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    Clinical Trial Results:
    A Phase 4, Open-label Trial to Assess the Safety, Tolerability, and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination

    Summary
    EudraCT number
    		 2014-004178-40
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Sep 2012

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

    Trial information

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    Trial identification
    Sponsor protocol code
    B1841008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01193582
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Protocol: 6114A1-4000
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc., 001 8007181021, linicalTrials.govInquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc., 001 8007181021, linicalTrials.govInquiries@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
    11 Jun 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the serotype-specific pneumococcal immune responses induced by Prevenar when measured 1 month after the last dose of Prevenar in each age group. To assess the pre-vaccination antibody levels to the 7 pneumococcal serotypes in Prevenar in each age 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 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
    09 Nov 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 505
    Worldwide total number of subjects
    505
    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)
    325
    Children (2-11 years)
    180
    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
    		 This report presents results following completion of all vaccinations, including data from the 12-month follow-up. This study was conducted at one site in China.

    Pre-assignment
    Screening details
    		 Subjects were enrolled into 1 of 4 groups based on inclusion/exclusion criteria without a screening period. A total of 506 subjects were enrolled in this study, 505 received at least 1 dose of vaccine Subject disposition and baseline characteristics are represented for the treated subjects.

    Period 1
    Period 1 title
    Vaccination Series
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Subjects 121 to less than (<) 212 days of age and received 4 doses of Prevenar.
    Arm type
    		 Experimental

    Investigational medicinal product name
    7-valent Pneumococcal Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 4 doses of Prevenar administered as a single 0.5 milliliter (mL) dose intramuscularly.

    Arm title
    		 Group 2
    Arm description
    		 Subjects 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
    Arm type
    		 Experimental

    Investigational medicinal product name
    7-valent Pneumococcal Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of Prevenar administered as a single 0.5 mL dose intramuscularly.

    Arm title
    		 Group 3
    Arm description
    		 Subjects 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar.
    Arm type
    		 Experimental

    Investigational medicinal product name
    7-valent Pneumococcal Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of Prevenar administered as a single 0.5 mL dose intramuscularly.

    Arm title
    		 Group 4
    Arm description
    		 Subjects 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
    Arm type
    		 Experimental

    Investigational medicinal product name
    7-valent Pneumococcal Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single 0.5 mL intramuscular doses of Prevenar.

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4
    Started
    100
    100
    125
    180
    Vaccinated Dose 1
    100
    100
    125
    180
    Vaccinated Dose 2
    92
    91
    118
    0 [1]
    Vaccinated Dose 3
    90
    89
    0 [2]
    0 [3]
    Vaccinated Dose 4
    90
    0 [4]
    0 [5]
    0 [6]
    Completed
    89
    88
    117
    177
    Not completed
    11
    12
    8
    3
         Consent withdrawn by subject
    11
    12
    8
    3
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects were planned to recieve only 1 dose of vaccination (Dose1).
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects were planned to recieve only 2 doses of vaccination (Dose1 and Dose 2).
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects were planned to recieve only 1 dose of vaccination (Dose1).
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects were planned to recieve only 3 doses of vaccination (Dose1, Dose 2 and Dose 3).
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects were planned to recieve only 2 doses of vaccination (Dose1 and Dose 2).
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects were planned to recieve only 1 dose of vaccination (Dose1).
    Period 2
    Period 2 title
    12 Month Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 Follow up period
    Arm description
    		 Included subjects 121 to less than (<) 212 days of age who received 4 doses of Prevenar during vaccination series (period 1).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2 Follow up period
    Arm description
    		 Included subjects 212 days to <12 months of age (before the first birthday) who received 3 doses of Prevenar during vaccination series (period 1).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 3 Follow up period
    Arm description
    		 Included subjects 12 to <24 months of age (before the second birthday) who received 2 doses of Prevenar during vaccination series (period 1).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4 Follow up period
    Arm description
    		 Included subjects 24 to <72 months of age (before the sixth birthday) who received 1 dose of Prevenar during vaccination series (period 1).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Group 1 Follow up period Group 2 Follow up period Group 3 Follow up period Group 4 Follow up period
    Started
    89
    88
    117
    177
    Completed
    83
    88
    113
    166
    Not completed
    6
    0
    4
    11
         Consent withdrawn by subject
    6
    -
    3
    11
         Death
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Subjects 121 to less than (<) 212 days of age and received 4 doses of Prevenar.

