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    Clinical Trial Results:
    A Phase 2, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of the New Liquid Formulation of Novartis Meningococcal C Conjugate Vaccine and of the Novartis Lyophilized Meningococcal C Conjugate Vaccine Manufactured at Two Different Sites, in Healthy Toddlers

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2011-000395-34
    Trial protocol
    		 PL  
    Global end of trial date
    02 Nov 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Jun 2016
    First version publication date
    01 Jan 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    re-QC study needed because of EudraCT system glitch and updates to results are required.

    Trial information

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    Trial identification
    Sponsor protocol code
    V14_57
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01434680
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines
    Sponsor organisation address
    Via Fiorentina, 1 , 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
    02 May 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The equivalence of MenC-CRM liquid to MenC-CRM EMV and the equivalence of MenC-CRM ROS to MenC-CRM EMV were to be simultaneously assessed with adjustment for multiple comparisons. 1. To demonstrate the equivalence of MenC-CRM liquid to MenC-CRM EMV when administered to toddlers, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against N meningitidis serogroup C, approximately 28 days after a single vaccination. 2. To demonstrate the equivalence of MenC-CRM ROS to MenC-CRM EMV when administered to toddlers, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against N meningitidis serogroup C, approximately 28 days after a single vaccination.
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 2011
    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
    Poland: 992
    Worldwide total number of subjects
    992
    EEA total number of subjects
    992
    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)
    991
    Children (2-11 years)
    1
    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
    		 Subjects were recruited from 11 centers.

    Pre-assignment
    Screening details
    		 Toddlers of both genders (aged 12 through 23 months of age) generally in good health were eligible for this study. For toddlers to be enrolled, the parent(s) or legally acceptable representative(s) had to provide written informed consent and had to be available for all study visits. Serious, acute, or chronic illnesses were reasons for exclusion.

    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, Data analyst, Carer, Assessor
    Blinding implementation details
    The study was designed as an observer-blind study. An unblinded administrator administered the study vaccine randomly assigned for the individual subject. The subjects’ parents, investigator and study site personnel involved in the conduct of the trial and safety follow-up were blinded to which study vaccine each subject received. NVD personnel were blinded in EDC, except the users with an ‘unblinded role’ in EDC.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenC-CRM LIQ
    Arm description
    		 Subjects received 1 injection of MenC-CRM vaccine, liquid formulation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal C-CRM conjugated
    Investigational medicinal product code
    MenC-CRM liquid
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 single dose 0.5 mL per injection

    Arm title
    		 MenC-CRM ROS
    Arm description
    		 Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningococcal C-CRM conjugated
    Investigational medicinal product code
    MenC-CRM ROS
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 single dose 0.5 mL per injection

    Arm title
    		 MenC-CRM EMV
    Arm description
    		 Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningococcal C-CRM conjugated
    Investigational medicinal product code
    MenC-CRM EMV
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 single dose 0.5 mL per injection

    Arm title
    		 MenC-CRM ROS_EMV
    Arm description
    		 Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
    Arm type
    		 administered mistakenly

    Investigational medicinal product name
    Meningococcal C-CRM conjugated
    Investigational medicinal product code
    MenC-CRM EMV
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 single dose 0.5 mL per injection. Note: a different lot was used than in the MenC-CRM EMV arm.

    Number of subjects in period 1
    		MenC-CRM LIQ MenC-CRM ROS MenC-CRM EMV MenC-CRM ROS_EMV
    Started
    299
    268
    306
    119
    Completed
    296
    266
    304
    119
    Not completed
    3
    2
    2
    0
         Consent withdrawn by subject
    1
    -
    2
    -
         Lost to follow-up
    1
    1
    -
    -
         Protocol deviation
    1
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenC-CRM LIQ
    Reporting group description
    		 Subjects received 1 injection of MenC-CRM vaccine, liquid formulation

    Reporting group title
    MenC-CRM ROS
    Reporting group description
    		 Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy

    Reporting group title
    MenC-CRM EMV
    Reporting group description
    		 Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA

    Reporting group title
    MenC-CRM ROS_EMV
    Reporting group description
    		 Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV

    Reporting group values
    		 MenC-CRM LIQ MenC-CRM ROS MenC-CRM EMV MenC-CRM ROS_EMV Total
    Number of subjects
    		 299 268 306 119 992
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 16.4 ± 3.4 16.2 ± 3.2 16.7 ± 3.4 17.2 ± 3.3 -
    Gender categorical
    Units: Subjects
        Female
    		 143 131 141 50 465
        Male
    		 156 137 165 69 527

    End points

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    End points reporting groups
    Reporting group title
    MenC-CRM LIQ
    Reporting group description
    		 Subjects received 1 injection of MenC-CRM vaccine, liquid formulation

    Reporting group title
    MenC-CRM ROS
    Reporting group description
    		 Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy

    Reporting group title
    MenC-CRM EMV
    Reporting group description
    		 Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA

    Reporting group title
    MenC-CRM ROS_EMV
    Reporting group description
    		 Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV

    Subject analysis set title
    Enrolled Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who had signed an informed consent, undergone screening procedure(s) and were randomized.

