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    Clinical Trial Results:
    A Phase 4, Randomized, Open-Label Trial to Describe The Safety, Tolerability, And Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines in Healthy Infants in India

    Summary
    EudraCT number
    		 2016-005134-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Dec 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    11 Feb 2021
    First version publication date
    25 Jun 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B4671004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03548337
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety profile of 13-valent pneumococcal conjugate (13vPnC) with 2-phenoxyethanol (2-PE) in the multidose vial (MDV) group and without 2-PE in the single dose pre-filled syringe (PFS) group.
    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 Council for 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
    31 Dec 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    India: 301
    Worldwide total number of subjects
    301
    EEA total number of subjects
    0
    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)
    301
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 301 subjects were enrolled and randomized in the study. Out of 301 subjects, 300 received the study vaccination.

    Period 1
    Period 1 title
    Infant Series
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC: Multi-dose Vial (With Preservative)
    Arm description
    		 Infant series: subjects were randomized to receive a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with preservative 2-phenoxyethanol (2-PE) from a multi-dose vial (MDV), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) diphtheria, tetanus, and pertussis; Haemophilus influenzae type b; and hepatitis B virus (DTP-Hib-HBV) vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: subjects were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    B467
    Other name
    13vPnC
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of 13vPnC from a MDV with preservative 2-PE, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3).

    Investigational medicinal product name
    Rotavirus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of rotavirus vaccine intramuscularly at age of 6 weeks, 10 weeks and 14 weeks.

    Investigational medicinal product name
    DTP-Hib-HBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of DTP-Hib-HBV intramuscularly at age of 6 weeks, 10 weeks and 14 weeks.

    Arm title
    		 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Arm description
    		 Infant series: subjects were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose prefilled syringe (PFS), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: subjects were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    B467
    Other name
    13vPnC
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of 13vPnC from single dose PFS without preservative 2-PE, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3).

    Investigational medicinal product name
    DTP-Hib-HBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of DTP-Hib-HBV intramuscularly at age of 6 weeks, 10 weeks and 14 weeks.

    Investigational medicinal product name
    Rotavirus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of rotavirus vaccine intramuscularly at age of 6 weeks, 10 weeks and 14 weeks.

    Number of subjects in period 1
    		13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Started
    151
    150
    Vaccination 1
    150
    150
    Vaccination 2
    144
    144
    Vaccination 3
    144
    141
    Completed
    139
    139
    Not completed
    12
    11
         Adverse event, non-fatal
    -
    2
         Randomized but not vaccinated
    1
    -
         No Longer Met Eligibility Criteria
    1
    -
         Lost to follow-up
    2
    1
         Withdrawal by parent/guardian
    8
    8
    Period 2
    Period 2 title
    Toddler dose
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC: Multi-dose Vial (With Preservative)
    Arm description
    		 Infant series: subjects were randomized to receive a single 0.5 mL dose of 13vPnC from a MDV with preservative 2-PE, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) respectively along with 2 routine vaccines: 1) diphtheria, tetanus, and pertussis; Haemophilus influenzae type b; and hepatitis B virus (DTP- Hib-HBV) vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Toddler dose followed infant series. Toddler dose: subjects were administered a single 0.5 mL dose of 13vPnC vaccine from MDV with preservative 2-PE (Vaccination 4), at age of 12 months along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hepatitis A virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of hepatitis A virus vaccine intramuscularly at age of 12 months.

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    B467
    Other name
    13vPnC
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of 13vPnC from a MDV with preservative 2-PE, intramuscularly at age of 12 months (Vaccination 4).

    Arm title
    		 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Arm description
    		 Infant series: subjects were randomized to receive a single 0.5 mL dose of 13vPnC from a single-dose PFS without preservative 2-PE, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) respectively along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Toddler dose followed infant series. Toddler dose: subjects were administered a single 0.5 mL dose of 13vPnC vaccine from single-dose PFS without preservative 2-PE (Vaccination 4), at age of 12 months along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hepatitis A virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of hepatitis A virus vaccine intramuscularly at age of 12 months.

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    B467
    Other name
    13vPnC
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of 13vPnC from single dose PFS without preservative 2-PE, intramuscularly at age of 12 months (Vaccination 4).

    Number of subjects in period 2
    		13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Started
    139
    139
    Vaccination 4
    139
    139
    Completed
    138
    138
    Not completed
    1
    1
         Withdrawal by parent/guardian
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC: Multi-dose Vial (With Preservative)
    Reporting group description
    		 Infant series: subjects were randomized to receive a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with preservative 2-phenoxyethanol (2-PE) from a multi-dose vial (MDV), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) diphtheria, tetanus, and pertussis; Haemophilus influenzae type b; and hepatitis B virus (DTP-Hib-HBV) vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: subjects were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).

    Reporting group title
    13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Reporting group description
    		 Infant series: subjects were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose prefilled syringe (PFS), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: subjects were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).

    Reporting group values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative) Total
    Number of subjects
    		 151 150 301
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 151 150 301
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Sex: Female, Male
    Units: Subjects
        Female
    		 75 67 142
        Male
    		 76 83 159
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 151 150 301
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 0 0 0
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 151 150 301
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    13vPnC: Multi-dose Vial (With Preservative)
    Reporting group description
    		 Infant series: subjects were randomized to receive a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with preservative 2-phenoxyethanol (2-PE) from a multi-dose vial (MDV), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) diphtheria, tetanus, and pertussis; Haemophilus influenzae type b; and hepatitis B virus (DTP-Hib-HBV) vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: subjects were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).

    Reporting group title
    13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Reporting group description
    		 Infant series: subjects were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose prefilled syringe (PFS), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: subjects were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
    Reporting group title
    13vPnC: Multi-dose Vial (With Preservative)
    Reporting group description
    		 Infant series: subjects were randomized to receive a single 0.5 mL dose of 13vPnC from a MDV with preservative 2-PE, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) respectively along with 2 routine vaccines: 1) diphtheria, tetanus, and pertussis; Haemophilus influenzae type b; and hepatitis B virus (DTP- Hib-HBV) vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Toddler dose followed infant series. Toddler dose: subjects were administered a single 0.5 mL dose of 13vPnC vaccine from MDV with preservative 2-PE (Vaccination 4), at age of 12 months along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).

