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    Clinical Trial Results:
    A Phase II, Observer-Blind, Randomized, Parallel Groups, Single Center, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of FLUAD™ versus Two 0.25mL Intramuscular Doses of Vaxigrip™ Influenza Vaccines in Healthy Subjects Aged 6 to <36 Months.

    Summary
    EudraCT number
    		 2006-003181-34
    Trial protocol
    		 FI  
    Global end of trial date
    24 Aug 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    31 Dec 2014
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Required for the re-QC project because of the EudraCT system glitch and possible updates to results may be required. Moreover, a change in system user for this study is necessary.

    Trial information

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    Trial identification
    Sponsor protocol code
    V70P2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00408395
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sample data: Sample data
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l.
    Sponsor organisation address
    Via Fiorentina, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.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
    13 Dec 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of one 0.25 mL intramuscular (IM) injection of Fluad™ influenza vaccine and that of two 0.25 mL IM injections of the conventional influenza vaccine Vaxigrip™, in terms of post-immunization geometric mean titers (GMTs), as measured by Hemagglutination Inhibition (HI) test.
    Protection of trial subjects
    Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and systemic steroids was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine was not injected into a blood vessel.
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    14 Nov 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 281
    Worldwide total number of subjects
    281
    EEA total number of subjects
    281
    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)
    171
    Children (2-11 years)
    110
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All subjects were enrolled from Finland.

    Pre-assignment
    Screening details
    		 All the enrolled subject participated in trial.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 aTIV
    Arm description
    		 Subjects aged 6 to < 36 months received one or two doses of adjuvanted trivalent influenza vaccine (aTIV) administered on day 1 and/or day 29.
    Arm type
    		 Experimental

    Investigational medicinal product name
    aTIV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One or two doses of 0.25 mL IM injections of aTIV

    Arm title
    		 Control_TIV
    Arm description
    		 Subjects aged 6 to < 36 months received one or two doses of non–adjuvanted trivalent influenza vaccine (TIV) administered on day 1 and/or day 29.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TIV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One or two doses of 0.25 mL IM injections of TIV.

    Number of subjects in period 1
    		aTIV Control_TIV
    Started
    139
    142
    Completed
    111
    123
    Not completed
    28
    19
         Consent withdrawn by subject
    14
    9
         Administrative Reason
    1
    -
         Unable To Classify
    2
    3
         Adverse Events
    1
    -
         Lost to follow-up
    2
    3
         Inappropriate Enrollment
    5
    2
         Protocol deviation
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    aTIV
    Reporting group description
    		 Subjects aged 6 to < 36 months received one or two doses of adjuvanted trivalent influenza vaccine (aTIV) administered on day 1 and/or day 29.

    Reporting group title
    Control_TIV
    Reporting group description
    		 Subjects aged 6 to < 36 months received one or two doses of non–adjuvanted trivalent influenza vaccine (TIV) administered on day 1 and/or day 29.

    Reporting group values
    		 aTIV Control_TIV Total
    Number of subjects
    		 139 142 281
    Age categorical
    Units: Subjects
    Age continuous
    Subjects aged 6 to < 36 months received one or two doses of adjuvanted trivalent influenza vaccine (aTIV) or non –adjuvanted trivalent influenza vaccine (TIV) administered on day 1 and/or day 29.
    Units: months
        arithmetic mean (standard deviation)
    		 20.9 ( 8.9 ) 20.7 ( 8.6 ) -
    Gender categorical
    Subjects aged 6 to < 36 months received one or two dose of aTIV and TIV administered on day 1 and/or day 29.
    Units: Subjects
        Female
    		 65 60 125
        Male
    		 74 82 156

    End points

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    End points reporting groups
    Reporting group title
    aTIV
    Reporting group description
    		 Subjects aged 6 to < 36 months received one or two doses of adjuvanted trivalent influenza vaccine (aTIV) administered on day 1 and/or day 29.

    Reporting group title
    Control_TIV
    Reporting group description
    		 Subjects aged 6 to < 36 months received one or two doses of non–adjuvanted trivalent influenza vaccine (TIV) administered on day 1 and/or day 29.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects with at least one vaccination and with some post-baseline safety data.