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects who signed an informed consent form, underwent screening procedure(s),were randomized, actually received a study vaccination, provided at least one evaluable serum sample, correctly received the vaccine, provided evaluable serum samples at the relevant time points (for subjects in the immunogenicity subset), and had no major protocol violation as defined prior to unblinding.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who signed an informed consent form, underwent screening procedure(s), were randomized and provided post vaccination safety data.

    Primary: Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination

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    End point title
    		 Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination [1]
    End point description
    Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.
    End point type
    Primary
    End point timeframe
    1 month postvaccination (day 29)
    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: No statistical analysis is associated to this Endpoint. Analyses were run descriptively.
    End point values
    		 MenC-CRM LIQ MenC-CRM ROS MenC-CRM EMV
    Number of subjects analysed
    283
    259
    281
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 1
    2.1 (2 to 2.2)
    2.16 (2.05 to 2.26)
    2.15 (2.05 to 2.25)
        Day 29
    9.84 (8.39 to 12)
    14 (12 to 16)
    12 (10 to 14)
    Statistical analysis title
    		 Equivalence of MenC-CRM liquid to MenC-CRM EMV
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM LIQ to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).
    Comparison groups
    MenC-CRM LIQ v MenC-CRM EMV
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    P-value
    		 < 0.05 [3]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1
    Notes
    [2] - The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons, MenC-CRM LIQ and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.
    [3] - 95% CIs for the GMTs ratios were obtained by exponentiating difference of least square means of log10 transformed titers and both the limits of 95% CIs.
    Statistical analysis title
    		 Equivalence of MenC-CRM EMV to MenC-CRM ROS
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM LIQ to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).
    Comparison groups
    MenC-CRM EMV v MenC-CRM ROS
    Number of subjects included in analysis
    540
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    P-value
    		 < 0.05 [5]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.41
    Notes
    [4] - The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons, MenC-CRM LIQ and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.
    [5] - 95% CIs for the GMTs ratios were obtained by exponentiating difference of least square means of log10 transformed titers and both the limits of 95% CIs.

    Secondary: Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination

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    End point title
    		 Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination [6]
    End point description
    Immunogenicity was measured by hSBA GMTs against N meningitidis type C, approximately 28 days (at day 29) after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM ROS.
    End point type
    Secondary
    End point timeframe
    1 month postvaccination (day 29)
    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: No statistical analysis is associated to this Endpoint. Analyses were run descriptively.
    End point values
    		 MenC-CRM LIQ MenC-CRM ROS
    Number of subjects analysed
    283
    259
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 1
    2.1 (2 to 2.2)
    2.16 (2.05 to 2.26)
        Day 29
    9.84 (8.39 to 12)
    14 (12 to 16)
    Statistical analysis title
    		 Equivalence of MenC-CRM LIQ to MenC-CRM ROS
    Statistical analysis description
    The secondary objective was to be assessed only if both primary objectives were met. Because of this, no adjustment for multiplicity was required. MenC-CRM liquid would be declared equivalent to MenC-CRM ROS if the two-sided 95% CI for the ratio of the hSBA GMTs at approximately 28 days following vaccination was within the equivalence interval (0.5, 2.0).
    Comparison groups
    MenC-CRM LIQ v MenC-CRM ROS
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [7]
    P-value
    		 < 0.05 [8]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.89
    Notes
    [7] - The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval, the two vaccine groups would be declared equivalent with respect to the immune response to the vaccines.
    [8] - 95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10 transformed titers and both the limits of 95% CIs

    Secondary: Number Of Subjects Reporting Solicited Local And Systemic Adverse Events

