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    Clinical Trial Results:
    Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine in Children Aged 6 months to 17 Years

    Summary
    EudraCT number
    		 2017-001044-35
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2019
    First version publication date
    13 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GQM00016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03391193
    WHO universal trial number (UTN)
    		 U1111-1183-5881
    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
    18 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the hemagglutination inhibition (HAI) antibody response induced by quadrivalent influenza vaccine (QIV) in multi-dose vial (MDV) presentation compared with QIV in single dose syringe presentation for the four strains.
    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 were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Dec 2017
    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
    Mexico: 302
    Worldwide total number of subjects
    302
    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)
    80
    Children (2-11 years)
    147
    Adolescents (12-17 years)
    75
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled in 3 centers in Mexico from 19 December 2017 to 19 January 2018.

    Pre-assignment
    Screening details
    		 A total of 302 subjects who met all inclusion and none of the exclusion criteria were enrolled and 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
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 QIV thio-containing: 6 to 35 Months
    Arm description
    		 Subjects aged 6 to 35 months received 1 dose of QIV (in a MDV presentation) at Day 0 and 1 dose at Day 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QIV (split-virion, inactivated) in a MDV presentation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    0.5 mL, Intramuscular (IM) or deep subcutaneous (SC) injection, 1 dose each at Day 0 and at Day 28.

    Arm title
    		 QIV thio-free: 6 to 35 Months
    Arm description
    		 Subjects aged 6 to 35 months received 1 dose of QIV (in a syringe presentation) at Day 0 and 1 dose at Day 28.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    QIV (split-virion, inactivated) in a syringe presentation
    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, IM or deep SC injection, 1 dose each at Day 0 and at Day 28.

    Arm title
    		 QIV thio-containing: 3 to 8 Years
    Arm description
    		 Subjects aged 3 to 8 years received 1 dose of QIV (in a MDV presentation) at Day 0 and 1 dose at Day 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QIV (split-virion, inactivated) in a MDV presentation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    0.5 mL, IM or deep SC injection, 1 dose each at Day 0 and at Day 28.

    Arm title
    		 QIV thio-free: 3 to 8 Years
    Arm description
    		 Subjects aged 3 to 8 years received 1 dose of QIV (in a syringe presentation) at Day 0 and 1 dose at Day 28.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    QIV (split-virion, inactivated) in a syringe presentation
    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, IM or deep SC injection, 1 dose each at Day 0 and at Day 28.

    Arm title
    		 QIV thio-containing: 9 to 17 Years
    Arm description
    		 Subjects aged 9 to 17 years received 1 dose of QIV in a MDV presentation at Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QIV (split-virion, inactivated) in a MDV presentation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    0.5 mL, IM or deep SC injection, single dose at Day 0.

    Arm title
    		 QIV thio-free: 9 to 17 Years
    Arm description
    		 Subjects aged 9 to 17 years received 1 dose of QIV in a syringe presentation at Day 0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    QIV (split-virion, inactivated) in a syringe presentation
    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, IM or deep SC injection, single dose at Day 0.

    Number of subjects in period 1
    		QIV thio-containing: 6 to 35 Months QIV thio-free: 6 to 35 Months QIV thio-containing: 3 to 8 Years QIV thio-free: 3 to 8 Years QIV thio-containing: 9 to 17 Years QIV thio-free: 9 to 17 Years
    Started
    61
    60
    31
    28
    61
    61
    Completed
    50
    54
    28
    25
    61
    61
    Not completed
    11
    6
    3
    3
    0
    0
         Lost to follow-up
    3
    1
    2
    -
    -
    -
         Withdrawal by parent/guardian
    8
    5
    1
    1
    -
    -
         Protocol deviation
    -
    -
    -
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    QIV thio-containing: 6 to 35 Months
    Reporting group description
    		 Subjects aged 6 to 35 months received 1 dose of QIV (in a MDV presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-free: 6 to 35 Months
    Reporting group description
    		 Subjects aged 6 to 35 months received 1 dose of QIV (in a syringe presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-containing: 3 to 8 Years
    Reporting group description
    		 Subjects aged 3 to 8 years received 1 dose of QIV (in a MDV presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-free: 3 to 8 Years
    Reporting group description
    		 Subjects aged 3 to 8 years received 1 dose of QIV (in a syringe presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-containing: 9 to 17 Years
    Reporting group description
    		 Subjects aged 9 to 17 years received 1 dose of QIV in a MDV presentation at Day 0.