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the ITT population who received all the injections of vaccine correctly, and provide evaluable serum samples at the relevant time points, and have no major protocol violation as defined prior to unblinding.

    Primary: Geometric Mean Titers (GMT) after one dose of aTIV and two doses of TIV.

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    End point title
    		 Geometric Mean Titers (GMT) after one dose of aTIV and two doses of TIV. [1]
    End point description
    The immunogenicity was assessed in subjects aged 6 to < 36 months in terms of GMT against each of three vaccine strains, four weeks after receiving one dose of aTIV and after two doses of TIV.
    End point type
    Primary
    End point timeframe
    Day 29 and Day 50 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: There were no statistical analysis done.
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    104
    118
    Units: Titers
    geometric mean (confidence interval 95%)
        Day1 (H1N1)
    5.93 (5.01 to 7)
    6.4 (5.47 to 7.49)
        aTIV Day 29 and TIV Day 50 (H1N1)
    34 (26 to 44)
    92 (76 to 111)
        Day 1 (H3N2)
    8.24 (6.25 to 11)
    8.79 (6.78 to 11)
        aTIV Day 29 and TIV Day 50 (H3N2)
    100 (74 to 135)
    195 (160 to 237)
        Day 1 (B strain)
    5.42 (5.08 to 5.77)
    5.18 (4.88 to 5.5)
        aTIV Day 29 and TIV Day 50 (B strain)
    8.11 (6.75 to 9.74)
    20 (17 to 24)
    No statistical analyses for this end point

    Secondary: GMTs against the three vaccine strains after two doses of aTIV and two doses of TIV.

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    End point title
    		 GMTs against the three vaccine strains after two doses of aTIV and two doses of TIV.
    End point description
    The immunogenicity was assessed in terms of GMT in subjects aged 6 to < 36 months against each of three vaccine strains after receiving two doses of aTIV and two doses of TIV.
    End point type
    Secondary
    End point timeframe
    Day 50 post vaccination.
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    104
    118
    Units: Titers
    geometric mean (confidence interval 95%)
        Day1 (H1N1)
    5.93 (5.01 to 7)
    6.4 (5.47 to 7.49)
        Day 50 (H1N1)
    195 (159 to 240)
    92 (76 to 111)
        Day 1 (H3N2)
    8.24 (6.25 to 11)
    8.79 (6.78 to 11)
        Day 50 (H3N2)
    507 (412 to 623)
    195 (160 to 237)
        Day 1 (B strain)
    5.42 (5.08 to 5.77)
    5.18 (4.88 to 5.5)
        Day 50 (B strain)
    105 (88 to 127)
    20 (17 to 24)
    No statistical analyses for this end point

    Secondary: Percentage of subjects in terms of seroprotection in antibody titer against the three vaccine strains after two doses of aTIV and two doses of TIV.

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    End point title
    		 Percentage of subjects in terms of seroprotection in antibody titer against the three vaccine strains after two doses of aTIV and two doses of TIV.
    End point description
    The immunogenicity was assessed in terms of percentage of subjects aged 6 to < 36 months with seroprotection as measured by HI assay against each of three vaccine strains after receiving two doses of aTIV and two doses of TIV. Analysis was done on the Per Protocol Set.
    End point type
    Secondary
    End point timeframe
    Day 50
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    104
    118
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day1 (H1N1)
    5 (2 to 11)
    7 (3 to 13)
        Day 50 (H1N1)
    100 (97 to 100)
    86 (79 to 92)
        Day 1 (H3N2)
    12 (6 to 19)
    13 (7 to 20)
        Day 50 (H3N2)
    100 (97 to 100)
    99 (95 to 100)
        Day 1 (B strain)
    3 (1 to 8)
    1 (0.021 to 5)
        Day 50 (B strain)
    99 (95 to 100)
    33 (25 to 42)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with seroconversion or significant increase in HI antibody titer after receiving two doses of aTIV and two doses of TIV.