    Reporting group title
    Group 2
    Reporting group description
    		 Subjects 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.

    Reporting group title
    Group 3
    Reporting group description
    		 Subjects 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar.

    Reporting group title
    Group 4
    Reporting group description
    		 Subjects 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.

    Reporting group values
    		 Group 1 Group 2 Group 3 Group 4 Total
    Number of subjects
    		 100 100 125 180 505
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 5.3 ( 0.88 ) 9.7 ( 1.45 ) 17.5 ( 4.15 ) 44.42 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 55 53 62 95 265
        Male
    		 45 47 63 85 240
        Unknown
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Subjects 121 to less than (<) 212 days of age and received 4 doses of Prevenar.

    Reporting group title
    Group 2
    Reporting group description
    		 Subjects 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.

    Reporting group title
    Group 3
    Reporting group description
    		 Subjects 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar.

    Reporting group title
    Group 4
    Reporting group description
    		 Subjects 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
    Reporting group title
    Group 1 Follow up period
    Reporting group description
    		 Included subjects 121 to less than (<) 212 days of age who received 4 doses of Prevenar during vaccination series (period 1).

    Reporting group title
    Group 2 Follow up period
    Reporting group description
    		 Included subjects 212 days to <12 months of age (before the first birthday) who received 3 doses of Prevenar during vaccination series (period 1).

    Reporting group title
    Group 3 Follow up period
    Reporting group description
    		 Included subjects 12 to <24 months of age (before the second birthday) who received 2 doses of Prevenar during vaccination series (period 1).

    Reporting group title
    Group 4 Follow up period
    Reporting group description
    		 Included subjects 24 to <72 months of age (before the sixth birthday) who received 1 dose of Prevenar during vaccination series (period 1).

    Primary: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prenevar

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    End point title
    		 Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prenevar [1]
    End point description
    Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95 percent (%) confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw. Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
    End point type
    Primary
    End point timeframe
    1 month after last dose in each group
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    88
    87
    115
    177
    Units: microgram per millilitre (mcg/mL)
    geometric mean (confidence interval 95%)
        Serotype 4 (n= 88, 87, 115, 177)
    6.9 (5.61 to 8.48)
    7.16 (6.09 to 8.42)
    7.53 (6.7 to 8.46)
    9.45 (8.38 to 10.65)
        Serotype 6B (n= 88, 87, 114, 177)
    8.01 (6.24 to 10.3)
    5.79 (4.64 to 7.23)
    4.81 (3.89 to 5.96)
    6.36 (5.32 to 7.59)
        Serotype 9V (n= 88, 87, 115, 177)
    4.11 (3.4 to 4.96)
    4.64 (3.93 to 5.47)
    4.67 (4.18 to 5.21)
    6.14 (5.42 to 6.95)
        Serotype 14 (n= 88, 87, 115, 177)
    12.75 (10.32 to 15.76)
    13.02 (10.89 to 15.57)
    11.98 (10.51 to 13.65)
    9.86 (8.03 to 12.1)
        Serotype 18C (n= 88, 87, 115, 177)
    4.65 (3.81 to 5.69)
    4.65 (3.86 to 5.61)
    5.4 (4.78 to 6.1)
    7.39 (6.41 to 8.51)
        Serotype 19F (n= 87, 87, 115, 177)
    4.05 (3.07 to 5.36)
    4.02 (3.05 to 5.31)
    4.03 (3.26 to 4.98)
    4.53 (3.73 to 5.49)
        Serotype 23F (n= 88, 87, 115, 177)
    4.75 (3.77 to 5.99)
    3.95 (3.19 to 4.89)
    4.18 (3.51 to 4.96)
    5.64 (4.84 to 6.57)
    No statistical analyses for this end point

