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    Clinical Trial Results:
    Safety of a Quadrivalent Influenza Vaccine (VaxigripTetraTM) in Subjects Aged 6 Months and Older in Vietnam

    Summary
    EudraCT number
    2019-002218-38
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    17 Mar 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Oct 2019
    First version publication date
    04 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GQM10
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03765437
    WHO universal trial number (UTN)
    U1111-1183-6274
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    14 Espace Henry Vallée, Lyon, France, 69007
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety of the Quadrivalent influenza vaccine (QIV) after each and any vaccination according to subjects’ age group.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Jan 2019
    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
    Vietnam: 230
    Worldwide total number of subjects
    230
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    44
    Children (2-11 years)
    134
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    41
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 1 centre in Vietnam from 15 January 2019 to 17 March 2019.

    Pre-assignment
    Screening details
    A total of 230 subjects were enrolled in the study.

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

    Arms
    Arm title
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Arm description
    Subjects received either 1 or 2 doses of the QIV based on their age and influenza vaccination history.
    Arm type
    Experimental

    Investigational medicinal product name
    Sanofi Pasteur licensed quadrivalent influenza vaccine (split-virion, inactivated)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    0.5 mL, intramuscular or deep subcutaneous injection, either 1 or 2 doses based on the age and influenza vaccination history of subjects.

    Number of subjects in period 1
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Started
    230
    Completed
    224
    Not completed
    6
         Consent withdrawn by subject
    5
         Adverse Event
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Reporting group description
    Subjects received either 1 or 2 doses of the QIV based on their age and influenza vaccination history.

    Reporting group values
    Quadrivalent Influenza Vaccine (VaxigripTetra) Total
    Number of subjects
    230 230
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    44 44
        Children (2-11 years)
    134 134
        Adolescents (12-17 years)
    4 4
        Adults (18-64 years)
    41 41
        From 65-84 years
    7 7
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    13.9 ± 20.6 -
    Gender categorical
    Units: Subjects
        Female
    116 116
        Male
    114 114

    End points

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    End points reporting groups
    Reporting group title
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Reporting group description
    Subjects received either 1 or 2 doses of the QIV based on their age and influenza vaccination history.

    Subject analysis set title
    Quadrivalent Influenza Vaccine: 6 to 23 months
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects aged 6 to 23 months received either 1 or 2 doses of the QIV based on their influenza vaccination history.

    Subject analysis set title
    Quadrivalent Influenza Vaccine: 24 to 35 months
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects aged 24 to 35 months received either 1 or 2 doses of the QIV based on their influenza vaccination history.

    Subject analysis set title
    Quadrivalent Influenza Vaccine: 6 to 35 months
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects aged 6 to 35 months received either 1 or 2 doses of the QIV based on their influenza vaccination history.

    Subject analysis set title
    Quadrivalent Influenza Vaccine: 3 to 8 years
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects aged 3 to 8 years received either 1 or 2 doses of the QIV based on their influenza vaccination history.

    Subject analysis set title
    Quadrivalent Influenza Vaccine: 9 to 17 years
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects aged 9 to 17 years received 1 dose of the QIV.

    Subject analysis set title
    Quadrivalent Influenza Vaccine: 18 to 60 years
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects aged 18 to 60 years received 1 dose of the QIV.

    Subject analysis set title
    Quadrivalent Influenza Vaccine: Greater Than (>) 60 years
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects aged >60 years received 1 dose of the QIV.

    Primary: Number of Subjects Reporting Immediate Systemic adverse Events (AEs)

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    End point title
    Number of Subjects Reporting Immediate Systemic adverse Events (AEs) [1]
    End point description
    Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occurred within the first 30 minutes after vaccination. Analysis was performed on safety analysis set (SafAS) which included subjects who had received at least 1 dose of the study vaccine. Here 'n' signifies number of subjects with available data for specified category.
    End point type
    Primary
    End point timeframe
    During the 30 minutes following the vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Number of subjects analysed
    228
    Units: subjects
        6 to 35 months (n=78)
    0
        3 to 8 years (n=80)
    0
        9 to 17 years (n=22)
    0
        18 to 60 years (n=28)
    0
        >60 years (n=20)
    0
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Solicited Injection (Inj.) Site Reactions and Systemic Reactions