    Reporting group title
    QIV thio-free: 9 to 17 Years
    Reporting group description
    		 Subjects aged 9 to 17 years received 1 dose of QIV in a syringe presentation at Day 0.

    Reporting group values
    		 QIV thio-containing: 6 to 35 Months QIV thio-free: 6 to 35 Months QIV thio-containing: 3 to 8 Years QIV thio-free: 3 to 8 Years QIV thio-containing: 9 to 17 Years QIV thio-free: 9 to 17 Years Total
    Number of subjects
    		 61 60 31 28 61 61 302
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 37 43 0 0 0 0 80
        Children (2-11 years)
    		 24 17 31 28 21 26 147
        Adolescents (12-17 years)
    		 0 0 0 0 40 35 75
        Adults (18-64 years)
    		 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0.984 ( 0.904 ) 0.850 ( 0.840 ) 4.77 ( 1.73 ) 4.46 ( 1.69 ) 12.8 ( 2.46 ) 12.4 ( 2.62 ) -
    Gender categorical
    Units: Subjects
        Female
    		 29 27 15 10 32 27 140
        Male
    		 32 33 16 18 29 34 162

    End points

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    End points reporting groups
    Reporting group title
    QIV thio-containing: 6 to 35 Months
    Reporting group description
    		 Subjects aged 6 to 35 months received 1 dose of QIV (in a MDV presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-free: 6 to 35 Months
    Reporting group description
    		 Subjects aged 6 to 35 months received 1 dose of QIV (in a syringe presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-containing: 3 to 8 Years
    Reporting group description
    		 Subjects aged 3 to 8 years received 1 dose of QIV (in a MDV presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-free: 3 to 8 Years
    Reporting group description
    		 Subjects aged 3 to 8 years received 1 dose of QIV (in a syringe presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-containing: 9 to 17 Years
    Reporting group description
    		 Subjects aged 9 to 17 years received 1 dose of QIV in a MDV presentation at Day 0.

    Reporting group title
    QIV thio-free: 9 to 17 Years
    Reporting group description
    		 Subjects aged 9 to 17 years received 1 dose of QIV in a syringe presentation at Day 0.

    Primary: Antibody Titers After Vaccination With Multi-Dose Quadrivalent Influenza Vaccine or Single-Dose Quadrivalent Influenza Vaccine

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    End point title
    		 Antibody Titers After Vaccination With Multi-Dose Quadrivalent Influenza Vaccine or Single-Dose Quadrivalent Influenza Vaccine [1]
    End point description
    Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, B/Victoria and B/Yamagata were assessed by HAI assay. Antibody titers were expressed as geometric mean titers (GMTs). Analysis was performed on Immunogenicity Analysis Set which included all randomized subjects who received at least 1 dose of the study vaccine and had a post-vaccination blood sample. Here "n' signifies subjects with available data for specified category.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 (post-last 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 statistical analyses has been reported for this end point.
    End point values
    		 QIV thio-containing: 6 to 35 Months QIV thio-free: 6 to 35 Months QIV thio-containing: 3 to 8 Years QIV thio-free: 3 to 8 Years QIV thio-containing: 9 to 17 Years QIV thio-free: 9 to 17 Years
    Number of subjects analysed
    50
    54
    28
    25
    61
    61
    Units: Titer (1/dilution)
    geometric mean (confidence interval 95%)
        A/H1N1: Pre vaccination (n=49,54,28,25,61,60)
    8.32 (5.71 to 12.1)
    10.3 (6.56 to 16.2)
    80.0 (38.4 to 167)
    46.6 (21.2 to 103)
    229 (167 to 315)
    244 (170 to 349)
        A/H1N1: Post vaccination (n=49,52,28,25,61,59)
    286 (182 to 450)
    243 (157 to 377)
    987 (694 to 1403)
    658 (438 to 988)
    1475 (1180 to 1845)
    1318 (1041 to 1668)
        A/H3N2: Pre vaccination (n=48,52,28,25,61,61)
    11.6 (7.54 to 18.0)
    10.0 (6.86 to 14.6)
    84.1 (40.0 to 177)
    88.2 (38.5 to 202)
    329 (231 to 470)
    254 (182 to 353)
        A/H3N2: Post vaccination (n=49,51,27,25,61,61)
    560 (356 to 879)
    281 (186 to 425)
    1676 (1244 to 2257)
    1084 (710 to 1655)
    1598 (1326 to 1924)
    1258 (1004 to 1577)
        B/Victoria: Pre vaccination (n=48,52,28,25,61,61)
    8.47 (6.03 to 11.9)
    7.12 (5.30 to 9.57)
    20.0 (9.50 to 42.1)
    20.8 (9.53 to 45.6)
    156 (111 to 221)
    156 (105 to 233)
        B/Victoria: Post vaccination (n=49,52,28,25,61,61)
    261 (167 to 406)
    190 (137 to 264)
    664 (424 to 1040)
    513 (282 to 931)
    1884 (1474 to 2407)
    1780 (1375 to 2303)
        B/Yamagata: Pre vaccination (n=48,53,28,25,61,61)
    11.0 (7.45 to 16.2)
    7.40 (6.03 to 9.08)
    51.2 (26.6 to 98.8)
    55.8 (24.9 to 125)
    216 (151 to 309)
    201 (143 to 282)
        B/Yamagata: Post vaccination (n=49,52,28,25,61,61)
    390 (271 to 562)
    245 (188 to 320)
    1233 (880 to 1729)
    1099 (753 to 1605)
    1434 (1153 to 1784)
    1450 (1167 to 1803)
    No statistical analyses for this end point

