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    Clinical Trial Results:
    Immunogenicity and Safety of a Booster Dose of Polysaccharide Pneumococcal vaccine (Pneumo 23®) in 12 to 18 Months-Old Children Primed with Three Doses of Pneumococcal Conjugate Vaccine (Prevnar®) in Thailand

    Summary
    EudraCT number
    		 2015-005337-45
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Mar 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Mar 2016
    First version publication date
    25 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PNA19
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00594347
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
    Public contact
    Franchise Medical Director, Sanofi Pasteur SA, 33 4 37 37 73 84, eric.desauziers@sanofipasteur.com
    Scientific contact
    Franchise Medical Director, Sanofi Pasteur SA, 33 4 37 37 73 84, eric.desauziers@sanofipasteur.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
    29 Jul 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity - To assess and describe the immunogenicity for 12 serotypes of the study vaccines one month after the booster vaccination in both groups Safety - To describe the safety of the study vaccines after the booster vaccination
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Children enrolled in this study completed a three-dose primary vaccination of Pneumococcal Conjugate Vaccine (Prevnar®) in a hexavalent combined vaccine study (2011-004457-87).
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    25 Nov 2007
    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
    Thailand: 339
    Worldwide total number of subjects
    339
    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)
    339
    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
    		 The study subjects were enrolled from 25 November 2007 to 09 February 2008 at 4 clinic centers in Thailand.

    Pre-assignment
    Screening details
    		 A total of 339 subjects who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    A blind observer study design was used in this study and neither the Investigator nor the subject knew which vaccine was administered. To maintain the blind, the product preparation and administration, and the assessment of safety was performed by two different individuals (a nurse and an Investigator, respectively) in two different rooms. In the event of an emergency (i.e., SAE), a scratchable emergency randomization list was provided to the Investigator for unblinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pneumo23
    Arm description
    		 Children 12 to 18 months of age received Pneumo23® vaccine as a booster dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    The 23-valent polysaccharide pneumococcal vaccine, Pneumo23®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the right deltoid, 1 booster injection on Day 0.

    Arm title
    		 Prevnar
    Arm description
    		 Children 12 to 18 months of age received Prevnar® vaccine as a booster dose.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    The 7-valent pneumococcal conjugate vaccine, Prevnar®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the right deltoid, 1 booster injection on Day 0.

    Number of subjects in period 1
    		Pneumo23 Prevnar
    Started
    170
    169
    Completed
    169
    167
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pneumo23
    Reporting group description
    		 Children 12 to 18 months of age received Pneumo23® vaccine as a booster dose.

    Reporting group title
    Prevnar
    Reporting group description
    		 Children 12 to 18 months of age received Prevnar® vaccine as a booster dose.

    Reporting group values
    		 Pneumo23 Prevnar Total
    Number of subjects
    		 170 169 339
    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)
    		 170 169 339
        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
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 14.8 ( 1.5 ) 14.8 ( 1.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 91 88 179
        Male
    		 79 81 160

    End points

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    End points reporting groups
    Reporting group title
    Pneumo23
    Reporting group description
    		 Children 12 to 18 months of age received Pneumo23® vaccine as a booster dose.

    Reporting group title
    Prevnar
    Reporting group description
    		 Children 12 to 18 months of age received Prevnar® vaccine as a booster dose.

    Primary: Summary of Geometric Mean Titers for all Vaccine Serotypes Before and Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine

