100)
        Additional Serotypes - Serotype 6A
    80.8 (74.6 to 86)
    99 (96.4 to 99.9)
    99.4 (96.5 to 100)
        Additional Serotypes - Serotype 7F
    94.5 (90.3 to 97.2)
    100 (98.2 to 100)
    99.4 (96.5 to 100)
        Additional Serotypes - Serotype 19A
    92.9 (88.4 to 96.1)
    99.5 (97.2 to 100)
    100 (97.5 to 100)
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose

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    End point title
    Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose [18]
    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. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed. 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
    One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
    Notes
    [18] - 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 After Infant Series Dose 2 13vPnC After Infant Series Dose 3 13vPnC After Toddler Dose
    Number of subjects analysed
    206
    197
    164
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Common Serotypes - Serotype 4
    1.55 (1.35 to 1.78)
    2.32 (2.08 to 2.6)
    3.88 (3.42 to 4.4)
        Common Serotypes - Serotype 6B
    0.21 (0.18 to 0.25)
    2.59 (2.2 to 3.05)
    12.25 (10.78 to 13.92)
        Common Serotypes - Serotype 9V
    1.15 (1.01 to 1.32)
    1.51 (1.35 to 1.68)
    2.67 (2.34 to 3.05)
        Common Serotypes - Serotype 14
    1.94 (1.64 to 2.29)
    4.51 (3.89 to 5.22)
    9.82 (8.54 to 11.3)
        Common Serotypes - Serotype 18C
    1.3 (1.11 to 1.51)
    1.86 (1.68 to 2.07)
    2.29 (2.01 to 2.61)
        Common Serotypes - Serotype 19F
    2.98 (2.6 to 3.41)
    2.46 (2.21 to 2.74)
    6.11 (5.21 to 7.16)
        Common Serotypes - Serotype 23F
    0.4 (0.34 to 0.48)
    1.67 (1.44 to 1.94)
    3.96 (3.43 to 4.59)
        Additional Serotypes - Serotype 1
    1.87 (1.61 to 2.16)
    2.95 (2.61 to 3.33)
    4.6 (3.94 to 5.37)
        Additional Serotypes - Serotype 3
    0.54 (0.48 to 0.61)
    0.85 (0.76 to 0.95)
    1.04 (0.91 to 1.19)
        Additional Serotypes - Serotype 5
    0.88 (0.77 to 1)
    1.83 (1.62 to 2.06)
    3.69 (3.26 to 4.18)
        Additional Serotypes - Serotype 6A
    0.81 (0.7 to 0.95)
    3.08 (2.76 to 3.44)
    7.71 (6.75 to 8.8)
        Additional Serotypes - Serotype 7F
    1.51 (1.33 to 1.71)
    3.41 (3.11 to 3.74)
    5.66 (4.9 to 6.53)
        Additional Serotypes - Serotype 19A
    1.52 (1.31 to 1.76)
    2.5 (2.27 to 2.75)
    10.21 (8.92 to 11.68)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving a Serum Bactericidal Assay (SBA) Titer >= 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

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    End point title
    Percentage of Subjects Achieving a Serum Bactericidal Assay (SBA) Titer >= 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
    End point description
    Percentage of subjects achieving a meningococcal C SBA serum antibody titer >= 1:8 along with the corresponding 95% CI were presented. Evaluable immunogenicity (per protocol) 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
    Secondary
    End point timeframe
    One month after toddler dose (at 16 months of age)
    End point values
    13vPnC After Toddler Dose 7vPnC After Toddler Dose
    Number of subjects analysed
    164 [19]
    172
    Units: percentage of subjects
        number (confidence interval 95%)
    100 (97.8 to 100)
    99.4 (96.8 to 100)
    Notes
    [19] - Subjects with a determinate IgG antibody concentration to the given concomitant vaccine component.
    Statistical analysis title
    SBA titer >=1:8 after todler dose
    Statistical analysis description
    For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at >= 1:8 titer was calculated.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    336
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [20]
    Method
    Parameter type
    Difference
    Point estimate
    0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    3.2
    Notes
    [20] - Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

