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    Clinical Trial Results:
    A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults

    Summary
    EudraCT number
    2015-002758-11
    Trial protocol
    LT   LV   EE  
    Global end of trial date
    09 Sep 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Aug 2017
    First version publication date
    23 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D4420C00005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02508194
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, 20878
    Public contact
    AstraZeneca Clinical Study Information Center, AstraZeneca, +1 3013980000, clinicaltrialenquiries@medimmune.com
    Scientific contact
    AstraZeneca Clinical Study Information Center, AstraZeneca, +1 3013980000, clinicaltrialenquiries@medimmune.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
    29 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy of a single intramuscular (IM) dose of MEDI7510 for the prevention of acute respiratory syncytial virus-associated respiratory illness (ARA-RI) in adults greater than or equal to (>=) 60 years of age in Season 1 of dosing.
    Protection of trial subjects
    The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization guideline: Good Clinical Practice, and applicable regulatory requirements. Participants signed an informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Sep 2015
    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
    Canada: 23
    Country: Number of subjects enrolled
    Chile: 75
    Country: Number of subjects enrolled
    Estonia: 87
    Country: Number of subjects enrolled
    Latvia: 7
    Country: Number of subjects enrolled
    South Africa: 224
    Country: Number of subjects enrolled
    United States: 1447
    Country: Number of subjects enrolled
    Lithuania: 37
    Worldwide total number of subjects
    1900
    EEA total number of subjects
    131
    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)
    674
    From 65 to 84 years
    1199
    85 years and over
    27

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 1900 participants were randomized and participated in the study at 60 sites in 7 countries.

    Pre-assignment
    Screening details
    A total of 2,044 participants were screened, of which 144 participants were screen failures and 1900 participants were randomized in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo + Inactivated Influenza Vaccine (IIV)
    Arm description
    Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
    Arm type
    Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Sterile saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single IM injection of placebo (matched with MEDI7510) in the arm.

    Investigational medicinal product name
    IIV
    Investigational medicinal product code
    Other name
    Marketed Inactivated Influenza Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single IM injection of IIV in the contralateral arm.

    Arm title
    MEDI7510 + IIV
    Arm description
    Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI7510
    Investigational medicinal product code
    Other name
    Respiratory Syncytial Virus soluble fusion (RSV sF) protein antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single IM injection of MEDI7510 in the arm.

    Investigational medicinal product name
    IIV
    Investigational medicinal product code
    Other name
    Marketed Inactivated Influenza Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single IM injection of IIV in the contralateral arm.

    Number of subjects in period 1
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Started
    949
    951
    Completed
    897
    907
    Not completed
    52
    44
         Death
    5
    3
         PI Decision
    1
    2
         Consent withdrawn by subject
    20
    18
         Error in Randomization
    1
    3
         Lost to follow-up
    25
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + Inactivated Influenza Vaccine (IIV)
    Reporting group description
    Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.

    Reporting group title
    MEDI7510 + IIV
    Reporting group description
    Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.

    Reporting group values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV Total
    Number of subjects
    949 951 1900
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    332 342 674
        From 65-84 years
    603 596 1199
        85 years and over
    14 13 27
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    68.1 ± 6.2 68.1 ± 6.3 -
    Gender, Male/Female
    Units: Subjects
        Female
    587 530 1117
        Male
    362 421 783

    End points

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    End points reporting groups
    Reporting group title
    Placebo + Inactivated Influenza Vaccine (IIV)
    Reporting group description
    Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.

    Reporting group title
    MEDI7510 + IIV
    Reporting group description
    Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.

    Primary: Percentage of Participants who had the First Episode of ARA-RI During RSV Surveillance Period in Season 1

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    End point title
    Percentage of Participants who had the First Episode of ARA-RI During RSV Surveillance Period in Season 1
    End point description
    ARA-RI was defined as an event in which a participant met specified clinical criteria and the event was laboratory-confirmed to be RSV-related. The specified clinical criteria included a minimum of 1 symptom from any 2 of the 3 symptom columns: one symptom from upper respiratory symptom column and one symptom from lower respiratory symptom column; one symptom from upper respiratory symptom column and one symptom from systemic symptom column; or one symptom from lower respiratory column and one from systemic symptom column and laboratory confirmation of RSV on at least 1 sample obtained between Day 1 to Day 8 of illness. Per-protocol population: All Participants in the As-treated Population (ATP) who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period.
    End point type
    Primary
    End point timeframe
    Day 14 after dosing through end of surveillance period
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    935
    931
    Units: Percentage of Participants
        number (not applicable)
    1.6
    1.7
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    2 sided 90 percent (%) confidence interval (CI) was used to compare vaccine efficacy (VE). VE = ([1 - relative risk (RR)] *100%), where RR was the RR of ARA-RI in the MEDI7510+IIV group compared with the placebo+IIV group. A lower bound of the 90% CI greater than (>) 0% would demonstrate the efficacy of MEDI7510. The CI was estimated by an exact conditional method.
    Comparison groups
    Placebo + Inactivated Influenza Vaccine (IIV) v MEDI7510 + IIV
    Number of subjects included in analysis
    1866
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Vaccine efficacy
    Point estimate
    -7.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -106.9
         upper limit
    44.3

