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    Clinical Trial Results:
    OPEN-LABEL, RANDOMIZED, THREE-ARM, PHASE IIIB CLINICAL STUDY TO INVESTIGATE THE SAFETY AND IMMUNOGENICITY OF A CONCOMITANT ADMINISTRATION OF GROUP C MENINGOCOCCAL POLYSACCHARIDE-TETANUS TOXOID CONJUGATE (MENC-TT) VACCINE AND 7-VALENT PNEUMOCOCCAL CRM197-CONJUGATE VACCINE (PCV7) IN TODDLERS PREVIOUSLY IMMUNIZED DURING INFANCY WITH PCV7

    Summary
    EudraCT number
    2007-004276-39
    Trial protocol
    DE  
    Global end of trial date
    30 Jul 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    670701
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00617760
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Alias: B9361010
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, 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
    29 Mar 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the concomitant administration of a single dose of MenC-TT vaccine and a PCV7 booster dose does not influence the immune response to any of the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone. To demonstrate that the concomitant administration of a single dose MenC-TT vaccine and a PCV7 booster dose does not influence the immune response to the MenC-TT vaccine as compared to administration of MenC-TT vaccine alone.
    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 participants were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Mar 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 329
    Worldwide total number of subjects
    329
    EEA total number of subjects
    329
    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)
    329
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted at 27 centers in Germany from 25 March 2008 to 30 July 2009. 333 subjects were enrolled in the study out of which 329 subjects were randomized. One subject randomized to the PCV7 group actually received both MenC-TT and PCV7. Subject disposition has been presented as per the actual treatment received.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    MenC-TT + PCV7
    Arm description
    Subjects recieved MenC-TT as primary immunization dose in combination with PCV7 as booster dose on Day 0 (vaccination visit).
    Arm type
    Experimental

    Investigational medicinal product name
    MenC-TT
    Investigational medicinal product code
    Other name
    NeisVac-C
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single 0.5 milliliter (mL) MenC-TT dose for primary immunization.

    Investigational medicinal product name
    PCV7
    Investigational medicinal product code
    Other name
    Prevenar
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single 0.5 milliliter (mL) PCV7 dose for primary immunization.

    Arm title
    PCV7
    Arm description
    Subjects recieved intramuscularly 0.5 mL dose of Prevenar as a booster dose.
    Arm type
    Active comparator

    Investigational medicinal product name
    PCV7
    Investigational medicinal product code
    Other name
    Prevenar
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5 mL dose of Prevenar was administered as a booster dose on Day 0 (vaccination visit).

    Arm title
    MenC-TT
    Arm description
    Subjects recieved intramuscularly 0.5mL of MenC-TT dose for primary immunization.
    Arm type
    Active comparator

    Investigational medicinal product name
    MenC-TT
    Investigational medicinal product code
    Other name
    NeisVac-C
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of 0.5mL of MenC-TT intramuscularly for primary immunization on Day 0 (vaccination visit).

    Number of subjects in period 1
    MenC-TT + PCV7 PCV7 MenC-TT
    Started
    166
    81
    82
    Completed
    165
    78
    82
    Not completed
    1
    3
    0
         Protocol violation
    1
    2
    -
         Consent withdrawn by subject
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenC-TT + PCV7
    Reporting group description
    Subjects recieved MenC-TT as primary immunization dose in combination with PCV7 as booster dose on Day 0 (vaccination visit).

    Reporting group title
    PCV7
    Reporting group description
    Subjects recieved intramuscularly 0.5 mL dose of Prevenar as a booster dose.

    Reporting group title
    MenC-TT
    Reporting group description
    Subjects recieved intramuscularly 0.5mL of MenC-TT dose for primary immunization.

    Reporting group values
    MenC-TT + PCV7 PCV7 MenC-TT Total
    Number of subjects
    166 81 82 329
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    13.4 ± 1.48 13.3 ± 1.55 13.6 ± 1.59 -
    Gender categorical
    Units: Subjects
        Female
    88 33 34 155
        Male
    78 48 48 174

    End points

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    End points reporting groups
    Reporting group title
    MenC-TT + PCV7
    Reporting group description
    Subjects recieved MenC-TT as primary immunization dose in combination with PCV7 as booster dose on Day 0 (vaccination visit).

    Reporting group title
    PCV7
    Reporting group description
    Subjects recieved intramuscularly 0.5 mL dose of Prevenar as a booster dose.

