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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 the United Kingdom

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2005-005130-12
    Trial protocol
    GB  
    Global end of trial date
    21 Oct 2008

    Results information
    Results version number
    v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    01 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Not completed reason having type "Other" with same other reason text

    Trial information

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    Trial identification
    Sponsor protocol code
    6096A1-007
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00384059
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Alias: B1851090
    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
    13 Feb 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immune response induced by NeisVac-C (meningococcal group C vaccine) given with 13-valent Pneumococcal Conjugate Vaccine (13vPnC) relative to the immune response induced by NeisVac-C given with 7-valent pneumococcal conjugate vaccine (7vPnC) when measured 1 month after the infant series. The immune response was assessed using a meningococcal group C-specific serum bactericidal assay (SBA). To evaluate the immune responses induced by Pediacel given with 13vPnC relative to the immune responses induced by Pediacel given with 7vPnC when measured 1 month after the infant series. The immune responses to the following antigens in Pediacel were assessed: acellular pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], and fimbrial agglutinogens [FIM]) and Hib.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 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
    United Kingdom: 286
    Worldwide total number of subjects
    286
    EEA total number of subjects
    286
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    286
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited in the United Kingdom (UK) from October 2006 to June 2007.

    Pre-assignment
    Screening details
    Subjects were enrolled into the study according to inclusion/exclusion criteria without a screening period. Out of 286 subjects, demographic has been reported for 278, since demographic information for 8 subjects was unknown, as they were pre-randomized but not consented.

    Period 1
    Period 1 title
    Infant Series
    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 Infant Series
    Arm description
    Subjects received 13vPnC coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visit (infant series). Pediacel was administered without study vaccine at 3 month visit.
    Arm type
    Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of 13vPnC at 2 and 4 month (infant series).

    Investigational medicinal product name
    Pediacel
    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 Pediacel at the 2, 3 and 4 month (infant series).

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5-mL dose of NeisVac-C at 2 and 4 months of age (infant series).

    Arm title
    7vPnC Infant Series
    Arm description
    Subjects received 7vPnC coadministered with meningococcal C-tetanus toxoid conjugate vaccine NeisVac-C and a combined DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visit (infant series). Pediacel was administered without study vaccine at 3-month visit.
    Arm type
    Active comparator

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of 7vPnC at the 2 and 4 month (infant series).

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of NeisVac-C at 2 and 4 month (infant series).

    Investigational medicinal product name
    Pediacel
    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 Pediacel at 2, 3 and 4 months (infant series).

    Number of subjects in period 1
    13vPnC Infant Series 7vPnC Infant Series
    Started
    141
    145
    Vaccinated Dose 1
    139
    139
    Vaccinated Dose 2
    136
    135
    Completed
    135
    132
    Not completed
    6
    13
         Protocol Violation
    1
    2
         Consent withdrawn by subject
    2
    2
         Adverse Event
    1
    2
         Lost to follow-up
    -
    1
         Not consented
    2
    6
    Period 2
    Period 2 title
    After Infant Series
    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 NeisVac-C vaccine and a combined DT5aP, IPVand Hib conjugate vaccine (Pediacel) at at the 2­ and 4­month visits (infant series). Pediacel was administered without study vaccine at 3­month visit.
    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 NeisVac-C vaccine and a combined DT5aP, IPV and Hib conjugate vaccine (Pediacel) at at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit.
    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
    135
    132
    Completed
    131
    122
    Not completed
    4
    10
         Physician decision
    -
    1
         Failed to return
    -
    2
         Protocol Violation
    2
    3
         Consent withdrawn by subject
    2
    2
         Adverse Event
    -
    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
    Investigator, Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    13vPnC Toddler Dose
    Arm description
    Subjects recieved 13vPnC coadministered with Hib and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
    Arm type
    Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of 13vPnC at 12-month visit (toddler dose).

    Investigational medicinal product name
    Menitorix
    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 Menitorix at the 12-month visit (toddler dose).

    Arm title
    7vPnC Toddler Dose
    Arm description
    Subjects received 7vPnC coadministered with Hib and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
    Arm type
    Active comparator

    Investigational medicinal product name
    Menitorix
    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 Menitorix at the 12-month visit (toddler dose).

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects recieved one single 0.5 mL dose of 7vPnC at the 12-month visit (toddler dose).

    Number of subjects in period 3
    13vPnC Toddler Dose 7vPnC Toddler Dose
    Started
    131
    122
    Completed
    130
    120
    Not completed
    1
    2
         Failed to return
    -
    1
         Lost to follow-up
    1
    1
    Period 4
    Period 4 title
    Baseline Period
    Is this the baseline period?
    Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    13vPnC
    Arm description
    Subjects received 13vPnC coadministered with NeisVac-C and a combined DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit.
    Arm type
    Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of 13vPnC at 2 and 4 month (infant series).

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5-mL dose of NeisVac-C at 2 and 4 months of age (infant series).

    Investigational medicinal product name
    Pediacel
    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 Pediacel at the 2, 3 and 4 month (infant series).

    Arm title
    7vPnC
    Arm description
    Subjects received 7vPnC coadministered with NeisVac-C and a combined DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit.
    Arm type
    Active comparator

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5-mL dose of 7vPnC at 2 and 4 months of age (infant series).

    Investigational medicinal product name
    Pediacel
    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 Pediacel at the 2, 3 and 4 month (infant series).

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5-mL dose of NeisVac-C at 2 and 4 months of age (infant series).

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The period 1 here does not represent the baseline period however period 4 is the baseline period as the baseline population is based on the evaluable infant immunogenicity population i.e., the primary immunogenicity analysis population. 
    Number of subjects in period 4 [2] [3]
    13vPnC 7vPnC
    Started
    120
    118
    Completed
    120
    118
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported in baseline period are not same as worldwide number because baseline period is based on the evaluable infant immunogenicity population i.e., the primary immunogenicity analysis population. 
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification:  Period 4 has been created to present the Baseline period and includes the data for evaluable infant immunogenicity population. 