    Primary: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group

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    End point title
    		 Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group [2]
    End point description
    End point description: Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all subjects with available data for the specified blood draw. Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
    End point type
    Primary
    End point timeframe
    Baseline
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    88
    87
    115
    177
    Units: mcg/ml
    geometric mean (confidence interval 95%)
        Serotype 4 (n= 88, 87, 115, 172)
    0.01 (0.01 to 0.02)
    0.01 (0.01 to 0.02)
    0.02 (0.01 to 0.02)
    0.06 (0.05 to 0.08)
        Serotype 6B (n= 86, 64, 100, 177)
    0.12 (0.1 to 0.15)
    0.16 (0.12 to 0.22)
    0.27 (0.21 to 0.35)
    1.3 (1.08 to 1.55)
        Serotype 9V (n= 88, 84, 113, 177)
    0.1 (0.08 to 0.12)
    0.1 (0.08 to 0.13)
    0.17 (0.13 to 0.21)
    0.66 (0.56 to 0.77)
        Serotype 14 (n= 88, 87, 115, 177)
    0.16 (0.12 to 0.22)
    0.04 (0.03 to 0.05)
    0.03 (0.02 to 0.04)
    0.36 (0.26 to 0.5)
        Serotype 18C (n= 88, 87, 114, 172)
    0.04 (0.03 to 0.06)
    0.02 (0.01 to 0.02)
    0.02 (0.02 to 0.03)
    0.12 (0.1 to 0.16)
        Serotype 19F (n= 88, 85, 115, 169)
    0.11 (0.09 to 0.14)
    0.09 (0.07 to 0.12)
    0.13 (0.1 to 0.17)
    0.71 (0.57 to 0.89)
        Serotype 23F (n= 85, 75, 102, 174)
    0.07 (0.06 to 0.09)
    0.08 (0.06 to 0.11)
    0.17 (0.12 to 0.23)
    0.88 (0.74 to 1.04)
    No statistical analyses for this end point

    Secondary: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1

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    End point title
    		 Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1 [3]
    End point description
    Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all with subjects available data for the specified blood draw. Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after third dose of Prevenar in Group 1
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be analysed to report data for Group 1 only.
    End point values
    		 Group 1
    Number of subjects analysed
    88
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype 4 (n= 88)
    6.38 (5.56 to 7.33)
        Serotype 6B (n= 87)
    2.88 (2.33 to 3.56)
        Serotype 9V (n= 88)
    4.18 (3.51 to 4.98)
        Serotype 14 (n= 88)
    11.16 (9.12 to 13.66)
        Serotype 18C (n= 88)
    4.6 (3.8 to 5.57)
        Serotype 19F (n= 88)
    3.6 (2.75 to 4.72)
        Serotype 23F (n= 88)
    2.45 (1.97 to 3.04)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1 .

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    End point title
    		 Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1 . [4]
    End point description
    End point description: GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Evaluable immunogenicity population consisted of eligible subjects in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination to 1 month after third dose of Prevenar in Group 1
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be analysed to report data for Group 1 only.
    End point values
    		 Group 1
    Number of subjects analysed
    88
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 4 (n= 88)
    453.17 (344.56 to 596.01)
        Serotype 6B (n= 85)
    23.1 (18.15 to 29.4)
        Serotype 9V (n= 88)
    43.38 (33.42 to 56.32)
        Serotype 14 (n= 88)
    69.9 (45.95 to 106.35)
        Serotype 18C (n= 88)
    106.74 (76.83 to 148.31)
        Serotype 19F (n= 88)
    32.52 (23.39 to 45.21)
        Serotype 23F (n= 85)
    34.01 (24.98 to 46.32)
    No statistical analyses for this end point

