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    Clinical Trial Results:
    Immunogenicity and Safety of Quadrivalent Influenza Vaccine (VaxigripTetra™) in Pregnant Women

    Summary
    EudraCT number
    2016-004763-40
    Trial protocol
    FI  
    Global end of trial date
    14 Jun 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    26 May 2019
    First version publication date
    26 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GQM14
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    U1111-1183-5650
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity: To describe the immune response of VaxigripTetra and Vaxigrip, 21 days after vaccination in pregnant women. Safety: To describe the safety profile of one dose of VaxigripTetra or Vaxigrip, 21 days after vaccination in pregnant women.
    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
    15 Sep 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
    Finland: 346
    Worldwide total number of subjects
    346
    EEA total number of subjects
    346
    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)
    346
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 10 centers in Finland from 15 September 2017 to 26 January 2018.

    Pre-assignment
    Screening details
    A total of 346 subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor
    Blinding implementation details
    The study was conducted in a blind observer manner. Neither the Investigator responsible for safety assessment, nor the subject knew which vaccine was administered.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Arm description
    Pregnant women aged >= 18 years and who were in the late second/third trimester of pregnancy received a single dose of VaxigripTetra vaccine.
    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 (IM) or deep subcutaneous (SC) injection, single dose on Day 0.

    Arm title
    Trivalent Influenza Vaccine (Vaxigrip)
    Arm description
    Pregnant women aged >= 18 years and who were in the late second/third trimester of pregnancy received a single dose of Vaxigrip vaccine.
    Arm type
    Active comparator

    Investigational medicinal product name
    Sanofi Pasteur licensed trivalent 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 (IM) or deep subcutaneous (SC) injection, single dose on Day 0.

    Number of subjects in period 1
    Quadrivalent Influenza Vaccine (VaxigripTetra) Trivalent Influenza Vaccine (Vaxigrip)
    Started
    230
    116
    Completed
    228
    115
    Not completed
    2
    1
         Protocol deviation
    1
    -
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Reporting group description
    Pregnant women aged >= 18 years and who were in the late second/third trimester of pregnancy received a single dose of VaxigripTetra vaccine.

    Reporting group title
    Trivalent Influenza Vaccine (Vaxigrip)
    Reporting group description
    Pregnant women aged >= 18 years and who were in the late second/third trimester of pregnancy received a single dose of Vaxigrip vaccine.

    Reporting group values
    Quadrivalent Influenza Vaccine (VaxigripTetra) Trivalent Influenza Vaccine (Vaxigrip) Total
    Number of subjects
    230 116 346
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    32.0 ± 4.39 31.4 ± 4.76 -
    Gender categorical
    Units: Subjects
        Female
    230 116 346
        Male
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Reporting group description
    Pregnant women aged >= 18 years and who were in the late second/third trimester of pregnancy received a single dose of VaxigripTetra vaccine.

    Reporting group title
    Trivalent Influenza Vaccine (Vaxigrip)
    Reporting group description
    Pregnant women aged >= 18 years and who were in the late second/third trimester of pregnancy received a single dose of Vaxigrip vaccine.

    Subject analysis set title
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Babies born to pregnant women aged >= 18 years, who were in the late second/third trimester of pregnancy received a single dose of VaxigripTetra vaccine.

    Subject analysis set title
    Trivalent Influenza Vaccine (Vaxigrip)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Babies born to pregnant women aged >= 18 years, who were in the late second/third trimester of pregnancy received a single dose of Vaxigrip vaccine.

    Primary: Hemagglutination Inhibition (HAI) Antibody Titers After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip)