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC
    Reporting group description
    Subjects received 13vPnC coadministered with NeisVac-C and a combined DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit.

    Reporting group title
    7vPnC
    Reporting group description
    Subjects received 7vPnC coadministered with NeisVac-C and a combined DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit.

    Reporting group values
    13vPnC 7vPnC Total
    Number of subjects
    120 118 238
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    2.1 ± 0.3 2.1 ± 0.2 -
    Gender categorical
    Units: Subjects
        Female
    55 57 112
        Male
    65 61 126

    End points

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    End points reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    Subjects received 13vPnC coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visit (infant series). Pediacel was administered without study vaccine at 3 month visit.

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    Subjects received 7vPnC coadministered with meningococcal C-tetanus toxoid conjugate vaccine NeisVac-C and a combined DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visit (infant series). Pediacel was administered without study vaccine at 3-month visit.
    Reporting group title
    13vPnC After Infant Series
    Reporting group description
    Included subjects who received 13vPnC coadministered with NeisVac-C vaccine and a combined DT5aP, IPVand Hib conjugate vaccine (Pediacel) at at the 2­ and 4­month visits (infant series). Pediacel was administered without study vaccine at 3­month visit.

    Reporting group title
    7vPnC After Infant Series
    Reporting group description
    Included subjects who received 7vPnC coadministered with NeisVac-C vaccine and a combined DT5aP, IPV and Hib conjugate vaccine (Pediacel) at at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit.
    Reporting group title
    13vPnC Toddler Dose
    Reporting group description
    Subjects recieved 13vPnC coadministered with Hib and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).

    Reporting group title
    7vPnC Toddler Dose
    Reporting group description
    Subjects received 7vPnC coadministered with Hib and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
    Reporting group title
    13vPnC
    Reporting group description
    Subjects received 13vPnC coadministered with NeisVac-C and a combined DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit.

    Reporting group title
    7vPnC
    Reporting group description
    Subjects received 7vPnC coadministered with NeisVac-C and a combined DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit.

    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 NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.

    Subject analysis set title
    13vPnC Before Toddler Dose
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.

    Subject analysis set title
    13vPnC After Toddler Dose
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministrated with Menitorix at the 12-month visit.

    Subject analysis set title
    13vPnC Dose 1
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.

    Subject analysis set title
    7vPnC Dose 1
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.

    Subject analysis set title
    13vPnC Dose 2
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.

    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 Menitorix at 12 months of age.

    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 Menitorix at 12 months of age.

    Subject analysis set title
    7vPnC Dose 2
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.

    Subject analysis set title
    13vPnC Before Toddler Dose
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.

    Subject analysis set title
    7vPnC Before Toddler Dose
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.

    Subject analysis set title
    13vPnC After Toddler Dose
    Subject analysis set type
    Per protocol
    Subject analysis set description
    'Subjects received one single 0.5 mL dose of 13vPnC coadministrated with Menitorix at the 12-month visit.

    Subject analysis set title
    7vPnC After Toddler Dose
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministrated with Menitorix at the 12-month visit.

    Primary: Percentage of Subjects Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer >=1:8 and Predefined Antibody Levels for Pertussis and Haemophilus influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.