    Secondary: Percentage of Participants who had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1

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    End point title
    Percentage of Participants who had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1
    End point description
    Detection of RSV was done by PCR method by using any respiratory sample. The incidence of RSV PCR-positive respiratory illness during the RSV surveillance period was evaluated. Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period.
    End point type
    Secondary
    End point timeframe
    Day 14 after dosing through end of surveillance period
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    935
    931
    Units: Percentage of participants
        number (not applicable)
    1.6
    1.7
    No statistical analyses for this end point

    Secondary: Geometric Mean Responses (GMRs) of Serum Antibodies Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay

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    End point title
    Geometric Mean Responses (GMRs) of Serum Antibodies Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
    End point description
    Anti-F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. GMR was calculated as: anti-log2[mean(log2 xi)], where xi is the assay result for participant i. Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510. Here "n" represents number of participants in particular category.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 29, and End of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    947
    946
    Units: Mean response
    geometric mean (confidence interval 95%)
        Day 1 (n = 944, 940)
    83.39 (78.91 to 88.12)
    77.96 (73.66 to 82.5)
        Day 29 (n = 926, 924)
    80.05 (75.68 to 84.68)
    999.03 (944.4 to 1056.81)
        End of Season 1 (n = 852, 857)
    79.95 (75.27 to 84.93)
    370.88 (350.9 to 391.99)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by Anti-F IgG Assay

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    End point title
    Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by Anti-F IgG Assay
    End point description
    Anti-F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. GMFR was calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody titer or T-cell count fold rise from baseline for each participant. Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510. Here "n" represents number of participants in particular category.
    End point type
    Secondary
    End point timeframe
    Day 29, and End of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    947
    946
    Units: Mean fold rise
    geometric mean (confidence interval 95%)
        Day 29 (n = 926, 924)
    0.96 (0.94 to 0.98)
    12.78 (11.96 to 13.65)
        End of Season 1 (n = 852, 857)
    0.94 (0.91 to 0.96)
    4.6 (4.34 to 4.88)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay

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    End point title
    Percentage of Participants who had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay
    End point description
    Anti-F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. Seroresponse was defined as a >= 3-fold rise of Serum Antibodies against RSV from baseline. Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510. Here "n" represents the number of participants in particular category.
    End point type
    Secondary
    End point timeframe
    Day 29, and End of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    947
    946
    Units: Percentage of Participants
    number (confidence interval 95%)
        Day 29 (n = 926, 924)
    0.8 (0.3 to 1.5)
    92.9 (91 to 94.4)
        End of Season 1 (n = 852, 857)
    1.6 (0.9 to 2.7)
    65.8 (62.5 to 69)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine

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    End point title
    Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
    End point description
    GMT was calculated as: anti-log2 [mean(log2 xi)], where xi is the assay result for participant i. GMTs of strain-Specific HAI antibodies (H1N1, H3N2, B Brisbane, and B Phuket) were reported. Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine. Here "n" represents number of participants in particular category.
    End point type
    Secondary
    End point timeframe
    Day 1 (post-dose), and Day 29 of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    464
    451
    Units: Mean titer
    geometric mean (confidence interval 95%)
        H1N1, Day 1 (n = 462, 450)
    54.26 (48.61 to 60.565)
    55.77 (50.066 to 62.115)
        H1N1, Day 29 (n = 460, 450)
    161.26 (146.241 to 177.823)
    155.14 (141.356 to 170.264)
        H3N2, Day 1 (n = 462, 450)
    34.81 (31.224 to 38.804)
    35.99 (32.271 to 40.136)
        H3N2, Day 29 (n = 460, 450)
    291.73 (260.581 to 326.604)
    269.58 (241.784 to 300.569)
        B BRISBANE, Day 1 (n = 462, 450)
    12.89 (11.851 to 14.025)
    13.46 (12.357 to 14.672)
        B BRISBANE, Day 29 (n = 460, 450)
    32.49 (29.314 to 36.007)
    30.15 (27.334 to 33.257)
        B PHUKET, Day 1 (n = 462, 450)
    11.42 (10.514 to 12.402)
    11.81 (10.857 to 12.841)
        B PHUKET, Day 29 (n = 460, 450)
    30 (27.088 to 33.219)
    28.29 (25.526 to 31.348)
    No statistical analyses for this end point