    Reporting group title
    MenC-TT
    Reporting group description
    Subjects recieved intramuscularly 0.5mL of MenC-TT dose for primary immunization.

    Primary: Percentage of Subjects With PCV7-Specific Antibody Concentrations of Greater than or Equal to (>=) 0.2 Microgram/Milliliter (mcg/mL)

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    End point title
    Percentage of Subjects With PCV7-Specific Antibody Concentrations of Greater than or Equal to (>=) 0.2 Microgram/Milliliter (mcg/mL) [1]
    End point description
    Number of subjects achieving seroprotective PCV7-specific antibody concentrations for each of the 7 vaccine serotypes (14, 18C, 19F, 23F, 4, 6B, 9V) 1 month after the PCV booster vaccination were reported. Immunoglobulin G (IgG) antibody concentrations in response to the administration of PCV7 were determined by Enzyme linked immune sorbant assay (ELISA) with antibody concentrations >= 0.2 mcg/mL considered the serological correlate of protection. The per protocol (PP) analysis data set included all randomized and vaccinated subjects who fulfilled all inclusion and exclusion criteria, had no major protocol deviation, and had data available for the respective analysis.
    End point type
    Primary
    End point timeframe
    1 month after vaccination
    Notes
    [1] - 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 assessed for only those reporting arms in which subjects received booster vaccination with PCV7.
    End point values
    MenC-TT + PCV7 PCV7
    Number of subjects analysed
    159
    77
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serotype 14
    100 (97.5 to 100)
    100 (95.2 to 100)
        Serotype 18C
    100 (97.6 to 100)
    100 (95.2 to 100)
        Serotype 19F
    100 (97.5 to 100)
    98.7 (93 to 99.8)
        Serotype 23F
    100 (97.5 to 100)
    100 (95.2 to 100)
        Serotype 4
    100 (97.6 to 100)
    100 (95.2 to 100)
        Serotype 6B
    100 (97.5 to 100)
    98.7 (93 to 99.8)
        Serotype 9V
    100 (97.6 to 100)
    100 (95.2 to 100)
    Statistical analysis title
    Statisctical Analysis of PVC7 >= 0.2 mcg/mL: 14
    Statistical analysis description
    Non inferiority criteria margin is -10 percent (%). 95% Confidence Interval (CI) for the difference on the proportion of subjects with PVC7-Specific Antibody Concentration of >= 0.2 mcg/mL was calculated between MenC-TT + PCV7 vs PCV7.
    Comparison groups
    MenC-TT + PCV7 v PCV7
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.8
         upper limit
    2.5
    Statistical analysis title
    Statisctical Analysis of PVC7 >= 0.2 mcg/mL: 18C
    Statistical analysis description
    Non inferiority criteria margin is -10%. 95% CI for the difference on the proportion of subjects with PVC7-Specific Antibody Concentration of >= 0.2 mcg/mL was calculated between MenC-TT + PCV7 vs PCV7.
    Comparison groups
    PCV7 v MenC-TT + PCV7
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.8
         upper limit
    2.4
    Statistical analysis title
    Statisctical Analysis of PVC7 >= 0.2 mcg/mL: 19F
    Statistical analysis description
    Non inferiority criteria margin is -10%. 95% CI for the difference on the proportion of subjects with PVC7-Specific Antibody Concentration of >= 0.2 mcg/mL was calculated between MenC-TT + PCV7 vs PCV7.
    Comparison groups
    MenC-TT + PCV7 v PCV7
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Difference in proportion
    Point estimate
    -1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7
         upper limit
    1.4
    Statistical analysis title
    Statisctical Analysis of PVC7 >= 0.2 mcg/mL: 23F
    Statistical analysis description
    Non inferiority criteria margin is -10%. 95% CI for the difference on the proportion of subjects with PVC7-Specific Antibody Concentration of >= 0.2 mcg/mL was calculated between MenC-TT + PCV7 vs PCV7.
    Comparison groups
    MenC-TT + PCV7 v PCV7
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.8
         upper limit
    2.5
    Statistical analysis title
    Statistical analysis PCV7 >= 0.2 mcg/mL: 4
    Statistical analysis description
    Non inferiority criteria margin is -10%. 95% CI for the difference on the proportion of subjects with PVC7-Specific Antibody Concentration of >= 0.2 mcg/mL was calculated between MenC-TT + PCV7 vs PCV7.
    Comparison groups
    PCV7 v MenC-TT + PCV7
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.8
         upper limit
    2.4
    Statistical analysis title
    Statistical analysis PCV7 >= 0.2 mcg/mL: 6B
    Statistical analysis description
    Non inferiority criteria margin is -10%. 95% CI for the difference on the proportion of subjects with PVC7-Specific Antibody Concentration of >= 0.2 mcg/mL was calculated between MenC-TT + PCV7 vs PCV7.
    Comparison groups
    MenC-TT + PCV7 v PCV7
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Difference in proportion
    Point estimate
    -1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7
         upper limit
    1.4
    Statistical analysis title
    Statistical analysis PCV7 >= 0.2 mcg/mL: 9V
    Statistical analysis description
    Non inferiority criteria margin is -10%. 95% CI for the difference on the proportion of subjects with PVC7-Specific Antibody Concentration of >= 0.2 mcg/mL was calculated between MenC-TT + PCV7 vs PCV7.
    Comparison groups
    MenC-TT + PCV7 v PCV7
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.8
         upper limit
    2.4

