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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 Routine Pediatric Vaccinations in Spain.

    Summary
    EudraCT number
    		 2005-004772-21
    Trial protocol
    		 ES  
    Global end of trial date
    28 Jul 2008

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    6096A1-501
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00368966
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: B1851097
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000036-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    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
    23 Sep 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immune response induced by Meningitec given with 13-valent pneumococcal conjugate vaccine (13vPnC) is noninferior to the immune response induced by Meningitec given with 7-valent pneumococcal conjugate vaccine (7vPnC) when measured 1 month after the 2-dose Meningitec 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 sbjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Oct 2006
    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: 619
    Worldwide total number of subjects
    619
    EEA total number of subjects
    619
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    7
    Infants and toddlers (28 days-23 months)
    612
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited in Spain from October 2006 to December 2006.

    Pre-assignment
    Screening details
    		 Subjects were enrolled into the study according to inclusion/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
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC Infant Series
    Arm description
    		 Subjects received 13vPnC coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Subjects received 13vPnC coadministered with Infanrix hexa at 6 months. At Dose 2, one subject was randomized in 13vPnC but incorrectly given 7vPnC.
    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 13vPnC at 2, 4 and 6 months.

    Investigational medicinal product name
    Meningitec
    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 Meningitec at 2 and 4 months.

    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 0.5 mL dose of combination vaccine DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) at 2, 4 and 6 months.

    Arm title
    		 7vPnC Infant Series
    Arm description
    		 Subjects received 7vPnC coadministered with a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 7vPnC coadministered with Infanrix hexa at 6 months. At dose 1, one subject was randomized to 7vPnC but given 13vPnC vaccine; 1 was withdrawn before receiving 7vPnC vaccine. At Dose 3, one subject was randomized in 7vPnC but incorrectly given 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 7vPnC at 2, 4 and 6 months.

    Investigational medicinal product name
    Meningitec
    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 Meningitec at 2 and 4 months.

    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 0.5 mL dose of Infanrix hexa at 2, 4 and 6 months.

    Number of subjects in period 1
    		13vPnC Infant Series 7vPnC Infant Series
    Started
    315
    304
    Vaccinated Dose 1
    314
    302
    Vaccinated Dose 2
    307
    298
    Vaccinated Dose 3
    301
    296
    Completed
    299
    294
    Not completed
    16
    10
         Randomization error
    -
    1
         Consent withdrawn by subject
    11
    6
         Failed to return
    1
    -
         Adverse Event
    -
    1
         'Protocol Violation '
    2
    1
         Lost to follow-up
    2
    -
         'Failed to meet eligibility criteria '
    -
    1
    Period 2
    Period 2 title
    After Infant
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC After Infant Series
    Arm description
    		 Included subjects who received 13vPnC coadministered with a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 13vPnC coadministered with Infanrix hexa at 6 months.
    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 a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 7vPnC coadministered with Infanrix hexa at 6 months.
    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
    299
    294
    Completed
    293
    289
    Not completed
    6
    5
         Consent withdrawn by subject
    1
    1
         Failed to return
    3
    1
         Adverse Event
    1
    2
         Death
    1
    -
         Lost to follow-up
    -
    1
    Period 3
    Period 3 title
    Toddler Dose
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC Toddler Dose
    Arm description
    		 Subjects received combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Subjects received 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
    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 15 months.

    Investigational medicinal product name
    Meningitec
    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 Meningitec at 15 months

    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 one single 0.5 mL dose of Infanrix-IPV+Hib at 15 months.

    Investigational medicinal product name
    MMR II
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of MMR II at 12 months.

    Arm title
    		 7vPnC Toddler Dose
    Arm description
    		 Subjects received combination vaccine MMR II at 12 months . Subjects received one single 7vPnC coadministered with vaccine Infanrix-IPV+Hib and Meningitec vaccine at 15 months.
    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 15 months.

    Investigational medicinal product name
    Meningitec
    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 Meningitec at 15 months.

    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 one single 0.5 mL dose of Infanrix-IPV+Hib at 15 months.

    Investigational medicinal product name
    MMR II
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of MMR II at 12 months.

    Number of subjects in period 3
    		13vPnC Toddler Dose 7vPnC Toddler Dose
    Started
    293
    289
    Completed
    292
    286
    Not completed
    1
    3
         Consent withdrawn by subject
    1
    1
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 Subjects received 13vPnC coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Subjects received 13vPnC coadministered with Infanrix hexa at 6 months. At Dose 2, one subject was randomized in 13vPnC but incorrectly given 7vPnC.

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    		 Subjects received 7vPnC coadministered with a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 7vPnC coadministered with Infanrix hexa at 6 months. At dose 1, one subject was randomized to 7vPnC but given 13vPnC vaccine; 1 was withdrawn before receiving 7vPnC vaccine. At Dose 3, one subject was randomized in 7vPnC but incorrectly given 13vPnC.

    Reporting group values
    		 13vPnC Infant Series 7vPnC Infant Series Total
    Number of subjects
    		 315 304 619
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 2.1 ± 0.5 2.1 ± 0.5 -
    Gender categorical
    Units: Subjects
        Female
    		 148 152 300
        Male
    		 167 152 319

    End points

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    End points reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 Subjects received 13vPnC coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Subjects received 13vPnC coadministered with Infanrix hexa at 6 months. At Dose 2, one subject was randomized in 13vPnC but incorrectly given 7vPnC.

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    		 Subjects received 7vPnC coadministered with a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 7vPnC coadministered with Infanrix hexa at 6 months. At dose 1, one subject was randomized to 7vPnC but given 13vPnC vaccine; 1 was withdrawn before receiving 7vPnC vaccine. At Dose 3, one subject was randomized in 7vPnC but incorrectly given 13vPnC.
    Reporting group title
    13vPnC After Infant Series
    Reporting group description
    		 Included subjects who received 13vPnC coadministered with a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 13vPnC coadministered with Infanrix hexa at 6 months.

    Reporting group title
    7vPnC After Infant Series
    Reporting group description
    		 Included subjects who received 7vPnC coadministered with a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 7vPnC coadministered with Infanrix hexa at 6 months.
    Reporting group title
    13vPnC Toddler Dose
    Reporting group description
    		 Subjects received combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Subjects received 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.

    Reporting group title
    7vPnC Toddler Dose
    Reporting group description
    		 Subjects received combination vaccine MMR II at 12 months . Subjects received one single 7vPnC coadministered with vaccine Infanrix-IPV+Hib and Meningitec vaccine at 15 months.