    Secondary: Post-dose GMFRs of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine

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    End point title
    Post-dose GMFRs of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
    End point description
    GMFR was calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody titer or T-cell count fold rise from baseline for each participant. GMFRs of strain-Specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) were reported. Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine. Here "n" represents number of participants in particular category.
    End point type
    Secondary
    End point timeframe
    Day 29 of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    464
    451
    Units: Mean fold rise
    geometric mean (confidence interval 95%)
        H1N1 (n = 460, 450)
    2.97 (2.652 to 3.329)
    2.78 (2.501 to 3.094)
        H3N2 (n = 460, 450)
    8.42 (7.525 to 9.421)
    7.49 (6.669 to 8.414)
        B BRISBANE (n = 460, 450)
    2.53 (2.301 to 2.771)
    2.24 (2.068 to 2.425)
        B PHUKET (n = 460, 450)
    2.63 (2.419 to 2.85)
    2.4 (2.217 to 2.589)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody

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    End point title
    Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody
    End point description
    Seroresponse was defined as a >= 4-fold rise of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) from baseline. Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine. Here "n" represents number of participants in particular category.
    End point type
    Secondary
    End point timeframe
    Day 29 of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    464
    451
    Units: Percentage of Participants
    number (not applicable)
        H1N1 (n = 460, 450)
    32.6
    32.4
        H3N2 (n = 460, 450)
    76.5
    74.2
        B BRISBANE (n = 460, 450)
    31.7
    26.9
        B PHUKET (n = 460, 450)
    33
    30.2
    No statistical analyses for this end point

    Secondary: Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay

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    End point title
    Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay
    End point description
    Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMT was to be calculated as: anti-log2 [mean(log2 xi)], where xi is the assay result for participant i. Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period.
    End point type
    Secondary
    End point timeframe
    Day 29, and End of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: Mean titer
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [1] - No participant was analyzed as the study was discontinued.
    [2] - No participant was analyzed as the study was discontinued.
    No statistical analyses for this end point

    Secondary: Post-dose GMFRs of Serum Antibodies Against RSV by Microneutralization Assay

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    End point title
    Post-dose GMFRs of Serum Antibodies Against RSV by Microneutralization Assay
    End point description
    Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMFR was to be calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody titer or T-cell count fold rise from baseline for each participant. Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period.
    End point type
    Secondary
    End point timeframe
    Day 29, and End of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: Mean titer
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [3] - No participant was analyzed as the study was discontinued.
    [4] - No participant was analyzed as the study was discontinued.
    No statistical analyses for this end point

    Secondary: Percentage of Participants who had a Post-dose Seroresponse to RSV by Microneutralization Assay

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    End point title
    Percentage of Participants who had a Post-dose Seroresponse to RSV by Microneutralization Assay
    End point description
    Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a >= 3-fold rise of Serum Antibodies against RSV from baseline. Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period.
    End point type
    Secondary
    End point timeframe
    Day 29, and End of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: Percentage of Participants
    Notes
    [5] - No participant was analyzed as the study was discontinued.
    [6] - No participant was analyzed as the study was discontinued.
    No statistical analyses for this end point

    Secondary: Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA)

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    End point title
    Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA)
    End point description
    Palivizumab-cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMC was to be calculated as: anti-log2 [mean(log2 xi)], where xi is the assay result for participant i. Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period.
    End point type
    Secondary
    End point timeframe
    Day 29, and End of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: Mean concentration
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [7] - No participant was analyzed as the study was discontinued.
    [8] - No participant was analyzed as the study was discontinued.
    No statistical analyses for this end point

    Secondary: Post-dose GMFRs of palivizumab competitive antibodies as measured by a palivizumab cELISA

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    End point title
    Post-dose GMFRs of palivizumab competitive antibodies as measured by a palivizumab cELISA
    End point description
    Palivizumab-cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMFR was to be calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody titer or T-cell count fold rise from baseline for each participant. Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period.
    End point type
    Secondary
    End point timeframe
    Day 29, and End of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: Mean Fold Rises
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [9] - No participant was analyzed as the study was discontinued.
    [10] - No participant was analyzed as the study was discontinued.
    No statistical analyses for this end point

    Secondary: Percentage of Participants who had a Post-dose Seroresponse to RSV as measured by palivizumab cELISA

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    End point title
    Percentage of Participants who had a Post-dose Seroresponse to RSV as measured by palivizumab cELISA
    End point description
    Palivizumab-cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a >= 3-fold rise of Serum Antibodies against RSV from baseline. Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period.
    End point type
    Secondary
    End point timeframe
    Day 29, and End of Season 1
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: Percentage of Participants
        number (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [11] - No participant was analyzed as the study was discontinued.
    [12] - No participant was analyzed as the study was discontinued.
    No statistical analyses for this end point