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    End point title
    Percentage of Subjects Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer >=1:8 and Predefined Antibody Levels for Pertussis and Haemophilus influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
    End point description
    Percentage of subjects achieving a meningococcal C SBA serum antibody titer greater than or equal to (>=) 1:8 and predefined antibody threshold levels with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigens polyribosylribitol phosphate (PRP) in Haemophilus influenzae type b [Hib](>=0.15 microgram per milliliter (mcg/mL) or >=1.0 mcg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (>=5 enzyme-linked immunosorbent assay (ELISA) Units (EU)/mL) and fimbrial agglutinogens [FIM] (>=2.2/mL) are presented. Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of subjects with a determinate postinfant series antibody concentration to the given concomitant antigen.
    End point type
    Primary
    End point timeframe
    One month after infant series dose 2 (5 months of age)
    End point values
    13vPnC Infant Series 7vPnC Infant Series
    Number of subjects analysed
    120
    118
    Units: Percentage of subjects
    number (confidence interval 95%)
        Meningococcal C >= 1:8 titer (n=120,118)
    99.2 (95.4 to 100)
    99.2 (95.4 to 100)
        Hib (PRP) >= 0.15 mcg/mL (n=114,102)
    96.5 (91.3 to 99)
    98 (93.1 to 99.8)
        Hib (PRP) >= 1.0 mcg/mL (n=114,102)
    85.1 (77.2 to 91.1)
    89.2 (81.5 to 94.5)
        Pertussis PT >= 5 EU/mL (n=119,112)
    100 (96.9 to 100)
    100 (96.8 to 100)
        Pertussis PT >= 17 EU/mL (n=119,112)
    96.6 (91.6 to 99.1)
    95.5 (89.9 to 98.5)
        Pertussis FHA >= 5 EU/mL (n=119,113)
    100 (96.9 to 100)
    100 (96.8 to 100)
        Pertussis FHA >= 7.82 EU/mL (n=119,113)
    100 (96.9 to 100)
    100 (96.8 to 100)
        Pertussis FHA >= 20 EU/mL (n=119,113)
    94.1 (88.3 to 97.6)
    95.6 (90 to 98.5)
        Pertussis PRN >= 5 EU/mL (n=119,113)
    100 (96.9 to 100)
    100 (96.8 to 100)
        Pertussis PRN >= 15 EU/mL (n=119,113)
    92.4 (86.1 to 96.5)
    95.6 (90 to 98.5)
        Pertussis FIM >= 2.2 EU/mL (n=119,113)
    100 (96.9 to 100)
    97.3 (92.4 to 99.4)
        Pertussis FIM >= 5 EU/mL (n=119,113)
    97.5 (92.8 to 99.5)
    96.5 (91.2 to 99)
    Statistical analysis title
    Analysis for Meningococcal C >=1:8 titer
    Statistical analysis description
    For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.8
         upper limit
    3.9
    Notes
    [1] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (>) -10%.
    Statistical analysis title
    Analysis for Hib (PRP) >=0.15 mcg/mL
    Statistical analysis description
    For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 mcg/mL threshold was calculated.
    Comparison groups
    7vPnC Infant Series v 13vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    Difference
    Point estimate
    -1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.1
         upper limit
    3.7
    Notes
    [2] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.
    Statistical analysis title
    Analysis for Pertussis PT >=5 EU/mL
    Statistical analysis description
    For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    3.3
    Notes
    [3] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.
    Statistical analysis title
    Analysis for Hib (PRP) >=1.0 mcg/mL
    Statistical analysis description
    For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 mcg/mL threshold was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    Method
    Parameter type
    Difference
    Point estimate
    -4.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.4
         upper limit
    5.1
    Notes
    [4] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.
    Statistical analysis title
    Analysis for Pertussis PT >=17 EU/mL
    Statistical analysis description
    For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 17 EU/mL threshold was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [5]
    Method
    Parameter type
    Difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.5
         upper limit
    7.1
    Notes
    [5] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.
    Statistical analysis title
    Analysis for Pertussis FHA >=5 EU/mL
    Statistical analysis description
    For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [6]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    3.2
    Notes
    [6] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.
    Statistical analysis title
    Analysis for Pertussis FHA >=7.82 EU/mL
    Statistical analysis description
    For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [7]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    3.2
    Notes
    [7] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.
    Statistical analysis title
    Analysis for Pertussis FHA >=20 EU/mL
    Statistical analysis description
    For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [8]
    Method
    Parameter type
    Difference
    Point estimate
    -1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.9
         upper limit
    4.8
    Notes
    [8] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.
    Statistical analysis title
    Analysis for Pertussis PRN >= 5 EU/mL
    Statistical analysis description
    For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [9]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    3.2
    Notes
    [9] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.
    Statistical analysis title
    Analysis for Pertussis PRN >=15 EU/mL
    Statistical analysis description
    For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 15 EU/mL threshold was calculated.
    Comparison groups
    7vPnC Infant Series v 13vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [10]
    Method
    Parameter type
    Difference
    Point estimate
    -3.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10
         upper limit
    3.4
    Notes
    [10] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.
    Statistical analysis title
    Analysis for Pertussis FIM >=2.2 EU/mL
    Statistical analysis description
    For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 2.2 EU/mL threshold was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [11]
    Method
    Parameter type
    Difference
    Point estimate
    2.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    7.6
    Notes
    [11] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.
    Statistical analysis title
    Analysis for Pertussis FIM >=5 EU/mL
    Statistical analysis description
    For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [12]
    Method
    Parameter type
    Difference
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.1
         upper limit
    6.5
    Notes
    [12] - Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.

    Primary: Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

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    End point title
    Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
    End point description
    Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Primary
    End point timeframe
    One month after infant series dose 2 (5 months of age)
    End point values
    13vPnC Infant Series 7vPnC Infant Series
    Number of subjects analysed
    120 [13]
    118 [14]
    Units: titer
        geometric mean (confidence interval 95%)
    306.2 (251.21 to 373.22)
    345.42 (287.91 to 414.41)
    Notes
    [13] - N=number of subjects with determinate antibody concentration/titer for specified concomitant antigen
    [14] - N=number of subjects with determinate antibody concentration/titer for specified concomitant antigen
    Statistical analysis title
    Analysis for Meningococcal C
    Statistical analysis description
    For Meningococcal C the geometric mean concentration (GMC) ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [15]
    Method
    Parameter type
    Ratio
    Point estimate
    0.89
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.68
         upper limit
    1.16
    Notes
    [15] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

    Primary: Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

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    End point title
    Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
    End point description
    Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Primary
    End point timeframe
    One month after infant series dose 2 (5 months of age)
    End point values
    13vPnC Infant Series 7vPnC Infant Series
    Number of subjects analysed
    114 [16]
    102 [17]
    Units: microgram per milliliter (mcg/mL)
        geometric mean (confidence interval 95%)
    3.4 (2.65 to 4.37)
    4.44 (3.5 to 5.63)
    Notes
    [16] - N=number of subjects with determinate antibody concentration/titer for specified concomitant antigen
    [17] - N=number of subjects with determinate antibody concentration/titer for specified concomitant antigen
    Statistical analysis title
    Analysis of GMC for Hib
    Statistical analysis description
    For Hib the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [18]
    Method
    Parameter type
    Ratio
    Point estimate
    0.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.54
         upper limit
    1.08
    Notes
    [18] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

    Primary: Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

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    End point title
    Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
    End point description
    Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. (n) = number of subjects with a determinate antibody concentration/titer for the specified concomitant antigen.
    End point type
    Primary
    End point timeframe
    One month after infant series dose 2 (5 months of age)
    End point values
    13vPnC Infant Series 7vPnC Infant Series
    Number of subjects analysed
    120
    118
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Pertussis FHA (n=119,113)
    54.74 (48.25 to 62.09)
    55.99 (49.55 to 63.28)
        Pertussis PT (n=119,112)
    66.26 (59.2 to 74.16)
    67.05 (58.75 to 76.52)
        Pertussis PRN (n=119,113)
    61.33 (51.78 to 72.65)
    61.07 (52.31 to 71.3)
        Pertussis FIM (n=119,113)
    21.72 (18.89 to 24.98)
    21.77 (18.54 to 25.56)
    Statistical analysis title
    Analysis of GMC for Pertussis FHA
    Statistical analysis description
    For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [19]
    Method
    Parameter type
    Ratio
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.82
         upper limit
    1.16
    Notes
    [19] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
    Statistical analysis title
    Analysis of GMC for Pertussis PT
    Statistical analysis description
    For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [20]
    Method
    Parameter type
    Ratio
    Point estimate
    0.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.83
         upper limit
    1.17
    Notes
    [20] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
    Statistical analysis title
    Analysis of GMC for Pertussis PRN
    Statistical analysis description
    For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [21]
    Method
    Parameter type
    Ratio
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.8
         upper limit
    1.26
    Notes
    [21] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
    Statistical analysis title
    Analysis of GMC for Pertussis FIM
    Statistical analysis description
    For Pertussis FIM the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC Infant Series v 7vPnC Infant Series
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [22]
    Method
    Parameter type
    Ratio
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    1.23
    Notes
    [22] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

