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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy and immunogenicity of an influenza A vaccine (Vaccine FP-01.1) in healthy volunteers following virus challenge

    Summary
    EudraCT number
    		 2013-004612-22
    Trial protocol
    		 GB  
    Global end of trial date
    27 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Mar 2016
    First version publication date
    26 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FP-01.1_CS_04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Altimmune UK Ltd, previously known as Immune Targeting Systems Ltd
    Sponsor organisation address
    London Bioscience Innovation Centre, 2 Royal College Street, London, United Kingdom, NW1 0NH
    Public contact
    General contact point, Altimmune UK Ltd, previously known as Immune Targeting Systems Ltd, +44 02076914908, info@altimmune.com
    Scientific contact
    General contact point, Altimmune UK Ltd, previously known as Immune Targeting Systems Ltd, +44 02076914908, info@altimmune.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
    24 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to further characterise the safety and tolerability profile of Vaccine FP-01.1.
    Protection of trial subjects
    The study was conducted in accordance with Good Clinical Practice as required by the International Conference on Harmonisation guidelines and in accordance with country-specific laws and regulations governing clinical studies of investigational products. A study-specific informed consent document was signed by the subject and the investigator before any study-related procedures were performed. A separate consent form was also provided for optional exploratory genomics research.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    29 Jan 2014
    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
    United Kingdom: 111
    Worldwide total number of subjects
    111
    EEA total number of subjects
    111
    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)
    111
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first subject was enrolled on 29 January 2014, and the last subject last visit occurred on 27 November 2014

    Pre-assignment
    Screening details
    		 Potential subjects first underwent panel screening (Study Visit 1) to demonstrate good health and acceptable haemagglutination inhibition titre to the challenge H1N1 virus. After completion of the panel screening, potential subjects underwent a protocol-specific screening to confirm eligibility (Study Visit 2, Days -28 to -2).

    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
    		 Investigator, Subject
    Blinding implementation details
    With the exception of the pharmacy department, the statistician preparing the randomisation to Vaccine FP-01.1/placebo, the member(s) of staff administering Vaccine FP-01.1/placebo and quality assurance auditors where necessary, all clinical and non-clinical staff remained blinded to the treatment allocation until after the database was locked.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vaccine FP-01.1
    Arm description
    		 Subjects who received 2 vaccinations of Vaccine FP-01.1, and were otherwise eligible, who were administered a single dose of the H1N1 challenge virus in the morning of Day C1 (Study Day 44). All subjects who were administered the challenge virus were given a 5-day course of Tamiflu, which was administered orally (75 mg twice daily; 10 capsules in total). The first dose was given to subjects in the evening of Day C7.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vaccine FP-01.1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 single doses of 250 μg/peptide Vaccine FP-01.1 (total 1.5 mg peptide). The first dose was administered on Day 1 and the second dose approximately 4 weeks later, on Day 29. Each dose of Vaccine FP-01.1 was administered as an IM injection (0.5 mL) in the deltoid muscle of the non-dominant arm by appropriately trained clinic staff members.

    Arm title
    		 Placebo
    Arm description
    		 Subjects who received 2 doses of placebo, and were otherwise eligible, who were administered a single dose of the H1N1 challenge virus in the morning of Day C1 (Study Day 44). All subjects who were administered the challenge virus were given a 5-day course of Tamiflu, which was administered orally (75 mg twice daily; 10 capsules in total). The first dose was given to subjects in the evening of Day C7.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 single doses of corresponding placebo for Vaccine FP-01.1. The first dose was administered on Day 1 and the second dose approximately 4 weeks later, on Day 29. Each dose of placebo was administered as an IM injection (0.5 mL) in the deltoid muscle of the non-dominant arm by appropriately trained clinic staff members.