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    End point title
    Number of Subjects Reporting Solicited Injection (Inj.) Site Reactions and Systemic Reactions [2]
    End point description
    Number of subjects experiencing at least 1 solicited injection site reaction (tenderness/pain, erythema, swelling, induration and ecchymosis) and at least 1 systemic reaction (fever [all age groups], headache, malaise, myalgia, shivering [for subjects aged >=2 years], vomiting, crying abnormal, drowsiness, appetite lost and irritability [for subjects <=23 months]) were reported. Analysis was performed on SafAS. Here, "99999" in the data field signifies that the subjects were not evaluable for the specified category for that arm. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Primary
    End point timeframe
    From Day (D)0 to D7 after the vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Quadrivalent Influenza Vaccine: 6 to 23 months Quadrivalent Influenza Vaccine: 24 to 35 months Quadrivalent Influenza Vaccine: 6 to 35 months Quadrivalent Influenza Vaccine: 3 to 8 years Quadrivalent Influenza Vaccine: 9 to 17 years Quadrivalent Influenza Vaccine: 18 to 60 years Quadrivalent Influenza Vaccine: Greater Than (>) 60 years
    Number of subjects analysed
    44
    34
    78
    80
    22
    28
    20
    Units: subjects with at least 1 reaction
        Solicited reaction (n=44,34,78,80,22,28,20)
    20
    11
    31
    32
    2
    5
    3
        Inj. site reaction (n=44,34,78,80,22,28,20)
    17
    8
    25
    31
    2
    5
    2
        Inj. site tenderness/pain (n=44,34,78,80,22,28,20)
    16
    6
    22
    26
    2
    5
    1
        Inj. site erythema (n=44,34,78,80,22,28,20)
    5
    2
    7
    8
    0
    0
    1
        Inj. site swelling (n=44,34,78,80,22,28,20)
    0
    0
    0
    4
    0
    0
    0
        Inj. site induration (n=44,34,78,80,22,28,20)
    0
    0
    0
    5
    0
    0
    0
        Inj. site ecchymosis (n=44,34,78,80,22,28,20)
    0
    0
    0
    3
    0
    0
    0
        Systemic reaction (n=44,34,78,80,22,28,20)
    13
    4
    17
    9
    0
    2
    2
        Fever (n=44,34,78,80,22,28,20)
    6
    1
    7
    4
    0
    0
    0
        Headache (n=0,34,34,80,22,28,20)
    99999
    2
    2
    4
    0
    1
    1
        Malaise (n=0,34,34,80,22,28,20)
    99999
    2
    2
    3
    0
    0
    0
        Myalgia (n=0,34,34,80,22,28,20)
    99999
    0
    0
    4
    0
    1
    1
        Shivering (n=0,34,34,80,22,28,20)
    99999
    0
    0
    1
    0
    0
    0
        Vomiting (n=44,0,44,0,0,0,0)
    2
    99999
    2
    99999
    99999
    99999
    99999
        Crying abnormal (n=44,0,44,0,0,0,0)
    5
    99999
    5
    99999
    99999
    99999
    99999
        Drowsiness (n=44,0,44,0,0,0,0)
    2
    99999
    2
    99999
    99999
    99999
    99999
        Appetite lost (n=44,0,44,0,0,0,0)
    6
    99999
    6
    99999
    99999
    99999
    99999
        Irritability (n=44,0,44,0,0,0,0)
    2
    99999
    2
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Unsolicited Non-Serious Adverse Events (AEs)

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    End point title
    Number of Subjects Reporting Unsolicited Non-Serious Adverse Events (AEs) [3]
    End point description
    An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on SafAS. Here 'n' signifies number of subjects with available data for specified category.
    End point type
    Primary
    End point timeframe
    From D0 to D28 after the 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Number of subjects analysed
    228
    Units: subects
        6 to 35 months (n=78)
    26
        3 to 8 years (n=80)
    4
        9 to 17 years (n=22)
    0
        18 to 60 years (n=28)
    1
        >60 years (n=20)
    0
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects Reporting Serious Adverse Events (SAEs) [4]
    End point description
    SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. Analysis was performed on SafAS. Here 'n' signifies number of subjects with available data for specified category.
    End point type
    Primary
    End point timeframe
    From D0 to the end of the study (up to 28 days 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Number of subjects analysed
    228
    Units: subjects
        6 to 35 months (n=78)
    0
        3 to 8 years (n=80)
    1
        9 to 17 years (n=22)
    0
        18 to 60 years (n=28)
    0
        >60 years (n=20)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE data collected from D0 up to 28 days post-vaccination. Data reported for overall population of 6 to 35 months as well for separate population of 6 to 23 months and 24 to 35 months.
    Adverse event reporting additional description
    Solicited adverse reaction (SAR): An AE, i.e. prelisted in CRB and considered related to vaccination. SAR is thus an adverse drug reaction observed, reported under the conditions (nature and onset) prelisted (i.e.solicited) in CRB. Unsolicited AE: an observed AE that does not fulfill conditions prelisted in CRB. Analysis was performed on SafAS.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Quadrivalent Influenza Vaccine: 6 to 23 months
    Reporting group description
    Subjects aged 6 to 23 months received either 1 or 2 doses of the QIV based on their influenza vaccination history.