    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 a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).

    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 a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).

    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 a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).

    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 a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).

    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 at 6 months (infant series).

    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 Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).

    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 at 6 months (infant series).

    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 Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).

    Subject analysis set title
    13vPnC After Infant Series Dose 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received 13vPnC coadministered with a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 13vPnC coadministered with Infanrix hexa at 6 months (infant series).

    Subject analysis set title
    13vPnC After Infant Series Dose 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months (infant series).

    Subject analysis set title
    13vPnC After Infant Series
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received 13vPnC coadministered with a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 13vPnC coadministered with Infanrix hexa at 6 months (infant series).

    Subject analysis set title
    7vPnC After Infant Series
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received 7vPnC coadministered with a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 7vPnC coadministered with Infanrix hexa at 6 months (infant series).

    Subject analysis set title
    13vPnC After the Toddler Dose
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).

    Subject analysis set title
    7vPnC After Infant Series Dose 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received 7vPnC coadministered with a combination DTPa, HBV, IPV, and Hib vaccine (Infanrix hexa) and a Meningitec vaccine at 2 and 4 months. Subjects received 7vPnC coadministered with Infanrix hexa at 6 months (infant series).

    Subject analysis set title
    7vPnC Afte the Toddler Dose
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months.

    Primary: Percentage of Subjects Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of >= 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of >= 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
    End point description
    Percentage of subjects achieving predefined antibody threshold levels; greater than or equal to (>=) 1:8 for meningococcal C SBA titer and >= 0.10 or >=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95 percentage (%) Confidence Interval (CI) are presented. 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 2-doses of the infant series (5 months of age)
    End point values
    		 13vPnC Infant Series 7vPnC Infant Series
    Number of subjects analysed
    297
    284
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Meningococcal C >= 1:8
    98.3 (96.1 to 99.5)
    98.9 (96.9 to 99.8)
        Diptheria >= 0.10 IU/mL
    95.9 (93 to 97.9)
    94.7 (91.4 to 97)
        Diptheria >= 0.01 IU/mL
    100 (98.8 to 100)
    100 (98.7 to 100)
    Statistical analysis title
    		 Meningococcal C >= 1:8
    Statistical analysis description
    For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at >= 1:8 threshold was calculated. 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) greater than (>) -10%.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    581
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 1.6
    Statistical analysis title
    		 Diptheria >= 0.10 IU/mL
    Statistical analysis description
    For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >= 0.10 IU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    581
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 4.9
    Statistical analysis title
    		 Diptheria >= 0.01 IU/mL
    Statistical analysis description
    For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >= 0.01 IU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    581
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.3

    Primary: Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series

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    End point title
    		 Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
    End point description
    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 2-doses of the infant series (5 months of age)
    End point values
    		 13vPnC Infant Series 7vPnC Infant Series
    Number of subjects analysed
    297
    284
    Units: titer
        geometric mean (confidence interval 95%)
    191.22 (167.72 to 218.02)
    266.19 (234.86 to 301.71)
    Statistical analysis title
    		 GMT ratio for Meningococcal C
    Statistical analysis description
    For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated. Non-inferiority for immune response induced by Meningitec 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).
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    581
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.86

    Primary: Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series

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    End point title
    		 Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
    End point description
    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 2-doses of the infant series (5 months of age)
    End point values
    		 13vPnC Infant Series 7vPnC Infant Series
    Number of subjects analysed
    296
    284
    Units: IU/mL
        geometric mean (confidence interval 95%)
    0.51 (0.47 to 0.57)
    0.63 (0.57 to 0.7)
    Statistical analysis title
    		 GMC ratio for Diphtheria
    Statistical analysis description
    For Diphtheria the GMC ratio (13vPnC/7vPnC) was calculated. Non-inferiority for immune response induced by Meningitec 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).
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    580
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.94

    Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Local Reactions [1]
    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 (>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
    Primary
    End point timeframe
    During the 4-day period after each dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 13vPnC 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
    314
    300
    306
    298
    301
    295
    293
    289
    Units: percentage of subjects
    number (not applicable)
        Tenderness-Any (n=275,270,227,232,217,215,193,170)
    49.5
    43.3
    45.4
    46.6
    47.9
    41.9
    64.2
    64.7
        Tenderness-Sig(n=247,250,192,203,181,171,136,118)
    2.8
    2.8
    4.2
    3.9
    6.1
    0
    5.9
    6.8
        Swelling-Any (n=252,254,206,212,203,188,153,140)
    19
    14.2
    28.2
    23.1
    27.6
    28.2
    33.3
    30.7
        Swelling-Mild (n=251,254,206,212,201,186,151,132)
    16.3
    14.2
    25.7
    20.3
    26.4
    25.8
    31.1
    24.2
        Swelling-Mod (n=247,248,191,201,180,173,136,124)
    4.3
    1.6
    5.8
    4.5
    5.6
    4
    11.8
    12.9
        Swelling-Severe(n=246,247,191,201,176,171,131,113)
    0
    0
    0
    0
    0
    0
    0
    0
        Redness-Any (n=255,251,211,217,203,198,159,146)
    22
    19.1
    34.1
    30.9
    31
    34.8
    40.9
    41.1
        Redness-Mild (n=254,251,210,215,203,195,157,141)
    20.1
    18.3
    32.4
    30.2
    29.1
    33.3
    35
    37.6
        Redness-Mod (n=247,247,192,203,177,175,137,120)
    2.4
    1.2
    3.1
    2.5
    4.5
    5.1
    13.1
    12.5
        Redness-Severe (n=246,247,191,201,176,171,131,113)
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Systemic Events [2]
    End point description
    Systemic events (fever [Fv] >= 37.5 degrees Celsius [C], fever >= 38 C but <= 39 C, fever >39 C but <= 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] 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
    Primary
    End point timeframe
    During the 4-day period after each dose
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    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
    314
    300
    306
    298
    301
    295
    293
    289
    Units: percentage of subjects
    number (not applicable)
        Fv>=38°C,<=39°C(n=262,253,213,223,198,196,162,145)
    30.5
    24.5
    40.4
    41.7
    34.3
    38.3
    38.9
    44.8
        Fv>39°C,<=40°C (n=249,247,194,204,177,174,135,118)
    0.8
    0.8
    2.6
    2.5
    5.6
    5.2
    8.1
    6.8
        Fv >40°C (n=249,247,192,201,176,171,132,113)
    0
    0
    0
    0
    0
    0
    0.8
    0
        Decr appetite (n=269,258,226,229,219,204,174,147)
    39.8
    36.8
    45.1
    44.5
    47
    42.6
    53.4
    47.6
        Irritability (n=276,267,234,244,229,221,183,170)
    51.4
    42.7
    64.5
    61.5
    57.2
    58.8
    61.7
    61.8
        Incr sleep (n=273,269,218,221,206,203,160,145)
    53.5
    51.3
    46.8
    41.6
    33.5
    34.5
    39.4
    35.2
        Decr sleep (n=263,255,218,223,205,190,151,129)
    34.6
    24.7
    36.2
    29.6
    30.2
    25.8
    27.2
    27.1
        Med-treat sx (n=267,256,232,243,216,209,176,163)
    50.6
    46.9
    60.3
    61.3
    55.6
    55.5
    59.7
    60.1
        Med-prevent sx (n=269,258,231,237,222,211,178,159)
    49.1
    47.7
    58.4
    58.6
    56.3
    53.6
    59.6
    61.6
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After 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) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
    End point description
    GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (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. (n)= number of subjects with a determinate IgG antibody concentration to the given serotype.
    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)
    End point values
    		 13vPnC After Infant Series Dose 2 13vPnC After Infant Series Dose 3 13vPnC After the Toddler Dose
    Number of subjects analysed
    297
    293
    275
    Units: microgram per mililitre (mcg/mL)
    geometric mean (confidence interval 95%)
        Common Serotype - Serotype 4 (n=269,269,241)
    1.89 (1.7 to 2.1)
    2.33 (2.11 to 2.57)
    4.97 (4.42 to 5.58)
        Common Serotype - Serotype 6B (n=267,267,228)
    0.42 (0.37 to 0.47)
    3.88 (3.41 to 4.41)
    11.88 (10.57 to 13.35)
        Common Serotype - Serotype 9V (n=273,273,241)
    1.49 (1.34 to 1.66)
    1.71 (1.56 to 1.86)
    3.44 (3.12 to 3.8)
        Common Serotype - Serotype 14 (n=270,270,230)
    3.84 (3.37 to 4.37)
    6.17 (5.45 to 6.98)
    11.37 (10.17 to 12.71)
        Common Serotype - Serotype 18C (n=267,267,239)
    1.58 (1.4 to 1.78)
    2.29 (2.08 to 2.52)
    3.96 (3.55 to 4.43)
        Common Serotype - Serotype 19F (n=270,270,231)
    2.85 (2.53 to 3.21)
    2.64 (2.42 to 2.89)
    8.04 (7.07 to 9.14)
        Common Serotype - Serotype 23F (n=260,260,233)
    0.54 (0.47 to 0.62)
    2.15 (1.89 to 2.45)
    5.07 (4.5 to 5.71)
        Additional Serotype - Serotype 1 (n=268,268,235)
    1.9 (1.7 to 2.13)
    3.04 (2.73 to 3.38)
    4.79 (4.21 to 5.45)
        Additional Serotype - Serotype 3 (n=267,267,243)
    0.79 (0.72 to 0.87)
    0.97 (0.87 to 1.08)
    1.07 (0.95 to 1.2)
        Additional Serotype - Serotype 5 (n=261,261,234)
    0.99 (0.9 to 1.1)
    1.93 (1.74 to 2.13)
    3.9 (3.53 to 4.31)
        Additional Serotype - Serotype 6A (n=269,269,235)
    1.1 (0.97 to 1.25)
    3.16 (2.82 to 3.53)
    7.07 (6.35 to 7.87)
        Additional Serotype - Serotype 7F (n=268,268,242)
    1.85 (1.69 to 2.02)
    4.03 (3.7 to 4.4)
    5.78 (5.13 to 6.53)
        Additional Serotype - Serotype 19A (n=267,267,226)
    2.36 (2.1 to 2.66)
    3.07 (2.79 to 3.37)
    11.64 (10.43 to 13)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    The Geometric Mean fold Rise (GMFR) were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.35
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    9.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.18
         upper limit
    		 10.53
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 1.25
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.41
         upper limit
    		 1.83
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 1.61
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 3 v 13vPnC After Infant Series Dose 2
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.03
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.55
         upper limit
    		 4.5
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 1.76
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.35
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.78
         upper limit
    		 2.11
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    2.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.58
         upper limit
    		 3.2
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    2.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.98
         upper limit
    		 2.41
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    The GMFR were calculated using all subjects with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.18
         upper limit
    		 1.44