    Number of subjects in period 1
    		Vaccine FP-01.1 Placebo
    Started
    57
    54
    Start of vaccination phase (Day 1)
    57
    54
    End of vaccination phase (Day C-1)
    42
    41
    Start of virus challenge phase (Day 44)
    42
    41
    End of virus challenge phase (Day 72)
    42
    41
    Final follow-up (Day 209)
    42
    40
    Completed
    42
    40
    Not completed
    15
    14
         Egg allergy
    1
    -
         Consent withdrawn by subject
    3
    2
         Physician decision
    1
    -
         Adverse event, non-fatal
    4
    1
         Day 29 H1N1 results out of range
    4
    7
         Out of range safety laboratory results on Day C-1
    1
    -
         Lost to follow-up
    -
    1
         Lack of response from subject's GP
    -
    3
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vaccine FP-01.1
    Reporting group description
    		 Subjects who received 2 vaccinations of Vaccine FP-01.1, and were otherwise eligible, who were administered a single dose of the H1N1 challenge virus in the morning of Day C1 (Study Day 44). All subjects who were administered the challenge virus were given a 5-day course of Tamiflu, which was administered orally (75 mg twice daily; 10 capsules in total). The first dose was given to subjects in the evening of Day C7.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who received 2 doses of placebo, and were otherwise eligible, who were administered a single dose of the H1N1 challenge virus in the morning of Day C1 (Study Day 44). All subjects who were administered the challenge virus were given a 5-day course of Tamiflu, which was administered orally (75 mg twice daily; 10 capsules in total). The first dose was given to subjects in the evening of Day C7.

    Reporting group values
    		 Vaccine FP-01.1 Placebo Total
    Number of subjects
    		 57 54 111
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.6 ± 6.54 33.6 ± 7.12 -
    Gender categorical
    Units: Subjects
        Female
    		 24 31 55
        Male
    		 33 23 56
    Race
    Units: Subjects
        Asian
    		 1 4 5
        Black or African American
    		 6 1 7
        Mixed race - White and Black
    		 0 1 1
        Mixed race - White and Black Caribbean
    		 1 0 1
        White
    		 49 47 96
        Zimbabwean
    		 0 1 1
    Ethnicity
    Units: Subjects
        Hispanic
    		 1 3 4
        Non-Hispanic
    		 56 51 107
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 173.11 ± 9.274 170.12 ± 8.458 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 74.51 ± 13.885 71.07 ± 9.769 -
    Body Mass Index
    Units: kg per square metre
        arithmetic mean (standard deviation)
    		 24.713 ± 3.249 24.528 ± 2.651 -

    End points

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    End points reporting groups
    Reporting group title
    Vaccine FP-01.1
    Reporting group description
    		 Subjects who received 2 vaccinations of Vaccine FP-01.1, and were otherwise eligible, who were administered a single dose of the H1N1 challenge virus in the morning of Day C1 (Study Day 44). All subjects who were administered the challenge virus were given a 5-day course of Tamiflu, which was administered orally (75 mg twice daily; 10 capsules in total). The first dose was given to subjects in the evening of Day C7.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who received 2 doses of placebo, and were otherwise eligible, who were administered a single dose of the H1N1 challenge virus in the morning of Day C1 (Study Day 44). All subjects who were administered the challenge virus were given a 5-day course of Tamiflu, which was administered orally (75 mg twice daily; 10 capsules in total). The first dose was given to subjects in the evening of Day C7.

    Primary: Adverse event profile

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    End point title
    		 Adverse event profile [1]
    End point description
    Overall summary of all adverse events for both treatment groups.
    End point type
    Primary
    End point timeframe
    Entire duration of study
    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: The primary objective of this study was to further characterise the safety and tolerability profile of Vaccine FP-01.1. Descriptive data are reported for the specified safety parameters.
    End point values
    		 Vaccine FP-01.1 Placebo
    Number of subjects analysed
    57
    54
    Units: Number of subjects
        Adverse event
    39
    30
        Treatment-emergent adverse event
    38
    30
        Serious adverse event
    1
    1
        Adverse event leading to withdrawal
    4
    1
        Adverse event leading to death
    0
    0
        Severe adverse event
    2
    3
        Treatment-related treatment-emergent adverse event
    14
    4
    No statistical analyses for this end point

    Primary: Abnormal clinical laboratory values

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    End point title
    		 Abnormal clinical laboratory values [2]
    End point description
    Number of subjects with abnormal clinical laboratory value for listed parameter in either the vaccination phase or the virus challenge phase
    End point type
    Primary
    End point timeframe
    Entire duration of study
    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: The primary objective of this study was to further characterise the safety and tolerability profile of Vaccine FP-01.1. Descriptive data are reported for the specified safety parameters.
    End point values
    		 Vaccine FP-01.1 Placebo
    Number of subjects analysed
    57
    54
    Units: Number of subjects
        Cotinine
    1
    0
        C Reactive Protein
    1
    1
        Leukocytes
    1
    0
        Neutrophils
    1
    0
        Total
    2
    1
    No statistical analyses for this end point