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    End point title
    		 Percentages of subjects with seroconversion or significant increase in HI antibody titer after receiving two doses of aTIV and two doses of TIV.
    End point description
    The immunogenicity was assessed in percentage of subjects aged 6 to 36 months with seroconversions or significant increase in HI antibody titer after two doses of aTIV against two doses of TIV. Analysis was done on the Per Protocol Set.
    End point type
    Secondary
    End point timeframe
    Day 50
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    104
    118
    Units: Percentages of subjects
    number (confidence interval 95%)
        H1N1
    100 (97 to 100)
    86 (78 to 91)
        H3N2
    98 (93 to 100)
    96 (90 to 99)
        B strain
    99 (95 to 100)
    33 (25 to 42)
    No statistical analyses for this end point

    Secondary: Percentage of subjects in terms of HI titer against the three vaccine strains after one dose of aTIV and two doses of TIV.

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    End point title
    		 Percentage of subjects in terms of HI titer against the three vaccine strains after one dose of aTIV and two doses of TIV.
    End point description
    The immunogenicity was assessed in terms of percentage of subjects aged 6 to < 36 months HI titer antibody response against each of three vaccine strains, after receiving one dose of aTIV and two doses of TIV. Analysis was done on the Per Protocol Set.
    End point type
    Secondary
    End point timeframe
    Day 29 and Day 50
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    104
    118
    Units: Percentages of subjects
    number (confidence interval 95%)
        Day1 (H1N1)
    5 (2 to 11)
    7 (3 to 13)
        aTIV Day 29 and TIV Day 50 (H1N1)
    51 (41 to 61)
    86 (79 to 92)
        Day 1 (H3N2)
    12 (6 to 19)
    13 (7 to 20)
        aTIV Day 29 and TIV Day 50 (H3N2)
    91 (84 to 96)
    99 (95 to 100)
        Day 1 (B strain)
    3 (1 to 8)
    1 (0.021 to 5)
        aTIV Day 29 and TIV Day 50 (B strain)
    5 (2 to 11)
    33 (25 to 42)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with seroconversion or significant increase in HI antibody titer after receiving one dose of aTIV and two doses of TIV.

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    End point title
    		 Percentages of subjects with seroconversion or significant increase in HI antibody titer after receiving one dose of aTIV and two doses of TIV.
    End point description
    The immunogenicity was assessed in percentage of subjects aged 6 to 36 months with seroconversions or significant increase in HI antibody titer after a single dose of aTIV against two doses of TIV. Analysis was done on the Per Protocol Set.
    End point type
    Secondary
    End point timeframe
    Day 29 and Day 50
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    104
    118
    Units: Percentages of subjects
    number (confidence interval 95%)
        aTIV Day 29 and TIV Day 50 (H1N1)
    51 (41 to 61)
    86 (78 to 91)
        aTIV Day 29 and TIV Day 50 (H3N2)
    89 (82 to 95)
    96 (90 to 99)
        aTIV Day 29 and TIV Day 50 (B strain)
    5 (2 to 11)
    33 (25 to 42)
    No statistical analyses for this end point

    Secondary: GMT against the three vaccine strains after one dose of aTIV and one dose of TIV.

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    End point title
    		 GMT against the three vaccine strains after one dose of aTIV and one dose of TIV.
    End point description
    The immunogenicity was assessed in terms of GMT against each of three vaccine strains, 29 days after receiving one dose of aTIV and one dose of TIV. Analysis was done on the Per Protocol Set.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    104
    118
    Units: Titers
    geometric mean (confidence interval 95%)
        Day1 (H1N1)
    5.93 (5.01 to 7)
    6.4 (5.47 to 7.49)
        Day 29 (H1N1)
    34 (26 to 44)
    17 (13 to 21)
        Day 1 (H3N2)
    8.24 (6.25 to 11)
    8.79 (6.78 to 11)
        Day 29 (H3N2)
    100 (74 to 135)
    38 (28 to 50)
        Day 1 (B strain)
    5.42 (5.08 to 5.77)
    5.18 (4.88 to 5.5)
        Day 29 (B strain)
    8.11 (6.75 to 9.74)
    5.79 (4.87 to 6.88)
    No statistical analyses for this end point

    Secondary: Percentage of subjects in terms of HI titer against the three vaccine strains after one dose of aTIV and one dose of TIV.