    Reporting group title
    13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Reporting group description
    		 Infant series: subjects were randomized to receive a single 0.5 mL dose of 13vPnC from a single-dose PFS without preservative 2-PE, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) respectively along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Toddler dose followed infant series. Toddler dose: subjects were administered a single 0.5 mL dose of 13vPnC vaccine from single-dose PFS without preservative 2-PE (Vaccination 4), at age of 12 months along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 [1]
    End point description
    Local reactions were recorded daily using an daily electronic diary(e-diary). Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 centimeters [cm]), moderate (2.5 to 7.0 cm) and, severe (greater than [>] 7 cm). Pain at injection site was graded as mild (hurts if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurts if gently touched [with crying]), and severe (causes limitation of limb movement). Subjects may be represented in more than 1 row. Here, “Any” for each of 3 local reactions represents any grade of local reaction among mild, moderate or severe. Safety population for infant series included all subjects who received at least 1 dose of study vaccine during infant series. Here, “Overall Number of Subjects analyzed, N” signifies subjects who were evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    147
    148
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any
    19.7 (13.6 to 27.1)
    16.9 (11.2 to 23.9)
        Redness: Mild
    17.7 (11.9 to 24.8)
    12.8 (7.9 to 19.3)
        Redness: Moderate
    2.0 (0.4 to 5.8)
    4.1 (1.5 to 8.6)
        Redness: Severe
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Swelling: Any
    27.9 (20.8 to 35.9)
    33.8 (26.2 to 42.0)
        Swelling: Mild
    21.8 (15.4 to 29.3)
    23.6 (17.1 to 31.3)
        Swelling: Moderate
    6.1 (2.8 to 11.3)
    10.1 (5.8 to 16.2)
        Swelling: Severe
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Pain at injection site: Any
    61.9 (53.5 to 69.8)
    67.6 (59.4 to 75.0)
        Pain at injection site: Mild
    28.6 (21.4 to 36.6)
    31.1 (25.6 to 41.3)
        Pain at injection site: Moderate
    30.6 (23.3 to 38.7)
    29.1 (21.9 to 37.1)
        Pain at injection site: Severe
    2.7 (0.7 to 6.8)
    5.4 (2.4 to 10.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events (SE) Within 7 Days After Vaccination 1

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    End point title
    		 Percentage of Subjects With Systemic Events (SE) Within 7 Days After Vaccination 1 [2]
    End point description
    Systemic Events:recorded daily using an daily e-diary. Systemic events:Fever graded 1)less than(<)38.0 degrees Celsius[C],2)greater than or equal to(>=)38.0 degree C to 38.4 degree C,3)38.5 degree C to 38.9 degree C,4)39.0 degree C to 40.0 degree C,5)>40.0 degree C; Decreased appetite graded:mild(decreased interest in eating),moderate(decreased oral intake), severe(refusal to feed);Drowsiness graded:mild(increased or prolonged sleeping bouts),moderate(slightly subdued; interfering with daily activity),severe(disabling;not interested in usual daily activity); Irritability graded:mild(easily consolable),moderate(required increased attention),severe(inconsolable;crying could not be comforted). Subjects may be represented in >1 row.“Any” for decreased appetite,increased sleep,irritability:any grade of these systemic events. Safety population for infant series:all subjects who received at least 1 dose of study vaccine during infant series. “N”:subjects who were evaluable for this measure.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 1
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    147
    148
    Units: percentage of subjects
    number (confidence interval 95%)
        Fever: <38.0 degree C
    15.0 (9.6 to 21.8)
    10.8 (6.3 to 17.0)
        Fever: >=38.0 degree C to 38.4 degree C
    10.9 (6.4 to 17.1)
    8.1 (4.3 to 13.7)
        Fever: 38.5 degree C to 38.9 degree C
    1.4 (0.2 to 4.8)
    2.7 (0.7 to 6.8)
        Fever: 39.0 degree C to 40.0 degree C
    1.4 (0.2 to 4.8)
    0 (0.0 to 2.5)
        Fever: >40.0 degree C
    1.4 (0.2 to 4.8)
    0 (0.0 to 2.5)
        Decreased appetite: Any
    42.2 (34.1 to 50.6)
    53.4 (45.0 to 61.6)
        Decreased appetite: Mild
    23.8 (17.2 to 31.5)
    30.4 (23.1 to 38.5)
        Decreased appetite: Moderate
    17.7 (11.9 to 24.8)
    21.6 (15.3 to 29.1)
        Decreased appetite: Severe
    0.7 (0.0 to 3.7)
    1.4 (0.2 to 4.8)
        Drowsiness: Any
    55.1 (46.7 to 63.3)
    66.2 (58.0 to 73.8)
        Drowsiness: Mild
    29.3 (22.0 to 37.3)
    33.1 (25.6 to 41.3)
        Drowsiness: Moderate
    25.2 (18.4 to 33.0)
    31.1 (23.7 to 39.2)
        Drowsiness: Severe
    0.7 (0.0 to 3.7)
    2.0 (0.4 to 5.8)
        Irritability: Any
    64.6 (56.3 to 72.3)
    65.5 (57.3 to 73.2)
        Irritability: Mild
    37.4 (29.6 to 45.8)
    32.4 (25.0 to 40.6)
        Irritability: Moderate
    21.8 (15.4 to 29.3)
    26.4 (19.5 to 34.2)
        Irritability: Severe
    5.4 (2.4 to 10.4)
    6.8 (3.3 to 12.1)
    No statistical analyses for this end point

    Primary: Percentage of Subejcts With Local Reactions Within 7 Days After Vaccination 2