    Other pre-specified: 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 (Sig)(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 (Mod) (2.5 to 7.0 cm); Severe (Sev) (>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, (n) = number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Other pre-specified
    End point timeframe
    During the 4-day period after each dose
    End point values
    13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Dose 3 7vPnC Dose 3 13vPnC Toddler Dose 7vPnC Toddler Dose
    Number of subjects analysed
    218
    226
    217
    222
    214
    221
    209
    220
    Units: percentage of subjects
    number (not applicable)
        Tenderness-Any (n=199,205,182,180,170,175,164,172)
    21.1
    18.5
    21.4
    16.1
    10.6
    14.3
    28.7
    26.7
        Tenderness-Sig (n=199,200,177,177,167,169,154,160)
    3
    4
    1.1
    4
    1.2
    1.2
    2.6
    3.8
        Swelling-Any (n=196,200,182,177,171,170,169,168)
    13.3
    14.5
    22
    14.7
    23.4
    20
    26.6
    18.5
        Swelling-Mild (n=196,200,182,177,171,170,166,168)
    12.2
    13
    20.3
    13
    20.5
    17.1
    22.9
    16
        Swelling-Mod (n=196,196,177,175,166,168,156,163)
    2.6
    2
    2.3
    2.3
    6.6
    6
    9
    5.5
        Swelling-Sev (n=196,196,177,175,166,168,152,156)
    0
    0
    0
    0
    0
    0
    0
    0
        Redness-Any (n=197,199,181,180,172,172,170,169)
    15.2
    15.1
    23.8
    20
    26.7
    22.7
    30
    23.1
        Redness-Mild (n=197,198,180,180,172,171,167,165)
    14.7
    14.1
    22.2
    19.4
    24.4
    21.1
    28.1
    21.2
        Redness-Mod (n=196,197,178,175,166,169,157,163)
    0.5
    1
    2.2
    1.1
    3.6
    3.6
    9.6
    6.7
        Redness-Sev (n=196,196,177,175,166,168,152,156)
    0
    0
    0
    0
    0.6
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: 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 [Fv] >= 37.5 degrees Celsius [C], fever >= 38 C but less than or equal to (=<) 39 C, fever >39 C but =< 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), 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, (n) = number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Other pre-specified
    End point timeframe
    During the 4-day period after each dose
    End point values
    13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Dose 3 7vPnC Dose 3 13vPnC Toddler Dose 7vPnC Toddler Dose
    Number of subjects analysed
    218
    226
    217
    222
    214
    221
    209
    220
    Units: percentage of subjects
    number (not applicable)
        Fv>=38,=<39°C(n=201,204,181,189,172,176,156,169)
    22.9
    19.6
    32.6
    41.8
    20.9
    29
    31.4
    34.3
        Fv >39, =<40°C(n=196,196,177,176,166,168,154,156)
    1
    0.5
    1.7
    1.1
    3.6
    3
    4.5
    2.6
        Fv >40°C (n=196,197,177,175,166,168,152,156)
    0
    0.5
    0
    0
    0
    0
    0.7
    0
        Decr appetite (n=204,207,189,191,178,178,163,178)
    31.4
    35.7
    46.6
    44
    37.1
    36
    31.9
    41
        Irritability (n=202,211,192,190,179,188,171,179)
    46.5
    49.8
    57.3
    60
    43
    39.4
    41.5
    53.6
        Incr sleep (n=204,206,189,187,175,174,162,165)
    38.7
    39.3
    39.2
    36.4
    21.1
    27
    16.7
    24.8
        Decr sleep (n=196,204,183,187,175,178,162,166)
    19.4
    27.5
    27.3
    27.8
    22.9
    25.3
    19.8
    18.7
        Meds-treat sx (n=205,209,193,197,175,189,165,177)
    41
    44.5
    54.4
    57.9
    39.4
    42.9
    50.3
    46.9
        Meds-prevent sx(n=201,210,194,196,177,185,168,177)
    41.3
    45.7
    47.9
    49.5
    44.6
    40.5
    43.5
    41.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were reported from baseline up to 1 month after infant series dose 3 and from toddler dose up to 1 month after toddler dose. SAE and newly diagnosed chronic medical conditions were reported from baseline up to 6 months after toddler dose
    Adverse event reporting additional description
    Version was not captured, here 0.0 is mentioned for dictionary version. Local reactions and Systemic events were to be assessed only for infant series and toddler dose reporting groups.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    7vPnC Infant Series
    Reporting group description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at vaccination 1, 2. Adverse events were reported from vaccination 1 to approximately 1 month after vaccination 3.