    Primary: Percentage of Subjects With Seroprotective Meningococcal Serogroup C (MenC)-Specific Serum Bactericidal Activity (SBA) Titers >= 1:8

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    End point title
    Percentage of Subjects With Seroprotective Meningococcal Serogroup C (MenC)-Specific Serum Bactericidal Activity (SBA) Titers >= 1:8 [2]
    End point description
    Number of subjects achieving seroprotective MenC-specific SBA titers 1 month after administration of MenC-TT vaccine were reported. Protection against serogroup C meningococcal disease correlated with the presence of anticapsular antibodies with SBA. A SBA titer of ≥ 1:8 was considered the serological correlate of protection for MenC vaccines. PP analysis data set contained all randomized and vaccinated subjects who fulfilled all inclusion and exclusion criteria, had no major protocol deviation, and had data available for the respective analysis.
    End point type
    Primary
    End point timeframe
    1 month after vaccination
    Notes
    [2] - 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 assessed for only those reporting arms in which subjects received vaccination with MenC-TT.
    End point values
    MenC-TT + PCV7 MenC-TT
    Number of subjects analysed
    159
    80
    Units: Percentage of subjects
        number (confidence interval 95%)
    100 (97.6 to 100)
    100 (95.4 to 100)
    Statistical analysis title
    Statistical analysis MenC-specific SBA titers ≥1:8
    Statistical analysis description
    Non inferiority criteria margin is -10%. 95% CI for the difference on the proportion of subjects with MenC-specific SBA titers ≥1:8 was calculated between MenC-TT + PCV7 vs MenC-TT.
    Comparison groups
    MenC-TT + PCV7 v MenC-TT
    Number of subjects included in analysis
    239
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.6
         upper limit
    2.4

    Secondary: Number of Subjects With PCV7-Specific Antibody Concentrations >= 0.35 mcg/mL

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    End point title
    Number of Subjects With PCV7-Specific Antibody Concentrations >= 0.35 mcg/mL [3]
    End point description
    Number of subjects achieving PCV7-specific antibody concentrations for each of the 7 vaccine serotypes (14, 18C, 19F, 23F, 4, 6B, 9V) 1 month after the PCV booster vaccination was determined by ELISA. The intent to treat (ITT) data set contained all randomized and vaccinated subjects with available data for the respective analysis.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination
    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 assessed for only those reporting arms in which subjects received booster vaccination with PVC7.
    End point values
    MenC-TT + PCV7 PCV7
    Number of subjects analysed
    164
    80
    Units: Subjects
    number (not applicable)
        Serotype 14
    156
    80
        Serotype 18C
    158
    80
        Serotype 19F
    155
    79
        Serotype 23F
    154
    80
        Serotype 4
    158
    80
        Serotype 6B
    155
    79
        Serotype 9V
    158
    80
    No statistical analyses for this end point

    Secondary: Number of Subjects With PCV7-Specific Antibody Concentrations >= 1 mcg/mL