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    End point title
    		 Percentage of Subejcts With Local Reactions Within 7 Days After Vaccination 2 [3]
    End point description
    Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurts if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurts if gently touched [with crying]), and severe (causes limitation of limb movement). Subjects may be represented in more than 1 row. Here, “Any” for each of 3 local reactions represents any grade of local reaction among mild, moderate or severe. Safety population for infant series included all subjects who received at least 1 dose of study vaccine during infant series. Here, “N”: number subjects who were evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 2
    Notes
    [3] - 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 analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    141
    140
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any
    17.0 (11.2 to 24.3)
    19.3 (13.1 to 26.8)
        Redness: Mild
    16.3 (10.6 to 23.5)
    17.9 (11.9 to 25.2)
        Redness: Moderate
    0.7 (0.0 to 3.9)
    1.4 (0.2 to 5.1)
        Redness: Severe
    0 (0.0 to 2.6)
    0 (0.0 to 2.6)
        Swelling: Any
    24.8 (17.9 to 32.8)
    27.9 (20.6 to 36.1)
        Swelling: Mild
    21.3 (14.8 to 29.0)
    22.9 (16.2 to 30.7)
        Swelling: Moderate
    3.5 (1.2 to 8.1)
    5.0 (2.0 to 10.0)
        Swelling: Severe
    0 (0.0 to 2.6)
    0 (0.0 to 2.6)
        Pain at injection site: Any
    59.6 (51.0 to 67.7)
    62.1 (53.6 to 70.2)
        Pain at injection site: Mild
    32.6 (25.0 to 41.0)
    29.3 (21.9 to 37.6)
        Pain at injection site: Moderate
    20.6 (14.2 to 28.2)
    26.4 (19.3 to 34.5)
        Pain at injection site: Severe
    6.4 (3.0 to 11.8)
    6.4 (3.0 to 11.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 [4]
    End point description
    Systemic Events:recorded daily using an daily e-diary. Systemic events:Fever graded 1)< 38.0 degrees C,2) >= 38.0 degree C to 38.4 degree C,3)38.5 degree C to 38.9 degree C,4)39.0 degree C to 40.0 degree C,5)>40.0 degree C; Decreased appetite graded: mild(decreased interest in eating),moderate(decreased oral intake), severe(refusal to feed);Drowsiness graded: mild(increased or prolonged sleeping bouts),moderate(slightly subdued; interfering with daily activity),severe (disabling;not interested in usual daily activity); Irritability graded: mild(easily consolable),moderate(required increased attention),severe(inconsolable;crying could not be comforted). Subjects may be represented in >1 row. “Any” for decreased appetite,increased sleep,irritability:any grade of these systemic events. Safety population for infant series:all subjects who received at least 1 dose of study vaccine during infant series. “N”:subjects who were evaluable for this measure.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 2
    Notes
    [4] - 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 analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    141
    140
    Units: percentage of subjects
    number (confidence interval 95%)
        Fever: <38.0 degree C
    8.5 (4.5 to 14.4)
    8.6 (4.5 to 14.5)
        Fever: >=38.0 degree C to 38.4 degree C
    6.4 (3.0 to 11.8)
    5.7 (2.5 to 10.9)
        Fever: 38.5 degree C to 38.9 degree C
    2.1 (0.4 to 6.1)
    2.1 (0.4 to 6.1)
        Fever: 39.0 degree C to 40.0 degree C
    0 (0.0 to 2.6)
    0 (0.0 to 2.6)
        Fever: >40.0 degree C
    0 (0.0 to 2.6)
    0.7 (0.0 to 3.9)
        Decreased appetite: Any
    40.4 (32.3 to 49.0)
    38.6 (30.5 to 47.2)
        Decreased appetite: Mild
    27.0 (19.8 to 35.1)
    25.0 (18.1 to 33.0)
        Decreased appetite: Moderate
    12.1 (7.2 to 18.6)
    12.1 (7.2 to 18.7)
        Decreased appetite: Severe
    1.4 (0.2 to 5.0)
    1.4 (0.2 to 5.1)
        Drowsiness: Any
    50.4 (41.8 to 58.9)
    52.1 (43.5 to 60.7)
        Drowsiness: Mild
    23.4 (16.7 to 31.3)
    22.1 (15.6 to 29.9)
        Drowsiness: Moderate
    25.5 (18.6 to 33.6)
    26.4 (19.3 to 34.5)
        Drowsiness: Severe
    1.4 (0.2 to 5.0)
    3.6 (1.2 to 8.1)
        Irritability: Any
    56.7 (48.1 to 65.0)
    60.0 (51.4 to 68.2)
        Irritability: Mild
    29.1 (21.7 to 37.3)
    37.9 (29.8 to 46.4)
        Irritability: Moderate
    24.8 (17.9 to 32.8)
    17.9 (11.9 to 25.2)
        Irritability: Severe
    2.8 (0.8 to 7.1)
    4.3 (1.6 to 9.1)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 3

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 3 [5]
    End point description
    Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurts if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurts if gently touched [with crying]), and severe (causes limitation of limb movement). Subjects may be represented in more than 1 row. Here, “Any” for each of 3 local reactions represents any grade of local reaction among mild, moderate or severe. Safety population for infant series included all subjects who received at least 1 dose of study vaccine during infant series. Here, “N”: number subjects who were evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 3
    Notes
    [5] - 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 analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    139
    140
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any
    20.1 (13.8 to 27.8)
    22.9 (16.2 to 30.7)
        Redness: Mild
    20.1 (13.8 to 27.8)
    20.0 (13.7 to 27.6)
        Redness: Moderate
    0 (0.0 to 2.6)
    2.9 (0.8 to 7.2)
        Redness: Severe
    0 (0.0 to 2.6)
    0 (0.0 to 2.6)
        Swelling: Any
    23.0 (16.3 to 30.9)
    27.1 (20.0 to 35.3)
        Swelling: Mild
    20.9 (14.4 to 28.6)
    23.6 (16.8 to 31.5)
        Swelling: Moderate
    2.2 (0.4 to 6.2)
    2.9 (0.8 to 7.2)
        Swelling: Severe
    0 (0.0 to 2.6)
    0.7 (0.0 to 3.9)
        Pain at injection site: Any
    55.4 (46.7 to 63.8)
    54.3 (45.7 to 62.7)
        Pain at injection site: Mild
    30.2 (22.7 to 38.6)
    27.9 (20.6 to 36.1)
        Pain at injection site: Moderate
    23.0 (16.3 to 30.9)
    21.4 (14.9 to 29.2)
        Pain at injection site: Severe
    2.2 (0.4 to 6.2)
    5.0 (2.0 to 10.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 3