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

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    End point title
    		 Percentage of Subjects Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
    End point description
    Percentage of subjects achieving predefined antibody threshold levels with the corresponding 95 % CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) 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 the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
    End point values
    		 13vPnC After Infant Series 7vPnC After Infant Series 13vPnC After the Toddler Dose 7vPnC Afte the Toddler Dose
    Number of subjects analysed
    293
    286
    275
    270
    Units: percentage of subjects
    number (confidence interval 95%)
        Pertussis, PT >= 5.0 EU/mL
    100 (98.7 to 100)
    100 (98.7 to 100)
    99.6 (98 to 100)
    99.6 (97.9 to 100)
        Pertussis, PT (Infant >=20; Toddler >= 11) EU/mL
    93.2 (89.7 to 95.8)
    95.1 (91.9 to 97.3)
    94.9 (91.6 to 97.2)
    96.3 (93.3 to 98.2)
        Pertussis, FHA >= 5.0 EU/mL
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.6 to 100)
        Pertussis, FHA >= 7.82 EU/mL
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.6 to 100)
        Pertussis, FHA (Infant >= 64; Toddler >= 99) EU/mL
    93.9 (90.5 to 96.3)
    95.1 (91.9 to 97.3)
    94.5 (91.1 to 96.9)
    95.1 (91.8 to 97.4)
        Pertussis, PRN >= 5 EU/mL
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.6 to 100)
        Pertussis, PRN (Infant >= 39; Toddler >= 69)EU/mL
    94.5 (91.3 to 96.8)
    95.1 (91.9 to 97.3)
    93.5 (89.9 to 96.1)
    95.2 (91.9 to 97.4)
        Diptheria >= 0.10 IU/mL
    99.3 (97.5 to 99.9)
    100 (98.7 to 100)
    99.2 (97.2 to 99.9)
    100 (98.5 to 100)
        Diptheria >= 0.01 IU/mL
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.6 to 100)
    100 (98.5 to 100)
        Tetanus >= 0.10 IU/mL
    98.6 (96.3 to 99.6)
    98.2 (95.8 to 99.4)
    98.6 (95.9 to 99.7)
    97.8 (94.9 to 99.3)
        Tetanus >= 0.01 IU/mL
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.3 to 100)
    100 (98.4 to 100)
        Poliovirus, Type 1 >= 1:8
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
        Poliovirus, Type 2 >= 1:8
    100 (98.7 to 100)
    99.3 (97.5 to 99.9)
    100 (98.6 to 100)
    99.6 (97.8 to 100)
        Poliovirus, Type 3 >= 1:8
    100 (98.7 to 100)
    99.6 (98 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
    Statistical analysis title
    		 Pertussis, PT >= 5.0 EU/mL: After Infant Series
    Statistical analysis description
    For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 enzyme-linked immunosorbent assay (ELISA) unit (EU)/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.3
    Statistical analysis title
    		 Pertussis, PT >=20 EU/mL: After Infant Series
    Statistical analysis description
    For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 2
    Statistical analysis title
    		 Pertussis, FHA >= 5.0 EU/mL: After Infant Series
    Statistical analysis description
    For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.3
    Statistical analysis title
    		 Pertussis, FHA >= 7.82 EU/mL: After Infant Series
    Statistical analysis description
    For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.3
    Statistical analysis title
    		 Pertussis, FHA >= 64 EU/mL: After Infant Series
    Statistical analysis description
    For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 64 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 2.6
    Statistical analysis title
    		 Pertussis, PRN >= 5 EU/mL: After Infant Series
    Statistical analysis description
    For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.3
    Statistical analysis title
    		 Pertussis, PRN >= 39 EU/mL: After Infant Series
    Statistical analysis description
    For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 39 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 3.2
    Statistical analysis title
    		 Pertussis, PT >= 5.0 EU/mL: After Toddler Series
    Statistical analysis description
    For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 1.7
    Statistical analysis title
    		 Pertussis, PT >=11 EU/mL: After Toddler Series
    Statistical analysis description
    For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 11 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 2.2
    Statistical analysis title
    		 Pertussis, FHA >= 5.0 EU/mL: After Toddler dose
    Statistical analysis description
    For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.4
    Statistical analysis title
    		 Pertussis, FHA ≥ 7.82 EU/mL: After Toddler dose
    Statistical analysis description
    For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.4
    Statistical analysis title
    		 Pertussis, FHA >= 99 EU/mL: After Toddler dose
    Statistical analysis description
    For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 99 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 3.3
    Statistical analysis title
    		 Pertussis, PRN >= 5 EU/mL: After Toddler dose
    Statistical analysis description
    For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.4
    Statistical analysis title
    		 Pertussis, PRN >= 69 EU/mL: After Toddler dose
    Statistical analysis description
    For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 69 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 2.3
    Statistical analysis title
    		 Diptheria ≥ 0.01 IU/mL: After Infant Series
    Statistical analysis description
    For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.3
    Statistical analysis title
    		 Diptheria >= 0.10 IU/mL: After Infant Series
    Statistical analysis description
    For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 International Units (IU)/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 0.7
    Statistical analysis title
    		 Diptheria >= 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. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 0.8
    Statistical analysis title
    		 Diptheria ≥ 0.01 IU/mL: After Toddler dose
    Statistical analysis description
    For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 1.5
    Statistical analysis title
    		 Tetanus ≥ 0.10 IU/mL : After Infant Series
    Statistical analysis description
    For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 2.9
    Statistical analysis title
    		 Tetanus >= 0.01 IU/mL: After Infant Series
    Statistical analysis description
    For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.4
    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. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 3.8
    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. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 1.7
    Statistical analysis title
    		 Poliovirus, Type 1 >= 1:8: After Infant Series
    Statistical analysis description
    For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.3
    Statistical analysis title
    		 Poliovirus, Type 2 >= 1:8: After Infant Series
    Statistical analysis description
    For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 2.6
    Statistical analysis title
    		 Poliovirus, Type 3 >= 1:8: After Infant Series
    Statistical analysis description
    For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated. 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%.
    Comparison groups
    13vPnC After Infant Series v 7vPnC After Infant Series
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 2
    Statistical analysis title
    		 Poliovirus, Type 2 >= 1:8: After Toddler dose
    Statistical analysis description
    For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 2.2
    Statistical analysis title
    		 Poliovirus, Type 1 >= 1:8: After Toddler dose
    Statistical analysis description
    For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 1.5
    Statistical analysis title
    		 Poliovirus, Type 3 >= 1:8: After Toddler dose
    Statistical analysis description
    For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated. 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%.
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 1.5

    Primary: Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose

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    End point title
    		 Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
    End point description
    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 the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
    End point values
    		 13vPnC After Infant Series Dose 3 7vPnC After Infant Series Dose 3 13vPnC After the Toddler Dose 7vPnC Afte the Toddler Dose
    Number of subjects analysed
    293
    286
    275
    270
    Units: titer
    geometric mean (confidence interval 95%)
        Poliovirus Type 1
    436.98 (378.21 to 504.88)
    436.15 (378.17 to 503.02)
    1057.4 (939.06 to 1190.7)
    1286.7 (1131 to 1463.8)
        Poliovirus Type 2
    266.34 (227.84 to 311.36)
    281.85 (240.04 to 330.94)
    1032.3 (912.96 to 1167.1)
    1141.1 (992.96 to 1311.4)
        Poliovirus Type 3
    897.67 (766.3 to 1051.6)
    943.95 (806.71 to 1104.5)
    2571.1 (2249.4 to 2938.9)
    2410.8 (2106.7 to 2758.8)
    Statistical analysis title
    		 Poliovirus Type 1: After Infant Series Dose 3
    Statistical analysis description
    For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated. Non-inferiority for concomitant antigens 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).
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.23
    Statistical analysis title
    		 Poliovirus Type 2: After Infant Series Dose 3
    Statistical analysis description
    For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated. Non-inferiority for concomitant antigens 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).
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.18
    Statistical analysis title
    		 Poliovirus Type 3: After Infant Series Dose 3
    Statistical analysis description
    For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated. Non-inferiority for concomitant antigens 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).
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.19
    Statistical analysis title
    		 Poliovirus Type 1: After Toddler Dose
    Statistical analysis description
    For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated. Non-inferiority for concomitant antigens 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).
    Comparison groups
    7vPnC Afte the Toddler Dose v 13vPnC After the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 0.98
    Statistical analysis title
    		 Poliovirus Type 2: After Toddler dose
    Statistical analysis description
    For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated. Non-inferiority for concomitant antigens 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).
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.09
    Statistical analysis title
    		 Poliovirus Type 3: After Toddler dose
    Statistical analysis description
    For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated. Non-inferiority for concomitant antigens 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).
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.29

