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    Clinical Trial Results:
    A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.

    Summary
    EudraCT number
    		 2012-001223-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Jun 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Jul 2016
    First version publication date
    17 Mar 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Required for the re-QC because of EudraCT system glitch as possible updates to results are required. Moreover, the study is now transferred to another primary user.

    Trial information

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    Trial identification
    Sponsor protocol code
    V58_31
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01857206
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics
    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
    29 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate safety and tolerability of one or two doses (administered 4 weeks apart) of mammalian cell culture-derived influenza vaccine (TIVc) and Fluvirin (TIVf) in children and adolescents ≥4 to ≤17 years of age.
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations, Novartis Vaccine and Diagnostics codes on protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki (European Council 2001, US Code of Federal Regulations, ICH 1997).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 May 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 7 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 322
    Country: Number of subjects enrolled
    United States: 314
    Country: Number of subjects enrolled
    New Zealand: 99
    Country: Number of subjects enrolled
    Philippines: 680
    Country: Number of subjects enrolled
    Thailand: 640
    Worldwide total number of subjects
    2055
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    1451
    Adolescents (12-17 years)
    604
    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 enrolled at a total of 34 centers in 5 countries. 18 sites in the US, 6 sites in Australia, 2 sites in New Zealand, 5 sites in the Philippines and 3 sites in Thailand.

    Pre-assignment
    Screening details
    		 All enrolled subjects were included in the 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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TIVc
    Arm description
    		 Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trivalent influenza virus vaccine (surface antigen, inactivated, mammalian cell culture-derived)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects ≥4 to ≤8 years previously vaccinated and all subjects ≥9 to ≤17: one dose of 0.5mL TIVc. Subjects ≥4 to ≤8 years not previously vaccinated: two doses of 0.5mL TIVc.

    Arm title
    		 TIVf
    Arm description
    		 Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Trivalent influenza virus vaccine (surface antigen, inactivated, egg-derived, Fluvirin platform)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects ≥4 to ≤8 years previously vaccinated and all subjects ≥9 to ≤17: one dose of 0.5mL TIVf. Subjects ≥4 to ≤8 years not previously vaccinated: two doses of 0.5mL TIVf.

    Number of subjects in period 1
    		TIVc TIVf
    Started
    1372
    683
    Completed
    1359
    673
    Not completed
    13
    10
         Consent withdrawn by subject
    1
    -
         Unclassified
    3
    3
         Lost to follow-up
    9
    6
         Administrative reason
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TIVc
    Reporting group description
    		 Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.

    Reporting group title
    TIVf
    Reporting group description
    		 Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.

    Reporting group values
    		 TIVc TIVf Total
    Number of subjects
    		 1372 683 2055
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.1 ( 3.8 ) 9.3 ( 3.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 703 349 1052
        Male
    		 669 334 1003

    End points

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    End points reporting groups
    Reporting group title
    TIVc
    Reporting group description
    		 Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.

    Reporting group title
    TIVf
    Reporting group description
    		 Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.

    Subject analysis set title
    TIVc (≥4 to ≤8 years)- Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed set who have either postvaccination safety data or solicited safety data.

    Subject analysis set title
    TIVf (≥4 to ≤8 years)- Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed set who have either postvaccination safety data or solicited safety data.

    Subject analysis set title
    TIVc (≥9 to ≤17 years)- Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed set who have either postvaccination safety data or solicited safety data.

    Subject analysis set title
    TIVc (≥9 to ≤17 years)- Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed set who have either postvaccination safety data or solicited safety data.

    Primary: 1. Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.

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    End point title
    		 1. Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. [1]
    End point description
    Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years. Analysis was done on the solicited safety dataset, i.e., the subjects in the exposed population who provided postvaccination solicited safety data.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 7 after any 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: Evaluation of the safety endpoints was of descriptive nature without prespecified criteria.
    End point values
    		 TIVc (≥4 to ≤8 years)- Safety Set TIVf (≥4 to ≤8 years)- Safety Set TIVc (≥9 to ≤17 years)- Safety Set TIVc (≥9 to ≤17 years)- Safety Set
    Number of subjects analysed
    688
    341
    341
    682
    Units: Subjects
        Any Local
    422
    202
    160
    370
        Injection site Induration (AE)
    109
    43
    33
    46
        Injection site Swelling (AE)
    87
    37
    26
    36
        Injection site Erythema (AE)
    148
    57
    37
    72
        Injection site Ecchymosis (AE)
    68
    30
    11
    27
        Injection site Pain (AE)
    384
    186
    142
    356
        Any Systemic
    252
    110
    113
    267
        Chills (AE)
    47
    17
    7
    39
        Nausea (AE)
    57
    26
    16
    45
        Myalgia (AE)
    113
    41
    44
    126
        Arthralgia (AE)
    39
    16
    14
    54
        Headache (AE)
    105
    42
    57
    128
        Fatigue (AE)
    92
    34
    56
    109
        Loss of appetite (AE)
    68
    25
    12
    50
        Malaise(AE)
    112
    43
    46
    99
        Sweating (AE)
    39
    20
    23
    52
        Fever (≥38°C) (AE)
    48
    30
    5
    12
        ≥40°C (AE)
    3
    0
    0
    0
        Prevention of pain and (or) fever (Indicator)
    61
    29
    10
    24
        Treatment of pain and (or) fever (Indicator)
    90
    40
    18
    39
    No statistical analyses for this end point

    Primary: 2. Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.