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 3 [6]
    End point description
    Systemic Events:recorded daily using an daily e-diary. Systemic events:Fever graded 1)< 38.0 degrees C,2) >= 38.0 degree C to 38.4 degree C,3)38.5 degree C to 38.9 degree C,4)39.0 degree C to 40.0 degree C,5)>40.0 degree C; Decreased appetite graded: mild(decreased interest in eating),moderate(decreased oral intake), severe(refusal to feed);Drowsiness graded: mild(increased or prolonged sleeping bouts),moderate(slightly subdued; interfering with daily activity),severe (disabling;not interested in usual daily activity); Irritability graded: mild(easily consolable),moderate(required increased attention),severe(inconsolable;crying could not be comforted). Subjects may be represented in >1 row. “Any” for decreased appetite,increased sleep,irritability:any grade of these systemic events. Safety population for infant series:all subjects who received at least 1 dose of study vaccine during infant series. “N”:subjects who were evaluable for this measure.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 3
    Notes
    [6] - 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 analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    139
    140
    Units: percentage of subjects
    number (confidence interval 95%)
        Fever: <38.0 degree C
    7.2 (3.5 to 12.8)
    9.3 (5.0 to 15.4)
        Fever: >=38.0 degree C to 38.4 degree C
    4.3 (1.6 to 9.2)
    6.4 (3.0 to 11.9)
        Fever: 38.5 degree C to 38.9 degree C
    2.2 (0.4 to 6.2)
    1.4 (0.2 to 5.1)
        Fever: 39.0 degree C to 40.0 degree C
    0 (0.0 to 2.6)
    1.4 (0.2 to 5.1)
        Fever: >40.0 degree C
    0.7 (0.0 to 3.9)
    0 (0.0 to 2.6)
        Decreased appetite: Any
    34.5 (26.7 to 43.1)
    36.4 (28.5 to 45.0)
        Decreased appetite: Mild
    20.1 (13.8 to 27.8)
    23.6 (16.8 to 31.5)
        Decreased appetite: Moderate
    11.5 (6.7 to 18.0)
    10.0 (5.6 to 16.2)
        Decreased appetite: Severe
    2.9 (0.8 to 7.2)
    2.9 (0.8 to 7.2)
        Drowsiness: Any
    36.0 (28.0 to 44.5)
    39.3 (31.1 to 47.9)
        Drowsiness: Mild
    20.9 (14.4 to 28.6)
    19.3 (13.1 to 26.8)
        Drowsiness: Moderate
    13.7 (8.4 to 20.5)
    17.9 (11.9 to 25.2)
        Drowsiness: Severe
    1.4 (0.2 to 5.1)
    2.1 (0.4 to 6.1)
        Irritability: Any
    54.7 (46.0 to 63.1)
    60.0 (51.4 to 68.2)
        Irritability: Mild
    31.7 (24.0 to 40.1)
    37.9 (29.8 to 46.4)
        Irritability: Moderate
    19.4 (13.2 to 27.0)
    15.7 (10.1 to 22.8)
        Irritability: Severe
    3.6 (1.2 to 8.2)
    6.4 (3.0 to 11.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 4

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 4 [7]
    End point description
    Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurts if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurts if gently touched [with crying]), and severe (causes limitation of limb movement). Subjects may be represented in more than 1 row. Here, “Any” for each of 3 local reactions represents any grade of local reaction(LR) among mild, moderate or severe. Safety population for infant series included all subjects who received at least 1 dose of study vaccine during infant series. Here, “N”: number subjects who were evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 4
    Notes
    [7] - 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 analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    132
    132
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any
    8.3 (4.2 to 14.4)
    11.4 (6.5 to 18.0)
        Redness: MIld
    8.3 (4.2 to 14.4)
    10.6 (5.9 to 17.2)
        Redness: Moderate
    0 (0.0 to 2.8)
    0.8 (0.0 to 4.1)
        Redness: Severe
    0 (0.0 to 2.8)
    0 (0.0 to 2.8)
        Swelling: Any
    9.1 (4.8 to 15.3)
    12.1 (7.1 to 18.9)
        Swelling: Mild
    6.8 (3.2 to 12.5)
    11.4 (6.5 to 18.0)
        Swelling: Moderate
    2.3 (0.5 to 6.5)
    0.8 (0.0 to 4.1)
        Swelling: Severe
    0 (0.0 to 2.8)
    0 (0.0 to 2.8)
        Pain at injection site: Any
    25.0 (17.9 to 33.3)
    19.7 (13.3 to 27.5)
        Pain at injection site: Mild
    18.9 (12.6 to 26.7)
    13.6 (8.3 to 20.7)
        Pain at injection site: Moderate
    6.1 (2.7 to 11.6)
    5.3 (2.2 to 10.6)
        Pain at injection site: Severe
    0 (0.0 to 2.8)
    0.8 (0.0 to 4.1)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 4