    Primary: Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and 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 the Toddler Dose
    End point description
    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 the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
    End point values
    		 13vPnC After Infant Series Dose 3 7vPnC After Infant Series Dose 3 13vPnC After the Toddler Dose 7vPnC Afte the Toddler Dose
    Number of subjects analysed
    293
    286
    275
    270
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Diphtheria
    1.19 (1.08 to 1.3)
    1.4 (1.28 to 1.53)
    3 (2.65 to 3.4)
    3.51 (3.08 to 3.99)
        Tetanus
    0.9 (0.8 to 1.01)
    0.87 (0.79 to 0.97)
    1.63 (1.38 to 1.91)
    1.45 (1.24 to 1.69)
    Statistical analysis title
    		 Diphtheria: After Infant Series Dose 3
    Statistical analysis description
    For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated. 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).
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.96
    Statistical analysis title
    		 Tetanus: After Infant Series Dose 3
    Statistical analysis description
    For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated. 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).
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.2
    Statistical analysis title
    		 Diphtheria: After Toddler dose
    Statistical analysis description
    For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated. 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).
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.02
    Statistical analysis title
    		 Tetanus: After Toddler dose
    Statistical analysis description
    For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated. 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).
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.4

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

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    End point title
    		 Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
    End point description
    GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL 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 the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
    End point values
    		 13vPnC After Infant Series Dose 3 7vPnC After Infant Series Dose 3 13vPnC After the Toddler Dose 7vPnC Afte the Toddler Dose
    Number of subjects analysed
    293
    286
    275
    270
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Pertussis PT
    51.51 (47.94 to 55.34)
    50.13 (46.8 to 53.7)
    36.13 (32.84 to 39.74)
    36.01 (32.94 to 39.37)
        Pertussis FHA
    179.04 (165.34 to 193.87)
    166.77 (155.2 to 179.2)
    347.96 (316.46 to 382.59)
    345.89 (315.14 to 379.65)
        Pertussis PRN
    141.39 (129.66 to 154.17)
    135.06 (123.56 to 147.63)
    232.96 (211.42 to 256.69)
    261.58 (237.29 to 288.36)
    Statistical analysis title
    		 Pertussis PT: After Infant Series Dose 3
    Statistical analysis description
    For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated. 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).
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.13
    Statistical analysis title
    		 Pertussis FHA: After Infant Series Dose 3
    Statistical analysis description
    For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated. 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).
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.2
    Statistical analysis title
    		 Pertussis PRN: After Infant Series Dose 3
    Statistical analysis description
    For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated. 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).
    Comparison groups
    13vPnC After Infant Series Dose 3 v 7vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.18
    Statistical analysis title
    		 Pertussis FHA: After Toddler dose
    Statistical analysis description
    For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated. 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).
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.15
    Statistical analysis title
    		 Pertussis PT: After Toddler dose
    Statistical analysis description
    For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated. 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).
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.14
    Statistical analysis title
    		 Pertussis PRN: After Toddler dose
    Statistical analysis description
    For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated. 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).
    Comparison groups
    13vPnC After the Toddler Dose v 7vPnC Afte the Toddler Dose
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.02

    Primary: Percentage of Subjects Achieving Antibody Level >= 0.35 mcg/mL in 13vPnC Group After the Second Dose and After 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 mcg/mL in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
    End point description
    Percentages of subjects achieving World Health Organization (WHO) predefined antibody threshold >= 0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (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)
    End point values
    		 13vPnC After Infant Series Dose 2 13vPnC After Infant Series Dose 3 13vPnC After the Toddler Dose
    Number of subjects analysed
    297
    293
    275
    Units: Percentage of subjects
    number (confidence interval 95%)
        Common Serotype - Serotype 4
    96.7 (93.7 to 98.5)
    98.9 (96.8 to 99.8)
    99.2 (97 to 99.9)
        Common Serotype - Serotype 6B
    57.3 (51.1 to 63.3)
    98.5 (96.2 to 99.6)
    99.6 (97.6 to 100)
        Common Serotype - Serotype 9V
    91.9 (88.1 to 94.9)
    99.3 (97.4 to 99.9)
    100 (98.5 to 100)
        Common Serotype - Serotype 14
    98.5 (96.3 to 99.6)
    97.4 (94.7 to 99)
    100 (98.4 to 100)
        Common Serotype - Serotype 18C
    91.8 (87.8 to 94.8)
    98.1 (95.7 to 99.4)
    99.6 (97.7 to 100)
        Common Serotype - Serotype 19F
    97.8 (95.2 to 99.2)
    99.3 (97.3 to 99.9)
    99.6 (97.6 to 100)
        Common Serotype - Serotype 23F
    68.1 (62 to 73.7)
    94.6 (91.1 to 97)
    99.1 (96.9 to 99.9)
        Additional Serotype - Serotype 1
    96.3 (93.2 to 98.2)
    99.3 (97.3 to 99.9)
    98.7 (96.3 to 99.7)
        Additional Serotype - Serotype 3
    88 (83.5 to 91.7)
    90.3 (86.1 to 93.5)
    92.2 (88.1 to 95.2)
        Additional Serotype - Serotype 5
    87.4 (82.7 to 91.1)
    97.3 (94.6 to 98.9)
    99.1 (96.9 to 99.9)
        Additional Serotype - Serotype 6A
    84.4 (79.5 to 88.5)
    97.4 (94.7 to 98.9)
    99.1 (97 to 99.9)
        Additional Serotype - Serotype 7F
    98.5 (96.2 to 99.6)
    100 (98.6 to 100)
    98.8 (96.4 to 99.7)
        Additional Serotype - Serotype 19A
    98.1 (95.7 to 99.4)
    99.6 (97.9 to 100)
    100 (98.4 to 100)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 4.4
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    41.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 34.9
         upper limit
    		 46.9
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.1
         upper limit
    		 10.4
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 1.2
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    6.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 9.5
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 3.4
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    26.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.7
         upper limit
    		 31.9
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 5.1
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 6.3
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.9
         upper limit
    		 13.9
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.6
         upper limit
    		 17.2
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 3.1
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    The difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated.
    Comparison groups
    13vPnC After Infant Series Dose 2 v 13vPnC After Infant Series Dose 3
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 3.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs: recorded from the signing of the ICF to 1 month after infant series and from toddler dose to 1 month after toddler dose. Serious adverse events (SAEs): recorded from the signing of the informed consent to 6 months after the last study vaccination
    Adverse event reporting additional description
    Version was not captured, here 0.0 is mentioned for dictionary version. Local reactions (LRs) and systemic events (SEs) were to be assessed only for infant series and toddler dose groups.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 Subjects received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Subjects received 13vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    		 Subjects received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Subjects received 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.