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    End point title
    		 Summary of Geometric Mean Titers for all Vaccine Serotypes Before and Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine [1]
    End point description
    Individual antibody titers for all serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Pneumo23 Prevnar
    Number of subjects analysed
    169
    169
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Serotype 1; Pre-dose
    0.14 (0.121 to 0.162)
    0.118 (0.105 to 0.132)
        Serotype 1; Post-dose
    7.16 (6.1 to 8.41)
    0.145 (0.128 to 0.165)
        Serotype 1; Post/Pre ratio
    52.5 (43.1 to 63.8)
    1.24 (1.12 to 1.37)
        Serotype 3; Pre-dose
    0.365 (0.309 to 0.43)
    0.303 (0.263 to 0.348)
        Serotype 3; Post-dose
    6.82 (5.51 to 8.44)
    0.666 (0.428 to 1.04)
        Serotype 3; Post/Pre ratio
    15.7 (12.3 to 20)
    1.6 (1.26 to 2.01)
        Serotype 4; Pre-dose
    0.582 (0.519 to 0.651)
    0.562 (0.498 to 0.635)
        Serotype 4; Post-dose
    8.93 (7.77 to 10.3)
    5.71 (5.02 to 6.51)
        Serotype 4; Post/Pre ratio
    15.4 (13 to 18.2)
    10.3 (8.9 to 11.8)
        Serotype 5; Pre-dose
    0.406 (0.353 to 0.466)
    0.381 (0.33 to 0.44)
        Serotype 5; Post-dose
    2.02 (1.75 to 2.32)
    0.435 (0.379 to 0.5)
        Serotype 5; Post/Pre ratio
    4.97 (4.31 to 5.74)
    1.12 (1.07 to 1.18)
        Serotype 6B; Pre-dose
    0.616 (0.52 to 0.729)
    0.562 (0.48 to 0.657)
        Serotype 6B; Post-dose
    11.1 (9.43 to 13.1)
    9.35 (7.91 to 11.1)
        Serotype 6B; Post/Pre ratio
    17.9 (14.9 to 21.6)
    16.5 (13.9 to 19.6)
        Serotype 7F; Pre-dose
    0.115 (0.103 to 0.13)
    0.115 (0.102 to 0.129)
        Serotype 7F; Post-dose
    2.34 (2 to 2.73)
    0.135 (0.12 to 0.153)
        Serotype 7F; Post/Pre ratio
    20.3 (17.3 to 23.7)
    1.18 (1.09 to 1.27)
        Serotype 9V; Pre-dose
    0.533 (0.47 to 0.604)
    0.551 (0.485 to 0.625)
        Serotype 9V; Post-dose
    8.04 (7 to 9.24)
    5.37 (4.7 to 6.13)
        Serotype 9V; Post/Pre ratio
    15.1 (12.9 to 17.6)
    9.76 (8.59 to 11.1)
        Serotype 14; Pre-dose
    2.4 (2.05 to 2.8)
    2.22 (1.91 to 2.57)
        Serotype 14; Post-dose
    16.1 (13.7 to 18.9)
    15.3 (13.2 to 17.6)
        Serotype 14; Post/Pre ratio
    6.72 (5.65 to 7.98)
    6.85 (5.87 to 7.99)
        Serotype 18C; Pre-dose
    0.342 (0.302 to 0.387)
    0.345 (0.306 to 0.39)
        Serotype 18C; Post-dose
    5.99 (5.24 to 6.85)
    3.11 (2.7 to 3.58)
        Serotype 18C; Post/Pre ratio
    17.3 (15 to 20.1)
    9.31 (8.26 to 10.5)
        Serotype 19A; Pre-dose
    0.592 (0.522 to 0.672)
    0.573 (0.502 to 0.655)
        Serotype 19A; Post-dose
    1.94 (1.65 to 2.27)
    1.46 (1.27 to 1.68)
        Serotype 19A; Post/Pre ratio
    3.26 (2.79 to 3.8)
    2.53 (2.24 to 2.86)
        Serotype 19F; Pre-dose
    1.1 (0.971 to 1.26)
    1.14 (0.988 to 1.31)
        Serotype 19F; Post-dose
    14.7 (12.7 to 17)
    5.89 (5.2 to 6.67)
        Serotype 19F; Post/Pre ratio
    13.2 (11.1 to 15.6)
    5.16 (4.49 to 5.94)
        Serotype 23F; Pre-dose
    0.684 (0.581 to 0.805)
    0.581 (0.497 to 0.68)
        Serotype 23F; Post-dose
    9.74 (8.09 to 11.7)
    8.74 (7.37 to 10.4)
        Serotype 23F; Post/Pre ratio
    14.4 (12 to 17.3)
    15.2 (13.1 to 17.5)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with at Least a 2-Fold Increase in Antibody Titers Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine