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    End point title
    Number of Subjects With PCV7-Specific Antibody Concentrations >= 1 mcg/mL [4]
    End point description
    Number of subjects achieving PCV7-specific antibody concentrations for each of the 7 vaccine serotypes (14, 18C, 19F, 23F, 4, 6B, 9V) 1 month after the PCV booster vaccination was determined by ELISA. ITT data set contains all randomized and vaccinated subjects with available data for the respective analysis.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination
    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 assessed for only those reporting arms in which subjects received booster vaccination with PVC7.
    End point values
    MenC-TT + PCV7 PCV7
    Number of subjects analysed
    164
    80
    Units: Subjects
    number (not applicable)
        Serotype 14
    156
    80
        Serotype 18C
    145
    73
        Serotype 19F
    153
    76
        Serotype 23F
    150
    77
        Serotype 4
    153
    80
        Serotype 6B
    151
    79
        Serotype 9V
    152
    80
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for PCV7-Specific Antibody 1 Month After Booster Vaccination With PVC7

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    End point title
    Geometric Mean Concentration (GMC) for PCV7-Specific Antibody 1 Month After Booster Vaccination With PVC7 [5]
    End point description
    PCV7-specific antibody GMC's 1 month after the PCV7 booster were assumed to be log-normally distributed. Concentration values were log-transformed, and their means and 95% Confidence Intervals (CIs) were calculated based on the t-distribution. ITT data set contains all randomized and vaccinated subjects with available data for the respective analysis.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination
    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 assessed for only those reporting arms in which subjects received booster vaccination with PVC7.
    End point values
    MenC-TT + PCV7 PCV7
    Number of subjects analysed
    164
    80
    Units: microgram per millilitre
    geometric mean (confidence interval 95%)
        Serotype 14
    10.94 (9.5 to 12.6)
    11.47 (9.41 to 13.99)
        Serotype 18C
    3.82 (3.3 to 4.41)
    3.6 (2.91 to 4.45)
        Serotype 19F
    7.14 (6.15 to 8.29)
    5.98 (4.65 to 7.69)
        Serotype 23F
    6.1 (5.15 to 7.23)
    6.14 (4.89 to 7.7)
        Serotype 4
    5.34 (4.56 to 6.24)
    5.97 (4.85 to 7.36)
        Serotype 6B
    11.05 (9.35 to 13.06)
    11.69 (9.05 to 15.09)
        Serotype 9V
    3.78 (3.34 to 4.28)
    4.25 (3.6 to 5.01)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer (GMT) for MenC-Specific SBA 1 Month After Primary Vaccination with MenC-TT

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    End point title
    Geometric Mean Titer (GMT) for MenC-Specific SBA 1 Month After Primary Vaccination with MenC-TT [6]
    End point description
    MenC-specific SBA GMTs 1 month after vaccination with MenC-TT were assumed to be log-normally distributed. The ITT data set contains all randomized and vaccinated subjects with available data for the respective analysis.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination
    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 assessed for only those reporting arms in which subjects received vaccination with MenC-TT.
    End point values
    MenC-TT + PCV7 MenC-TT
    Number of subjects analysed
    164
    81
    Units: Titer
        geometric mean (confidence interval 95%)
    1114.32 (946.63 to 1311.72)
    1429.68 (1162.12 to 1758.86)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Seroconversion 1 Month After Vaccination With MenC-TT

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    End point title
    Number of Subjects With Seroconversion 1 Month After Vaccination With MenC-TT [7]
    End point description
    Seroconversion is a 4-fold increase in MenC-specific SBA titers, one month after vaccination. ITT data set contains all randomized and vaccinated subjects with available data for the respective analysis.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination
    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 assessed for only those reporting arms in which subjects received vaccination with MenC-TT.
    End point values
    MenC-TT + PCV7 MenC-TT
    Number of subjects analysed
    164
    81
    Units: Subjects
        number (not applicable)
    164
    81
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Increase in PCV7-Specific Antibody Concentrations From Before PCV7 Booster Vaccination to 1 Month After the PCV7 Booster Vaccination