    Primary: Percentage of Subjects in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration >=0.35 mcg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose

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    End point title
    Percentage of Subjects in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration >=0.35 mcg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose [23]
    End point description
    Percentages of subjects achieving WHO predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (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 (5 months of age), before and after toddler dose (12 months of age)
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification:  Only descriptive data was planned to be reported for this endpoint. 
    End point values
    13vPnC After Infant Series Dose 2 13vPnC Before Toddler Dose 13vPnC After Toddler Dose
    Number of subjects analysed
    120
    120
    110
    Units: Percentage of subjects
    number (confidence interval 95%)
        Common Serotypes - Serotype 4 (n=107,89,102)
    95.3 (89.4 to 98.5)
    24.7 (16.2 to 35)
    99 (94.7 to 100)
        Common Serotypes - Serotype 6B (n=107,86,102)
    40.2 (30.8 to 50.1)
    74.4 (63.9 to 83.2)
    98 (93.1 to 99.8)
        Common Serotypes - Serotype 9V (n=104,91,101)
    85.6 (77.3 to 91.7)
    44 (33.6 to 54.8)
    98 (93 to 99.8)
        Common Serotypes - Serotype 14 (n=107,88,101)
    92.5 (85.8 to 96.7)
    92 (84.3 to 96.7)
    100 (96.4 to 100)
        Common Serotypes - Serotype 18C (n=111,91,105)
    92.8 (86.3 to 96.8)
    13.2 (7 to 21.9)
    97.1 (91.9 to 99.4)
        Common Serotypes - Serotype 19F (n=109,91,104)
    93.6 (87.2 to 97.4)
    67 (56.4 to 76.5)
    98.1 (93.2 to 99.8)
        Common Serotypes - Serotype 23F (n=111,89,104)
    66.7 (57.1 to 75.3)
    37.1 (27.1 to 48)
    98.1 (93.2 to 99.8)
        Additional Serotypes - Serotype 1 (n=107,88,101)
    97.2 (92 to 99.4)
    50 (39.1 to 60.9)
    100 (96.4 to 100)
        Additional Serotypes - Serotype 3 (n=107,87,102)
    86 (77.9 to 91.9)
    12.6 (6.5 to 21.5)
    88.2 (80.4 to 93.8)
        Additional Serotypes - Serotype 5 (n=103,88,101)
    89.3 (81.7 to 94.5)
    78.4 (68.4 to 86.5)
    100 (96.4 to 100)
        Additional Serotypes - Serotype 6A (n=106,86,99)
    79.2 (70.3 to 86.5)
    79.1 (69 to 87.1)
    98 (92.9 to 99.8)
        Additional Serotypes - Serotype 7F (n=107,91,100)
    94.4 (88.2 to 97.9)
    71.4 (61 to 80.4)
    100 (96.4 to 100)
        Additional Serotypes - Serotype 19A (n=110,91,103)
    92.7 (86.2 to 96.8)
    86.8 (78.1 to 93)
    100 (96.5 to 100)
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose

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    End point title
    Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose [24]
    End point description
    Antibody concentration/geometric mean concentration (GMC) as measured by ELISA for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented with corresponding 2-sided 95% CI. Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of subjects with a determinate antibody concentration for the specified serotype.
    End point type
    Primary
    End point timeframe
    One month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification:  Only descriptive data was planned to be reported for this endpoint. 
    End point values
    13vPnC After Infant Series Dose 2 13vPnC Before Toddler Dose 13vPnC After Toddler Dose
    Number of subjects analysed
    120
    120
    110
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common Serotypes - Serotype 4 (n=107,87,87)
    1.37 (1.16 to 1.62)
    0.21 (0.17 to 0.24)
    3.52 (2.91 to 4.26)
        Common Serotypes - Serotype 6B (n=107,85,85)
    0.26 (0.21 to 0.33)
    0.77 (0.6 to 0.99)
    7.67 (5.88 to 10.01)
        Common Serotypes - Serotype 9V (n=104,88,88)
    0.87 (0.72 to 1.05)
    0.29 (0.24 to 0.36)
    2.46 (2.03 to 2.99)
        Common Serotypes - Serotype 14 (n=107,87,87)
    1.83 (1.47 to 2.27)
    1.34 (1.09 to 1.66)
    11.32 (9.27 to 13.83)
        Common Serotypes - Serotype 18C (n=111,91,91)
    1.37 (1.14 to 1.64)
    0.2 (0.17 to 0.23)
    2.14 (1.82 to 2.53)
        Common Serotypes - Serotype 19F (n=109,90,90)
    2.38 (1.88 to 3.01)
    0.6 (0.46 to 0.79)
    7.25 (5.65 to 9.31)
        Common Serotypes - Serotype 23F (n=111,88,88)
    0.53 (0.42 to 0.67)
    0.24 (0.19 to 0.32)
    3.13 (2.59 to 3.78)
        Additional Serotypes - Serotype 1 (n=107,85,85)
    1.69 (1.41 to 2.04)
    0.39 (0.33 to 0.46)
    5.6 (4.6 to 6.82)
        Additional Serotypes - Serotype 3 (n=107,85,85)
    0.63 (0.56 to 0.71)
    0.14 (0.1 to 0.18)
    0.98 (0.78 to 1.22)
        Additional Serotypes - Serotype 5 (n=103,86,86)
    0.95 (0.79 to 1.14)
    0.59 (0.49 to 0.72)
    3.68 (3.04 to 4.45)
        Additional Serotypes - Serotype 6A (n=106,83,83)
    0.86 (0.68 to 1.07)
    0.81 (0.64 to 1.03)
    6.31 (5.06 to 7.87)
        Additional Serotypes - Serotype 7F (n=107,87,87)
    2.14 (1.75 to 2.62)
    0.56 (0.48 to 0.66)
    4.06 (3.42 to 4.83)
        Additional Serotypes - Serotype 19A (n=110,89,89)
    1.9 (1.54 to 2.34)
    1.01 (0.77 to 1.32)
    11.33 (9.29 to 13.83)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving an SBA Titer >=1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose

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    End point title
    Percentage of Subjects Achieving an SBA Titer >=1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
    End point description
    Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of subjects with a determinate posttoddler dose antibody concentration to the given concomitant antigen.
    End point type
    Secondary
    End point timeframe
    Before and 1 month after the toddler dose (13 months of age)
    End point values
    13vPnC Before Toddler Dose 7vPnC Before Toddler Dose 13vPnC After Toddler Dose 7vPnC After Toddler Dose
    Number of subjects analysed
    102
    93
    109
    98
    Units: Percentage of Subjects
        number (confidence interval 95%)
    44.1 (34.3 to 54.3)
    49.5 (38.9 to 60)
    91.7 (84.9 to 96.2)
    91.8 (84.5 to 96.4)
    Statistical analysis title
    Meningococcal C: After Toddler Dose
    Statistical analysis description
    For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated.
    Comparison groups
    7vPnC After Toddler Dose v 13vPnC After Toddler Dose
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [25]
    Method
    Parameter type
    Difference
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8
         upper limit
    8.1
    Notes
    [25] - Non-inferiority was used to assess, but the study has not been powered to show non-inferiority.
    Statistical analysis title
    Meningococcal C: Before Toddler Dose
    Statistical analysis description
    For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated.
    Comparison groups
    13vPnC Before Toddler Dose v 7vPnC Before Toddler Dose
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [26]
    Method
    Parameter type
    Difference
    Point estimate
    -5.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.7
         upper limit
    8.8
    Notes
    [26] - Non-inferiority was used to assess, but the study has not been powered to show non-inferiority.

    Secondary: Percentage of Subjects Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose

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    End point title
    Percentage of Subjects Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose
    End point description
    Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    One month after toddler dose (13 months of age)
    End point values
    13vPnC Toddler Dose 7vPnC Toddler Dose
    Number of subjects analysed
    105 [27]
    96 [28]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Hib (PRP) >=0.15 mcg/mL
    100 (96.5 to 100)
    100 (96.2 to 100)
        Hib (PRP)>=1.0 mcg/mL
    99 (94.8 to 100)
    100 (96.2 to 100)
    Notes
    [27] - Subjects with determinate posttoddler dose antibody concentration to given concomitant antigen
    [28] - Subjects with determinate posttoddler dose antibody concentration to given concomitant antigen
    Statistical analysis title
    Analysis for Hib at 1.0 mcg/mL
    Statistical analysis description
    For Hib the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 mcg/mL threshold was calculated.
    Comparison groups
    13vPnC Toddler Dose v 7vPnC Toddler Dose
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [29]
    Method
    Parameter type
    Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.3
         upper limit
    2.8
    Notes
    [29] - Non-inferiority was used to assess, but the study has not been powered to show non-inferiority.
    Statistical analysis title
    Analysis for Hib at 0.15 mcg/mL
    Statistical analysis description
    For Hib the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 mcg/mL threshold was calculated.
    Comparison groups
    7vPnC Toddler Dose v 13vPnC Toddler Dose
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [30]
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.5
         upper limit
    3.8
    Notes
    [30] - Non-inferiority was used to assess, but the study has not been powered to show non-inferiority.

    Secondary: Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

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    End point title
    Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
    End point description
    Evaluable immunogenicity (per protocol) population of eligible subjects who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    One month after toddler dose (13 months of age)
    End point values
    13vPnC Toddler Dose 7vPnC Toddler Dose
    Number of subjects analysed
    105 [31]
    96 [32]
    Units: mcg/mL
        geometric mean (confidence interval 95%)
    22.22 (17.66 to 27.96)
    19.75 (16.05 to 24.3)
    Notes
    [31] - N=number of subjects with determinate antibody concentration/titer for specified concomitant antigen
    [32] - N=number of subjects with determinate antibody concentration/titer for specified concomitant antigen
    Statistical analysis title
    Analysis of GMC for Hib PRP
    Statistical analysis description
    For Hib the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC Toddler Dose v 7vPnC Toddler Dose
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [33]
    Method
    Parameter type
    Ratio
    Point estimate
    1.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.83
         upper limit
    1.53
    Notes
    [33] - Non-inferiority was used to assess, but the study has not been powered to show non-inferiority.