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    End point title
    		 Percentage of subjects in terms of HI titer against the three vaccine strains after one dose of aTIV and one dose of TIV.
    End point description
    The immunogenicity was assessed in terms of percentage of subjects aged 6 to < 36 months with HI titer against each of three vaccine strains, after receiving one dose of aTIV and one dose of TIV. Analysis was done on the Per Protocol Set.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    104
    118
    Units: Percentages of subjects
    number (confidence interval 95%)
        Day1 (H1N1)
    5 (2 to 11)
    7 (3 to 13)
        Day 29 (H1N1)
    51 (41 to 61)
    18 (11 to 26)
        Day 1 (H3N2)
    12 (6 to 19)
    13 (7 to 20)
        Day 29 (H3N2)
    91 (84 to 96)
    49 (40 to 59)
        Day 1 (B strain)
    3 (1 to 8)
    1 (0.021 to 5)
        Day 29 (B strain)
    5 (2 to 11)
    3 (1 to 7)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with seroconversion or significant increase in HI antibody titer after receiving one dose of aTIV and one dose of TIV.

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    End point title
    		 Percentages of subjects with seroconversion or significant increase in HI antibody titer after receiving one dose of aTIV and one dose of TIV.
    End point description
    The immunogenicity was assessed in percentage of subjects aged 6 to <36 months with seroconversions or significant increase in HI antibody titer after administration of one dose of aTIV against one dose of TIV. Analysis was done on the Per Protocol Set.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    104
    118
    Units: Percentages of subjects
    number (confidence interval 95%)
        H1N1
    51 (41 to 61)
    17 (11 to 25)
        H3N2
    89 (82 to 95)
    45 (36 to 54)
        B Strain
    5 (2 to 11)
    3 (1 to 7)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving two doses of aTIV and two doses of TIV, four weeks apart.

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    End point title
    		 Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving two doses of aTIV and two doses of TIV, four weeks apart.
    End point description
    The number of subjects aged 6 to <36 months reporting solicited local and systemic adverse events and other solicited adverse events after receiving two doses of aTIV and two doses of TIV, administered four weeks apart, are reported. Analysis was done on the Safety Set.
    End point type
    Secondary
    End point timeframe
    Day1 through Day 7
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    130
    139
    Units: Number
    number (not applicable)
        Any Local
    74
    61
        Ecchymosis
    18
    19
        Erythema
    46
    38
        Induration
    21
    20
        Swelling
    16
    7
        Tenderness
    58
    47
        Any systemic
    63
    56
        Change in eat. habits
    32
    30
        Sleepiness
    35
    26
        Unusual Crying
    24
    19
        Irritability
    53
    46
        Vomiting
    8
    8
        Diarrhea
    17
    17
        Fever ( >= 38C )
    16
    13
        Axill. Temp. (C) >= 40.0 C
    0
    0
        Analg. Antipyr. Med. Used
    34
    32
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Unsolicited Adverse Events After Receiving two doses of aTIV and two doses of TIV, four weeks apart.

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    End point title
    		 Number of Subjects Reporting Unsolicited Adverse Events After Receiving two doses of aTIV and two doses of TIV, four weeks apart.
    End point description
    The number of subjects 6months to <36 months of age reporting any unsolicited adverse event (AEs) between Day 1 to 7 and serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study between Day 1 to Day 209 after receiving two doses of aTIV and two doses of TIV, administered four weeks apart are reported. Analysis was done on the Safety Set.
    End point type
    Secondary
    End point timeframe
    Day1 through Day 209
    End point values
    		 aTIV Control_TIV
    Number of subjects analysed
    130
    139
    Units: Number of Subjects
    number (not applicable)
        Any AE
    107
    111
        At least possibly related AEs
    21
    21
        Serious AEs
    2
    6
        AEs leading to withdrawal
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study ( solicited and unsolicited from Day 1 to Day 209).
    Adverse event reporting additional description
    Any solicited and unsolicited adverse events were reported up to day 7 post vaccination. Unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 209.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    aTIV
    Reporting group description
    		 Subjects aged 6 to < 36 months received one or two dose of aTIV administered on day 1 and/or day 29.