    Primary: Local injection site reaction - Day 1

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    End point title
    		 Local injection site reaction - Day 1 [3]
    End point description
    Injection site reaction of any severity
    End point type
    Primary
    End point timeframe
    0.5h 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: The primary objective of this study was to further characterise the safety and tolerability profile of Vaccine FP-01.1. Descriptive data are reported for the specified safety parameters.
    End point values
    		 Vaccine FP-01.1 Placebo
    Number of subjects analysed
    57
    54
    Units: Number of subjects
        Pain
    35
    3
        Erythema/redness
    8
    2
        Bruising
    0
    0
        Induration/swelling
    4
    0
        Itching
    0
    0
        Other
    0
    0
    No statistical analyses for this end point

    Primary: Local injection site reaction - Day 29

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    End point title
    		 Local injection site reaction - Day 29 [4]
    End point description
    Injection site reaction of any severity
    End point type
    Primary
    End point timeframe
    0.5h 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: The primary objective of this study was to further characterise the safety and tolerability profile of Vaccine FP-01.1. Descriptive data are reported for the specified safety parameters.
    End point values
    		 Vaccine FP-01.1 Placebo
    Number of subjects analysed
    54
    53
    Units: Number of subjects
        Pain
    16
    1
        Erythema/redness
    5
    0
        Bruising
    0
    0
        Induration/swelling
    0
    0
        Itching
    0
    0
        Other
    0
    0
    No statistical analyses for this end point

    Secondary: Laboratory-confirmed illness

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    End point title
    		 Laboratory-confirmed illness
    End point description
    Incidence of laboratory-confirmed illness during the efficacy assessment period
    End point type
    Secondary
    End point timeframe
    During efficacy assessment period (from first assessment after virus challenge until last assessment prior to administration of Tamiflu)
    End point values
    		 Vaccine FP-01.1 Placebo
    Number of subjects analysed
    42
    41
    Units: Number of subjects
        Laboratory-confirmed mild illness
    26
    22
        Laboratory-confirmed moderate illness
    10
    11
    Statistical analysis title
    		 Laboratory-confirmed mild illness
    Comparison groups
    Vaccine FP-01.1 v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5904 [5]
    Method
    		 Pearson's chi-square test
    Confidence interval
    Notes
    [5] - P-value from Pearson's chi-square test with Yates's correction
    Statistical analysis title
    		 Laboratory-confirmed moderate illness
    Comparison groups
    Vaccine FP-01.1 v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9491 [6]
    Method
    		 Pearson's chi-square test
    Confidence interval
    Notes
    [6] - P-value from Pearson's chi-square test with Yates's correction

    Secondary: Incidence of symptoms and signs of influenza-like illness

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    End point title
    		 Incidence of symptoms and signs of influenza-like illness
    End point description
    Incidence and severity of symptoms and signs of influenza-like illness and pyrexia during the efficacy assessment period
    End point type
    Secondary
    End point timeframe
    During efficacy assessment period (from first assessment after virus challenge until last assessment prior to administration of Tamiflu)
    End point values
    		 Vaccine FP-01.1 Placebo
    Number of subjects analysed
    42
    41
    Units: Number of subjects
        Any mild or worse symptom or sign or pyrexia
    38
    31
        Any moderate or worse symptom or sign or pyrexia
    10
    13
    Statistical analysis title
    		 Any mild or worse symptom or sign or pyrexia
    Comparison groups
    Placebo v Vaccine FP-01.1
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.1297 [7]
    Method
    		 Pearson's chi-square test
    Confidence interval
    Notes
    [7] - P-value from Pearson's chi-square test with Yates's correction.
    Statistical analysis title
    		 Any moderate or worse symptom or sign or pyrexia
    Comparison groups
    Placebo v Vaccine FP-01.1
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5765 [8]
    Method
    		 Pearson's chi-square test
    Confidence interval
    Notes
    [8] - P-value from Pearson's chi-square test with Yates's correction.