    Secondary: Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

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    End point title
    Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
    End point description
    Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    One month after toddler dose (13 months of age)
    End point values
    13vPnC Toddler Dose 7vPnC Toddler Dose
    Number of subjects analysed
    109 [34]
    98 [35]
    Units: titer
        geometric mean (confidence interval 95%)
    656.11 (445.46 to 966.38)
    771.67 (509.98 to 1167.64)
    Notes
    [34] - N=number of subjects with determinate antibody concentration/titer for specified concomitant antigen
    [35] - N=number of subjects with determinate antibody concentration/titer for specified concomitant antigen
    Statistical analysis title
    Analysis of GMC for Meningococcal C
    Statistical analysis description
    For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC Toddler Dose v 7vPnC Toddler Dose
    Number of subjects included in analysis
    207
    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
    0.48
         upper limit
    1.49

    Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (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
    Other pre-specified
    End point timeframe
    During the 4-day period after each dose
    End point values
    13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Toddler Dose 13vPnC Toddler Dose 7vPnC Dose 2
    Number of subjects analysed
    139
    139
    136
    122
    131
    135
    Units: Percentage of Subjects
    number (not applicable)
        Tenderness-Any (n=123,127,114,96,87,71)
    44.7
    43.3
    42.1
    50.7
    44.8
    40.6
        Tenderness-Significant (n=116,122,97,89,77,58)
    1.7
    6.6
    4.1
    3.4
    3.9
    4.5
        Swelling-Any (n=121,126,106,93,83,68)
    24.8
    29.4
    30.2
    39.7
    30.1
    34.4
        Swelling-Mild (n=120,125,105,93,82,66)
    21.7
    27.2
    28.6
    34.8
    28
    29
        Swelling-Moderate (n=118,121,98,88,77,60)
    6.8
    6.6
    8.2
    11.7
    3.9
    6.8
        Swelling-Severe (n=115,119,96,88,76,57)
    0
    0
    1
    0
    0
    0
        Redness-Any (n=122,126,107,99,85,73)
    22.1
    39.7
    39.3
    53.4
    38.8
    40.4
        Redness-Mild (n=122,126,106,99,83,71)
    21.3
    39.7
    37.7
    49.3
    33.7
    37.4
        Redness-Moderate (n=116,119,98,88,78,61)
    1.7
    0
    4.1
    16.4
    12.8
    3.4
        Redness-Severe (n=115,119,97,88,76,57)
    0
    0
    2.1
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events

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    End point title
    Percentage of Subjects Reporting Pre-Specified Systemic Events
    End point description
    Systemic events (fever >= 38 degrees Celsius [C] but <= 39 C, fever >39 C but <= 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of subjects with each event was evaluated. Safety population included all subjects who received at least 1 dose of vaccine. (n) = number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Other pre-specified
    End point timeframe
    During the 4-day period after each dose
    End point values
    13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Toddler Dose 13vPnC Toddler Dose 7vPnC Dose 2
    Number of subjects analysed
    139
    139
    136
    122
    131
    135
    Units: Percentage of Subjects
    number (not applicable)
        Fever >=38°C but <=39°C (n=116,119,96,88,78,61)
    6
    3.4
    3.1
    16.4
    7.7
    4.5
        Fever >39°C but <=40°C (n=115,119,95,88,76,58)
    0.9
    0
    0
    5.2
    0
    0
        Fever >40°C (n=115,119,96,88,76,57)
    0
    0
    2.1
    0
    0
    0
        Decreased appetite (n=120,129,104,98,92,68)
    39.2
    34.1
    35.6
    44.1
    39.1
    37.8
        Irritability (n=128,135,117,119,97,80)
    76.6
    74.1
    71.8
    76.3
    74.2
    80.7
        Increased sleep (n=129,129,114,109,88,71)
    69.8
    66.7
    51.8
    40.8
    38.6
    56.9
        Decreased sleep (n=119,124,98,100,81,67)
    32.8
    33.9
    35.7
    44.8
    32.1
    38
        Meds to treat symptoms (n=123,128,108,110,85,72)
    43.9
    40.6
    50.9
    58.3
    49.4
    54.5
        Meds to prevent symptoms (n=122,124,117,103,92,77)
    49.2
    40.3
    48.7
    67.5
    52.2
    50.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs)/Serious AEs: recorded from sigining of informed consent to 6 months after the last study vaccination. Subjects recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 4 days after each vaccination)
    Adverse event reporting additional description
    MedDRA 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 NeisVac-C and a DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visits (AE/SAE assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and a DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visits (AE/SAE assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.

    Reporting group title
    13vPnC After Infant Series
    Reporting group description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and a DT5aP, IPV and Hib conjugate vaccine Pediacel at the 2- and 4-month visits (AE/SAE assessment at 5 months of age, 1 month after the infant dose to before toddler dose). Pediacel was administered without study vaccine at 3-month visit.

    Reporting group title
    7vPnC After Infant Series
    Reporting group description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and a DT5aP, IPV and Hib conjugate vaccine (Pediacel) at the 2- and 4-month visits (AE/SAE assessment at 5 months of age, 1 month after the infant dose to before toddler dose). Pediacel was administered without study vaccine at 3-month visit.

    Reporting group title
    13vPnC Toddler Series
    Reporting group description
    Subjects recieved one single 0.5 mL dose of 13vPnC coadministered with Hib and Menitorix at the 12-month visit (toddler dose). AE/SAE assessment at 1 month after the toddler dose.

    Reporting group title
    7vPnC Toddler Series
    Reporting group description
    Subjects recieved one single 0.5 mL dose of 7vPnC coadministered with Hib and Menitorix at the 12-month visit (toddler dose). AE/SAE assessment at 1 month after the toddler dose.

    Reporting group title
    13vPnC 6-Month Follow-up
    Reporting group description
    Subjects recieved one single 0.5 mL dose of 13vPnC coadministered with Hib and Menitorix at the 12-month visit (AE/SAE assessment at 18 months of age, 6 months after the toddler dose).

    Reporting group title
    7vPnC 6-Month Follow-up
    Reporting group description
    Subjects recieved one single 0.5 mL dose of 7vPnC coadministered with Hib and Menitorix at the 12-month visit (AE/SAE assessment at 18 months of age, 6 months after the toddler dose).