    Reporting group title
    13vPnC Infant Series
    Reporting group description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at vaccination 1, 2. Adverse events were reported from vaccination 1 to approximately 1 month after vaccination 3.

    Reporting group title
    13vPnC Toddler Series
    Reporting group description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at vaccination 4. Adverse events were reported for approximately 1 month after toddler dose.

    Reporting group title
    13vPnC Post-Infant Series
    Reporting group description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at vaccination 3. Adverse events were reported from approximately 1 month after vaccination 3 to toddler dose.

    Reporting group title
    7vPnC Toddler Series
    Reporting group description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at vaccination 4. Adverse events were reported for approximately 1 month after toddler dose.

    Reporting group title
    7vPnC Post-Infant Series
    Reporting group description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at vaccination 3. Adverse events were reported from approximately 1 month after vaccination 3 to toddler dose.

    Reporting group title
    13vPnC 6-Month Follow-up
    Reporting group description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at vaccination 1, 2 (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at vaccination 3 (infant series dose 3). Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at vaccination 4 (toddler dose). MMR was administered 6 months after vaccination 4, without study vaccine. Adverse events were reported for approximately 6 months after vaccination 4.

    Reporting group title
    7vPnC 6-Month Follow-up
    Reporting group description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at vaccination 1, 2 (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at vaccination 3 (infant series dose 3). Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at vaccination 4 (toddler dose). MMR was administered 6 months after vaccination 3, without study vaccine. Adverse events were reported for approximately 6 months after vaccination 4.

