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    Clinical Trial Results:
    A Phase II, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus Vaccine (Agrippal®) in Healthy Adults

    Summary
    EudraCT number
    		 2013-000545-39
    Trial protocol
    		 BE  
    Global end of trial date
    20 Aug 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    18 Nov 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
    V71_34S
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01879553
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l.
    Sponsor organisation address
    Via Fiorentina, 1, Siena, Italy, 53100
    Public contact
    Michelangelo Barone, Novartis Vaccines and Diagnostics S.r.l., +39 0577243516, michelangelo.barone@novartis.com
    Scientific contact
    Michelangelo Barone, Novartis Vaccines and Diagnostics S.r.l., +39 0577243516, michelangelo.barone@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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity Objective To evaluate the antibody response to each influenza vaccine antigen after vaccination with the TIV vaccine, as measured by single radial hemolysis (SRH) or hemagglutination inhibition (HI) assay in accordance with Guidance CPMP/BWP/214/96 Safety Objective To evaluate the safety of TIV in adult subjects in compliance with the requirements of the current European Union recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96)
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for GCP, with applicable local regulations, including the European Directive 2001/20/EC, the US CFR Title 21, and the Japanese Ministry of Health, Labor, and Welfare, Novartis codes on the protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jul 2013
    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
    Belgium: 126
    Worldwide total number of subjects
    126
    EEA total number of subjects
    126
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    75
    From 65 to 84 years
    50
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled from one study center in Belgium.

    Pre-assignment
    Screening details
    		 All enrolled subjects were included in study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TIV (18 to ≤ 60 Years)
    Arm description
    		 Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere.
    Arm type
    		 Experimental

    Investigational medicinal product name
    trivalent influenza virus vaccine (surface antigen, inactivated, egg-derived)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of one 0.5 mL dose administered IM in the deltoid muscle, preferably of the non-dominant arm.

    Arm title
    		 TIV (≥ 61 Years)
    Arm description
    		 Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere.
    Arm type
    		 Experimental

    Investigational medicinal product name
    trivalent influenza virus vaccine (surface antigen, inactivated, egg-derived)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of one 0.5 mL dose administered IM in the deltoid muscle, preferably of the non-dominant arm.

    Number of subjects in period 1
    		TIV (18 to ≤ 60 Years) TIV (≥ 61 Years)
    Started
    63
    63
    Completed
    62
    63
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TIV (18 to ≤ 60 Years)
    Reporting group description
    		 Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere.

    Reporting group title
    TIV (≥ 61 Years)
    Reporting group description
    		 Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere.

    Reporting group values
    		 TIV (18 to ≤ 60 Years) TIV (≥ 61 Years) Total
    Number of subjects
    		 63 63 126
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 63 12 75
        From 65-84 years
    		 0 50 50
        85 years and over
    		 0 1 1
        Adults (18 to ≤ 60 Years)
    		 0 0 0
        Adults (≥ 61 Years)
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 40 29 69
        Male
    		 23 34 57
    Subject analysis sets

    Subject analysis set title
    Enrolled Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All screened subjects who provided informed consent and provided demographic and/or baseline screening assessments and received a ‘Subject ID’.

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination, and were not excluded due to reasons defined prior to unblinding or analysis.

    Subject analysis set title
    Safety Set (solicited AEs and other solicited events)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed Set who provided postvaccination reactogenicity data.

    Subject analysis set title
    Safety Set (unsolicited AEs)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed Set who had postvaccination unsolicited AE records.

    Subject analysis sets values
    		 Enrolled Set Per Protocol Set Safety Set (solicited AEs and other solicited events) Safety Set (unsolicited AEs)
    Number of subjects
    126
    124
    126
    126
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
        Adults (18 to ≤ 60 Years)
    63
    61
    63
    63
        Adults (≥ 61 Years)
    63
    63
    63
    63
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    TIV (18 to ≤ 60 Years)
    Reporting group description
    		 Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere.

    Reporting group title
    TIV (≥ 61 Years)
    Reporting group description
    		 Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere.