    Primary: GMTs Ratio after Vaccination with Multi-Dose Quadrivalent Influenza Vaccine or Single-Dose Quadrivalent Influenza Vaccine

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    End point title
    		 GMTs Ratio after Vaccination with Multi-Dose Quadrivalent Influenza Vaccine or Single-Dose Quadrivalent Influenza Vaccine [2]
    End point description
    Serum antibody titer ratio for the Influenza vaccine serogroups A/H1N1, A/H3N2, B/Victoria and B/Yamagata were assessed by HAI assay. Analysis was performed on Immunogenicity Analysis Set. Here 'n' signifies subjects with available data for specified category.
    End point type
    Primary
    End point timeframe
    Day 0 and Day 28 (post-last 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 statistical analyses has been reported for this end point.
    End point values
    		 QIV thio-containing: 6 to 35 Months QIV thio-free: 6 to 35 Months QIV thio-containing: 3 to 8 Years QIV thio-free: 3 to 8 Years QIV thio-containing: 9 to 17 Years QIV thio-free: 9 to 17 Years
    Number of subjects analysed
    50
    54
    28
    25
    61
    61
    Units: Ratio
    geometric mean (confidence interval 95%)
        A/H1N1 serogroup (n=48,52,28,25,61,59)
    34.6 (20.6 to 58.2)
    23.6 (15.4 to 36.0)
    12.3 (7.13 to 21.3)
    14.1 (7.83 to 25.5)
    6.45 (4.51 to 9.22)
    5.33 (3.63 to 7.84)
        A/H3N2 serogroup (n=47,50,27,25,61,61)
    47.3 (28.8 to 77.6)
    26.2 (17.2 to 39.9)
    21.0 (10.7 to 40.9)
    12.3 (6.03 to 25.1)
    4.85 (3.31 to 7.11)
    4.96 (3.41 to 7.22)
        B/Victoria serogroup (n=47,50,28,25,61,61)
    31.8 (20.3 to 49.6)
    26.0 (17.7 to 38.3)
    33.2 (19.5 to 56.5)
    24.6 (15.1 to 40.0)
    12.0 (8.29 to 17.5)
    11.4 (7.78 to 16.6)
        B/Yamagata serogroup (n=47,51,28,25,61,61)
    35.0 (22.0 to 55.6)
    32.7 (22.7 to 46.9)
    24.1 (14.2 to 40.7)
    19.7 (10.7 to 36.3)
    6.63 (4.57 to 9.63)
    7.22 (4.93 to 10.6)
    No statistical analyses for this end point