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    End point title
    Hemagglutination Inhibition (HAI) Antibody Titers After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip) [1]
    End point description
    Serum antibody titers for the strains A/H1N1, A/H3N2, B1 and B2 were assessed by HAI assay. Antibody titers were expressed as geometric mean titers (GMTs). Analysis was performed on Per-Protocol Analysis set which included subjects who received one dose of any of the study vaccines and had no protocol deviations.
    End point type
    Primary
    End point timeframe
    Day 0 (Pre-vaccination) and Day 21 (Post-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) Trivalent Influenza Vaccine (Vaxigrip)
    Number of subjects analysed
    216
    109
    Units: Titer (1/dilution)
    geometric mean (confidence interval 95%)
        A/H1N1: Pre vaccination
    138 (114 to 166)
    121 (88.4 to 166)
        A/H1N1: Post vaccination
    525 (466 to 592)
    638 (529 to 769)
        A/H3N2: Pre vaccination
    39.6 (32.2 to 48.6)
    40.0 (29.4 to 54.5)
        A/H3N2: Post vaccination
    341 (286 to 407)
    369 (283 to 483)
        B1: Pre vaccination
    67.1 (55.2 to 81.4)
    72.5 (54.7 to 96.1)
        B1: Post vaccination
    568 (496 to 651)
    697 (569 to 855)
        B2: Pre vaccination
    159 (131 to 193)
    155 (120 to 202)
        B2: Post vaccination
    993 (870 to 1134)
    529 (415 to 674)
    No statistical analyses for this end point

    Primary: Individual Antibody Titer Ratio After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip)

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    End point title
    Individual Antibody Titer Ratio After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip) [2]
    End point description
    Individual antibody titer ratio for the strains A/H1N1, A/H3N2, B1 and B2 were assessed by HAI assay. Antibody titer ratio were expressed as Day 21/Day 0. Analysis was performed on Per-Protocol Analysis set.
    End point type
    Primary
    End point timeframe
    Day 0 (Pre-vaccination) and Day 21 (Post-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 (VaxigripTetra) Trivalent Influenza Vaccine (Vaxigrip)
    Number of subjects analysed
    216
    109
    Units: titer ratio
    geometric mean (confidence interval 95%)
        A/H1N1
    3.81 (3.11 to 4.66)
    5.26 (3.66 to 7.55)
        A/H3N2
    8.63 (6.85 to 10.9)
    9.23 (6.56 to 13.0)
        B1
    8.48 (6.81 to 10.6)
    9.62 (6.89 to 13.4)
        B2
    6.26 (5.12 to 7.65)
    3.40 (2.68 to 4.32)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Detectable Antibody Titer After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip)

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    End point title
    Percentage of Subjects With Detectable Antibody Titer After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip) [3]
    End point description
    Detectable antibody titers for the strains A/H1N1, A/H3N2, B1 and B2 were assessed by HAI assay. Detectable antibody titer value was >=10 (1/dilution [1/dil]). Analysis was performed on Per-Protocol Analysis set.
    End point type
    Primary
    End point timeframe
    Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Quadrivalent Influenza Vaccine (VaxigripTetra) Trivalent Influenza Vaccine (Vaxigrip)
    Number of subjects analysed
    216
    109
    Units: Percentage of Subjects
    number (not applicable)
        A/H1N1: Pre vaccination
    94.9
    89.0
        A/H1N1: Post vaccination
    100
    100
        A/H3N2: Pre vaccination
    77.8
    75.2
        A/H3N2: Post vaccination
    99.1
    100
        B1: Pre vaccination
    89.8
    90.8
        B1: Post vaccination
    100
    100
        B2: Pre vaccination
    94.9
    99.1
        B2: Post vaccination
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Antibody Titer >= 40 (1/Dilution) After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip)

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    End point title
    Percentage of Subjects With Antibody Titer >= 40 (1/Dilution) After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip) [4]
    End point description
    Antibody titer >= 40 (1/dilution) for the strains A/H1N1, A/H3N2, B1 and B2 were assessed by HAI assay. Analysis was performed on Per-Protocol Analysis set.
    End point type
    Primary
    End point timeframe
    Day 0 (Pre-vaccination) and Day 21 (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) Trivalent Influenza Vaccine (Vaxigrip)
    Number of subjects analysed
    216
    109
    Units: Percentage of Subjects
    number (not applicable)
        A/H1N1: Pre vaccination
    86.1
    78.0
        A/H1N1: Post vaccination
    99.5
    100
        A/H3N2: Pre vaccination
    55.1
    53.2
        A/H3N2: Post vaccination
    95.8
    94.5
        B1: Pre vaccination
    69.4
    65.1
        B1: Post vaccination
    100
    99.1
        B2: Pre vaccination
    85.2
    83.5
        B2: Post vaccination
    100
    97.2
    No statistical analyses for this end point