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 4 [8]
    End point description
    Systemic Events:recorded daily using an daily e-diary. Systemic events:Fever graded 1)< 38.0 degrees C,2) >= 38.0 degree C to 38.4 degree C,3)38.5 degree C to 38.9 degree C,4)39.0 degree C to 40.0 degree C,5)>40.0 degree C; Decreased appetite graded: mild(decreased interest in eating),moderate(decreased oral intake), severe(refusal to feed);Drowsiness graded: mild(increased or prolonged sleeping bouts),moderate(slightly subdued; interfering with daily activity),severe (disabling;not interested in usual daily activity); Irritability graded: mild(easily consolable),moderate(required increased attention),severe(inconsolable;crying could not be comforted). Subjects may be represented in >1 row. “Any” for decreased appetite,increased sleep,irritability:any grade of these systemic events(SE). Safety population for infant series:all subjects who received at least 1 dose of study vaccine during infant series. “N”:subjects who were evaluable for this measure.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination 4
    Notes
    [8] - 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 analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    132
    132
    Units: percentage of subjects
    number (confidence interval 95%)
        Fever: <38.0 degree C
    3.0 (0.8 to 7.6)
    4.5 (1.7 to 9.6)
        Fever: >=38.0 degree C to 38.4 degree C
    1.5 (0.2 to 5.4)
    3.8 (1.2 to 8.6)
        Fever: 38.5 degree C to 38.9 degree C
    0 (0.0 to 2.8)
    0 (0.0 to 2.8)
        Fever: 39.0 degree C to 40.0 degree C
    0 (0.0 to 2.8)
    0.8 (0.0 to 4.1)
        Fever: >40.0 degree C
    1.5 (0.2 to 5.4)
    0 (0.0 to 2.8)
        Decreased appetite: Any
    15.2 (9.5 to 22.4)
    16.7 (10.7 to 24.1)
        Decreased appetite: Mild
    10.6 (5.9 to 17.2)
    6.8 (3.2 to 12.5)
        Decreased appetite: Moderate
    4.5 (1.7 to 9.6)
    9.8 (5.3 to 16.3)
        Decreased appetite: Severe
    0 (0.0 to 2.8)
    0 (0.0 to 2.8)
        Drowsiness: Any
    7.6 (3.7 to 13.5)
    18.9 (12.6 to 26.7)
        Drowsiness: Mild
    3.8 (1.2 to 8.6)
    12.9 (7.7 to 19.8)
        Drowsiness: Moderate
    3.8 (1.2 to 8.6)
    6.1 (2.7 to 11.6)
        Drowsiness: Severe
    0 (0.0 to 2.8)
    0 (0.0 to 2.8)
        Irritability: Any
    24.2 (17.2 to 32.5)
    23.5 (16.5 to 31.6)
        Irritability: Mild
    15.9 (10.1 to 23.3)
    16.7 (10.7 to 24.1)
        Irritability: Moderate
    7.6 (3.7 to 13.5)
    5.3 (2.2 to 10.6)
        Irritability: Severe
    0.8 (0.0 to 4.1)
    1.5 (0.2 to 5.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3 [9]
    End point description
    An AE was any untoward medical occurrence in a subjects who received study vaccine without regard to possibility of causal relationship. AEs do not include local and systemic reactogenicity. Safety population for infant series included all subjects who received at least 1 dose of study vaccine during infant series.
    End point type
    Primary
    End point timeframe
    First Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months)
    Notes
    [9] - 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 analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    150
    150
    Units: percentage of subjects
        number (confidence interval 95%)
    47.3 (39.1 to 55.6)
    49.3 (41.1 to 57.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4 [10]
    End point description
    An AE was any untoward medical occurrence in a subjects who received study vaccine without regard to possibility of causal relationship. AEs do not include local and systemic reactogenicity. Safety population for toddler dose included all subjects who received at least 1 dose of study vaccine during toddler dosing.
    End point type
    Primary
    End point timeframe
    From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month)
    Notes
    [10] - 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 analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    139
    139
    Units: percentage of subjects
        number (confidence interval 95%)
    7.9 (4.0 to 13.7)
    8.6 (4.5 to 14.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4

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    End point title
    		 Percentage of Subjects With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4 [11]
    End point description
    An AE was any untoward medical occurrence in a subject who received study vaccine without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Safety population for study included all subjects who received at least 1 dose of study vaccine in study.
    End point type
    Primary
    End point timeframe
    From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months)
    Notes
    [11] - 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 analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    150
    150
    Units: percentage of subjects
        number (confidence interval 95%)
    8.0 (4.2 to 13.6)
    4.7 (1.9 to 9.4)
    No statistical analyses for this end point

    Primary: Number of Subjects With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4

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    End point title
    		 Number of Subjects With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4 [12]
    End point description
    A newly diagnosed chronic medical condition was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. Safety population for study included all subjects who received at least 1 dose of study vaccine in study.
    End point type
    Primary
    End point timeframe
    From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months)
    Notes
    [12] - 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 analyzed for this endpoint.
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    150
    150
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3

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    End point title
    		 Percentage of Subjects With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
    End point description
    Percentage of subjects achieving predefined antibody threshold: >=0.35 microgram per milliliter (mcg/mL) for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F; threshold >= 0.23 mcg/mL for serotype 5, threshold >= 0.10 mcg/mL for serotype 6B, threshold >= 0.12 mcg/mL for serotype 19A, along with the corresponding 95 percent (%) confidence interval (CI) are reported. Evaluable immunogenicity population for infant series: all eligible subjects aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post-Dose 3 within 27 to 56 days (inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 3
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    136
    133
    Units: percentage of subjects
    number (confidence interval 95%)
        Serotype: 1
    91.2 (85.1 to 95.4)
    85.0 (77.7 to 90.6)
        Serotype: 3
    91.9 (86.0 to 95.9)
    85.7 (78.6 to 91.2)
        Serotype: 4
    91.2 (85.1 to 95.4)
    91.0 (84.8 to 95.3)
        Serotype: 5
    84.6 (77.4 to 90.2)
    82.0 (74.4 to 88.1)
        Serotype: 6A
    83.8 (76.5 to 89.6)
    71.4 (63.0 to 78.9)
        Serotype: 6B
    77.2 (69.2 to 84.0)
    75.2 (67.0 to 82.3)
        Serotype: 7F
    96.3 (91.6 to 98.8)
    93.2 (87.5 to 96.9)
        Serotype: 9V
    85.3 (78.2 to 90.8)
    83.5 (76.0 to 89.3)
        Serotype: 14
    88.2 (81.6 to 93.1)
    82.7 (75.2 to 88.7)
        Serotype: 18C
    92.6 (86.9 to 96.4)
    84.2 (76.9 to 90.0)
        Serotype: 19A
    100.0 (97.3 to 100.0)
    98.5 (94.7 to 99.8)
        Serotype: 19F
    97.8 (93.7 to 99.5)
    95.5 (90.4 to 98.3)
        Serotype: 23F
    84.6 (77.4 to 90.2)
    76.7 (68.6 to 83.6)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4