    Primary: Seroconversion Rates After Vaccination With Multi-Dose Quadrivalent Influenza Vaccine or Single-Dose Quadrivalent Influenza Vaccine

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    End point title
    		 Seroconversion Rates After Vaccination With Multi-Dose Quadrivalent Influenza Vaccine or Single-Dose Quadrivalent Influenza Vaccine [3]
    End point description
    The seroconversion rates for each serogroups were defined as the percentages of subjects with a pre-vaccination titer (Day 0) < 10 (1/dilution) and a post-vaccination titer (Day 28 or Day 56) >= 40 (1/dilution), or with a pre-vaccination titer (Day 0) >=10 (1/dilution) and >= 4-fold increase of the titer. Analysis was performed on Immunogenicity Analysis Set.
    End point type
    Primary
    End point timeframe
    Day 0 and Day 28 (post-last 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 statistical analyses has been reported for this end point.
    End point values
    		 QIV thio-containing: 6 to 35 Months QIV thio-free: 6 to 35 Months QIV thio-containing: 3 to 8 Years QIV thio-free: 3 to 8 Years QIV thio-containing: 9 to 17 Years QIV thio-free: 9 to 17 Years
    Number of subjects analysed
    50
    54
    28
    25
    61
    61
    Units: percentage of subjects
    number (not applicable)
        A/H1N1 serogroup
    85.4
    78.8
    78.6
    92.0
    63.9
    54.2
        A/H3N2 serogroup
    93.6
    88.0
    92.6
    72.0
    47.5
    49.2
        B/Victoria serogroup
    89.4
    88.0
    96.4
    92.0
    72.1
    73.8
        B/Yamagata serogroup
    93.6
    90.2
    89.3
    84.0
    65.6
    60.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection (Inj.) Site or Systemic Reaction After Vaccination With Multi-Dose Quadrivalent Influenza Vaccine or Single-Dose Quadrivalent Influenza Vaccine: 6 to 35 Months

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection (Inj.) Site or Systemic Reaction After Vaccination With Multi-Dose Quadrivalent Influenza Vaccine or Single-Dose Quadrivalent Influenza Vaccine: 6 to 35 Months [4]
    End point description
    Percentage of subjects experiencing at least 1 solicited injection site reaction (tenderness/pain, erythema, swelling, induration and ecchymosis) and at least 1 systemic reaction (fever, headache, malaise, myalgia, shivering, vomiting, crying abnormal, drowsiness, appetite lost and irritability) were reported. Analysis was performed on safety analysis set which included all subjects who had received at least 1 dose of the study vaccines. Here 'n' signifies subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) to Day 7 (after any vaccination)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for rest of the arms is provided in separate endpoint.
    End point values
    		 QIV thio-containing: 6 to 35 Months QIV thio-free: 6 to 35 Months
    Number of subjects analysed
    59
    58
    Units: percentage of subjects
    number (not applicable)
        Inj. site tenderness/pain (n=50,54)
    44.0
    44.4
        Inj. site erythema (n=50,54)
    26.0
    13.0
        Inj. site swelling (n=50,54)
    12.0
    11.1
        Inj. site induration (n=50,54)
    10.0
    7.4
        Inj. site ecchymosis (n=50,54)
    10.0
    7.4
        Fever (n=49,54)
    34.7
    16.7
        Headache (n=23,17)
    17.4
    5.9
        Malaise (n=23,17)
    43.5
    29.4
        Myalgia (n=23,17)
    34.8
    11.8
        Shivering (n=23,17)
    17.4
    0
        Vomiting (n=27,37)
    11.1
    8.1
        Crying abnormal (n=27,37)
    63.0
    32.4
        Drowsiness (n=27,37)
    37.0
    21.6
        Appetite lost (n=27,37)
    29.6
    27.0
        Irritability (n=27,37)
    44.4
    37.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Inj. Site or Systemic Reaction After Vaccination With Multi-Dose Quadrivalent Influenza Vaccine or Single-Dose Quadrivalent Influenza Vaccine: 3 to 17 Years