    Primary: Seroconversion or Significant Increase of Antibody Titers After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip)

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    End point title
    Seroconversion or Significant Increase of Antibody Titers After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip) [5]
    End point description
    Seroconversion was defined as the pre-vaccination titer < 10 (1/dil) on Day 0 and post-vaccination titer >= 40 (1/dil) on Day 21, or significant increase was defined as the pre vaccination titer >=10 (1/dil) and >= 4-fold increase of post-injection titer on Day 21. Analysis was performed on Per-Protocol Analysis set.
    End point type
    Primary
    End point timeframe
    Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
    Notes
    [5] - 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) Trivalent Influenza Vaccine (Vaxigrip)
    Number of subjects analysed
    216
    109
    Units: percentage of subjects
    number (not applicable)
        A/H1N1
    38.0
    41.3
        A/H3N2
    59.3
    62.4
        B1
    61.1
    60.6
        B2
    59.7
    38.5
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip)

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    End point title
    Percentage of Subjects Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Quadrivalent Influenza Vaccine (VaxigripTetra) or Trivalent Influenza Vaccine (Vaxigrip) [6]
    End point description
    Percentage of subjects experiencing at least 1 solicited injection site reaction (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 which included all subjects who had received at least 1 dose of the study or control vaccine; all subjects had their safety analyzed according to the vaccine actually received.
    End point type
    Primary
    End point timeframe
    Day 0 to Day 7 (Post-vaccination)
    Notes
    [6] - 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) Trivalent Influenza Vaccine (Vaxigrip)
    Number of subjects analysed
    230
    115
    Units: Percentage of Subjects
    number (not applicable)
        Injection site pain
    88.7
    76.5
        Injection site erythema
    10.4
    13.9
        Injection site swelling
    5.7
    5.2
        Injection site induration
    3.5
    4.3
        Injection site ecchymosis
    0.9
    1.7
        Fever
    0
    1.7
        Headache
    41.7
    47.8
        Malaise
    29.1
    27.8
        Myalgia
    37.0
    25.2
        Shivering
    26.5
    26.1
    No statistical analyses for this end point

    Secondary: Geometric Mean Ratio of the Hemagglutination-Inhibition Titers in Infants and Mothers at the Time of Delivery

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    End point title
    Geometric Mean Ratio of the Hemagglutination-Inhibition Titers in Infants and Mothers at the Time of Delivery
    End point description
    Geometric mean ratio of the Hemagglutination-Inhibition titers in infants and mothers for each strain at the time of delivery was reported. Analysis was performed on Other Immunogenicity Analysis Set which included subjects who received one dose of any of the study vaccines, delivered at least 2 weeks after injection and with available cord blood sample (BL) and mother BL at the time of delivery or at Visit 2 (Day 21) if delivery occurred during the time window of Visit 2 (Day 21).
    End point type
    Secondary
    End point timeframe
    At the time of Delivery (on average 103 day after vaccination)
    End point values
    Quadrivalent Influenza Vaccine (VaxigripTetra) Trivalent Influenza Vaccine (Vaxigrip)
    Number of subjects analysed
    178
    89
    Units: geometric mean ratio
    geometric mean (confidence interval 95%)
        A/H1N1
    1.89 (1.72 to 2.08)
    1.83 (1.64 to 2.04)
        A/H3N2
    1.71 (1.56 to 1.87)
    1.75 (1.55 to 1.97)
        B1
    1.53 (1.37 to 1.71)
    1.64 (1.46 to 1.85)
        B2
    1.69 (1.54 to 1.85)
    1.47 (1.28 to 1.69)
    No statistical analyses for this end point