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    End point title
    		 Percentage of Subjects With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
    End point description
    Percentage of subjects achieving predefined antibody threshold >=0.35 mcg/mL for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F, threshold >= 0.23 mcg/mL for serotype 5, threshold >= 0.10 mcg/mL for serotype 6B, threshold >= 0.12 mcg/mL for serotype 19A, along with the corresponding 95% CI are reported. Evaluable immunogenicity population for toddler dose: all eligible subjects who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days, inclusive, post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations. "Overall number of Subjects Analyzed": signifies number of subjects evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 4
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    132
    129
    Units: percentage of subjects
    number (confidence interval 95%)
        Serotype: 1
    99.2 (95.9 to 100.0)
    100.0 (97.2 to 100.0)
        Serotype: 3
    97.0 (92.4 to 99.2)
    98.4 (94.5 to 99.8)
        Serotype: 4
    99.2 (95.9 to 100.0)
    100.0 (97.2 to 100.0)
        Serotype: 5
    99.2 (95.9 to 100.0)
    100.0 (97.2 to 100.0)
        Serotype: 6A
    96.2 (91.4 to 98.8)
    96.9 (92.3 to 99.1)
        Serotype: 6B
    98.5 (94.6 to 99.8)
    96.9 (92.3 to 99.1)
        Serotype: 7F
    99.2 (95.9 to 100.0)
    99.2 (95.8 to 100.0)
        Serotype: 9V
    98.5 (94.6 to 99.8)
    99.2 (95.8 to 100.0)
        Serotype: 14
    97.7 (93.5 to 99.5)
    96.1 (91.2 to 98.7)
        Serotype: 18C
    97.0 (92.4 to 99.2)
    99.2 (95.8 to 100.0)
        Serotype: 19A
    99.2 (95.9 to 100.0)
    99.2 (95.8 to 100.0)
        Serotype: 19F
    98.5 (94.6 to 99.8)
    100.0 (97.2 to 100.0)
        Serotype: 23F
    99.2 (95.9 to 100.0)
    96.9 (92.3 to 99.1)
    No statistical analyses for this end point

    Secondary: Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3

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    End point title
    		 Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
    End point description
    Antibody (IgG) GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported. Evaluable immunogenicity population for infant series: all eligible subjects aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post-Dose 3 within 27 to 56 days (inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 3
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    136
    133
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype: 1
    1.36 (1.15 to 1.60)
    1.13 (0.94 to 1.36)
        Serotype: 3
    1.01 (0.88 to 1.16)
    0.93 (0.80 to 1.07)
        Serotype: 4
    1.67 (1.40 to 1.98)
    1.75 (1.45 to 2.11)
        Serotype: 5
    0.83 (0.67 to 1.02)
    0.86 (0.67 to 1.11)
        Serotype: 6A
    1.45 (1.13 to 1.87)
    0.86 (0.66 to 1.12)
        Serotype: 6B
    0.41 (0.31 to 0.55)
    0.33 (0.24 to 0.46)
        Serotype: 7F
    2.01 (1.74 to 2.33)
    1.85 (1.52 to 2.26)
        Serotype: 9V
    1.42 (1.17 to 1.73)
    1.28 (1.02 to 1.62)
        Serotype: 14
    1.66 (1.33 to 2.06)
    1.39 (1.09 to 1.76)
        Serotype: 18C
    1.81 (1.50 to 2.18)
    1.37 (1.10 to 1.71)
        Serotype: 19A
    2.33 (1.96 to 2.78)
    1.86 (1.51 to 2.28)
        Serotype: 19F
    2.89 (2.52 to 3.31)
    2.43 (2.04 to 2.89)
        Serotype: 23F
    1.48 (1.20 to 1.81)
    0.94 (0.73 to 1.21)
    No statistical analyses for this end point

    Secondary: Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4

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    End point title
    		 Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
    End point description
    Antibody (IgG) GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported. Evaluable immunogenicity population for toddler dose: all eligible subjects who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post-Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 4
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    132
    130
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype: 1
    4.35 (3.71 to 5.10)
    4.27 (3.65 to 4.99)
        Serotype: 3
    1.58 (1.36 to 1.83)
    1.63 (1.43 to 1.86)
        Serotype: 4
    10.58 (8.89 to 12.60)
    11.91 (10.19 to 13.93)
        Serotype: 5
    5.16 (4.37 to 6.10)
    5.68 (4.81 to 6.70)
        Serotype: 6A
    18.55 (14.32 to 24.02)
    20.51 (16.32 to 25.78)
        Serotype: 6B
    11.76 (9.24 to 14.98)
    10.87 (8.14 to 14.53)
        Serotype: 7F
    7.92 (6.88 to 9.13)
    8.29 (7.17 to 9.57)
        Serotype: 9V
    8.78 (7.19 to 10.73)
    9.57 (8.00 to 11.44)
        Serotype: 14
    13.20 (10.69 to 16.30)
    11.78 (9.31 to 14.90)
        Serotype: 18C
    6.21 (5.19 to 7.44)
    6.27 (5.25 to 7.48)
        Serotype: 19A
    12.26 (10.26 to 14.65)
    12.02 (9.75 to 14.82)
        Serotype: 19F
    13.65 (11.16 to 16.69)
    14.09 (11.71 to 16.96)
        Serotype: 23F
    10.89 (8.78 to 13.50)
    9.90 (7.75 to 12.66)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3

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    End point title
    		 Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
    End point description
    Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs. Evaluable immunogenicity population for infant series: all eligible subjects aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post Dose 3 within 27 to 56 days (inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 3
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    136
    133
    Units: titer (1/dilution)
    geometric mean (confidence interval 95%)
        Serotype: 1
    21.8 (18.1 to 26.2)
    22.5 (18.1 to 27.9)
        Serotype: 3
    79.7 (68.8 to 92.3)
    72.8 (62.7 to 84.6)
        Serotype: 4
    1158.8 (938.3 to 1431.1)
    1159.2 (948.3 to 1417.0)
        Serotype: 5
    37.0 (31.4 to 43.5)
    40.9 (34.0 to 49.3)
        Serotype: 6A
    1211.7 (896.4 to 1638.0)
    1321.9 (1026.7 to 1701.9)
        Serotype: 6B
    1145.8 (870.4 to 1508.3)
    957.6 (708.2 to 1294.8)
        Serotype: 7F
    1743.3 (1436.6 to 2115.5)
    1178.8 (952.6 to 1458.6)
        Serotype: 9V
    643.9 (498.6 to 831.7)
    683.3 (522.6 to 893.3)
        Serotype: 14
    496.9 (344.2 to 717.3)
    341.8 (236.0 to 495.0)
        Serotype: 18C
    3055.8 (2378.5 to 3926.0)
    2183.9 (1686.9 to 2827.3)
        Serotype: 19A
    219.3 (169.4 to 283.9)
    275.7 (212.0 to 358.6)
        Serotype: 19F
    236.1 (191.6 to 291.1)
    272.7 (219.1 to 339.4)
        Serotype: 23F
    1036.4 (746.9 to 1438.0)
    926.8 (673.9 to 1274.7)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4