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    End point title
    		 2. Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. [2]
    End point description
    Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years. Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 28 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Evaluation of the safety endpoints was of descriptive nature without prespecified criteria.
    End point values
    		 TIVc (≥4 to ≤8 years)- Safety Set TIVf (≥4 to ≤8 years)- Safety Set TIVc (≥9 to ≤17 years)- Safety Set TIVc (≥9 to ≤17 years)- Safety Set
    Number of subjects analysed
    688
    341
    341
    682
    Units: Subjects
        Any AE
    277
    139
    88
    158
        At least possibly related AEs
    50
    26
    22
    32
    No statistical analyses for this end point

    Primary: 3. Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.

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    End point title
    		 3. Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. [3]
    End point description
    Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years. Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 183 for previously vaccinated subjects and Day 1 to Day 213 for not-previously vaccinated subjects
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Evaluation of the safety endpoints was of descriptive nature without prespecified criteria.
    End point values
    		 TIVc (≥4 to ≤8 years)- Safety Set TIVf (≥4 to ≤8 years)- Safety Set TIVc (≥9 to ≤17 years)- Safety Set TIVc (≥9 to ≤17 years)- Safety Set
    Number of subjects analysed
    688
    341
    341
    682
    Units: Subjects
        SAE
    17
    7
    9
    7
        At least possibly related SAEs
    0
    0
    0
    0
        AE leading to withdrawal
    0
    0
    0
    0
        Medically attended AE
    284
    139
    105
    172
        NOCD
    5
    4
    1
    3
        Death
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months or 7 months based on the previous vaccination status of the subjects. Of a total of 2055 subjects and 2050 subjects were included in unolicited safety set.
    Adverse event reporting additional description
    Subjects aged ≥4 to ≤8 years not previously vaccinated, AEs collected from day 1 to 7 and day 29 to 35; SAEs, medically attended AEs and NOCD till day 213. Subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years, AEs were collected from day 1 to 7; SAEs, medically attended AEs and NOCD were collected till day 183.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    TIVc
    Reporting group description
    		 Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.

    Reporting group title
    TIVf
    Reporting group description
    		 Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.

    Serious adverse events
    		 TIVc TIVf
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 1370 (1.75%)
    16 / 682 (2.35%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    3 / 1370 (0.22%)
    3 / 682 (0.44%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal scratch
         subjects affected / exposed
    1 / 1370 (0.07%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 1370 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 1370 (0.07%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebellar ataxia
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual field defect
         subjects affected / exposed
    0 / 1370 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 1370 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adnexal torsion
         subjects affected / exposed
    0 / 1370 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 1370 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 1370 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    2 / 1370 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 1370 (0.07%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    3 / 1370 (0.22%)
    3 / 682 (0.44%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 1370 (0.15%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 1370 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 1370 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 1370 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis bacterial
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 1370 (0.07%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TIVc TIVf
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1019 / 1370 (74.38%)
    482 / 682 (70.67%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    245 / 1370 (17.88%)
    106 / 682 (15.54%)
         occurrences all number
    310
    125
    General disorders and administration site conditions
    Chills
    alternative assessment type: Systematic
         subjects affected / exposed
    87 / 1370 (6.35%)
    26 / 682 (3.81%)
         occurrences all number
    95
    28
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    204 / 1370 (14.89%)
    92 / 682 (13.49%)
         occurrences all number
    247
    111
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    249 / 1370 (18.18%)
    111 / 682 (16.28%)
         occurrences all number
    295
    134
    Injection site haemorrhage
         subjects affected / exposed
    96 / 1370 (7.01%)
    41 / 682 (6.01%)
         occurrences all number
    110
    51
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    162 / 1370 (11.82%)
    78 / 682 (11.44%)
         occurrences all number
    185
    85
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    818 / 1370 (59.71%)
    370 / 682 (54.25%)
         occurrences all number
    979
    456
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    136 / 1370 (9.93%)
    72 / 682 (10.56%)
         occurrences all number
    157
    83
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    211 / 1370 (15.40%)
    89 / 682 (13.05%)
         occurrences all number
    260
    109
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    80 / 1370 (5.84%)
    51 / 682 (7.48%)
         occurrences all number
    92
    60
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    106 / 1370 (7.74%)
    44 / 682 (6.45%)
         occurrences all number
    121
    49
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    91 / 1370 (6.64%)
    43 / 682 (6.30%)
         occurrences all number
    100
    55
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    98 / 1370 (7.15%)
    31 / 682 (4.55%)
         occurrences all number
    109
    35
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    245 / 1370 (17.88%)
    86 / 682 (12.61%)
         occurrences all number
    275
    95
    Infections and infestations
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    191 / 1370 (13.94%)
    86 / 682 (12.61%)
         occurrences all number
    229
    104
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    119 / 1370 (8.69%)
    37 / 682 (5.43%)
         occurrences all number
    144
    39

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2012
    Included comprehensive revision of the protocol in accordance with the memo provided by CBER, following the revised “Safety Data Collection process” as agreed with CBER.
    14 Mar 2013
    Included comprehensive revision of the protocol, including language to allow extension in northern hemisphere, improve clarity on the definition of previously vaccinated status, allow reminder and safety calls to be performed as a clinic visit, correct reflection of diary card, further specification in exclusion criteria, further specification of the physical examination requirements and a number of other corrections; impacting study conduct and/or analyses, and EC/IRB approval was obtained prior to FSFV.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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