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    End point title
    		 Percentage of Subjects with at Least a 2-Fold Increase in Antibody Titers Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine [2]
    End point description
    Individual antibody titers for all serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) to Day 30 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Pneumo23 Prevnar
    Number of subjects analysed
    165
    161
    Units: Percentage of subjects
    number (not applicable)
        Serotype 1
    98.8
    11.9
        Serotype 3
    93.1
    17.1
        Serotype 4
    95.9
    96.4
        Serotype 5
    84.6
    4.8
        Serotype 6B
    93.2
    92.4
        Serotype 7F
    98.2
    6
        Serotype 9V
    96.4
    96.4
        Serotype 14
    84.6
    91
        Serotype 18C
    98.2
    97
        Serotype 19A
    61.3
    57.8
        Serotype 19F
    93.5
    84.4
        Serotype 23F
    92.7
    97
    No statistical analyses for this end point

    Primary: Percentage of Subjects with at Least a 4-Fold Increase in Antibody Titers Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine

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    End point title
    		 Percentage of Subjects with at Least a 4-Fold Increase in Antibody Titers Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine [3]
    End point description
    Individual antibody titers for all serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) to Day 30 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Pneumo23 Prevnar
    Number of subjects analysed
    160
    154
    Units: Percentage of subjects
    number (not applicable)
        Serotype 1
    97.5
    3.1
        Serotype 3
    91.7
    5.7
        Serotype 4
    87
    83.8
        Serotype 5
    52.1
    1.2
        Serotype 6B
    89.4
    88
        Serotype 7F
    92.9
    1.8
        Serotype 9V
    92.3
    88
        Serotype 14
    65.1
    66.5
        Serotype 18C
    95.2
    86.7
        Serotype 19A
    36.9
    24.1
        Serotype 19F
    86.9
    63.5
        Serotype 23F
    90.2
    93.3
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Antibody titers ≥ 0.15 µg/mL Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine

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    End point title
    		 Percentage of Subjects with Antibody titers ≥ 0.15 µg/mL Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine [4]
    End point description
    Individual antibody titers for all serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) to Day 30 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Pneumo23 Prevnar
    Number of subjects analysed
    169
    169
    Units: Percentage of subjects
    number (not applicable)
        Serotype 1; Pre-dose
    39.3
    31.1
        Serotype 1; Post-dose
    99.4
    44.2
        Serotype 3; Pre-dose
    88.1
    83.7
        Serotype 3; Post-dose
    98.7
    90.2
        Serotype 4; Pre-dose
    96.4
    95.9
        Serotype 4; Post-dose
    100
    100
        Serotype 5; Pre-dose
    87.6
    83.3
        Serotype 5; Post-dose
    99.4
    89.1
        Serotype 6B; Pre-dose
    94.4
    94.5
        Serotype 6B; Post-dose
    100
    100
        Serotype 7F; Pre-dose
    33.3
    29.8
        Serotype 7F; Post-dose
    99.4
    42.2
        Serotype 9V; Pre-dose
    94.7
    94.7
        Serotype 9V; Post-dose
    100
    100
        Serotype 14; Pre-dose
    98.8
    98.8
        Serotype 14; Post-dose
    100
    100
        Serotype 18C; Pre-dose
    84.5
    88.7
        Serotype 18C; Post-dose
    100
    100
        Serotype 19A; Pre-dose
    97.6
    94.1
        Serotype 19A; Post-dose
    100
    100
        Serotype 19F; Pre-dose
    100
    98.8
        Serotype 19F; Post-dose
    100
    100
        Serotype 23F; Pre-dose
    92.7
    92.2
        Serotype 23F; Post-dose
    100
    98.8
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Antibody titers ≥ 0.35 µg/mL Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine

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    End point title
    		 Percentage of Subjects with Antibody titers ≥ 0.35 µg/mL Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine [5]
    End point description
    Individual antibody titers for all serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) to Day 30 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Pneumo23 Prevnar
    Number of subjects analysed
    169
    169
    Units: Percentage of subjects
    number (not applicable)
        Serotype 1; Pre-dose
    12.3
    9.8
        Serotype 1; Post-dose
    99.4
    12.3
        Serotype 3; Pre-dose
    44.8
    39.5
        Serotype 3; Post-dose
    98.7
    70.7
        Serotype 4; Pre-dose
    75.7
    74.6
        Serotype 4; Post-dose
    100
    100
        Serotype 5; Pre-dose
    56.8
    50.6
        Serotype 5; Post-dose
    97.6
    57.6
        Serotype 6B; Pre-dose
    66
    67.5
        Serotype 6B; Post-dose
    99.4
    99.4
        Serotype 7F; Pre-dose
    6
    11.9
        Serotype 7F; Post-dose
    95.9
    10.2
        Serotype 9V; Pre-dose
    70.4
    70.4
        Serotype 9V; Post-dose
    100
    99.4
        Serotype 14; Pre-dose
    96.4
    94.7
        Serotype 14; Post-dose
    100
    100
        Serotype 18C; Pre-dose
    46.4
    48.2
        Serotype 18C; Post-dose
    100
    99.4
        Serotype 19A; Pre-dose
    73.2
    71.6
        Serotype 19A; Post-dose
    94.1
    96.4
        Serotype 19F; Pre-dose
    94.6
    94.1
        Serotype 19F; Post-dose
    100
    100
        Serotype 23F; Pre-dose
    71.5
    70.1
        Serotype 23F; Post-dose
    99.4
    98.8
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Antibody titers ≥ 0.5 µg/mL Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine

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    End point title
    		 Percentage of Subjects with Antibody titers ≥ 0.5 µg/mL Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine [6]
    End point description
    Individual antibody titers for all serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) to Day 30 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Pneumo23 Prevnar
    Number of subjects analysed
    169
    169
    Units: Percentage of subjects
    number (not applicable)
        Serotype 1; Pre-dose
    7.4
    3
        Serotype 1; Post-dose
    98.8
    6.7
        Serotype 3; Pre-dose
    27.3
    16.3
        Serotype 3; Post-dose
    97.5
    51.2
        Serotype 4; Pre-dose
    58
    57.4
        Serotype 4; Post-dose
    99.4
    100
        Serotype 5; Pre-dose
    42.6
    38.1
        Serotype 5; Post-dose
    95.3
    43
        Serotype 6B; Pre-dose
    48.8
    51.5
        Serotype 6B; Post-dose
    98.8
    99.4
        Serotype 7F; Pre-dose
    5.4
    5.4
        Serotype 7F; Post-dose
    92.3
    6.6
        Serotype 9V; Pre-dose
    50.9
    55.6
        Serotype 9V; Post-dose
    100
    98.8
        Serotype 14; Pre-dose
    92.3
    92.3
        Serotype 14; Post-dose
    100
    100
        Serotype 18C; Pre-dose
    28.6
    26.8
        Serotype 18C; Post-dose
    100
    98.8
        Serotype 19A; Pre-dose
    52.4
    54.4
        Serotype 19A; Post-dose
    92.3
    88
        Serotype 19F; Pre-dose
    87.5
    84.6
        Serotype 19F; Post-dose
    100
    100
        Serotype 23F; Pre-dose
    61.2
    58.7
        Serotype 23F; Post-dose
    98.2
    98.2
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Antibody titers ≥ 1.0 µg/mL Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine

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    End point title
    		 Percentage of Subjects with Antibody titers ≥ 1.0 µg/mL Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine [7]
    End point description
    Individual antibody titers for all serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) to Day 30 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Pneumo23 Prevnar
    Number of subjects analysed
    169
    169
    Units: Percentage of subjects
    number (not applicable)
        Serotype 1; Pre-dose
    2.5
    1.2
        Serotype 1; Post-dose
    97
    1.8
        Serotype 3; Pre-dose
    10.5
    3.4
        Serotype 3; Post-dose
    96.2
    24.4
        Serotype 4; Pre-dose
    21.3
    21.3
        Serotype 4; Post-dose
    99.4
    98.2
        Serotype 5; Pre-dose
    17.2
    14.9
        Serotype 5; Post-dose
    76.9
    17.6
        Serotype 6B; Pre-dose
    26.5
    22.1
        Serotype 6B; Post-dose
    98.2
    96.3
        Serotype 7F; Pre-dose
    1.2
    1.8
        Serotype 7F; Post-dose
    82.8
    3
        Serotype 9V; Pre-dose
    20.1
    22.5
        Serotype 9V; Post-dose
    98.2
    96.4
        Serotype 14; Pre-dose
    84
    82.8
        Serotype 14; Post-dose
    98.8
    99.4
        Serotype 18C; Pre-dose
    8.3
    7.1
        Serotype 18C; Post-dose
    97.6
    88.6
        Serotype 19A; Pre-dose
    23.8
    24.3
        Serotype 19A; Post-dose
    73.4
    65.1
        Serotype 19F; Pre-dose
    47.6
    47.9
        Serotype 19F; Post-dose
    98.8
    98.2
        Serotype 23F; Pre-dose
    29.7
    26.3
        Serotype 23F; Post-dose
    94.6
    97
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine

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    End point title
    		 Number of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following a Booster Dose of Either Pneumo23® or Prevnar® Vaccine [8]
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥ 5 cm. Grade 3 sytemic reactions: Fever (Temperature), > 39.5°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Pneumo23 Prevnar
    Number of subjects analysed
    169
    168
    Units: Number of subjects
    number (not applicable)
        Injection site Tenderness
    99
    88
        Grade 3 Injection site Tenderness
    2
    2
        Injection site Erythema
    60
    53
        Grade 3 Injection site Erythema
    0
    1
        Injection site Swelling
    35
    33
        Grade 3 Injection site Swelling
    0
    0
        Fever
    29
    20
        Grade 3 Fever
    0
    1
        Vomiting
    28
    16
        Grade 3 Vomiting
    1
    1
        Crying abnormal
    51
    46
        Grade 3 Crying abnormal
    0
    3
        Drowsiness
    20
    24
        Grade 3 Drowsiness
    0
    1
        Appetite lost
    41
    41
        Grade 3 Appetite lost
    1
    0
        Irritability
    54
    64
        Grade Irritability
    2
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 up to Day 30 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9
    Reporting groups
    Reporting group title
    Pneumo23
    Reporting group description
    		 Children 12 to 18 months of age received Pneumo23® vaccine as a booster dose.

    Reporting group title
    Prevnar
    Reporting group description
    		 Children 12 to 18 months of age received Prevnar® vaccine as a booster dose.

    Serious adverse events
    		 Pneumo23 Prevnar
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 169 (3.55%)
    1 / 169 (0.59%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Near drowning
         subjects affected / exposed
    1 / 169 (0.59%)
    0 / 169 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Croup infectious
         subjects affected / exposed
    1 / 169 (0.59%)
    0 / 169 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 169 (1.18%)
    0 / 169 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 169 (0.59%)
    1 / 169 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 169 (0.59%)
    0 / 169 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pneumo23 Prevnar
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    99 / 169 (58.58%)
    88 / 169 (52.07%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    20 / 169 (11.83%)
    24 / 167 (14.37%)
         occurrences all number
    20
    24
    General disorders and administration site conditions
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    99 / 169 (58.58%)
    88 / 168 (52.38%)
         occurrences all number
    99
    88
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    60 / 169 (35.50%)
    53 / 167 (31.74%)
         occurrences all number
    60
    53
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    35 / 169 (20.71%)
    33 / 167 (19.76%)
         occurrences all number
    35
    33
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    29 / 168 (17.26%)
    20 / 165 (12.12%)
         occurrences all number
    29
    20
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    28 / 169 (16.57%)
    16 / 167 (9.58%)
         occurrences all number
    28
    16
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    51 / 169 (30.18%)
    46 / 167 (27.54%)
         occurrences all number
    51
    46
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    54 / 169 (31.95%)
    64 / 167 (38.32%)
         occurrences all number
    54
    64
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    17 / 169 (10.06%)
    18 / 169 (10.65%)
         occurrences all number
    17
    19
    Upper respiratory tract infection
         subjects affected / exposed
    27 / 169 (15.98%)
    23 / 169 (13.61%)
         occurrences all number
    28
    25
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    41 / 169 (24.26%)
    41 / 167 (24.55%)
         occurrences all number
    41
    41
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Feb 2008
    Serotype 19A was included in the analysis of individual Opsonophagocytosis (OPA) titers in addition to serotypes 1, 6B, 14, and 23F.
    08 Mar 2008
    Additional analysis of individual Opsonophagocytosis (OPA) titers against the serotypes 1, 6B, 14, and 23F was included.

    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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