    Serious adverse events
    7vPnC Infant Series 13vPnC Infant Series 13vPnC Toddler Series 13vPnC Post-Infant Series 7vPnC Toddler Series 7vPnC Post-Infant Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 225 (3.56%)
    6 / 218 (2.75%)
    1 / 209 (0.48%)
    9 / 218 (4.13%)
    0 / 218 (0.00%)
    6 / 225 (2.67%)
    4 / 218 (1.83%)
    9 / 224 (4.02%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Increased bronchial secretion
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 209 (0.48%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 218 (0.46%)
    1 / 209 (0.48%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Aphthous stomatitis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coeliac disease
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolic acidosis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    2 / 225 (0.89%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    2 / 218 (0.92%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis viral
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    2 / 224 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    2 / 218 (0.92%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    7vPnC Infant Series 13vPnC Infant Series 13vPnC Toddler Series 13vPnC Post-Infant Series 7vPnC Toddler Series 7vPnC Post-Infant Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    217 / 225 (96.44%)
    211 / 218 (96.79%)
    182 / 209 (87.08%)
    6 / 218 (2.75%)
    193 / 218 (88.53%)
    13 / 225 (5.78%)
    4 / 218 (1.83%)
    2 / 224 (0.89%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    1 / 224 (0.45%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    1
    Milk allergy
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    9 / 225 (4.00%)
    6 / 218 (2.75%)
    5 / 209 (2.39%)
    0 / 218 (0.00%)
    2 / 218 (0.92%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    9
    7
    5
    0
    2
    0
    0
    0
    Irritability
         subjects affected / exposed
    0 / 225 (0.00%)
    2 / 218 (0.92%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Developmental delay
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Fever ≥38°C but ≤39°C Dose 1
    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 Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    40 / 204 (19.61%)
    46 / 201 (22.89%)
    49 / 156 (31.41%)
    0 / 218 (0.00%)
    58 / 169 (34.32%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    40
    46
    49
    0
    58
    0
    0
    0
    Fever >39°C but ≤40°C Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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]
    1 / 196 (0.51%)
    2 / 196 (1.02%)
    7 / 154 (4.55%)
    0 / 218 (0.00%)
    4 / 156 (2.56%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    2
    7
    0
    4
    0
    0
    0
    Fever >40°C Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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]
    1 / 197 (0.51%)
    0 / 196 (0.00%)
    1 / 152 (0.66%)
    0 / 218 (0.00%)
    0 / 156 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Decreased appetite Dose 1
    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 Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    74 / 207 (35.75%)
    64 / 204 (31.37%)
    52 / 163 (31.90%)
    0 / 218 (0.00%)
    73 / 178 (41.01%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    74
    64
    52
    0
    73
    0
    0
    0
    Increased sleep Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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]
    81 / 206 (39.32%)
    79 / 204 (38.73%)
    27 / 162 (16.67%)
    0 / 218 (0.00%)
    41 / 165 (24.85%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    81
    79
    27
    0
    41
    0
    0
    0
    Irritability Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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]
    105 / 211 (49.76%)
    94 / 202 (46.53%)
    71 / 171 (41.52%)
    0 / 218 (0.00%)
    96 / 179 (53.63%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    105
    94
    71
    0
    96
    0
    0
    0
    Decreased sleep Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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 [7]
    56 / 204 (27.45%)
    38 / 196 (19.39%)
    32 / 162 (19.75%)
    0 / 218 (0.00%)
    31 / 166 (18.67%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    56
    38
    32
    0
    31
    0
    0
    0
    Fever ≥38°C but ≤39°C Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [8]
    79 / 189 (41.80%)
    59 / 181 (32.60%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    79
    59
    0
    0
    0
    0
    0
    0
    Fever >39°C but ≤40°C Dose 2
    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 Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    2 / 176 (1.14%)
    3 / 177 (1.69%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    0
    0
    Decreased appetite Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [10]
    84 / 191 (43.98%)
    88 / 189 (46.56%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    84
    88
    0
    0
    0
    0
    0
    0
    Irritability Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [11]
    114 / 190 (60.00%)
    110 / 192 (57.29%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    114
    110
    0
    0
    0
    0
    0
    0
    Increased sleep Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [12]
    68 / 187 (36.36%)
    74 / 189 (39.15%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    68
    74
    0
    0
    0
    0
    0
    0
    Decreased sleep Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [13]
    52 / 187 (27.81%)
    50 / 183 (27.32%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    52
    50
    0
    0
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [14]
    51 / 176 (28.98%)
    36 / 172 (20.93%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    51
    36
    0
    0
    0
    0
    0
    0
    Fever >39°C but ≤40°C Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [15]
    5 / 168 (2.98%)
    6 / 166 (3.61%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    5
    6
    0
    0
    0
    0
    0
    0
    Decreased appetite Dose 3
    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 Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    64 / 178 (35.96%)
    66 / 178 (37.08%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    64
    66
    0
    0
    0
    0
    0
    0
    Increased sleep Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [17]
    47 / 174 (27.01%)
    37 / 175 (21.14%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    47
    37
    0
    0
    0
    0
    0
    0
    Decreased sleep Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [18]
    45 / 178 (25.28%)
    40 / 175 (22.86%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    45
    40
    0
    0
    0
    0
    0
    0
    Irritability Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [19]
    74 / 188 (39.36%)
    77 / 179 (43.02%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    74
    77
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    0
    Burns third degree
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    2 / 209 (0.96%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Thalassaemia beta