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    End point title
    		 Percentage of Subjects Reporting Solicited Inj. Site or Systemic Reaction After Vaccination With Multi-Dose Quadrivalent Influenza Vaccine or Single-Dose Quadrivalent Influenza Vaccine: 3 to 17 Years [5]
    End point description
    Percentage of subjects experiencing at least 1 solicited injection site reaction (tenderness/pain, erythema, swelling, induration and ecchymosis) and at least 1 systemic reaction (fever, headache, malaise, myalgia and shivering) were reported. Analysis was performed on safety analysis set. Here 'n' signifies subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) to Day 7 (after any vaccination)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for rest of the arms is provided in separate endpoint.
    End point values
    		 QIV thio-containing: 3 to 8 Years QIV thio-free: 3 to 8 Years QIV thio-containing: 9 to 17 Years QIV thio-free: 9 to 17 Years
    Number of subjects analysed
    30
    28
    61
    61
    Units: percentage of subjects
    number (not applicable)
        Inj. site tenderness/pain (n=28,27,61,61)
    53.6
    51.9
    42.6
    63.9
        Inj. site erythema (n=28,27,61,61)
    14.3
    14.8
    3.3
    9.8
        Inj. site swelling (n=28,27,61,61)
    14.3
    29.6
    4.9
    9.8
        Inj. site induration (n=28,27,61,61)
    17.9
    18.5
    3.3
    6.6
        Inj. site ecchymosis (n=28,27,61,61)
    14.3
    7.4
    0
    1.6
        Fever (n=27,25,61,61)
    11.1
    4.0
    4.9
    4.9
        Headache (n=28,27,61,61)
    17.9
    22.2
    21.3
    36.1
        Malaise (n=28,27,61,61)
    42.9
    40.7
    24.6
    21.3
        Myalgia (n=28,27,61,61)
    32.1
    37.0
    27.9
    32.8
        Shivering (n=28,27,61,61)
    10.7
    18.5
    3.3
    11.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event (AE) data collected from Day 0 up to 28 days post-vaccination. Serious AE data was collected throughout the study (up to Day 208 for subjects aged 6 months to 8 years and up to Day 180 for subjects aged 9 to 17 years).
    Adverse event reporting additional description
    Solicited reaction (SR): An AE, i.e.prelisted in electronic case report form (eCRF) and considered related to vaccination. SR is an adverse drug reaction observed,reported under the conditions (nature and onset) prelisted (i.e.solicited) in eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in eCRF. Safety set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    QIV thio-containing: 6 to 35 months
    Reporting group description
    		 Subjects aged 6 to 35 months received 1 dose of QIV (in a MDV presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-free: 6 to 35 months
    Reporting group description
    		 Subjects aged 6 to 35 months received 1 dose of QIV (in a syringe presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-containing: 3 to 8 years
    Reporting group description
    		 Subjects aged 3 to 8 years received 1 dose of QIV (in a MDV presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-free: 3 to 8 years
    Reporting group description
    		 Subjects aged 3 to 8 years received 1 dose of QIV (in a syringe presentation) at Day 0 and 1 dose at Day 28.

    Reporting group title
    QIV thio-containing: 9 to 17 years
    Reporting group description
    		 Subjects aged 9 to 17 years received 1 dose of QIV in a MDV presentation at Day 0.

    Reporting group title
    QIV thio-free: 9 to 17 years
    Reporting group description
    		 Subjects aged 9 to 17 years received 1 dose of QIV in a syringe presentation at Day 0.