    Secondary: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2

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    End point title
    		 Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2 [5]
    End point description
    Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. Evaluable immunogenicity population consisted of eligible subjects in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after second dose of Prevenar in Group 2
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be analysed to report data for Group 2 only.
    End point values
    		 Group 2
    Number of subjects analysed
    87
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype 4 (n= 87)
    8.46 (7.36 to 9.72)
        Serotype 6B (n= 85)
    2.67 (2.06 to 3.46)
        Serotype 9V (n= 87)
    4.71 (3.91 to 5.66)
        Serotype 14 (n= 87)
    8.05 (6.71 to 9.68)
        Serotype 18C (n= 87)
    4.93 (4 to 6.08)
        Serotype 19F (n= 87)
    3.03 (2.27 to 4.04)
        Serotype 23F (n= 87)
    2.66 (2.1 to 3.37)
    No statistical analyses for this end point

    Secondary: GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2

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    End point title
    		 GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2 [6]
    End point description
    GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Evaluable immunogenicity population consisted of eligible subjects in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    Pre vaccination to 1 month after second dose of Prevenar in Group 2
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be analysed to report data for Group 2 only.
    End point values
    		 Group 2
    Number of subjects analysed
    87
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 4 (n= 87)
    705.95 (540.5 to 922.05)
        Serotype 6B (n= 63)
    16.64 (11.17 to 24.79)
        Serotype 9V (n= 84)
    44.72 (34.22 to 58.44)
        Serotype 14 (n= 87)
    217.21 (152.52 to 309.33)
        Serotype 18C (n= 87)
    317.9 (219.65 to 460.1)
        Serotype 19F (n= 85)
    33.66 (24.28 to 46.65)
        Serotype 23F (n= 75)
    30.77 (21.3 to 44.45)
    No statistical analyses for this end point

    Secondary: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3

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    End point title
    		 Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3 [7]
    End point description
    Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. Evaluable immunogenicity population consisted of eligible subjects in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after first dose of Prevenar in Group 3
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be analysed to report data for Group 3 only.
    End point values
    		 Group 3
    Number of subjects analysed
    115
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype 4 (n= 115)
    8.44 (7.25 to 9.81)
        Serotype 6B (n= 113)
    1.92 (1.51 to 2.42)
        Serotype 9V (n= 115)
    4.77 (4.09 to 5.56)
        Serotype 14 (n= 115)
    3.37 (2.74 to 4.16)
        Serotype 18C (n= 115)
    5.72 (4.82 to 6.77)
        Serotype 19F (n= 113)
    1.96 (1.55 to 2.49)
        Serotype 23F (n= 115)
    2.83 (2.26 to 3.53)
    No statistical analyses for this end point

    Secondary: GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3

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    End point title
    		 GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3 [8]
    End point description
    GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Evaluable immunogenicity population consisted of eligible subjects in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination to 1 month after first dose of Prevenar in Group 3
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be analysed to report data for Group 3 only.
    End point values
    		 Group 3
    Number of subjects analysed
    115
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 4 (n= 115)
    476.49 (363.31 to 624.93)
        Serotype 6B (n= 99)
    7.06 (5.5 to 9.05)
        Serotype 9V (n= 113)
    28.11 (22.18 to 35.63)
        Serotype 14 (n= 115)
    108.18 (78.76 to 148.6)
        Serotype 18C (n= 114)
    236.39 (182.65 to 305.93)
        Serotype 19F (n= 113)
    15.13 (11.02 to 20.77)
        Serotype 23F (n= 102)
    17.64 (13.43 to 23.17)
    No statistical analyses for this end point

