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    Clinical Trial Results:
    A Phase 4, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Prevenar in Healthy Children in China Who Have Been Previously Immunized with a 4-dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 0887x-101518

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-004179-22
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Mar 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    02 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    reporting periods and duplicate AEs in their data

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B1841009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01298544
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: 6114A1-4001
    Sponsors
    Sponsor organisation name
    Pfizer
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, 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
    18 Jan 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the antibody levels to the 7 pneumococcal vaccine serotypes at least 36 months after administration of the toddler vaccination in groups 1 and 2 in Wyeth study 0887X 101518, as measured by serotype specific immunoglobulin G (IgG) concentrations.
    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 Dec 2010
    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
    China: 335
    Worldwide total number of subjects
    335
    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)
    0
    Children (2-11 years)
    335
    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
    		 All eligible subjects who completed a previous study, 0887X-101518 (NCT00488826), were invited to participate in this study, at a timepoint at least 3 years after their last vaccination in study 0887X-101518.

    Pre-assignment
    Screening details
    		 No vaccines administered during study. However, subjects assessed according to the vaccine group they were assigned to in study 0887X‑101518: 7-valent pneumococcal conjugate vaccine (7vPnC) alone (Group 1), 7vPnC given concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) (Group 2), or DTaP alone (Group 3).

    Period 1
    Period 1 title
    Entire Study Population (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Entire Study Population
    Arm description
    		 All randomized subjects.
    Arm type
    		 No intervention

    Investigational medicinal product name
    DTaP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No investigational product was administered during the Study. Subjects previously received DTaP in a preceding study, 0887X101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3) of age, with or without combination of 7vPnC at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3) and 12 to 15 months (vaccination 4) of age.

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No investigational product was administered during the Study. Subjects previously received 7vPnC in a preceding study, 0887X101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age, with or without combination of DTaP at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3) of age.

    Number of subjects in period 1
    		Entire Study Population
    Started
    335
    Completed
    335

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Entire Study Population
    Reporting group description
    		 -

    Reporting group values
    		 Entire Study Population Total
    Number of subjects
    		 335 335
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 5.04 ( 0.15 ) -
    Gender, Male/Female
    Units: subjects
        Female
    		 149 149
        Male
    		 186 186

    End points

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    End points reporting groups
    Reporting group title
    Entire Study Population
    Reporting group description
    		 All randomized subjects.

    Subject analysis set title
    DTaP Alone
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    No investigational product was administered during the study. Subjects previously received DTaP in a preceding study, 0887X101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).

    Subject analysis set title
    7vPnC
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    No investigational product was administered during the study. Subjects previously received 7vPnC in a preceding study, 0887X101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.

    Subject analysis set title
    7vPnC and DTaP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    No investigational product was administered during the study. Subjects previously received 7vPnC in a preceding study, 0887X101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age, with combination of DTaP at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3) of age.

    Primary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
    End point description
    Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw. Evaluable Immunogenicity population: eligible subjects who had blood drawn within required time frame, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Primary
    End point timeframe
    Day 1 (36 months after toddler dose)
    End point values
    		 DTaP Alone 7vPnC 7vPnC and DTaP
    Number of subjects analysed
    91
    123
    121
    Units: microgram per milliliter (mcg/mL)
    geometric mean (confidence interval 95%)
        Serotype 4
    0.41 (0.29 to 0.58)
    0.98 (0.77 to 1.23)
    0.66 (0.52 to 0.84)
        Serotype 6B
    3.37 (2.76 to 4.13)
    11.35 (9.71 to 13.27)
    9.24 (7.66 to 11.16)
        Serotype 9V
    1.05 (0.83 to 1.32)
    1.35 (1.13 to 1.62)
    1.29 (1.08 to 1.54)
        Serotype 14
    0.55 (0.4 to 0.76)
    4.5 (3.38 to 5.98)
    3.02 (2.25 to 4.05)
        Serotype 18C
    0.34 (0.24 to 0.47)
    0.8 (0.66 to 0.97)
    0.77 (0.6 to 0.98)
        Serotype 19F
    1.7 (1.35 to 2.15)
    10.14 (8.06 to 12.75)
    5.67 (4.5 to 7.14)
        Serotype 23F
    1.44 (1.17 to 1.76)
    3.31 (2.8 to 3.91)
    2.71 (2.26 to 3.25)
    Statistical analysis title
    		 Serotype 4: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 2 - Group 1).
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 0.94
    Statistical analysis title
    		 Serotype 6B: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 2 - Group 1).
    Comparison groups
    7vPnC and DTaP v 7vPnC
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.04
    Statistical analysis title
    		 Serotype 9V: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 2 - Group 1).
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.23
    Statistical analysis title
    		 Serotype 14: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Ratio of GMC,s was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 2 - Group 1).
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.01
    Statistical analysis title
    		 Serotype 18C: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 2 - Group 1).
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.31
    Statistical analysis title
    		 Serotype 19F: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 2 - Group 1).
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.77
    Statistical analysis title
    		 Serotype 23F: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 2 - Group 1).
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.05
    Statistical analysis title
    		 Serotype 4: All groups
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).
    Comparison groups
    7vPnC v 7vPnC and DTaP v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    1.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.39
         upper limit
    		 2.8
    Statistical analysis title
    		 Serotyope 6B: All groups
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).
    Comparison groups
    7vPnC and DTaP v 7vPnC v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    3.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.41
         upper limit
    		 3.84
    Statistical analysis title
    		 Serotype 9V: All groups
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).
    Comparison groups
    7vPnC v 7vPnC and DTaP v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.62
    Statistical analysis title
    		 Serotype 14: All groups
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).
    Comparison groups
    7vPnC v 7vPnC and DTaP v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    6.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.53
         upper limit
    		 9.79
    Statistical analysis title
    		 Serotype 18C: All groups
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).
    Comparison groups
    7vPnC v 7vPnC and DTaP v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    2.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.68
         upper limit
    		 3.24
    Statistical analysis title
    		 Serotype 19F: All groups
    Statistical analysis description
    Ratio of GMC's was calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).
    Comparison groups
    7vPnC v 7vPnC and DTaP v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    4.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.29
         upper limit
    		 6.07
    Statistical analysis title
    		 Serotype 23F: All groups
    Statistical analysis description
    Ratio of GMC's is calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).
    Comparison groups
    7vPnC v 7vPnC and DTaP v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of GMC's
    Point estimate
    2.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.65
         upper limit
    		 2.63