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    End point title
    Geometric Mean Fold Increase in PCV7-Specific Antibody Concentrations From Before PCV7 Booster Vaccination to 1 Month After the PCV7 Booster Vaccination [8]
    End point description
    PCV7-specific antibody concentrations one month after booster vaccination with PCV7 were assumed to be log-normally distributed. Concentration values were log-transformed, and changes from baseline were calculated for each subject. Mean changes (95% CIs) from baseline were calculated based on the t-distribution. ITT data set contains all randomized and vaccinated subjects with available data for the respective analysis.
    End point type
    Secondary
    End point timeframe
    Before PCV7 vaccination, 1 month after PCV7 vaccination
    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 assessed for only those reporting arms in which subjects received booster vaccination with PVC7.
    End point values
    MenC-TT + PCV7 PCV7
    Number of subjects analysed
    164
    80
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 14
    4.62 (3.95 to 5.42)
    4.69 (3.78 to 5.83)
        Serotype 18C
    9.56 (8.36 to 10.93)
    8.51 (7.12 to 10.17)
        Serotype 19F
    10.08 (8.42 to 12.07)
    9.02 (7.03 to 11.58)
        Serotype 23F
    10.26 (8.81 to 11.96)
    9.41 (7.63 to 11.61)
        Serotype 4
    9.77 (8.36 to 11.41)
    9.88 (7.88 to 12.39)
        Serotype 6B
    9.16 (7.87 to 10.67)
    8.4 (6.53 to 10.8)
        Serotype 9V
    5.86 (5.21 to 6.6)
    5.82 (4.89 to 6.93)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Increase in MenC-specific SBA Titers From Before MenC-TT Primary Immunizaton Vaccination to 1 Month After Primary Immunization With MenC-TT

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    End point title
    Geometric Mean Fold Increase in MenC-specific SBA Titers From Before MenC-TT Primary Immunizaton Vaccination to 1 Month After Primary Immunization With MenC-TT [9]
    End point description
    MenC-specific SBA titers one month after vaccination with MenC-TT were assumed to be log-normally distributed. Titer values were log-transformed, and changes from baseline were calculated for each subject. Mean changes (95% CIs) from baseline were calculated based on the t-distribution. ITT data set contains all randomized and vaccinated subjects with available data for the respective analysis.
    End point type
    Secondary
    End point timeframe
    Before MenC-TT vaccination, 1 month after MenC-TT vaccination
    Notes
    [9] - 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 assessed for only those reporting arms in which subjects received vaccination with MenC-TT.
    End point values
    MenC-TT + PCV7 MenC-TT
    Number of subjects analysed
    164
    81
    Units: Titer
        geometric mean (confidence interval 95%)
    547.82 (464.7 to 645.81)
    690.79 (557.74 to 855.58)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Pre-Specified Injection Site Reactions

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    End point title
    Number of Subjects Reporting Pre-Specified Injection Site Reactions
    End point description
    The severity of injection site reactions was rated for Redness, induration, or swelling (diameter) as Mild (1.0–2.5 cm), Moderate (2.5.–5.0 cm) Severe (> 5.0 cm) and for Injection site pain or tenderness as Mild (No impairment of arm movement), Moderate (Impairment of arm movement) and Severe (Severe impairment, arm not moving). The safety analysis data set contains all vaccinated subjects. Unkown refers to injection site reactions whose severity score was missing because of a lesion size of less than 1 cm, i.e., less than mild.
    End point type
    Secondary
    End point timeframe
    Within 1 month after vaccination
    End point values
    MenC-TT + PCV7 PCV7 MenC-TT
    Number of subjects analysed
    166
    81
    82
    Units: Subjects
    number (not applicable)
        Mild
    30
    12
    10
        Moderate
    18
    12
    3
        Severe
    2
    5
    1
        Unknown
    32
    8
    10
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Pre-Specified Systemic Reactions

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    End point title
    Number of Subjects Reporting Pre-Specified Systemic Reactions
    End point description
    Systemic reactions are treatment-related systemic adverse events. Systemic reactions were reported in subject diary and includes vomiting, sweating, inconsolable or persisting crying, irritability, sleepiness, and food rejection. Unkown refers to injection site reactions whose severity score was missing because of a lesion size of less than 1 cm, i.e., less than mild.The safety analysis set contained all subjects vaccinated at least once with NeisVac-C.
    End point type
    Secondary
    End point timeframe
    Within 1 month after vaccination
    End point values
    MenC-TT + PCV7 PCV7 MenC-TT
    Number of subjects analysed
    166
    81
    82
    Units: Subjects
    number (not applicable)
        Mild
    51
    28
    17
        Moderate
    14
    8
    8
        Severe
    1
    0
    0
        Unknown
    0
    0
    0
        Total with Reaction
    66
    36
    25
    No statistical analyses for this end point

    Secondary: Number of Subjects With Local and Systemic Non-Serious Reactions Related to the Vaccination