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Phimosis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 224 (0.45%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    0
    1
    Infantile asthma
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Cough
         subjects affected / exposed
    2 / 225 (0.89%)
    4 / 218 (1.83%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    2
    4
    1
    0
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    5 / 225 (2.22%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    7
    1
    0
    0
    0
    0
    0
    0
    Wheezing
         subjects affected / exposed
    3 / 225 (1.33%)
    3 / 218 (1.38%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    3
    3
    0
    1
    0
    0
    0
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Asphyxia
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Bronchospasm
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    11 / 225 (4.89%)
    3 / 218 (1.38%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    15
    4
    0
    0
    1
    0
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 225 (4.00%)
    8 / 218 (3.67%)
    2 / 209 (0.96%)
    0 / 218 (0.00%)
    3 / 218 (1.38%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    11
    9
    2
    0
    3
    1
    0
    0
    Vomiting
         subjects affected / exposed
    4 / 225 (1.78%)
    3 / 218 (1.38%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    4
    4
    0
    0
    0
    0
    0
    0
    Gastrointestinal inflammation
         subjects affected / exposed
    2 / 225 (0.89%)
    3 / 218 (1.38%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Enteritis
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Abnormal faeces
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Infantile colic
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Aphthous stomatitis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    3 / 225 (1.33%)
    3 / 218 (1.38%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    2 / 225 (0.89%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    5
    3
    0
    1
    0
    2
    0
    0
    Rash
         subjects affected / exposed
    6 / 225 (2.67%)
    0 / 218 (0.00%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    6
    0
    1
    0
    0
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 225 (0.00%)
    3 / 218 (1.38%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    3
    0
    0
    1
    0
    0
    0
    Urticaria
         subjects affected / exposed [20]
    2 / 225 (0.89%)
    1 / 218 (0.46%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 209 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    3
    1
    1
    0
    1
    0
    0
    0
    Angioedema
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Petechiae
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Tenderness (Any) Dose 1
    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.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 [21]
    38 / 205 (18.54%)
    42 / 199 (21.11%)
    47 / 164 (28.66%)
    0 / 218 (0.00%)
    46 / 172 (26.74%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    38
    42
    47
    0
    46
    0
    0
    0
    Tenderness (Significant) Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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 [22]
    8 / 200 (4.00%)
    6 / 199 (3.02%)
    4 / 154 (2.60%)
    0 / 218 (0.00%)
    6 / 160 (3.75%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    8
    6
    4
    0
    6
    0
    0
    0
    Induration (Any) Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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 [23]
    29 / 200 (14.50%)
    26 / 196 (13.27%)
    45 / 169 (26.63%)
    0 / 218 (0.00%)
    31 / 168 (18.45%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    29
    26
    45
    0
    31
    0
    0
    0
    Induration (Mild) Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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 [24]
    26 / 200 (13.00%)
    24 / 196 (12.24%)
    38 / 166 (22.89%)
    0 / 218 (0.00%)
    26 / 163 (15.95%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    26
    24
    38
    0
    26
    0
    0
    0
    Induration (Moderate) Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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 [25]
    4 / 196 (2.04%)
    5 / 196 (2.55%)
    14 / 156 (8.97%)
    0 / 218 (0.00%)
    9 / 163 (5.52%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    4
    5
    14
    0
    9
    0
    0
    0
    Erythema (Any) Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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 [26]
    30 / 199 (15.08%)
    30 / 197 (15.23%)
    51 / 170 (30.00%)
    0 / 218 (0.00%)
    39 / 169 (23.08%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    30
    30
    51
    0
    0
    0
    0
    0
    Erythema (Mild) Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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 [27]
    28 / 198 (14.14%)
    29 / 197 (14.72%)
    47 / 167 (28.14%)
    0 / 218 (0.00%)
    35 / 165 (21.21%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    28
    29
    47
    0
    35
    0
    0
    0
    Erythema (Moderate) Dose 1
    Additional description: Dose 1: Subjects affected and occurrences for SE 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 [28]
    2 / 197 (1.02%)
    1 / 196 (0.51%)
    15 / 157 (9.55%)
    0 / 218 (0.00%)
    11 / 163 (6.75%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    2
    1
    15
    0
    11
    0
    0
    0
    Tenderness (Any) Dose 2
    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 Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    29 / 180 (16.11%)
    39 / 182 (21.43%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    29
    39
    0
    0
    0
    0
    0
    0
    Tenderness (Significant) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [30]
    7 / 177 (3.95%)
    2 / 177 (1.13%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    7
    2
    0
    0
    0
    0
    0
    0
    Induration (Any) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [31]
    26 / 177 (14.69%)
    40 / 182 (21.98%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    26
    40
    0
    0
    0
    0
    0
    0
    Induration (Mild) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [32]
    23 / 177 (12.99%)
    37 / 182 (20.33%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    23
    37
    0
    0
    0
    0
    0
    0
    Induration (Moderate) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [33]
    4 / 175 (2.29%)
    4 / 177 (2.26%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    4
    4
    0
    0
    0
    0
    0
    0
    Erythema (Any) Dose 2
    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 Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    36 / 180 (20.00%)
    43 / 181 (23.76%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    36
    43
    0
    0
    0
    0
    0
    0
    Erythema (Mild) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [35]
    35 / 180 (19.44%)
    40 / 180 (22.22%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    35
    40
    0
    0
    0
    0
    0
    0
    Erythema (Moderate) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE 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 [36]
    2 / 175 (1.14%)
    4 / 178 (2.25%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    0