    Secondary: Number of Participants With all Solicited Symptoms

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    End point title
    Number of Participants With all Solicited Symptoms
    End point description
    Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever >= 100.4 degrees Fahrenheit by any route from Day 1 to Day 7. ATP: Participants who received any dose of investigational product (IP). Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.
    End point type
    Secondary
    End point timeframe
    Day 1 (post-dose) through Day 7
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    948
    946
    Units: Participants
    558
    606
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events

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    End point title
    Number of Participants With Treatment-Emergent Adverse Events
    End point description
    An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received IP. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between administration of study drug and Day 29 that were absent before treatment or that worsened relative to pre-treatment state. ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.
    End point type
    Secondary
    End point timeframe
    Day 1 (post-dose) through Day 29  
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    948
    946
    Units: Participants
    141
    146
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs) 

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    End point title
    Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs) 
    End point description
    AE was any untoward medical occurrence attributed to study drug in a participant who received IP. SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and approx 1 year follow up that were absent before treatment or that worsened relative to pre-treatment state. An AESI was one of scientific and medical interest specific to understanding of study product and required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving IP and was assessed by investigator as medically significant. ATP was analyzed.
    End point type
    Secondary
    End point timeframe
    Day 1 (post-dose) through final season 1 (follow-up period) (up to approximately 1 year)
    End point values
    Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
    Number of subjects analysed
    948
    946
    Units: Participants
        TEAESIs
    0
    1
        TESAEs
    3
    4
        NOCDs
    5
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 (post-dose) through final season 1 (follow-up period) (up to approximately 1 year)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    MEDI7510+IIV
    Reporting group description
    Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.

    Reporting group title
    Placebo + IIV
    Reporting group description
    Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.

    Serious adverse events
    MEDI7510+IIV Placebo + IIV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    64 / 946 (6.77%)
    57 / 948 (6.01%)
         number of deaths (all causes)
    3
    5
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Aortic occlusion
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 946 (0.00%)
    3 / 948 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma metastatic
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-hodgkin's lymphoma
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal neoplasm
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 946 (0.21%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage i
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of head and neck
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 946 (0.11%)
    2 / 948 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 946 (0.11%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug dependence
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Femur fracture
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 946 (0.11%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 946 (0.21%)
    2 / 948 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 946 (0.00%)
    2 / 948 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    4 / 946 (0.42%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 946 (0.21%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 946 (0.11%)
    6 / 948 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 946 (0.11%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 946 (0.00%)
    2 / 948 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic diathesis
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain stem infarction
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 946 (0.00%)
    3 / 948 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 946 (0.00%)
    3 / 948 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 946 (0.11%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis relapsing
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    2 / 946 (0.21%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 946 (0.21%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 946 (0.11%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 946 (0.21%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    2 / 946 (0.21%)
    5 / 948 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 946 (0.11%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 946 (0.11%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 946 (0.11%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 946 (0.00%)
    3 / 948 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 946 (0.00%)
    1 / 948 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 946 (0.00%)
    2 / 948 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 946 (0.11%)
    0 / 948 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    MEDI7510+IIV Placebo + IIV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 946 (5.07%)
    52 / 948 (5.49%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 946 (1.06%)
    13 / 948 (1.37%)
         occurrences all number
    11
    15
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    16 / 946 (1.69%)
    11 / 948 (1.16%)
         occurrences all number
    19
    13
    Injection site pain
         subjects affected / exposed
    10 / 946 (1.06%)
    18 / 948 (1.90%)
         occurrences all number
    28
    35
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    13 / 946 (1.37%)
    10 / 948 (1.05%)
         occurrences all number
    13
    10
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 946 (1.69%)
    10 / 948 (1.05%)
         occurrences all number
    16
    10

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2015
    The overall reason for the amendment was to: - Respiratory illness assessments, including nasal swabs and review illness workbook. - Collect and review illness workbook and 3) Provide thermometers, solicited symptom diary card, measuring tape/ruler, illness workbook, nasal swab kit and instructions; educate in use of all. - Changes were made in reference to the blinding process for IIV based on the type of presentation and whether it was a visual match to the MEDI7510 and placebo syringe or not. The on-site unblinded vaccine administrator was added to the list of individuals who had access to information that might have identified a participant’s treatment allocation. - Post-dose was added to the following sentence: these individuals must not reveal randomization or treatment information to anyone or participate in or be associated with the “post-dose” evaluation of study participants.

    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.
    The study was terminated due to failure to meet the primary efficacy endpoint.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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