    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
    1 / 138 (0.72%)
    3 / 139 (2.16%)
    5 / 138 (3.62%)
    2 / 139 (1.44%)
    1 / 130 (0.77%)
    2 / 122 (1.64%)
    2 / 138 (1.45%)
    0 / 139 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (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
    Tongue injury
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (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
    Fall
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (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
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (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
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (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
    Hemiplegia
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (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
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (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
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (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
    Vomiting
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (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
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    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
    Cellulitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (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
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (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
    Gastroenteritis
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (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
    Mastoiditis
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (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
    Pneumonia
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (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
    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
    128 / 138 (92.75%)
    124 / 139 (89.21%)
    9 / 138 (6.52%)
    8 / 139 (5.76%)
    87 / 130 (66.92%)
    82 / 122 (67.21%)
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Gait disturbance
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    9 / 138 (6.52%)
    7 / 139 (5.04%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    5 / 130 (3.85%)
    6 / 122 (4.92%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    12
    7
    0
    0
    5
    6
    0
    0
    Injection site erythema
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Injection site bruising
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Irritability
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Vessel puncture site haematoma
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Injection site induration
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Injection site swelling
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    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 SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    7 / 116 (6.03%)
    4 / 119 (3.36%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    6 / 78 (7.69%)
    10 / 61 (16.39%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    7
    4
    0
    0
    6
    10
    0
    0
    Fever >39 degrees C but <=40 degrees C Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    1 / 115 (0.87%)
    0 / 119 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 76 (0.00%)
    3 / 58 (5.17%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    3
    0
    0
    Decreased appetite Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    47 / 120 (39.17%)
    44 / 129 (34.11%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    36 / 92 (39.13%)
    30 / 68 (44.12%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    47
    44
    0
    0
    36
    30
    0
    0
    Irritability Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    98 / 128 (76.56%)
    100 / 135 (74.07%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    72 / 97 (74.23%)
    61 / 80 (76.25%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    98
    100
    0
    0
    72
    61
    0
    0
    Increased sleep Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    90 / 129 (69.77%)
    86 / 129 (66.67%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    34 / 88 (38.64%)
    29 / 71 (40.85%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    90
    86
    0
    0
    34
    29
    0
    0
    Decreased sleep Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    39 / 119 (32.77%)
    42 / 124 (33.87%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    26 / 81 (32.10%)
    30 / 67 (44.78%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    39
    42
    0
    0
    26
    30
    0
    0
    Fever >=38 degrees C but <=39 degrees C Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    3 / 96 (3.13%)
    4 / 88 (4.55%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    3
    4
    0
    0
    0
    0
    0
    0
    Fever >40 degrees C Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    2 / 96 (2.08%)
    0 / 88 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Decreased appetite Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    37 / 104 (35.58%)
    37 / 98 (37.76%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    37
    37
    0
    0
    0
    0
    0
    0
    Irritability Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    84 / 117 (71.79%)
    96 / 119 (80.67%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    84
    96
    0
    0
    0
    0
    0
    0
    Increased sleep Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    59 / 114 (51.75%)
    62 / 109 (56.88%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    59
    62
    0
    0
    0
    0
    0
    0
    Decreased sleep Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    35 / 98 (35.71%)
    38 / 100 (38.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    35
    38
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Crying
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 139 (2.88%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    4
    4
    0
    0
    1
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Agitation
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Restlessness
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Staring
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    Radius fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Head injury
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Traumatic haematoma
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Physical examination abnormal
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Cardiac disorders
    Cyanosis
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Dacryostenosis congenital
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Lymphangioma
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    3 / 139 (2.16%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    1 / 139 (0.72%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    29 / 138 (21.01%)
    16 / 139 (11.51%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    10 / 130 (7.69%)
    10 / 122 (8.20%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    32
    17
    1
    0
    10
    11
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 138 (0.72%)
    7 / 139 (5.04%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    7
    0
    0
    1
    1
    0
    0
    Wheezing
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 139 (1.44%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    3
    1
    0
    1
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Sneezing
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Dysphonia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Grunting
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    High-pitched crying
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Hypertonia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    7 / 138 (5.07%)
    13 / 139 (9.35%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    3 / 130 (2.31%)
    4 / 122 (3.28%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    7
    13
    0
    0
    3
    5
    0
    0
    Eye discharge
         subjects affected / exposed
    5 / 138 (3.62%)
    3 / 139 (2.16%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    6
    3
    0
    0
    0
    0
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Astigmatism
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Dacryostenosis acquired
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Hypermetropia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    24 / 138 (17.39%)
    17 / 139 (12.23%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    12 / 130 (9.23%)
    13 / 122 (10.66%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    32
    17
    0
    0
    14
    14
    0
    0
    Vomiting
         subjects affected / exposed
    19 / 138 (13.77%)
    11 / 139 (7.91%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    12 / 130 (9.23%)
    13 / 122 (10.66%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    25
    12
    0
    0
    13
    14
    0
    0
    Teething
         subjects affected / exposed
    11 / 138 (7.97%)
    9 / 139 (6.47%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    4 / 130 (3.08%)
    3 / 122 (2.46%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    12
    9
    0
    0
    4
    3
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 138 (3.62%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    5
    2
    0
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Infantile spitting up
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    Stomach discomfort
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Reflux oesophagitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    11 / 138 (7.97%)
    5 / 139 (3.60%)
    1 / 138 (0.72%)
    2 / 139 (1.44%)
    1 / 130 (0.77%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    13