    Subject analysis set title
    Enrolled Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All screened subjects who provided informed consent and provided demographic and/or baseline screening assessments and received a ‘Subject ID’.

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination, and were not excluded due to reasons defined prior to unblinding or analysis.

    Subject analysis set title
    Safety Set (solicited AEs and other solicited events)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed Set who provided postvaccination reactogenicity data.

    Subject analysis set title
    Safety Set (unsolicited AEs)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed Set who had postvaccination unsolicited AE records.

    Primary: Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV

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    End point title
    		 Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV [1]
    End point description
    Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years.
    End point type
    Primary
    End point timeframe
    Day 22 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
    		 TIV (18 to ≤ 60 Years) TIV (≥ 61 Years)
    Number of subjects analysed
    61
    63
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 1 (H1N1 strain)
    52 (39 to 65)
    41 (29 to 54)
        Day 22 (H1N1 strain)
    100 (94 to 100)
    78 (66 to 87)
        Day 1 (H3N2 strain)
    31 (20 to 44)
    46 (33 to 59)
        Day 22 (H3N2 strain)
    92 (82 to 97)
    78 (66 to 87)
        Day 1 (B strain)
    38 (26 to 51)
    67 (54 to 78)
        Day 22 (B strain)
    92 (82 to 97)
    89 (78 to 95)
    No statistical analyses for this end point

    Primary: Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, against Each of Three Vaccine Strains After Receiving One Dose of TIV

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    End point title
    		 Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, against Each of Three Vaccine Strains After Receiving One Dose of TIV [2]
    End point description
    Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area. The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination SRH areas.
    End point type
    Primary
    End point timeframe
    Day 22 post vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 TIV (18 to ≤ 60 Years) TIV (≥ 61 Years)
    Number of subjects analysed
    61
    63
    Units: Percentage of subjects
    number (confidence interval 95%)
        H1N1 strain
    69 (56 to 80)
    49 (36 to 62)
        H3N2 strain
    70 (57 to 81)
    43 (30 to 56)
        B strain
    70 (57 to 81)
    30 (19 to 43)
    No statistical analyses for this end point

    Primary: Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination GMAs, After one Dose of TIV

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    End point title
    		 Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination GMAs, After one Dose of TIV [3]
    End point description
    The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years.
    End point type
    Primary
    End point timeframe
    Day 22 post vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 TIV (18 to ≤ 60 Years) TIV (≥ 61 Years)
    Number of subjects analysed
    61
    63
    Units: Ratio
    geometric mean (confidence interval 95%)
        H1N1 strain
    3.41 (2.51 to 4.63)
    1.85 (1.52 to 2.25)
        H3N2 strain
    3.07 (2.45 to 3.85)
    1.74 (1.46 to 2.08)
        B strain
    2.06 (1.75 to 2.42)
    1.49 (1.29 to 1.73)
    No statistical analyses for this end point

    Primary: Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, against Each of Three Vaccine Strains After Receiving One Dose of TIV

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    End point title
    		 Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, against Each of Three Vaccine Strains After Receiving One Dose of TIV [4]
    End point description
    Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years.
    End point type
    Primary
    End point timeframe
    Day 22 post vaccination
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 TIV (18 to ≤ 60 Years) TIV (≥ 61 Years)
    Number of subjects analysed
    61
    63
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 1 (H1N1 strain)
    59 (46 to 71)
    60 (47 to 72)
        Day 22 (H1N1 strain)
    100 (94 to 100)
    90 (80 to 96)
        Day 1 (H3N2 strain)
    66 (52 to 77)
    86 (75 to 93)
        Day 22 (H3N2 strain)
    100 (94 to 100)
    98 (91 to 100)
        Day 1 (B strain)
    66 (52 to 77)
    70 (57 to 81)
        Day 22 (B strain)
    98 (91 to 100)
    89 (78 to 95)
    No statistical analyses for this end point