    Reporting group title
    13vPnC After Infant Series
    Reporting group description
    		 Subjects received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Subjects received 13vPnC coadministered with Infanrix hexa at 6 months, assessment was done at 15 months (toddler dose) to summarize AE/SAE between approximately one month after dose 3 at 7 months of age and toddler dose at 15 month of age.

    Reporting group title
    7vPnC After Infant Series
    Reporting group description
    		 Subjects received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Subjects received 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done at 15 months (toddler dose) to summarize AE/SAE between approximately one month after dose 3 at 7 months of age and toddler dose at 15 month of age.

    Reporting group title
    13vPnC Toddler Series
    Reporting group description
    		 Subjects received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.

    Reporting group title
    7vPnC Toddler Series
    Reporting group description
    		 Subjects received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.

    Reporting group title
    13vPnC 6-Month Follow-up
    Reporting group description
    		 Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age.

    Reporting group title
    7vPnC 6-Month Follow-up
    Reporting group description
    		 Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age.

    Serious adverse events
    		 13vPnC Infant Series 7vPnC Infant Series 13vPnC After Infant Series 7vPnC After Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 314 (5.10%)
    16 / 300 (5.33%)
    9 / 314 (2.87%)
    9 / 300 (3.00%)
    3 / 291 (1.03%)
    1 / 284 (0.35%)
    3 / 312 (0.96%)
    6 / 299 (2.01%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Skull fracture
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Thermal burn
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Congenital, familial and genetic disorders
    Congenital nystagmus
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Scaphocephaly
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    1 / 314 (0.32%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    2 / 299 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    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
    Fontanelle bulging
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Hypotonia
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Partial seizures
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 314 (0.32%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    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
    Sudden infant death syndrome
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         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
    Gastrointestinal disorders
    Oral disorder
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         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 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Vomiting
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Musculoskeletal and connective tissue disorders
    Synovitis
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 314 (0.32%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    2 / 312 (0.64%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    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
    Bronchitis
         subjects affected / exposed
    2 / 314 (0.64%)
    1 / 300 (0.33%)
    1 / 314 (0.32%)
    2 / 300 (0.67%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 2
    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
    Bronchopneumonia
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Lobar pneumonia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         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
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    1 / 312 (0.32%)
    0 / 299 (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
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    2 / 314 (0.64%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    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
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         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
    Pneumonia
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Tuberculosis
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         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
    Bronchiolitis
         subjects affected / exposed
    6 / 314 (1.91%)
    6 / 300 (2.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    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
    4 / 314 (1.27%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    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
    Urinary tract infection
         subjects affected / exposed
    0 / 314 (0.00%)
    4 / 300 (1.33%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    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
    Rotavirus infection
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Viral infection
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Infected cyst
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Meningitis viral
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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
    Respiratory tract infection
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Arthritis bacterial
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    1 / 284 (0.35%)
    0 / 312 (0.00%)
    0 / 299 (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
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Diabetes mellitus
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13vPnC Infant Series 7vPnC Infant Series 13vPnC After Infant Series 7vPnC After Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    254 / 314 (80.89%)
    226 / 300 (75.33%)
    7 / 314 (2.23%)
    10 / 300 (3.33%)
    170 / 291 (58.42%)
    155 / 284 (54.58%)
    3 / 312 (0.96%)
    2 / 299 (0.67%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    20 / 314 (6.37%)
    16 / 300 (5.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    8 / 291 (2.75%)
    4 / 284 (1.41%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    23
    18
    0
    0
    9
    4
    0
    0
    Injection site swelling
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Irritability
         subjects affected / exposed
    1 / 314 (0.32%)
    4 / 300 (1.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    0
    0
    Cyst
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Hypothermia
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Fever >=38 degree C but <=39 degree C Infant Series Dose 1 and Toddler Dose
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    80 / 262 (30.53%)
    62 / 253 (24.51%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    63 / 162 (38.89%)
    65 / 145 (44.83%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    80
    62
    0
    0
    63
    65
    0
    0
    Fever >39 degree C but <=40 degree C Infant Series Dose 1 and Toddler Dose
    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 [2]
    2 / 249 (0.80%)
    2 / 247 (0.81%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    11 / 135 (8.15%)
    8 / 118 (6.78%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    2
    2
    0
    0
    11
    8
    0
    0
    Fever >40 degree C Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [3]
    0 / 249 (0.00%)
    0 / 247 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 132 (0.76%)
    0 / 113 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Decreased appetite Infant Series Dose 1 and Toddler Dose
    Additional description: 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.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    107 / 269 (39.78%)
    95 / 258 (36.82%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    93 / 174 (53.45%)
    70 / 147 (47.62%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    107
    95
    0
    0
    93
    70
    0
    0
    Irritability Infant Series Dose 1 and Toddler Dose
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    142 / 276 (51.45%)
    114 / 267 (42.70%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    113 / 183 (61.75%)
    105 / 170 (61.76%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    142
    114
    0
    0
    113
    105
    0
    0
    Increased sleep Infant Series Dose 1 and Toddler Dose
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    146 / 273 (53.48%)
    138 / 269 (51.30%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    63 / 160 (39.38%)
    51 / 145 (35.17%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    146
    138
    0
    0
    63
    51
    0
    0
    Decreased sleep Infant Series Dose 1 and Toddler Dose
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    91 / 263 (34.60%)
    63 / 255 (24.71%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    41 / 151 (27.15%)
    35 / 129 (27.13%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    91
    63
    0
    0
    41
    35
    0
    0
    Fever >=38 degree C but <=39 degree C Infant Series Dose 2
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    86 / 213 (40.38%)
    93 / 223 (41.70%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    86
    93
    0
    0
    0
    0
    0
    0
    Fever >39 degree C but <=40 degree C Infant Series Dose 2
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    5 / 194 (2.58%)
    5 / 204 (2.45%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    5
    5
    0
    0
    0
    0
    0
    0
    Decreased appetite Infant Series Dose 2
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    102 / 226 (45.13%)