    Serious adverse events
    		 QIV thio-containing: 6 to 35 months QIV thio-free: 6 to 35 months QIV thio-containing: 3 to 8 years QIV thio-free: 3 to 8 years QIV thio-containing: 9 to 17 years QIV thio-free: 9 to 17 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 58 (1.72%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Haemolytic Anaemia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 58 (1.72%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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: 5%
    Non-serious adverse events
    		 QIV thio-containing: 6 to 35 months QIV thio-free: 6 to 35 months QIV thio-containing: 3 to 8 years QIV thio-free: 3 to 8 years QIV thio-containing: 9 to 17 years QIV thio-free: 9 to 17 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 59 (66.10%)
    36 / 58 (62.07%)
    19 / 30 (63.33%)
    20 / 28 (71.43%)
    39 / 61 (63.93%)
    50 / 61 (81.97%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 58 (1.72%)
    5 / 30 (16.67%)
    6 / 28 (21.43%)
    13 / 61 (21.31%)
    22 / 61 (36.07%)
         occurrences all number
    4
    1
    5
    6
    13
    22
    Somnolence
         subjects affected / exposed
    10 / 59 (16.95%)
    8 / 58 (13.79%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    13
    11
    0
    0
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    4 / 59 (6.78%)
    0 / 58 (0.00%)
    3 / 30 (10.00%)
    5 / 28 (17.86%)
    2 / 61 (3.28%)
    7 / 61 (11.48%)
         occurrences all number
    4
    0
    3
    5
    2
    7
    Crying
         subjects affected / exposed
    17 / 59 (28.81%)
    12 / 58 (20.69%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    20
    17
    0
    0
    0
    0
    Injection Site Erythema
         subjects affected / exposed
    13 / 59 (22.03%)
    7 / 58 (12.07%)
    4 / 30 (13.33%)
    4 / 28 (14.29%)
    2 / 61 (3.28%)
    6 / 61 (9.84%)
         occurrences all number
    17
    11
    6
    5
    2
    6
    Injection Site Haemorrhage
         subjects affected / exposed
    5 / 59 (8.47%)
    4 / 58 (6.90%)
    4 / 30 (13.33%)
    2 / 28 (7.14%)
    0 / 61 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    5
    5
    4
    3
    0
    1
    Injection Site Induration
         subjects affected / exposed
    5 / 59 (8.47%)
    4 / 58 (6.90%)
    5 / 30 (16.67%)
    5 / 28 (17.86%)
    2 / 61 (3.28%)
    4 / 61 (6.56%)
         occurrences all number
    5
    7
    5
    6
    2
    4
    Injection Site Pain
         subjects affected / exposed
    22 / 59 (37.29%)
    24 / 58 (41.38%)
    15 / 30 (50.00%)
    14 / 28 (50.00%)
    26 / 61 (42.62%)
    39 / 61 (63.93%)
         occurrences all number
    34
    36
    21
    20
    26
    39
    Injection Site Swelling
         subjects affected / exposed
    6 / 59 (10.17%)
    6 / 58 (10.34%)
    4 / 30 (13.33%)
    8 / 28 (28.57%)
    3 / 61 (4.92%)
    6 / 61 (9.84%)
         occurrences all number
    8
    9
    5
    10
    3
    6
    Malaise
         subjects affected / exposed
    10 / 59 (16.95%)
    5 / 58 (8.62%)
    12 / 30 (40.00%)
    11 / 28 (39.29%)
    15 / 61 (24.59%)
    13 / 61 (21.31%)
         occurrences all number
    14
    6
    16
    13
    15
    13
    Pyrexia
         subjects affected / exposed
    18 / 59 (30.51%)
    10 / 58 (17.24%)
    5 / 30 (16.67%)
    3 / 28 (10.71%)
    3 / 61 (4.92%)
    3 / 61 (4.92%)
         occurrences all number
    18
    10
    5
    4
    3
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 58 (1.72%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    4 / 59 (6.78%)
    3 / 58 (5.17%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    4
    4
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 59 (13.56%)
    3 / 58 (5.17%)
    3 / 30 (10.00%)
    4 / 28 (14.29%)
    2 / 61 (3.28%)
    2 / 61 (3.28%)
         occurrences all number
    8
    3
    4
    4
    2
    2
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    12 / 59 (20.34%)
    14 / 58 (24.14%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    15
    20
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    8 / 59 (13.56%)
    2 / 58 (3.45%)
    9 / 30 (30.00%)
    10 / 28 (35.71%)
    17 / 61 (27.87%)
    20 / 61 (32.79%)
         occurrences all number
    9
    3
    12
    11
    17
    20
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 58 (1.72%)
    2 / 30 (6.67%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    3
    1
    2
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    14 / 59 (23.73%)
    14 / 58 (24.14%)
    1 / 30 (3.33%)
    1 / 28 (3.57%)
    1 / 61 (1.64%)
    2 / 61 (3.28%)
         occurrences all number
    17
    15
    1
    1
    1
    2
    Pharyngitis
         subjects affected / exposed
    6 / 59 (10.17%)
    8 / 58 (13.79%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    6
    8
    2
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    8 / 59 (13.56%)
    10 / 58 (17.24%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    9
    13
    0
    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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