    Secondary: Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose

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    End point title
    		 Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose
    End point description
    Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all subjects with available data for the specified blood draw. Evaluable immunogenicity population consisted subjects who had received all, assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    12 months after the last dose
    End point values
    		 Group 1 Follow up period Group 2 Follow up period Group 3 Follow up period Group 4 Follow up period
    Number of subjects analysed
    81
    79
    111
    162
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype 4 (n=81, 79, 111, 162)
    0.78 (0.62 to 0.98)
    0.65 (0.52 to 0.82)
    0.96 (0.8 to 1.14)
    1.27 (1.11 to 1.45)
        Serotype 6B (n=81, 78, 109, 161 )
    3.22 (2.41 to 4.29)
    2.31 (1.77 to 3.03)
    2.38 (1.89 to 3)
    4.2 (3.49 to 5.04)
        Serotype 9V (n=81, 79, 111, 162 )
    1.26 (1 to 1.59)
    0.98 (0.79 to 1.21)
    1.44 (1.2 to 1.71)
    2.23 (1.94 to 2.56)
        Serotype 14 (n=81, 79, 111, 162)
    1.84 (1.4 to 2.41)
    2.18 (1.62 to 2.94)
    2.61 (2.09 to 3.27)
    5.19 (4.25 to 6.33)
        Serotype 18C (n=81, 79, 111, 162)
    0.87 (0.69 to 1.1)
    0.71 (0.59 to 0.85)
    0.98 (0.84 to 1.15)
    1.46 (1.24 to 1.72)
        Serotype 19F (n=80, 76, 109, 156)
    1.25 (0.95 to 1.64)
    1.29 (0.85 to 1.95)
    1.39 (1.03 to 1.88)
    2.85 (2.28 to 3.56)
        Serotype 23F (n=81, 78, 110, 162)
    1.38 (1.07 to 1.77)
    1.2 (0.91 to 1.59)
    1.79 (1.45 to 2.21)
    2.49 (2.13 to 2.92)
    No statistical analyses for this end point

    Secondary: GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose

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    End point title
    		 GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose
    End point description
    GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination to 12 months after the last dose
    End point values
    		 Group 1 Follow up period Group 2 Follow up period Group 3 Follow up period Group 4 Follow up period
    Number of subjects analysed
    81
    79
    111
    162
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 4 (n= 81, 79, 111, 157)
    52.86 (37.61 to 74.31)
    50.54 (37.47 to 68.18)
    52.19 (39.75 to 68.53)
    21.01 (17.04 to 25.91)
        Serotype 6B (n= 79, 58, 95, 161)
    25.52 (18.57 to 35.07)
    15.58 (10.18 to 23.83)
    7.99 (5.98 to 10.67)
    3.16 (2.7 to 3.7)
        Serotype 9V (n= 81, 76, 109, 162)
    12.73 (9.41 to 17.24)
    8.97 (6.84 to 11.77)
    8.4 (6.55 to 10.77)
    3.35 (2.93 to 3.83)
        Serotype 14 (n= 81, 79, 111, 162)
    10.19 (6.84 to 15.19)
    55.55 (37.23 to 82.87)
    88.27 (63.53 to 122.63)
    15.67 (11.43 to 21.47)
        Serotype 18C (n= 81, 79, 110, 158)
    19.75 (14 to 27.87)
    45.07 (33.12 to 61.33)
    41.14 (32.18 to 52.59)
    11.43 (9.38 to 13.92)
        Serotype 19F (n= 80, 74, 109, 150)
    10.06 (6.85 to 14.77)
    12.62 (8.67 to 18.39)
    11.15 (7.87 to 15.8)
    4.19 (3.19 to 5.51)
        Serotype 23F (n= 79, 67, 97, 159)
    18.8 (13.26 to 26.66)
    13.5 (9.56 to 19.04)
    11.39 (8.31 to 15.61)
    2.86 (2.39 to 3.42)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through 12 months following last dose of Prevenar
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. EU BR specific AE tables were generated using latest coding.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Subjects 121 to <212 days of age and received 4 doses of Prevenar.

    Reporting group title
    Group 2
    Reporting group description
    		 Subjects 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.

    Reporting group title
    Group 3
    Reporting group description
    		 Subjects 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar.

    Reporting group title
    Group 4
    Reporting group description
    		 Subjects 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.

    Serious adverse events
    		 Group 1 Group 2 Group 3 Group 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    1 / 125 (0.80%)
    0 / 180 (0.00%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 125 (0.80%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 125 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 125 (0.80%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis shigella
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 125 (0.80%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 1 Group 2 Group 3 Group 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 100 (3.00%)
    4 / 100 (4.00%)
    3 / 125 (2.40%)
    1 / 180 (0.56%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 100 (2.00%)
    4 / 100 (4.00%)
    1 / 125 (0.80%)
    1 / 180 (0.56%)
         occurrences all number
    2
    4
    2
    1
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 125 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dermatitis Allergic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    2 / 125 (1.60%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0

    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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