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    Clinical Trial Results:
    A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed InaCTivated inflUenza vaccine in adultS aged 65 years and above

    Summary
    EudraCT number
    		 2017-001103-77
    Trial protocol
    		 GB  
    Global end of trial date
    31 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Nov 2019
    First version publication date
    11 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FLU007 INVICTUS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03300362
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vaccitech Limited
    Sponsor organisation address
    The Schrodinger Building, Heatley Avenue, Oxford Science Park, Oxford, United Kingdom, OX4 4GE
    Public contact
    Dr Thomas Evans, Vaccitech Limited, 44 1865 818008, enquiries@vaccitech.co.uk
    Scientific contact
    Dr Thomas Evans, Vaccitech Limited, 44 1865 818008, tom.evans@vaccitech.co.uk
    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
    20 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy of MVA-NP+M1 in combination with licensed inactivated influenza vaccine in adults ≥65 years.
    Protection of trial subjects
    standard procedures for emergency care were followed for any adverse events if clinically needed. The study also incorporated stopping rules and IDMC reviews at pre-defined time points.
    Background therapy
    		 annual licensed QIV influenza vaccine
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 862
    Worldwide total number of subjects
    862
    EEA total number of subjects
    862
    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)
    0
    From 65 to 84 years
    862
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 participants aged 65 years or over who were eligible for the annual seasonal influenza vaccine were approached after screening by their General Practitioner. If interest was obtained, they were brought into their GP practice for screening, consenting and vaccination on the same day. They were then sent home with a diary card.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 1020 [1]
    Number of subjects completed
    		 862

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 On anti-coagulants: 2
    Reason: Number of subjects
    		 Did not attend appointment: 77
    Reason: Number of subjects
    		 History of anaphlyaxis: 2
    Reason: Number of subjects
    		 Attended visit and changed mind: 44
    Reason: Number of subjects
    		 Other medical reason: 2
    Reason: Number of subjects
    		 Involved in other trial: 1
    Reason: Number of subjects
    		 Previous allergic reaction to vaccine: 1
    Reason: Number of subjects
    		 Unknown: 20
    Reason: Number of subjects
    		 Physician decision: 9
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1020 people screened and invited to participate, only 862 decided or were eligible to participate.
    Period 1
    Period 1 title
    Enrolment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [2]
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 MVA-NP+M1 plus seasonal influenza vaccine
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA-NP+M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MVA dose 1.5x10*8 pfu given into deltoid muscle

    Investigational medicinal product name
    Quadrivalent Influenza Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Influenza virus (inactivated, split) of the following strains*: Per 0.5 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin

    Arm title
    		 Placebo
    Arm description
    		 0.9% Saline placebo and seasonal influenza vaccine
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.9% saline 0.5mL given into deltoid muscle

    Investigational medicinal product name
    Quadrivalent Influenza Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose was 0.5ml and administered via intramuscular injection

    Notes
    [2] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Due to the appearance of MVA it was not possible to conduct a double blind trial, however, to maintain as much blind as possible all study roles that could be kept blind were as shown here.
    Number of subjects in period 1
    		Active Placebo
    Started
    432
    430
    Completed
    431
    429
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    -
         ineligible
    -
    1
    Period 2
    Period 2 title
    Vaccination
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [3]
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 MVA-NP+M1 plus seasonal influenza vaccine
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA-NP+M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MVA dose 1.5x10*8 pfu given into deltoid muscle

    Investigational medicinal product name
    Quadrivalent Influenza Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Influenza virus (inactivated, split) of the following strains*: Per 0.5 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin

    Arm title
    		 Placebo
    Arm description
    		 0.9% Saline placebo and seasonal influenza vaccine
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.9% saline 0.5mL given into deltoid muscle

    Investigational medicinal product name
    Quadrivalent Influenza Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose was 0.5ml and administered via intramuscular injection

    Notes
    [3] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Due to the appearance of MVA it was not possible to conduct a double blind trial, however, to maintain as much blind as possible all study roles that could be kept blind were as shown here.
    Number of subjects in period 2
    		Active Placebo
    Started
    431
    429
    Completed
    420
    426
    Not completed
    11
    3
         Consent withdrawn by subject
    3
    -
         unknown reason
    1
    1
         non adherence
    7
    2
    Period 3
    Period 3 title
    Diary Card Completion
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [4]
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 MVA-NP+M1 plus seasonal influenza vaccine
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA-NP+M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MVA dose 1.5x10*8 pfu given into deltoid muscle

    Investigational medicinal product name
    Quadrivalent Influenza Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Influenza virus (inactivated, split) of the following strains*: Per 0.5 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin

    Arm title
    		 Placebo
    Arm description
    		 0.9% Saline placebo and seasonal influenza vaccine
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.9% saline 0.5mL given into deltoid muscle

    Investigational medicinal product name
    Quadrivalent Influenza Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose was 0.5ml and administered via intramuscular injection