    Reporting group title
    Control_TIV
    Reporting group description
    		 Subjects aged 6 to < 36 months received one or two dose of non –adjuvanted trivalent influenza vaccine (TIV) administered on day 1 and/or day 29.

    Serious adverse events
    		 aTIV Control_TIV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 130 (1.54%)
    6 / 139 (4.32%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 130 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 130 (0.00%)
    2 / 139 (1.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media
         subjects affected / exposed
    0 / 130 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    0 / 130 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 130 (1.54%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Chronic
         subjects affected / exposed
    0 / 130 (0.00%)
    2 / 139 (1.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 aTIV Control_TIV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 130 (89.23%)
    125 / 139 (89.93%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    35 / 130 (26.92%)
    27 / 139 (19.42%)
         occurrences all number
    35
    27
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    26 / 130 (20.00%)
    21 / 139 (15.11%)
         occurrences all number
    26
    21
    Injection Site Haemorrhage
         subjects affected / exposed
    18 / 130 (13.85%)
    19 / 139 (13.67%)
         occurrences all number
    18
    19
    Injection Site Erythema
         subjects affected / exposed
    46 / 130 (35.38%)
    38 / 139 (27.34%)
         occurrences all number
    46
    38
    Injection Site Induration
         subjects affected / exposed
    21 / 130 (16.15%)
    20 / 139 (14.39%)
         occurrences all number
    21
    20
    Injection Site Pain
         subjects affected / exposed
    58 / 130 (44.62%)
    47 / 139 (33.81%)
         occurrences all number
    58
    47
    Injection Site Swelling
         subjects affected / exposed
    16 / 130 (12.31%)
    7 / 139 (5.04%)
         occurrences all number
    16
    7
    Pyrexia
         subjects affected / exposed
    44 / 130 (33.85%)
    39 / 139 (28.06%)
         occurrences all number
    44
    39
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    23 / 130 (17.69%)
    20 / 139 (14.39%)
         occurrences all number
    23
    20
    Vomiting
         subjects affected / exposed
    10 / 130 (7.69%)
    11 / 139 (7.91%)
         occurrences all number
    10
    11
    Teething
         subjects affected / exposed
    7 / 130 (5.38%)
    6 / 139 (4.32%)
         occurrences all number
    7
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    26 / 130 (20.00%)
    30 / 139 (21.58%)
         occurrences all number
    26
    30
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    53 / 130 (40.77%)
    47 / 139 (33.81%)
         occurrences all number
    53
    47
    Eating Disorder
         subjects affected / exposed
    32 / 130 (24.62%)
    30 / 139 (21.58%)
         occurrences all number
    32
    30
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    13 / 130 (10.00%)
    5 / 139 (3.60%)
         occurrences all number
    13
    5
    Conjunctivitis
         subjects affected / exposed
    13 / 130 (10.00%)
    16 / 139 (11.51%)
         occurrences all number
    13
    16
    Gastroenteritis
         subjects affected / exposed
    11 / 130 (8.46%)
    9 / 139 (6.47%)
         occurrences all number
    11
    9
    Ear Infection
         subjects affected / exposed
    8 / 130 (6.15%)
    7 / 139 (5.04%)
         occurrences all number
    8
    7
    Otitis Media
         subjects affected / exposed
    33 / 130 (25.38%)
    43 / 139 (30.94%)
         occurrences all number
    33
    43
    Respiratory Tract Infection
         subjects affected / exposed
    9 / 130 (6.92%)
    11 / 139 (7.91%)
         occurrences all number
    9
    11
    Rhinitis
         subjects affected / exposed
    35 / 130 (26.92%)
    23 / 139 (16.55%)
         occurrences all number
    35
    23
    Upper Respiratory Tract Infection
         subjects affected / exposed
    29 / 130 (22.31%)
    28 / 139 (20.14%)
         occurrences all number
    29
    28

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2006
    Amendment to permit an interim analysis after all day 7 reactogenicity data have been collected from the first 100 children enrolled.
    26 Feb 2007
    Amendment to permit a preliminary analysis after day 29 data, 1 month after the first injection.
    27 Apr 2007
    Amendment to permit diary cards to collect information on all the AEs and Concomitant Medications which occurred during the follow up period, between day 50 and 209.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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