    102 / 229 (44.54%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    102
    102
    0
    0
    0
    0
    0
    0
    Irritability Infant Series Dose 2
    Additional description: 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.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    151 / 234 (64.53%)
    150 / 244 (61.48%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    151
    150
    0
    0
    0
    0
    0
    0
    Increased sleep Infant Series Dose 2
    Additional description: 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.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    102 / 218 (46.79%)
    92 / 221 (41.63%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    102
    92
    0
    0
    0
    0
    0
    0
    Decreased sleep Infant Series Dose 2
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    79 / 218 (36.24%)
    66 / 223 (29.60%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    79
    66
    0
    0
    0
    0
    0
    0
    Fever >=38 degree C but <=39 degree C Infant Series Dose 3
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    68 / 198 (34.34%)
    75 / 196 (38.27%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    68
    75
    0
    0
    0
    0
    0
    0
    Fever >39 degree C but <=40 degree C Infant Series Dose 3
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    10 / 177 (5.65%)
    9 / 174 (5.17%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    10
    9
    0
    0
    0
    0
    0
    0
    Irritability Infant Series Dose 3
    Additional description: 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.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    131 / 229 (57.21%)
    130 / 221 (58.82%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    131
    130
    0
    0
    0
    0
    0
    0
    Increased sleep Infant Series Dose 3
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    69 / 206 (33.50%)
    70 / 203 (34.48%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    69
    70
    0
    0
    0
    0
    0
    0
    Decreased sleep Infant Series Dose 3
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    62 / 205 (30.24%)
    49 / 190 (25.79%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    62
    49
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    2 / 314 (0.64%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    1 / 312 (0.32%)
    1 / 299 (0.33%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    1
    Milk allergy
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 300 (0.67%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    1 / 312 (0.32%)
    0 / 299 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    1
    0
    Social circumstances
    Exposure to communicable disease
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Genital rash
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Penis disorder
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Testicular retraction
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 300 (0.33%)
    1 / 314 (0.32%)
    1 / 300 (0.33%)
    3 / 291 (1.03%)
    1 / 284 (0.35%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    1
    1
    1
    3
    1
    0
    0
    Asthma
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    7 / 314 (2.23%)
    4 / 300 (1.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    3 / 291 (1.03%)
    2 / 284 (0.70%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    7
    4
    0
    0
    3
    2
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    1 / 284 (0.35%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    1
    0
    0
    Bronchitis chronic
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    0
    Respiratory failure
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Bronchospasm
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Agitation
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Traumatic brain injury
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Overdose
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Head injury
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Hip dysplasia
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Atrial septal defect
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Double ureter
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Hydrocele
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Hypospadias
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Strabismus congenital
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Ear and labyrinth disorders
    Otorrhoea
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    1 / 284 (0.35%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Ear pain
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    10 / 314 (3.18%)
    10 / 300 (3.33%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    9 / 291 (3.09%)
    3 / 284 (1.06%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    12
    11
    0
    1
    9
    3
    0
    0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Coeliac disease
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    11 / 314 (3.50%)
    5 / 300 (1.67%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    5 / 291 (1.72%)
    4 / 284 (1.41%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    12
    5
    1
    0
    7
    4
    0
    0
    Vomiting
         subjects affected / exposed
    7 / 314 (2.23%)
    4 / 300 (1.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    5 / 291 (1.72%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    7
    4
    0
    0
    5
    0
    0
    0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    2 / 314 (0.64%)
    4 / 300 (1.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    24
    4
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 314 (0.96%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Decreased appetite Infant Series Dose 3
    Additional description: 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.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    103 / 219 (47.03%)
    87 / 204 (42.65%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    103
    87
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    6 / 314 (1.91%)
    9 / 300 (3.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    1 / 312 (0.32%)
    0 / 299 (0.00%)
         occurrences all number
    6
    9
    0
    0
    1
    0
    1
    0
    Dermatitis diaper
         subjects affected / exposed
    2 / 314 (0.64%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    1 / 314 (0.32%)
    4 / 300 (1.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    1 / 284 (0.35%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    1
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 314 (0.00%)
    3 / 300 (1.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    0
    0
    Rash generalised
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 314 (0.00%)
    3 / 300 (1.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 314 (0.32%)
    4 / 300 (1.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    0
    0
    Tenderness (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [20]
    136 / 275 (49.45%)
    117 / 270 (43.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    124 / 193 (64.25%)
    110 / 170 (64.71%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    136
    117
    0
    0
    124
    110
    0
    0
    Tenderness (Significant) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [21]
    7 / 247 (2.83%)
    7 / 250 (2.80%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    8 / 136 (5.88%)
    8 / 118 (6.78%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    7
    7
    0
    0
    8
    8
    0
    0
    Induration (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [22]
    48 / 252 (19.05%)
    36 / 254 (14.17%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    51 / 153 (33.33%)
    43 / 140 (30.71%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    48
    36
    0
    0
    51
    43
    0
    0
    Induration (Mild) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [23]
    41 / 251 (16.33%)
    36 / 254 (14.17%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    47 / 151 (31.13%)
    32 / 132 (24.24%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    41
    36
    0
    0
    47
    32
    0
    0
    Induration (Moderate) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [24]
    12 / 247 (4.86%)
    4 / 248 (1.61%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    16 / 136 (11.76%)
    16 / 124 (12.90%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    12
    4
    0
    0
    16
    16
    0
    0
    Erythema (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [25]
    56 / 255 (21.96%)
    48 / 251 (19.12%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    65 / 159 (40.88%)
    60 / 146 (41.10%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    56
    48
    0
    0
    65
    60
    0
    0
    Erythema (Mild) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [26]
    51 / 254 (20.08%)
    46 / 251 (18.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    55 / 157 (35.03%)
    53 / 141 (37.59%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    51
    46
    0
    0
    55
    53
    0
    0
    Erythema (Moderate) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [27]
    6 / 247 (2.43%)
    3 / 247 (1.21%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    18 / 137 (13.14%)
    15 / 120 (12.50%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    6
    3
    0
    0
    18
    15
    0
    0
    Tenderness (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [28]
    103 / 227 (45.37%)
    108 / 232 (46.55%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    103