    Other pre-specified: Percentage of subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose

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    End point title
    		 Percentage of subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
    End point description
    Percentage of subjects achieving predefined antibody threshold greater than or equal to (≥)0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of subjects. Evaluable Immunogenicity population.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 (36 months after toddler dose)
    End point values
    		 DTaP Alone 7vPnC 7vPnC and DTaP
    Number of subjects analysed
    91
    123
    121
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serotype 4
    48.8 (37.7 to 60)
    82.9 (75.1 to 89.1)
    64.5 (55.2 to 73)
        Serotype 6B
    97.8 (92.3 to 99.7)
    100 (97 to 100)
    100 (97 to 100)
        Serotype 9V
    83.5 (74.3 to 90.5)
    93.5 (87.6 to 97.2)
    94.2 (88.4 to 97.6)
        Serotype 14
    63.7 (53 to 73.6)
    95.1 (89.7 to 98.2)
    91.7 (85.3 to 96)
        Serotype 18C
    45.5 (34.8 to 56.4)
    81.3 (73.3 to 87.8)
    69.4 (60.4 to 77.5)
        Serotype 19F
    92.2 (84.6 to 96.8)
    100 (97 to 100)
    97.5 (92.9 to 99.5)
        Serotype 23F
    93.4 (86.2 to 97.5)
    100 (97 to 100)
    99.2 (95.5 to 100)
    Statistical analysis title
    		 Serotype 4: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -18.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.4
         upper limit
    		 -7.3
    Statistical analysis title
    		 Serotype 6B: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 3
    Statistical analysis title
    		 Serotype 9V: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 7.3
    Statistical analysis title
    		 Serotype 14: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 3.1
    Statistical analysis title
    		 Serotype 18C: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -11.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.7
         upper limit
    		 -1
    Statistical analysis title
    		 Serotype 19F: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 0.6
    Statistical analysis title
    		 Serotype 23F: 7vPnC vs 7vPnC and DTaP
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 2.3
    Statistical analysis title
    		 Serotype 4: All groups
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.
    Comparison groups
    7vPnC v DTaP Alone v 7vPnC and DTaP
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.7
         upper limit
    		 37
    Statistical analysis title
    		 Serotype 6B: All groups
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 7.7
    Statistical analysis title
    		 Serotype 9V: All groups
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.9
         upper limit
    		 19.6
    Statistical analysis title
    		 Serotype 14: All groups
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    29.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.4
         upper limit
    		 40.5
    Statistical analysis title
    		 Serotype 18C: All groups
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.
    Comparison groups
    7vPnC and DTaP v 7vPnC v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.9
         upper limit
    		 41.5
    Statistical analysis title
    		 Serotype 19F: All groups
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.
    Comparison groups
    7vPnC v 7vPnC and DTaP v DTaP Alone
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 13.9
    Statistical analysis title
    		 Serotype 23F: All groups
    Statistical analysis description
    Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.
    Comparison groups
    7vPnC v DTaP Alone v 7vPnC and DTaP
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 13

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Time of informed consent to blood withdraw on day 1
    Adverse event reporting additional description
    MedDRA dictionary version was not available, hence 0.0 is mentioned for dictionary version.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Entire Study Population
    Reporting group description
    		 All randomized subjects.

    Serious adverse events
    		 Entire Study Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 335 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Entire Study Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 335 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No Serious Adverse Event or Non Serious Adverse Event had been reported during the study.

    More information

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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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