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    End point title
    Number of Subjects With Local and Systemic Non-Serious Reactions Related to the Vaccination
    End point description
    Local reactions include induration, injection site pain, swelling, redness, and tenderness. Systemic reactions includes vomiting, sweating, inconsolable and persisting crying, irritability, sleepiness, and food rejection. The safety analysis data set contains all vaccinated subjects.
    End point type
    Secondary
    End point timeframe
    Within 1 month after vaccination
    End point values
    MenC-TT + PCV7 PCV7 MenC-TT
    Number of subjects analysed
    166
    81
    82
    Units: Subjects
    number (not applicable)
        Food rejection
    4
    2
    5
        Inconsolable/persisting crying
    1
    7
    11
        Induration
    14
    22
    50
        Injection site pain
    2
    9
    19
        Irritability
    2
    13
    14
        Redness
    11
    27
    67
        Sleepiness
    7
    13
    16
        Sweating
    1
    2
    4
        Swelling
    3
    16
    27
        Tenderness
    12
    18
    40
        Vomiting
    1
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within 1 month after vaccination
    Adverse event reporting additional description
    SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in subject diary (local and pre specified systemic reactions) and AEs collected on case report form at each visit. MedDRA dictionary version was not captured, here 0.0 is included for the MedDRA version.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    MenC-TT and PCV7
    Reporting group description
    Subjects recieved MenC-TT as primary immunization dose in combination with PCV7 as booster dose on Day 0 (vaccination visit).

    Reporting group title
    PCV7
    Reporting group description
    Subjects recieved intramuscularly 0.5 mL dose of Prevenar as a booster dose.

    Reporting group title
    MenC-TT
    Reporting group description
    Subjects recieved intramuscularly 0.5mL of MenC-TT dose for primary immunization.