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    End point title
    		 Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
    End point description
    Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs. Evaluable immunogenicity population for toddler dose: all eligible subjects who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 4
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    132
    130
    Units: titer (1/dilution)
    geometric mean (confidence interval 95%)
        Serotype: 1
    204.2 (164.7 to 253.3)
    217.0 (176.4 to 266.9)
        Serotype: 3
    121.0 (104.4 to 140.3)
    129.8 (111.7 to 150.8)
        Serotype: 4
    2991.4 (2437.5 to 3671.3)
    2519.0 (2098.7 to 3023.6)
        Serotype: 5
    157.6 (131.9 to 188.3)
    153.4 (126.6 to 185.8)
        Serotype: 6A
    2945.7 (2376.0 to 3652.1)
    3092.5 (2493.5 to 3835.4)
        Serotype: 6B
    1948.9 (1521.4 to 2496.7)
    1750.1 (1360.9 to 2250.8)
        Serotype: 7F
    4161.5 (3498.0 to 4950.9)
    4353.8 (3706.5 to 5114.0)
        Serotype: 9V
    6927.5 (5765.9 to 8323.2)
    6460.4 (5277.3 to 7908.7)
        Serotype: 14
    1505.8 (1246.5 to 1819.0)
    1302.2 (1106.1 to 1533.2)
        Serotype: 18C
    8028.3 (6233.7 to 10339.7)
    7830.0 (5998.5 to 10220.7)
        Serotype: 19A
    1848.9 (1472.0 to 2322.2)
    1832.5 (1454.9 to 2308.1)
        Serotype: 19F
    808.0 (633.0 to 1033.5)
    766.0 (609.2 to 963.2)
        Serotype: 23F
    3125.0 (2450.8 to 3984.7)
    3348.8 (2639.5 to 4248.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3

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    End point title
    		 Percentage of Subjects With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
    End point description
    Percentage of subjects achieving OPA titer >=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of subjects was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Seotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13. Evaluable immunogenicity population for infant series: all eligible subjects aged 6 weeks at time of Dose 1, who received 3 doses of vaccine, had blood drawn post-Dose 3 within 27 to 56 days (inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations. "Overall Number of Subjects Analyzed": signifies number of subjects evaluable for this measure. "Number Analyzed, n": signifies subjects evaluable for specific serotype.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 3
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    114
    108
    Units: percentage of subjects
    number (confidence interval 95%)
        Serotype: 1 (n=111, 106)
    51.4 (41.7 to 61.0)
    46.2 (36.5 to 56.2)
        Serotype: 3 (n=109, 107)
    98.2 (93.5 to 99.8)
    98.1 (93.4 to 99.8)
        Serotype: 4 (n=105, 101)
    98.1 (93.3 to 99.8)
    99.0 (94.6 to 100.0)
        Serotype: 5 (n=114, 107)
    62.3 (52.7 to 71.2)
    62.6 (52.7 to 71.8)
        Serotype: 6A (n= 113, 107)
    91.2 (84.3 to 95.7)
    94.4 (88.2 to 97.9)
        Serotype: 6B (n=109, 104)
    94.5 (88.4 to 98.0)
    92.3 (85.4 to 96.6)
        Serotype: 7F (n=96, 93)
    99.0 (94.3 to 100.0)
    96.8 (90.9 to 99.3)
        Serotype: 9V (n=103, 100)
    88.3 (80.5 to 93.8)
    88.0 (80.0 to 93.6)
        Serotype: 14 (n= 111, 108)
    82.9 (74.6 to 89.4)
    76.9 (67.8 to 84.4)
        Serotype: 18C (n=103, 99)
    98.1 (93.2 to 99.8)
    98.0 (92.9 to 99.8)
        Serotype: 19A (n= 101, 92)
    92.1 (85.0 to 96.5)
    95.7 (89.2 to 98.8)
        Serotype: 19F (n=107, 105)
    89.7 (82.3 to 94.8)
    91.4 (84.4 to 96.0)
        Serotype: 23F (n= 99, 98)
    94.9 (88.6 to 98.3)
    94.9 (88.5 to 98.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination(V) 4

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    End point title
    		 Percentage of Subjects With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination(V) 4
    End point description
    Percentage of subjects achieving OPA titer >=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of subjects was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Seotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13. Evaluable immunogenicity population for toddler dose: all eligible subejcts who received 3 doses in infant series(IS) and 1 toddler dose(TD) of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations."Overall Number of Subjects Analyzed": signifies number of subjects evaluable for this measure. "Number Analyzed, n": signifies subjects evaluable for specific serotype.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 4
    End point values
    		 13vPnC: Multi-dose Vial (With Preservative) 13vPnC: Single-dose Prefilled Syringe (Without Preservative)
    Number of subjects analysed
    106
    102
    Units: percentage of subjects
    number (confidence interval 95%)
        Serotype: 1 (n=105, 102)
    97.1 (91.9 to 99.4)
    97.1 (91.6 to 99.4)
        Serotype: 3 (n=106, 101)
    98.1 (93.4 to 99.8)
    100.0 (96.4 to 100.0)
        Serotype: 4 (n=102, 99)
    100.0 (96.4 to 100.0)
    100.0 (96.3 to 100.0)
        Serotype: 5 (n=105, 102)
    95.2 (89.2 to 98.4)
    97.1 (91.6 to 99.4)
        Serotype: 6A (n=104, 101)
    100.0 (96.5 to 100.0)
    99.0 (94.6 to 100.0)
        Serotype: 6B (n=101, 101)
    97.0 (91.6 to 99.4)
    95.0 (88.8 to 98.4)
        Serotype: 7F (n=97, 90)
    100.0 (96.3 to 100.0)
    100.0 (96.0 to 100.0)
        Serotype: 9V (n=100, 98)
    100.0 (96.4 to 100.0)
    99.0 (94.4 to 100.0)
        Serotype: 14 (n=106, 101)
    100.0 (96.6 to 100.0)
    100.0 (96.4 to 100.0)
        Serotype: 18C (n=100, 100)
    99.0 (94.6 to 100.0)
    99.0 (94.6 to 100.0)
        Serotype: 19A (n=97, 96)
    100.0 (96.3 to 100.0)
    99.0 (94.3 to 100.0)
        Serotype: 19F (n=102, 99)
    96.1 (90.3 to 98.9)
    97.0 (91.4 to 99.4)
        Serotype: 23F (n=102, 96)
    99.0 (94.7 to 100.0)
    99.0 (94.3 to 100.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    IS:SAEs/Non SAEs=V1 upto 1month post V3(upto 3months).TD:SAEs/Non SAEs=upto 1month post V4(upto 1month). Gap between IS and TD:SAEs=1month post V3 upto V4(up to 7.5months),Non-SAEs:not planned to be collected. LR/SE=7days post any V(systematic assessment)
    Adverse event reporting additional description
    AE=both SAE & non-SAE,but are distinct events.Subject may have both SAE & non-SAE.Safety population evaluated.Infant series(IS):subjects followed from V1 to pre-V 4(toddler dose[TD]),so counted in arms:"13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose".TD series:139 subjects who had V4.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    13vPnC, MDV With Preservative: Infant Series
    Reporting group description
    		 Infant series: subjects were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).