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    End point title
    		 Number Of Subjects Reporting Solicited Local And Systemic Adverse Events
    End point description
    Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following a single injection with either MenC-CRM LIQ or MenC-CRM ROS or MenC-CRM EMV. Safety was also assessed in subjects who mistakenly received MenC-CRM EMV instead of MenC-CRM ROS.
    End point type
    Secondary
    End point timeframe
    From day 1 through day 7
    End point values
    		 MenC-CRM LIQ MenC-CRM ROS MenC-CRM EMV MenC-CRM ROS_EMV
    Number of subjects analysed
    299
    267
    304
    119
    Units: Number of Subjects
        Any local
    124
    115
    148
    58
        Injection site Tenderness
    88
    64
    101
    41
        Injection site Erythema
    222
    200
    211
    81
        Injection site Induration
    252
    227
    236
    88
        Any systemic
    163
    140
    155
    60
        Change in Eating habits
    87
    68
    83
    26
        Sleepiness
    66
    55
    56
    24
        Persistent Crying
    45
    41
    36
    15
        Vomiting
    9
    11
    7
    4
        Diarrhea
    42
    30
    34
    17
        Irritability
    101
    76
    87
    32
        Fever (≥38°C)
    20
    11
    18
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination).
    Adverse event reporting additional description
    All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. The total no. of subjects affected by non-serious adverse events refers to the total no. and percent of subjects with a non-serious AE that occurred at >5% in any group.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    MenC-CRM LIQ
    Reporting group description
    		 Subjects received 1 injection of MenC-CRM vaccine, liquid formulation

    Reporting group title
    MenC-CRM ROS
    Reporting group description
    		 Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy

    Reporting group title
    MenC-CRM EMV
    Reporting group description
    		 Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA

    Reporting group title
    MenC-CRM ROS_EMV
    Reporting group description
    		 Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV

    Serious adverse events
    		 MenC-CRM LIQ MenC-CRM ROS MenC-CRM EMV MenC-CRM ROS_EMV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 299 (0.00%)
    3 / 267 (1.12%)
    2 / 304 (0.66%)
    1 / 119 (0.84%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Diarrhea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 267 (0.00%)
    1 / 304 (0.33%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 267 (0.00%)
    1 / 304 (0.33%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 299 (0.00%)
    2 / 267 (0.75%)
    0 / 304 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 267 (0.37%)
    1 / 304 (0.33%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MenC-CRM LIQ MenC-CRM ROS MenC-CRM EMV MenC-CRM ROS_EMV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    196 / 299 (65.55%)
    178 / 267 (66.67%)
    206 / 304 (67.76%)
    79 / 119 (66.39%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    66 / 299 (22.07%)
    55 / 267 (20.60%)
    56 / 304 (18.42%)
    24 / 119 (20.17%)
         occurrences all number
    71
    59
    61
    26
    General disorders and administration site conditions
    Crying
    alternative assessment type: Systematic
         subjects affected / exposed
    45 / 299 (15.05%)
    41 / 267 (15.36%)
    36 / 304 (11.84%)
    15 / 119 (12.61%)
         occurrences all number
    50
    43
    40
    20
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    77 / 299 (25.75%)
    67 / 267 (25.09%)
    93 / 304 (30.59%)
    38 / 119 (31.93%)
         occurrences all number
    79
    68
    95
    39
    Injection site induration
         subjects affected / exposed
    47 / 299 (15.72%)
    40 / 267 (14.98%)
    68 / 304 (22.37%)
    31 / 119 (26.05%)
         occurrences all number
    48
    40
    70
    32
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    88 / 299 (29.43%)
    64 / 267 (23.97%)
    101 / 304 (33.22%)
    41 / 119 (34.45%)
         occurrences all number
    91
    64
    103
    42
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    101 / 299 (33.78%)
    76 / 267 (28.46%)
    87 / 304 (28.62%)
    32 / 119 (26.89%)
         occurrences all number
    122
    91
    103
    35
    Pyrexia
         subjects affected / exposed
    27 / 299 (9.03%)
    15 / 267 (5.62%)
    23 / 304 (7.57%)
    17 / 119 (14.29%)
         occurrences all number
    32
    17
    25
    22
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    44 / 299 (14.72%)
    32 / 267 (11.99%)
    36 / 304 (11.84%)
    17 / 119 (14.29%)
         occurrences all number
    59
    39
    43
    19
    Psychiatric disorders
    Eating disorder
         subjects affected / exposed
    88 / 299 (29.43%)
    68 / 267 (25.47%)
    83 / 304 (27.30%)
    26 / 119 (21.85%)
         occurrences all number
    106
    84
    92
    31
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    10 / 299 (3.34%)
    7 / 267 (2.62%)
    12 / 304 (3.95%)
    6 / 119 (5.04%)
         occurrences all number
    10
    7
    12
    6

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jan 2012
    Amendment 1 issued dealt with changes to the randomization ratio and sample size.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    22 May 2011
    There was an unplanned interruption to subject enrollment due to the identification of the erroneously dispatched vaccine lot.
    13 Aug 2012

    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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    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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