    Reporting group title
    Quadrivalent Influenza Vaccine: 24 to 35 months
    Reporting group description
    Subjects aged 24 to 35 months received either 1 or 2 doses of the QIV based on their influenza vaccination history.

    Reporting group title
    Quadrivalent Influenza Vaccine: 6 to 35 months
    Reporting group description
    Subjects aged 6 to 35 months received either 1 or 2 doses of the QIV based on their influenza vaccination history.

    Reporting group title
    Quadrivalent Influenza Vaccine: 3 to 8 years
    Reporting group description
    Subjects aged 3 to 8 years received either 1 or 2 doses of the QIV based on their influenza vaccination history.

    Reporting group title
    Quadrivalent Influenza Vaccine: 9 to 17 years
    Reporting group description
    Subjects aged 9 to 17 years received 1 dose of the QIV.

    Reporting group title
    Quadrivalent Influenza Vaccine: 18 to 60 years
    Reporting group description
    Subjects aged 18 to 60 years received 1 dose of the QIV.

    Reporting group title
    Quadrivalent Influenza Vaccine: >60 years
    Reporting group description
    Subjects aged >60 years received 1 dose of the QIV.

    Serious adverse events
    Quadrivalent Influenza Vaccine: 6 to 23 months Quadrivalent Influenza Vaccine: 24 to 35 months Quadrivalent Influenza Vaccine: 6 to 35 months Quadrivalent Influenza Vaccine: 3 to 8 years Quadrivalent Influenza Vaccine: 9 to 17 years Quadrivalent Influenza Vaccine: 18 to 60 years Quadrivalent Influenza Vaccine: >60 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 34 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Multiple Injuries
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 34 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Quadrivalent Influenza Vaccine: 6 to 23 months Quadrivalent Influenza Vaccine: 24 to 35 months Quadrivalent Influenza Vaccine: 6 to 35 months Quadrivalent Influenza Vaccine: 3 to 8 years Quadrivalent Influenza Vaccine: 9 to 17 years Quadrivalent Influenza Vaccine: 18 to 60 years Quadrivalent Influenza Vaccine: >60 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 44 (56.82%)
    18 / 34 (52.94%)
    43 / 78 (55.13%)
    33 / 80 (41.25%)
    2 / 22 (9.09%)
    5 / 28 (17.86%)
    3 / 20 (15.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 34 (5.88%)
    2 / 78 (2.56%)
    4 / 80 (5.00%)
    0 / 22 (0.00%)
    1 / 28 (3.57%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    2
    4
    0
    1
    1
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    5 / 44 (11.36%)
    0 / 34 (0.00%)
    5 / 78 (6.41%)
    0 / 80 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    6
    0
    6
    0
    0
    0
    0
    Injection Site Erythema
         subjects affected / exposed
    5 / 44 (11.36%)
    2 / 34 (5.88%)
    7 / 78 (8.97%)
    8 / 80 (10.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    5
    2
    7
    8
    0
    0
    1
    Injection Site Induration
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 34 (0.00%)
    0 / 78 (0.00%)
    5 / 80 (6.25%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    6
    0
    0
    0
    Injection Site Pain
         subjects affected / exposed
    16 / 44 (36.36%)
    6 / 34 (17.65%)
    22 / 78 (28.21%)
    26 / 80 (32.50%)
    2 / 22 (9.09%)
    5 / 28 (17.86%)
    1 / 20 (5.00%)
         occurrences all number
    18
    6
    24
    32
    2
    5
    1
    Malaise
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 34 (5.88%)
    2 / 78 (2.56%)
    3 / 80 (3.75%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    2
    2
    4
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    6 / 44 (13.64%)
    1 / 34 (2.94%)
    7 / 78 (8.97%)
    4 / 80 (5.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    7
    1
    8
    4
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    6 / 44 (13.64%)
    0 / 34 (0.00%)
    6 / 78 (7.69%)
    0 / 80 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    7
    0
    7
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 44 (13.64%)
    7 / 34 (20.59%)
    13 / 78 (16.67%)
    1 / 80 (1.25%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    7
    7
    14
    2
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    2 / 44 (4.55%)
    4 / 34 (11.76%)
    6 / 78 (7.69%)
    1 / 80 (1.25%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    4
    6
    1
    0
    0
    0

    More information

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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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