    6
    1
    2
    1
    1
    0
    0
    Rash
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 139 (3.60%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    3
    5
    0
    0
    0
    1
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 139 (3.60%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    7
    0
    0
    1
    0
    0
    0
    Dry skin
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Eczema infantile
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Heat rash
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Rash papular
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Skin discolouration
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Umbilical erythema
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Tenderness (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    55 / 123 (44.72%)
    55 / 127 (43.31%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    39 / 87 (44.83%)
    36 / 71 (50.70%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    55
    55
    0
    0
    39
    36
    0
    0
    Tenderness (Significant) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    2 / 116 (1.72%)
    8 / 122 (6.56%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    3 / 77 (3.90%)
    2 / 58 (3.45%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    8
    0
    0
    3
    2
    0
    0
    Induration (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    30 / 121 (24.79%)
    37 / 126 (29.37%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    25 / 83 (30.12%)
    27 / 68 (39.71%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    30
    37
    0
    0
    25
    27
    0
    0
    Induration (Mild) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    26 / 120 (21.67%)
    34 / 125 (27.20%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    23 / 82 (28.05%)
    23 / 66 (34.85%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    26
    34
    0
    0
    23
    23
    0
    0
    Induration (Moderate) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    8 / 118 (6.78%)
    8 / 121 (6.61%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    3 / 77 (3.90%)
    7 / 60 (11.67%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    8
    8
    0
    0
    3
    7
    0
    0
    Erythema (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    27 / 122 (22.13%)
    50 / 126 (39.68%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    33 / 85 (38.82%)
    39 / 73 (53.42%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    27
    50
    0
    0
    33
    39
    0
    0
    Erythema (Mild) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    26 / 122 (21.31%)
    50 / 126 (39.68%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    28 / 83 (33.73%)
    35 / 71 (49.30%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    26
    50
    0
    0
    28
    35
    0
    0
    Erythema (Moderate) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    2 / 116 (1.72%)
    0 / 119 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    10 / 78 (12.82%)
    10 / 61 (16.39%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    0
    0
    0
    10
    10
    0
    0
    Tenderness (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    48 / 114 (42.11%)
    39 / 96 (40.63%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    48
    39
    0
    0
    0
    0
    0
    0
    Tenderness (Significant) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: l 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    4 / 97 (4.12%)
    4 / 89 (4.49%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    4
    4
    0
    0
    0
    0
    0
    0
    Induration (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    32 / 106 (30.19%)
    32 / 93 (34.41%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    32
    32
    0
    0
    0
    0
    0
    0
    Induration (Mild) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    30 / 105 (28.57%)
    27 / 93 (29.03%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    30
    27
    0
    0
    0
    0
    0
    0
    Induration (Moderate) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    8 / 98 (8.16%)
    6 / 88 (6.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    8
    6
    0
    0
    0
    0
    0
    0
    Induration (Severe) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    1 / 96 (1.04%)
    0 / 88 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Erythema (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    42 / 107 (39.25%)
    40 / 99 (40.40%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    42
    40
    0
    0
    0
    0
    0
    0
    Erythema (Mild) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    40 / 106 (37.74%)
    37 / 99 (37.37%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    40
    37
    0
    0
    0
    0
    0
    0
    Erythema (Moderate) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    4 / 98 (4.08%)
    3 / 88 (3.41%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    4
    3
    0
    0
    0
    0
    0
    0
    Erythema (Severe) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    2 / 97 (2.06%)
    0 / 88 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    0
    Anorexia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Increased appetite
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Weight gain poor
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Lactose intolerance
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    32 / 138 (23.19%)
    26 / 139 (18.71%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    11 / 130 (8.46%)
    10 / 122 (8.20%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    40
    39
    1
    0
    11
    10
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 138 (11.59%)
    19 / 139 (13.67%)
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    4 / 130 (3.08%)
    4 / 122 (3.28%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    19
    21
    0
    1
    4
    4
    0
    0
    Otitis media
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    1 / 138 (0.72%)
    1 / 139 (0.72%)
    1 / 130 (0.77%)
    2 / 122 (1.64%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    1
    1
    1
    1
    2
    0
    0
    Bronchiolitis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    1 / 130 (0.77%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    2
    0
    1
    1
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    15 / 138 (10.87%)
    14 / 139 (10.07%)
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    9 / 130 (6.92%)
    8 / 122 (6.56%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    18
    19
    0
    1
    9
    9
    0
    0
    Rubella
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    7 / 138 (5.07%)
    4 / 139 (2.88%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    8 / 130 (6.15%)
    2 / 122 (1.64%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    8
    5
    0
    0
    8
    2
    0
    0
    Varicella
         subjects affected / exposed
    2 / 138 (1.45%)
    8 / 139 (5.76%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    8
    0
    0
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    5 / 138 (3.62%)
    4 / 139 (2.88%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    6
    4
    0
    0
    0
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    5 / 138 (3.62%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    5
    2
    0
    0
    0
    1
    0
    0
    Viral infection
         subjects affected / exposed
    4 / 138 (2.90%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    2 / 130 (1.54%)
    2 / 122 (1.64%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    4
    2
    0
    0
    2
    2
    0
    0
    Herpes zoster
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    Injection site infection
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Viral skin infection
         subjects affected / exposed
    2 / 138 (1.45%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 139 (1.44%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    5 / 130 (3.85%)
    3 / 122 (2.46%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    2
    0
    0
    5
    4
    0
    0
    Eczema infected
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Candidiasis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Dermatitis infected
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Impetigo
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    2 / 130 (1.54%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Skin candida
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 139 (0.72%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Eye infection
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    1 / 122 (0.82%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    1 / 130 (0.77%)
    0 / 122 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
    0 / 130 (0.00%)
    2 / 122 (1.64%)
    0 / 138 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    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. 

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2007
    An amendment was made to change the medical monitor and to decrease the sample size from 600 to a minimum of 250 subjects in order to reach a target enrollment number within a reasonable time frame. Because the sample size was decreased, the statistical approach was changed from non-inferiority testing with regard to concomitant vaccine immunogenicity to descriptive statistics with a given level of precision. Given the level of precision for the immunogenicity assessments, the amended protocol will provide important information on the use of 13vPnC in the United Kingdom schedule to support licensure and provide information to vaccine recommending bodies.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    The status of studies in GB is no longer updated from 1.1.2021
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