    Secondary: Duration of signs and symptoms of influenza-like illness

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    End point title
    		 Duration of signs and symptoms of influenza-like illness
    End point description
    Number of days subjects experienced signs and symptoms of influenza-like illness and pyrexia
    End point type
    Secondary
    End point timeframe
    During efficacy assessment period (from first assessment after virus challenge until last assessment prior to administration of Tamiflu)
    End point values
    		 Vaccine FP-01.1 Placebo
    Number of subjects analysed
    42
    41
    Units: Number of days
    arithmetic mean (standard deviation)
        Mild or worse sign or symptom or pyrexia
    2.86 ± 1.98
    2.68 ± 2.31
        Moderate or worse sign or symptom or pyrexia
    0.5 ± 1.09
    0.59 ± 1.14
    Statistical analysis title
    		 Mild or worse symptoms, signs, and pyrexia
    Comparison groups
    Vaccine FP-01.1 v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6346
    Method
    		 Mann-Whitney non-parametric test
    Confidence interval
    Statistical analysis title
    		 Moderate or worse symptoms, signs, and pyrexia
    Comparison groups
    Vaccine FP-01.1 v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5168
    Method
    		 Mann-Whitney non-parametric test
    Confidence interval

    Secondary: Incidence of viral shedding

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    End point title
    		 Incidence of viral shedding
    End point description
    Incidence of virus shedding as determined by reverse transcription polymerase chain reaction (RT-PCR) or tissue culture infectivity (TCI)
    End point type
    Secondary
    End point timeframe
    During efficacy assessment period (from first assessment after virus challenge until last assessment prior to administration of Tamiflu)
    End point values
    		 Vaccine FP-01.1 Placebo
    Number of subjects analysed
    42
    41
    Units: Number of subjects
        Virus shedding by RT-PCR or TCI
    28
    27
        Virus shedding by RT-PCR
    28
    27
        Virus shedding by TCI
    23
    26
    Statistical analysis title
    		 Virus shedding by RT-PCR or TCI
    Comparison groups
    Vaccine FP-01.1 v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1 [9]
    Method
    		 Pearson's chi-square test
    Confidence interval
    Notes
    [9] - Pearson's chi-square test with Yates's correction
    Statistical analysis title
    		 Virus shedding by RT-PCR
    Comparison groups
    Vaccine FP-01.1 v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1 [10]
    Method
    		 Pearson's chi-square test
    Confidence interval
    Notes
    [10] - Pearson's chi-square test with Yates's correction
    Statistical analysis title
    		 Virus shedding by TCI
    Comparison groups
    Vaccine FP-01.1 v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5631 [11]
    Method
    		 Pearson's chi-square test
    Confidence interval
    Notes
    [11] - Pearson's chi-square test with Yates's correction

    Secondary: Duration of viral shedding

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    End point title
    		 Duration of viral shedding
    End point description
    Number of days demonstrating virus shedding as determined by reverse transcription polymerase chain reaction (RT-PCR) or tissue culture infectivity (TCI)
    End point type
    Secondary
    End point timeframe
    During efficacy assessment period (from first assessment after virus challenge until last assessment prior to administration of Tamiflu)
    End point values
    		 Vaccine FP-01.1 Placebo
    Number of subjects analysed
    42
    41
    Units: Number of days
    arithmetic mean (standard deviation)
        Virus shedding by RT-PCR or TCI
    2.57 ± 2.25
    2.71 ± 2.25
        Virus shedding by RT-PCR
    2.57 ± 2.25
    2.71 ± 2.25
        Virus shedding by TCI
    2.1 ± 2.2
    2.24 ± 1.95
    Statistical analysis title
    		 Virus shedding by RT-PCR or TCI
    Comparison groups
    Vaccine FP-01.1 v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8224 [12]
    Method
    		 Mann-Whitney non-parametric test
    Confidence interval
    Notes
    [12] - P-value from Mann-Whitney non-parametric test.
    Statistical analysis title
    		 Virus shedding by RT-PCR
    Comparison groups
    Vaccine FP-01.1 v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8224 [13]
    Method
    		 Mann-Whitney non-parametric test
    Confidence interval
    Notes
    [13] - P-value from Mann-Whitney non-parametric test.
    Statistical analysis title
    		 Virus shedding by TCI
    Comparison groups
    Vaccine FP-01.1 v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6826 [14]
    Method
    		 Mann-Whitney non-parametric test
    Confidence interval
    Notes
    [14] - P-value from Mann-Whitney non-parametric test.