    Secondary: Birth Outcomes

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    End point title
    Birth Outcomes
    End point description
    Number of babies with different birth outcomes assessed by methods used in routine at the hospital. Analysis was performed on the Babies other Safety analysis set which included babies of the subjects from the other Safety analysis set (defined as the subset of subjects who received one dose of the study or control vaccine and delivered at least 2 weeks after vaccination).
    End point type
    Secondary
    End point timeframe
    At the time of Delivery (on average 103 day after vaccination)
    End point values
    Quadrivalent Influenza Vaccine (VaxigripTetra) Trivalent Influenza Vaccine (Vaxigrip)
    Number of subjects analysed
    231
    119
    Units: babies
        Live Birth
    231
    119
        Spontaneous Abortion (< 20 week gestation)
    0
    0
        Early Fetal Death (20-27 weeks gestation)
    0
    0
        Late Fetal Death (at least 28 weeks gestation)
    0
    0
        Elective Abortion
    0
    0
        Maternal Death Resulting in Fetal Death
    0
    0
        Ectopic Pregnancy
    0
    0
        Congenital Abnormalities
    6
    5
        Death
    0
    0
    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 (pre-vaccination) up to date of delivery (on an average 103 day after vaccination)
    Adverse event reporting additional description
    Solicited adverse reaction (SAR): An AE, i.e.prelisted in electronic case report form (eCRF) and considered related to vaccination. SAR is an adverse drug reaction observed,reported under the conditions (nature and onset) prelisted (i.e.solicited) in eCRF. Unsolicited AE: an observed AE that does not fulfill conditions prelisted in eCRF. Safety set
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Quadrivalent Influenza Vaccine (VaxigripTetra)
    Reporting group description
    Pregnant women aged >= 18 years and in late second/third trimester of pregnancy received a single dose of VaxigripTetra vaccine.

    Reporting group title
    Trivalent Influenza Vaccine (Vaxigrip)
    Reporting group description
    Pregnant women aged >= 18 years and in late second/third trimester of pregnancy received a single dose of Vaxigrip vaccine.

    Serious adverse events
    Quadrivalent Influenza Vaccine (VaxigripTetra) Trivalent Influenza Vaccine (Vaxigrip)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 230 (11.30%)
    18 / 116 (15.52%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 230 (0.87%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Perineal Injury
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Rupture
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Gestational Hypertension
         subjects affected / exposed
    1 / 230 (0.43%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intrapartum Haemorrhage
         subjects affected / exposed
    2 / 230 (0.87%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructed Labour
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripartum Haemorrhage
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpartum Haemorrhage
         subjects affected / exposed
    16 / 230 (6.96%)
    13 / 116 (11.21%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pre-Eclampsia
         subjects affected / exposed
    2 / 230 (0.87%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature Labour
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Preterm Premature Rupture Of Membranes
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholestasis Of Pregnancy
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Amniotic Cavity Infection
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Infection
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 116 (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: 5%
    Non-serious adverse events
    Quadrivalent Influenza Vaccine (VaxigripTetra) Trivalent Influenza Vaccine (Vaxigrip)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    216 / 230 (93.91%)
    107 / 116 (92.24%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal Pain
         subjects affected / exposed
    16 / 230 (6.96%)
    4 / 116 (3.45%)
         occurrences all number
    16
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    102 / 230 (44.35%)
    58 / 116 (50.00%)
         occurrences all number
    112
    62
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    24 / 230 (10.43%)
    16 / 116 (13.79%)
         occurrences all number
    24
    16
    Injection Site Pain
         subjects affected / exposed
    204 / 230 (88.70%)
    88 / 116 (75.86%)
         occurrences all number
    204
    88
    Injection Site Swelling
         subjects affected / exposed
    13 / 230 (5.65%)
    6 / 116 (5.17%)
         occurrences all number
    13
    6
    Malaise
         subjects affected / exposed
    67 / 230 (29.13%)
    33 / 116 (28.45%)
         occurrences all number
    67
    33
    Shivering
         subjects affected / exposed
    61 / 230 (26.52%)
    30 / 116 (25.86%)
         occurrences all number
    61
    30
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    8 / 230 (3.48%)
    7 / 116 (6.03%)
         occurrences all number
    9
    8
    Myalgia
         subjects affected / exposed
    86 / 230 (37.39%)
    29 / 116 (25.00%)
         occurrences all number
    86
    29
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    11 / 230 (4.78%)
    6 / 116 (5.17%)
         occurrences all number
    12
    6
    Upper Respiratory Tract Infection
         subjects affected / exposed
    26 / 230 (11.30%)
    14 / 116 (12.07%)
         occurrences all number
    28
    14

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Feb 2018
    Corrections made to the following sections of the protocol: the objectives, endpoints, statistical methods and sample size. Recently available information regarding vaccine development and strains content was also added to background of IP. One additional month was allotted to the enrollment period.

    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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