    Notes
    [4] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Due to the appearance of MVA it was not possible to conduct a double blind trial, however, to maintain as much blind as possible all study roles that could be kept blind were as shown here.
    Number of subjects in period 3
    		Active Placebo
    Started
    420
    426
    Completed
    413
    420
    Not completed
    7
    6
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    2
    2
         Adverse event, non-fatal
    1
    1
         non adherence
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 MVA-NP+M1 plus seasonal influenza vaccine

    Reporting group title
    Placebo
    Reporting group description
    		 0.9% Saline placebo and seasonal influenza vaccine

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 432 430 862
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.5 ( 5.1 ) 72.4 ( 4.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 192 193 385
        Male
    		 240 237 477

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 MVA-NP+M1 plus seasonal influenza vaccine

    Reporting group title
    Placebo
    Reporting group description
    		 0.9% Saline placebo and seasonal influenza vaccine
    Reporting group title
    Active
    Reporting group description
    		 MVA-NP+M1 plus seasonal influenza vaccine

    Reporting group title
    Placebo
    Reporting group description
    		 0.9% Saline placebo and seasonal influenza vaccine
    Reporting group title
    Active
    Reporting group description
    		 MVA-NP+M1 plus seasonal influenza vaccine

    Reporting group title
    Placebo
    Reporting group description
    		 0.9% Saline placebo and seasonal influenza vaccine

    Primary: Number of Days with Moderate/Severe Influenza-like Symptoms during ILI

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    End point title
    		 Number of Days with Moderate/Severe Influenza-like Symptoms during ILI
    End point description
    End point type
    Primary
    End point timeframe
    Day 8 until end of influenza season which was 30th April 2018
    End point values
    		 Active Placebo
    Number of subjects analysed
    420
    426
    Units: days
        arithmetic mean (standard deviation)
    1.1 ( 3.8 )
    1.1 ( 3.3 )
    Statistical analysis title
    		 Unadjusted Linear Mixed Effect Model
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    846
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.872
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.954
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.537
         upper limit
    		 1.694
    Notes
    [1] - unadjusted linear mixed effect model for presence of moderate or severe symptoms

    Secondary: Incidence of Influenza like Illness

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    End point title
    		 Incidence of Influenza like Illness
    End point description
    Protocol defined ILI episodes
    End point type
    Secondary
    End point timeframe
    Day 8 to 30th April 2018
    End point values
    		 Active Placebo
    Number of subjects analysed
    420
    426
    Units: episodes
    83
    94
    No statistical analyses for this end point

    Secondary: Duration of Influenza like Illness

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    End point title
    		 Duration of Influenza like Illness
    End point description
    End point type
    Secondary
    End point timeframe
    Day 08 to 30th April 2018
    End point values
    		 Active Placebo
    Number of subjects analysed
    83
    94
    Units: Days
        median (full range (min-max))
    7.0 (1.0 to 58.0)
    5.0 (1.0 to 28.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    date of consent to day 28 for non-serious events date of consent until end of study for serious adverse events
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 -

    Serious adverse events
    		 Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 860 (3.02%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Surgical and medical procedures
    Elective surgery
         subjects affected / exposed
    6 / 860 (0.70%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 860 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Social circumstances
    Physical assault
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Pancreatitis relapsing
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic cyst
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Renal Colic
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    2 / 860 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 860 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 860 (6.98%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 860 (1.05%)
         occurrences all number
    10
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    11 / 860 (1.28%)
         occurrences all number
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    14 / 860 (1.63%)
         occurrences all number
    14
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    14 / 860 (1.63%)
         occurrences all number
    14
    Myalgia
         subjects affected / exposed
    12 / 860 (1.40%)
         occurrences all number
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Nov 2017
     Sponsor Address  24 Hour Safety Hotline number and safety email  Treatment duration and follow-up duration  ILI definition  Clarification of trial design for immunology cohort  Date to start recording their illness diary cards  Criteria for postponement of vaccination.  Details of randomisation for immunology cohort  Randomisation details not recorded in eCRF  Illness reporting and safety follow-up – details of ILI symptoms given here.  Medical Notes Review includes: chest imaging results when available  Deleted: Guidelines for assessing the relationship of vaccine administration to an AE  Start date for data analysis  Primary Outcome definition  Interim analysis: to include after the first 100 participants have been randomised
    27 Mar 2018
    Updated information on previous clinical use of MVA-NP+M1.  Added laboratory confirmed influenza as a secondary trial endpoint.  Addition of nasal swab procedure to collect laboratory confirmed influenza secondary endpoint  Clarifications on secondary endpoints and immunology endpoints.  Clarifications on trial design, AE reporting and causality assessment procedures  Updated list of solicited AEs and ILI symptoms recorded  Updated safety reporting information: GP consultations due to respiratory illness only, collected from week 5 onward. Previously scheduled elective procedures will not be reported as SAEs.  Clarification of which investigators will be blinded to group allocation.  Clarifications on study procedures for data collection on defined endpoints.  Updated compensation amount to reflect additional screening visit needed for participants recruited into the Immunology Cohort via general advertisements.  Increased window from 90 to 120 days between screening and vaccination visit for participants recruited via general advertisements  Update clarification of the statistical analysis of ILI

    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
    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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