    108
    0
    0
    0
    0
    0
    0
    Tenderness (Significant) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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]
    8 / 192 (4.17%)
    8 / 203 (3.94%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    8
    8
    0
    0
    0
    0
    0
    0
    Induration (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [30]
    58 / 206 (28.16%)
    49 / 212 (23.11%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    58
    49
    0
    0
    0
    0
    0
    0
    Induration (Mild) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    53 / 206 (25.73%)
    43 / 212 (20.28%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    53
    43
    0
    0
    0
    0
    0
    0
    Induration (Moderate) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [32]
    11 / 191 (5.76%)
    9 / 201 (4.48%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    11
    9
    0
    0
    0
    0
    0
    0
    Erythema (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [33]
    72 / 211 (34.12%)
    67 / 217 (30.88%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    72
    67
    0
    0
    0
    0
    0
    0
    Erythema (Mild) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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]
    68 / 210 (32.38%)
    65 / 215 (30.23%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    68
    65
    0
    0
    0
    0
    0
    0
    Erythema (Moderate) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    6 / 192 (3.13%)
    5 / 203 (2.46%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    6
    5
    0
    0
    0
    0
    0
    0
    Tenderness (Any) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [36]
    104 / 217 (47.93%)
    90 / 215 (41.86%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    104
    90
    0
    0
    0
    0
    0
    0
    Tenderness (Significant) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [37]
    11 / 181 (6.08%)
    0 / 171 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    11
    0
    0
    0
    0
    0
    0
    0
    Induration (Any) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [38]
    56 / 203 (27.59%)
    53 / 188 (28.19%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    56
    53
    0
    0
    0
    0
    0
    0
    Induration (Mild) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [39]
    53 / 201 (26.37%)
    48 / 186 (25.81%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    53
    48
    0
    0
    0
    0
    0
    0
    Induration (Moderate) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [40]
    10 / 180 (5.56%)
    7 / 173 (4.05%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    10
    7
    0
    0
    0
    0
    0
    0
    Erythema (Any) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [41]
    63 / 203 (31.03%)
    69 / 198 (34.85%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    63
    69
    0
    0
    0
    0
    0
    0
    Erythema (Mild) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [42]
    59 / 203 (29.06%)
    65 / 195 (33.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    59
    65
    0
    0
    0
    0
    0
    0
    Erythema (Moderate) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries 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 [43]
    8 / 177 (4.52%)
    9 / 175 (5.14%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    8
    9
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Pyelocaliectasis
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Torticollis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Tuberculosis
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    1 / 299 (0.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    25 / 314 (7.96%)
    23 / 300 (7.67%)
    0 / 314 (0.00%)
    2 / 300 (0.67%)
    11 / 291 (3.78%)
    16 / 284 (5.63%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    34
    32
    0
    2
    12
    17
    0
    0
    Bronchopneumonia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    8 / 314 (2.55%)
    6 / 300 (2.00%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    1 / 291 (0.34%)
    3 / 284 (1.06%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    8
    9
    0
    1
    1
    3
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    23 / 314 (7.32%)
    33 / 300 (11.00%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    10 / 291 (3.44%)
    9 / 284 (3.17%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    26
    35
    0
    1
    10
    9
    0
    0
    Rhinitis
         subjects affected / exposed
    3 / 314 (0.96%)
    4 / 300 (1.33%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    3
    6
    0
    1
    0
    0
    0
    0
    Varicella
         subjects affected / exposed
    3 / 314 (0.96%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    3
    1
    0
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    19 / 314 (6.05%)
    22 / 300 (7.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    16 / 291 (5.50%)
    15 / 284 (5.28%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    19
    23
    0
    0
    16
    15
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    53 / 314 (16.88%)
    47 / 300 (15.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    15 / 291 (5.15%)
    12 / 284 (4.23%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    86
    67
    0
    0
    16
    16
    0
    0
    Pharyngitis
         subjects affected / exposed
    5 / 314 (1.59%)
    7 / 300 (2.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    6 / 291 (2.06%)
    6 / 284 (2.11%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    6
    10
    0
    0
    6
    6
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    9 / 314 (2.87%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    5 / 291 (1.72%)
    4 / 284 (1.41%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    10
    4
    0
    0
    5
    5
    0
    0
    Otitis media
         subjects affected / exposed
    3 / 314 (0.96%)
    6 / 300 (2.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    4 / 291 (1.37%)
    5 / 284 (1.76%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    3
    9
    0
    0
    4
    6
    0
    0
    Laryngitis
         subjects affected / exposed
    1 / 314 (0.32%)
    3 / 300 (1.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    2 / 291 (0.69%)
    3 / 284 (1.06%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    3
    0
    0
    2
    3
    0
    0
    Otitis media acute
         subjects affected / exposed
    4 / 314 (1.27%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    3 / 284 (1.06%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    4
    1
    0
    0
    1
    3
    0
    0
    Bronchiolitis
         subjects affected / exposed
    32 / 314 (10.19%)
    35 / 300 (11.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    2 / 284 (0.70%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    35
    39
    0
    0
    1
    2
    0
    0
    Acute tonsillitis
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    2 / 291 (0.69%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    3 / 291 (1.03%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    3 / 314 (0.96%)
    3 / 300 (1.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    2 / 291 (0.69%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    3
    3
    0
    0
    2
    0
    0
    0
    Coxsackie viral infection
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    1 / 291 (0.34%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    2 / 314 (0.64%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    1 / 284 (0.35%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    0
    0
    Dacryocystitis
         subjects affected / exposed
    3 / 314 (0.96%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    4
    2
    0
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 314 (0.96%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    4
    2
    0
    0
    0
    0
    0
    0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 314 (0.64%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    3 / 314 (0.96%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    0
    Candidiasis
         subjects affected / exposed
    2 / 314 (0.64%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    0
    Viral skin infection
         subjects affected / exposed
    1 / 314 (0.32%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    2 / 314 (0.64%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 300 (0.67%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Acarodermatitis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Herpangina
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Impetigo
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Skin candida
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Tracheitis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 300 (0.00%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Lactose intolerance
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 300 (0.33%)
    0 / 314 (0.00%)
    0 / 300 (0.00%)
    0 / 291 (0.00%)
    0 / 284 (0.00%)
    0 / 312 (0.00%)
    0 / 299 (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.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 May 2006
    1. Changed measles, mumps, rubella vaccine (MMR) window to 365 to 395 days of age. 2. Added Hib as a component of Infanrix hexa.
    15 Nov 2006
    1. Added sentence stating that rotavirus vaccine may be given concomitantly with study vaccines.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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