    Reporting group title
    13vPnC, PFS Without Preservative: Infant Series
    Reporting group description
    		 Infant series: subjects were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Subjects were followed-up to 1 month after Vaccination 3. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).

    Reporting group title
    13vPnC, MDV With Preservative: Toddler Dose
    Reporting group description
    		 Toddler dose followed infant series. Toddler dose: subjects were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).

    Reporting group title
    13vPnC, PFS Without Preservative: Toddler Dose
    Reporting group description
    		 Toddler dose followed infant series. Toddler dose: subjects were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Subjects were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).

    Reporting group title
    13vPnC, MDV: Gap Between Infant Series and Toddler Dose
    Reporting group description
    		 This arm is created to report the safety data of subjects for the duration “from 1 month after infant series until the time of toddler dose vaccination (pre-vaccination)”. It included subjects who received any dose of 13vPnC vaccine with preservative 2-PE from a MDV, intramuscularly during infant series and followed up to vaccination in toddler dose.

    Reporting group title
    13vPnC, PFS: Gap Between Infant Series and Toddler Dose
    Reporting group description
    		 This arm is created to report the safety data of subjects for the duration “from 1 month after infant series until the time of toddler dose vaccination (pre-vaccination)”. It included subjects who received any dose of 13vPnC vaccine without preservative 2-PE from a single dose PFS, intramuscularly during infant series and followed up to vaccination in toddler dose.

    Serious adverse events
    		 13vPnC, MDV With Preservative: Infant Series 13vPnC, PFS Without Preservative: Infant Series 13vPnC, MDV With Preservative: Toddler Dose 13vPnC, PFS Without Preservative: Toddler Dose 13vPnC, MDV: Gap Between Infant Series and Toddler Dose 13vPnC, PFS: Gap Between Infant Series and Toddler Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 150 (3.33%)
    4 / 150 (2.67%)
    1 / 139 (0.72%)
    0 / 139 (0.00%)
    6 / 150 (4.00%)
    3 / 150 (2.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 150 (1.33%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 139 (0.72%)
    0 / 139 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    4 / 150 (2.67%)
    2 / 150 (1.33%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 139 (0.72%)
    0 / 139 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    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
    Cellulitis
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    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
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 13vPnC, MDV With Preservative: Infant Series 13vPnC, PFS Without Preservative: Infant Series 13vPnC, MDV With Preservative: Toddler Dose 13vPnC, PFS Without Preservative: Toddler Dose 13vPnC, MDV: Gap Between Infant Series and Toddler Dose 13vPnC, PFS: Gap Between Infant Series and Toddler Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    145 / 150 (96.67%)
    141 / 150 (94.00%)
    58 / 139 (41.73%)
    54 / 139 (38.85%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    Nervous system disorders
    Hypersomnia (Increased sleep)
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
         subjects affected / exposed
    105 / 150 (70.00%)
    116 / 150 (77.33%)
    10 / 139 (7.19%)
    25 / 139 (17.99%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    228
    274
    10
    27
    0
    0
    General disorders and administration site conditions
    Injection site pain-1
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
         subjects affected / exposed
    44 / 150 (29.33%)
    46 / 150 (30.67%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    103
    111
    0
    0
    0
    0
    Injection site pain-2
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
    alternative assessment type: Systematic
         subjects affected / exposed
    117 / 150 (78.00%)
    125 / 150 (83.33%)
    33 / 139 (23.74%)
    26 / 139 (18.71%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    261
    291
    33
    27
    0
    0
    Injection site swelling
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
         subjects affected / exposed
    17 / 150 (11.33%)
    16 / 150 (10.67%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    22
    20
    0
    0
    0
    0
    Pyrexia-1
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
         subjects affected / exposed
    12 / 150 (8.00%)
    7 / 150 (4.67%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    15
    12
    0
    0
    0
    0
    Pyrexia- 2
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
    alternative assessment type: Systematic
         subjects affected / exposed
    37 / 150 (24.67%)
    32 / 150 (21.33%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    45
    41
    0
    0
    0
    0
    Swelling
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
    alternative assessment type: Systematic
         subjects affected / exposed
    64 / 150 (42.67%)
    70 / 150 (46.67%)
    12 / 139 (8.63%)
    16 / 139 (11.51%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    116
    149
    12
    18
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema (Redness)
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
    alternative assessment type: Systematic
         subjects affected / exposed
    52 / 150 (34.67%)
    49 / 150 (32.67%)
    11 / 139 (7.91%)
    15 / 139 (10.79%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    92
    96
    11
    17
    0
    0
    Psychiatric disorders
    Irritability
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
    alternative assessment type: Systematic
         subjects affected / exposed
    114 / 150 (76.00%)
    117 / 150 (78.00%)
    32 / 139 (23.02%)
    31 / 139 (22.30%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    293
    315
    36
    35
    0
    0
    Infections and infestations
    Upper respiratory tract infection
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
         subjects affected / exposed
    16 / 150 (10.67%)
    10 / 150 (6.67%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    16
    15
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
    Additional description: Gap between Infant series and Toddler dose=non-SAEs: were not planned to be collected. Database does not accept zero for numbers exposed, therefore, mentioned the number of exposed subjects.
    alternative assessment type: Systematic
         subjects affected / exposed
    92 / 150 (61.33%)
    107 / 150 (71.33%)
    20 / 139 (14.39%)
    22 / 139 (15.83%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    186
    213
    24
    28
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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