    0
    Tenderness (Any) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [37]
    25 / 175 (14.29%)
    18 / 170 (10.59%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    25
    18
    0
    0
    0
    0
    0
    0
    Tenderness (Significant) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [38]
    2 / 169 (1.18%)
    2 / 167 (1.20%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    Induration (Any) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [39]
    34 / 170 (20.00%)
    40 / 171 (23.39%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    34
    40
    0
    0
    0
    0
    0
    0
    Induration (Mild) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [40]
    29 / 170 (17.06%)
    35 / 171 (20.47%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    29
    35
    0
    0
    0
    0
    0
    0
    Induration (Moderate) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [41]
    10 / 168 (5.95%)
    11 / 166 (6.63%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    10
    11
    0
    0
    0
    0
    0
    0
    Erythema (Any) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [42]
    39 / 172 (22.67%)
    46 / 172 (26.74%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    39
    46
    0
    0
    0
    0
    0
    0
    Erythema (Mild) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [43]
    36 / 171 (21.05%)
    42 / 172 (24.42%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    36
    42
    0
    0
    0
    0
    0
    0
    Erythema (Moderate) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [44]
    6 / 169 (3.55%)
    6 / 166 (3.61%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    6
    6
    0
    0
    0
    0
    0
    0
    Erythema (Severe) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE 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 [45]
    0 / 168 (0.00%)
    1 / 166 (0.60%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Cow's milk intolerance
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    0
    Anorexia
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    0
    Failure to thrive
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Herpangina
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    27 / 225 (12.00%)
    21 / 218 (9.63%)
    9 / 209 (4.31%)
    0 / 218 (0.00%)
    6 / 218 (2.75%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    31
    27
    10
    0
    6
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    24 / 225 (10.67%)
    23 / 218 (10.55%)
    5 / 209 (2.39%)
    1 / 218 (0.46%)
    4 / 218 (1.83%)
    2 / 225 (0.89%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    36
    34
    5
    1
    4
    2
    0
    0
    Gastroenteritis
         subjects affected / exposed
    15 / 225 (6.67%)
    19 / 218 (8.72%)
    7 / 209 (3.35%)
    0 / 218 (0.00%)
    3 / 218 (1.38%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    16
    19
    7
    0
    3
    0
    0
    0
    Bronchiolitis
         subjects affected / exposed
    17 / 225 (7.56%)
    12 / 218 (5.50%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    20
    15
    1
    0
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    14 / 225 (6.22%)
    9 / 218 (4.13%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    17
    11
    0
    0
    1
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    13 / 225 (5.78%)
    9 / 218 (4.13%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    15
    9
    1
    0
    1
    1
    0
    0
    Laryngitis
         subjects affected / exposed
    8 / 225 (3.56%)
    5 / 218 (2.29%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    8
    5
    1
    0
    1
    0
    0
    0
    Otitis media
         subjects affected / exposed
    8 / 225 (3.56%)
    3 / 218 (1.38%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    8
    6
    0
    0
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    7 / 225 (3.11%)
    4 / 218 (1.83%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    7
    5
    0
    0
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    5 / 225 (2.22%)
    5 / 218 (2.29%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    5 / 218 (2.29%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    5
    6
    0
    0
    5
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    2 / 225 (0.89%)
    4 / 218 (1.83%)
    5 / 209 (2.39%)
    0 / 218 (0.00%)
    3 / 218 (1.38%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    2
    4
    5
    0
    3
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    3 / 225 (1.33%)
    2 / 218 (0.92%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    4 / 218 (1.83%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    4
    2
    1
    0
    5
    0
    0
    0
    Viral infection
         subjects affected / exposed
    4 / 225 (1.78%)
    1 / 218 (0.46%)
    2 / 209 (0.96%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    4
    1
    2
    0
    0
    0
    0
    0
    Candidiasis
         subjects affected / exposed
    3 / 225 (1.33%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    0
    Otitis media acute
         subjects affected / exposed
    2 / 225 (0.89%)
    1 / 218 (0.46%)
    2 / 209 (0.96%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    0
    0
    0
    Varicella
         subjects affected / exposed
    2 / 225 (0.89%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 225 (0.00%)
    2 / 218 (0.92%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    2
    1
    0
    1
    0
    0
    0
    Acarodermatitis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Injection site abscess
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    1 / 218 (0.46%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Lice infestation
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    Roseola
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    1 / 218 (0.46%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    Viral rash
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    1 / 209 (0.48%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Bronchopneumonia
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Campylobacter intestinal infection
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Croup infectious
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Exanthema subitum
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Paronychia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Viral skin infection
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 218 (0.00%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 218 (0.46%)
    0 / 209 (0.00%)
    0 / 218 (0.00%)
    0 / 218 (0.00%)
    0 / 225 (0.00%)
    0 / 218 (0.00%)
    0 / 224 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    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. 
    [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. 
    [43] - 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. 
    [44] - 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. 
    [45] - 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? Yes
    Date
    Amendment
    01 May 2007
    Previous vaccination with meningococcal vaccine and contraindication to vaccination with meningococcal vaccine was added as exclusion criteria.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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