    Primary: Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV

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    End point title
    		 Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV [5]
    End point description
    Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers. The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers.
    End point type
    Primary
    End point timeframe
    Day 22 post vaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 TIV (18 to ≤ 60 Years) TIV (≥ 61 Years)
    Number of subjects analysed
    61
    63
    Units: Percentage of subjects
    number (confidence interval 95%)
        H1N1 strain
    64 (51 to 76)
    32 (21 to 45)
        H3N2 strain
    64 (51 to 76)
    16 (8 to 27)
        B strain
    52 (39 to 65)
    13 (6 to 23)
    No statistical analyses for this end point

    Primary: Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV

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    End point title
    		 Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV [6]
    End point description
    The antibody responses following one dose of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years.
    End point type
    Primary
    End point timeframe
    Day 22 post vaccination
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 TIV (18 to ≤ 60 Years) TIV (≥ 61 Years)
    Number of subjects analysed
    61
    63
    Units: Ratio
    geometric mean (confidence interval 95%)
        H1N1 strain
    9.65 (5.96 to 16)
    2.6 (1.97 to 3.45)
        H3N2 strain
    8.47 (5.44 to 13)
    1.85 (1.37 to 2.5)
        B strain
    4.56 (3.26 to 6.37)
    1.49 (1.22 to 1.83)
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV

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    End point title
    		 Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV [7]
    End point description
    The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one dose of TIV is reported.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 22 post vaccination
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 TIV (18 to ≤ 60 Years) TIV (≥ 61 Years)
    Number of subjects analysed
    63
    63
    Units: Subjects
        Any AE (Day 1 to 4)
    10
    8
        At least Possibly related AE
    9
    6
        Any SAE
    0
    0
        At least Possibly related SAE
    0
    0
        Medically attended AE
    0
    0
        AE leading to discontinuation
    0
    0
        Death
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Solicited Adverse Events After

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    End point title
    		 Number of Subjects Reporting Solicited Adverse Events After [8]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 to Day 4 post vaccination
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 TIV (18 to ≤ 60 Years) TIV (≥ 61 Years)
    Number of subjects analysed
    62
    63
    Units: Subjects
        Any Local
    38
    18
        Injection site induration
    13
    9
        Injection site erythema
    10
    8
        Injection site ecchymosis
    4
    1
        Injection site pain
    34
    12
        Any Systemic
    17
    10
        Shivering/Chills
    0
    0
        Myalgia
    1
    1
        Arthralgia
    0
    1
        Fatigue
    15
    8
        Headache
    5
    3
        Malaise
    2
    4
        Fever (≥ 38°C)
    0
    0
        Prophylactic use of analgesics/antipyretics
    0
    0
        Therapeutic use of analgesics/antipyretics
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    TIV (≥ 61 Years)
    Reporting group description
    		 Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere.

    Reporting group title
    TIV (18 to ≤ 60 Years)
    Reporting group description
    		 Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere.

    Serious adverse events
    		 TIV (≥ 61 Years) TIV (18 to ≤ 60 Years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TIV (≥ 61 Years) TIV (18 to ≤ 60 Years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 63 (42.86%)
    41 / 63 (65.08%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 63 (4.76%)
    5 / 63 (7.94%)
         occurrences all number
    3
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 63 (12.70%)
    15 / 63 (23.81%)
         occurrences all number
    8
    17
    Injection site erythema
         subjects affected / exposed
    9 / 63 (14.29%)
    9 / 63 (14.29%)
         occurrences all number
    17
    16
    Injection site haemorrhage
         subjects affected / exposed
    1 / 63 (1.59%)
    4 / 63 (6.35%)
         occurrences all number
    2
    8
    Injection site induration
         subjects affected / exposed
    8 / 63 (12.70%)
    11 / 63 (17.46%)
         occurrences all number
    12
    19
    Injection site pain
         subjects affected / exposed
    16 / 63 (25.40%)
    35 / 63 (55.56%)
         occurrences all number
    16
    36
    Malaise
         subjects affected / exposed
    5 / 63 (7.94%)
    2 / 63 (3.17%)
         occurrences all number
    5
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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