    Secondary: Immunogenicity (interferon-gamma ELISPOT score)

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    End point title
    		 Immunogenicity (interferon-gamma ELISPOT score)
    End point description
    Interferon-gamma enzyme-linked immunosorbent spot (ELISPOT) score , for sum of the six individual long peptides comprising FP-01.1, after incubation of peripheral blood mononuclear cells isolated from subject blood samples with these peptides
    End point type
    Secondary
    End point timeframe
    Comparison between baseline (ie prior to first injection of vaccine/placebo) and day before virus challenge
    End point values
    		 Vaccine FP-01.1 Placebo
    Number of subjects analysed
    56
    52
    Units: ELISPOT score
    median (full range (min-max))
        Baseline
    87 (0 to 788)
    66 (0 to 1146)
        Day before virus challenge (Day C-1)
    363 (0 to 1261)
    134 (0 to 733)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) were recorded throughout the entire study period, from study-specific screening (Visit 2) to final follow-up visit (Day 209).
    Adverse event reporting additional description
    Solicited (collected via subject score cards) and unsolicited (collected via targeted physical examination) symptoms and signs of influenza were not routinely reported as AEs, as these were study efficacy endpoints, unless there was a reason to do so. Injection site reactions graded as moderate or severe were recorded as AEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    FP-01.1 - Vaccination phase
    Reporting group description
    		 AEs occurring during vaccination phase - Day 1 to Day C1 - for subjects who received FP-01.1

    Reporting group title
    Placebo - Vaccination phase
    Reporting group description
    		 AEs occurring during vaccination phase - Day 1 to Day C1 - for subjects who received placebo

    Reporting group title
    FP-01.1 - Virus challenge phase
    Reporting group description
    		 AEs occurring during virus challenge phase - Day C1 to Day C29 - for subjects who received FP-01.1

    Reporting group title
    Placebo - Virus challenge phase
    Reporting group description
    		 AEs occurring during virus challenge phase - Day C1 to Day C29 - for subjects who received placebo

    Reporting group title
    FP-01.1 - Follow-up
    Reporting group description
    		 AEs occurring during follow-up phase - Day C29 to Day C209 - for subjects who received FP-01.1

    Reporting group title
    Placebo - Follow-up
    Reporting group description
    		 AEs occurring during follow-up phase - Day C29 to Day C209 - for subjects who received placebo

    Serious adverse events
    		 FP-01.1 - Vaccination phase Placebo - Vaccination phase FP-01.1 - Virus challenge phase Placebo - Virus challenge phase FP-01.1 - Follow-up Placebo - Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 57 (1.75%)
    1 / 54 (1.85%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 FP-01.1 - Vaccination phase Placebo - Vaccination phase FP-01.1 - Virus challenge phase Placebo - Virus challenge phase FP-01.1 - Follow-up Placebo - Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 57 (45.61%)
    12 / 54 (22.22%)
    19 / 42 (45.24%)
    16 / 41 (39.02%)
    9 / 57 (15.79%)
    10 / 54 (18.52%)
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    6 / 57 (10.53%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    6
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 54 (3.70%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 54 (1.85%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Hangover
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    Social circumstances
    Sexual abuse
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Physical assault
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 54 (3.70%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    4 / 42 (9.52%)
    3 / 41 (7.32%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    4
    5
    0
    0
    Cough
         subjects affected / exposed
    2 / 57 (3.51%)
    1 / 54 (1.85%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    2
    1
    1
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    3
    0
    0
    0
    0
    2
    Nasal congestion
         subjects affected / exposed
    2 / 57 (3.51%)
    1 / 54 (1.85%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Dry throat
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Tendon injury
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Wrist fracture
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 57 (12.28%)
    3 / 54 (5.56%)
    2 / 42 (4.76%)
    5 / 41 (12.20%)
    3 / 57 (5.26%)
    1 / 54 (1.85%)
         occurrences all number
    8
    3
    2
    5
    5
    2
    Presyncope
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Eye disorders
    Asthenopia
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Eye pain
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Eye swelling
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    2 / 42 (4.76%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Rash
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    Pseudofolliculitis barbae
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Acne
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    Arthralgia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Neck mass
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 57 (8.77%)
    5 / 54 (9.26%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    3 / 57 (5.26%)
    2 / 54 (3.70%)
         occurrences all number
    6
    5
    1
    1
    3
    3
    Chlamydial infection
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Ear infection
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 54 (1.85%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Influenza
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Localised infection
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0

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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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