    Serious adverse events
    MenC-TT and PCV7 PCV7 MenC-TT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple
    Additional description: “Multiple” includes subjects with more than one event reported under a single Reported Term”.
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    MenC-TT and PCV7 PCV7 MenC-TT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    105 / 166 (63.25%)
    56 / 81 (69.14%)
    34 / 82 (41.46%)
    Vascular disorders
    Peripheral coldness
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Joint injury
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    1
    0
    1
    Mouth injury
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Poisoning
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 166 (3.61%)
    2 / 81 (2.47%)
    2 / 82 (2.44%)
         occurrences all number
    6
    2
    2
    Nervous system disorders
    Crying
         subjects affected / exposed
    15 / 166 (9.04%)
    8 / 81 (9.88%)
    2 / 82 (2.44%)
         occurrences all number
    15
    8
    2
    Poor quality sleep
         subjects affected / exposed
    5 / 166 (3.01%)
    2 / 81 (2.47%)
    1 / 82 (1.22%)
         occurrences all number
    6
    2
    1
    Somnolence
         subjects affected / exposed
    19 / 166 (11.45%)
    15 / 81 (18.52%)
    7 / 82 (8.54%)
         occurrences all number
    19
    15
    7
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    5 / 166 (3.01%)
    2 / 81 (2.47%)
    1 / 82 (1.22%)
         occurrences all number
    5
    2
    1
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    0
    1
    Irritability
         subjects affected / exposed
    18 / 166 (10.84%)
    14 / 81 (17.28%)
    2 / 82 (2.44%)
         occurrences all number
    18
    14
    2
    Pyrexia
         subjects affected / exposed
    50 / 166 (30.12%)
    32 / 81 (39.51%)
    15 / 82 (18.29%)
         occurrences all number
    56
    37
    19
    Injection site erythema
         subjects affected / exposed
    67 / 166 (40.36%)
    27 / 81 (33.33%)
    11 / 82 (13.41%)
         occurrences all number
    86
    27
    11
    Injection site haematoma
         subjects affected / exposed
    3 / 166 (1.81%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    3
    0
    1
    Injection site haemorrhage
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site induration
         subjects affected / exposed
    50 / 166 (30.12%)
    22 / 81 (27.16%)
    14 / 82 (17.07%)
         occurrences all number
    69
    22
    14
    Injection site pain (Local reaction)
         subjects affected / exposed
    46 / 166 (27.71%)
    19 / 81 (23.46%)
    12 / 82 (14.63%)
         occurrences all number
    86
    27
    14
    Injection site swelling
         subjects affected / exposed
    27 / 166 (16.27%)
    16 / 81 (19.75%)
    3 / 82 (3.66%)
         occurrences all number
    32
    16
    3
    Multiple
    Additional description: “Multiple” includes subjects with more than one event reported under a single Reported Term”.
         subjects affected / exposed
    6 / 166 (3.61%)
    6 / 81 (7.41%)
    2 / 82 (2.44%)
         occurrences all number
    8
    7
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    1
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    2
    0
    Food aversion
         subjects affected / exposed
    10 / 166 (6.02%)
    2 / 81 (2.47%)
    4 / 82 (4.88%)
         occurrences all number
    10
    2
    4
    Insomnia
         subjects affected / exposed
    2 / 166 (1.20%)
    2 / 81 (2.47%)
    2 / 82 (2.44%)
         occurrences all number
    2
    2
    2
    Nervousness
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Restlessness
         subjects affected / exposed
    4 / 166 (2.41%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    4
    1
    0
    Sleep disorder
         subjects affected / exposed
    2 / 166 (1.20%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    2
    0
    1
    Gastrointestinal disorders
    Aphthous stomatitis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    1
    0
    1
    Constipation
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    8 / 166 (4.82%)
    6 / 81 (7.41%)
    2 / 82 (2.44%)
         occurrences all number
    8
    6
    2
    Enteritis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Faecal incontinence
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    1
    1
    0
    Faeces hard
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    1
    2
    0
    Teething
         subjects affected / exposed
    6 / 166 (3.61%)
    1 / 81 (1.23%)
    3 / 82 (3.66%)
         occurrences all number
    9
    1
    3
    Vomiting
         subjects affected / exposed
    5 / 166 (3.01%)
    4 / 81 (4.94%)
    4 / 82 (4.88%)
         occurrences all number
    5
    5
    4
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    0
    1
    Dermatitis diaper
         subjects affected / exposed
    5 / 166 (3.01%)
    2 / 81 (2.47%)
    1 / 82 (1.22%)
         occurrences all number
    6
    2
    1
    Eczema
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    4 / 166 (2.41%)
    3 / 81 (3.70%)
    1 / 82 (1.22%)
         occurrences all number
    4
    3
    1
    Neurodermatitis
         subjects affected / exposed
    2 / 166 (1.20%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    2
    0
    0
    Petechiae
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    3 / 166 (1.81%)
    1 / 81 (1.23%)
    2 / 82 (2.44%)
         occurrences all number
    3
    1
    3
    Rash maculo-papular
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Appetite disorder
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Decreased appetite
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Fluid imbalance
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Acute tonsillitis
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    1
    1
    0
    Bacterial infection
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 166 (0.60%)
    2 / 81 (2.47%)
    1 / 82 (1.22%)
         occurrences all number
    1
    2
    1
    Bronchopneumonia
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Candida nappy rash
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema infected
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema infectiosum
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Exanthema subitum
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    1
    1
    0
    Febrile infection
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    1
    0
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    1
    0
    1
    Gastroenteritis
         subjects affected / exposed
    4 / 166 (2.41%)
    1 / 81 (1.23%)
    3 / 82 (3.66%)
         occurrences all number
    4
    1
    3
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Genital candidiasis
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    1
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    7 / 166 (4.22%)
    3 / 81 (3.70%)
    3 / 82 (3.66%)
         occurrences all number
    7
    3
    3
    Otitis media
         subjects affected / exposed
    5 / 166 (3.01%)
    2 / 81 (2.47%)
    3 / 82 (3.66%)
         occurrences all number
    5
    2
    3
    Pharyngitis
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    11 / 166 (6.63%)
    5 / 81 (6.17%)
    1 / 82 (1.22%)
         occurrences all number
    11
    5
    1
    Sinobronchitis
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 166 (2.41%)
    5 / 81 (6.17%)
    2 / 82 (2.44%)
         occurrences all number
    4
    5
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Varicella
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 81 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    0
    1
    Viral infection
         subjects affected / exposed
    4 / 166 (2.41%)
    1 / 81 (1.23%)
    0 / 82 (0.00%)
         occurrences all number
    4
    1
    0
    Viral rash
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 81 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jan 2008
    The protocol was amended to restrict the withdrawal of blood following 3 unsuccessful attempts in order to limit the stress caused on the subject.

    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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