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    The EU Clinical Trials Register currently displays   37564   clinical trials with a EudraCT protocol, of which   6160   are clinical trials conducted with subjects less than 18 years old.
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    Clinical Trial Results:
    A phase III/IV open-label study of the immunogenicity and safety of a single dose of a Live Attenuated Influenza Vaccine (LAIV) (FluenzTM) for each of three successive years in children naïve to, or in previous receipt of the AS03B adjuvanted H1N1 (2009) influenza vaccine (Pandemrix ™).

    Summary
    EudraCT number
    2013-003592-35
    Trial protocol
    GB  
    Global end of trial date
    31 Mar 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Feb 2019
    First version publication date
    07 Feb 2019
    Other versions
    Summary report(s)
    Responses to live attenduated flu vaccine in children vaccinated previously with Pandremix

    Trial information

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    Trial identification
    Sponsor protocol code
    LAIV Immuno
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02143882
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    LAIV IMMUNO: LAIN IMMUNO
    Sponsors
    Sponsor organisation name
    Public Health England
    Sponsor organisation address
    Wellington House , London , United Kingdom, SE1 8UG
    Public contact
    Elizabeth Coates elizabeth.coates@phe.gov.uk, Public Health England Wellington House, London SE1 8UG, +44 0208 327 6084, elizabeth.coates@phe.gov.uk
    Scientific contact
    Elizabeth Coates elizabeth.coates@phe.gov.uk, Public Health England Wellington House, London SE1 8UG, +44 0208 327 6084, elizabeth.coates@phe.gov.uk
    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
    31 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Technical version: To compare the immune response to homologous and heterologous strains before and after to annual doses of LAIV over three consecutive years in children aged 4-9(+364days) years at enrollment in naïve children vs those in previous receipt of the AS03B adjuvanted pandemic influenza vaccine to homologous vaccine strains . Lay version: To compare the immune system responses to various strains of flu after having the nasal influenza vaccine (LAIV) for each of three consecutive years in children aged 4-8 when they join the study and who have either previously had a dose of Pandemirix (a pandemic flu vaccine) or have never had any pandemic flu vaccine.
    Protection of trial subjects
    Parents will remain at the study visit location for at least 10 minutes after vaccination to be observed by the VRN for any immediate reactions. Reactogenicity and short term safety will be assessed in several ways. Parents/guardians will be instructed to inform the VRN if their child is unwell or if they visit a GP or the hospital during the study duration. Health diaries will be completed from the day of vaccination until seven days after vaccination. Staff will engage in active surveillance of study participants through a telephone interview on day 8 following immunisation. On day 21 staff will collect the health diary and make further enquiry about the child's health. GPs will be asked to let the VRN know if the child becomes ill or needs care by the GP or hospital.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 254
    Worldwide total number of subjects
    254
    EEA total number of subjects
    254
    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)
    254
    Adolescents (12-17 years)
    0
    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
    Healthy UK children (age range 4-9 years) who have previously received Pandremix vaccine or who are naive to pandemic influenza vaccine, who are eligible to receive LAIV.

    Pre-assignment
    Screening details
    Healthy UK children (age range 4-9 years) who have previously received Pandremix vaccine or who are naive to pandemic influenza vaccine, who are eligible to receive LAIV.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ARM1
    Arm description
    Previously vaccinated with pandemrix
    Arm type
    Experimental

    Investigational medicinal product name
    LAIV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    0.2ml

    Arm title
    ARM2
    Arm description
    Naiive to pandemrix
    Arm type
    Experimental

    Investigational medicinal product name
    LAIV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    0.2ml

    Number of subjects in period 1
    ARM1 ARM2
    Started
    97
    157
    Completed
    97
    157

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ARM1
    Reporting group description
    Previously vaccinated with pandemrix

    Reporting group title
    ARM2
    Reporting group description
    Naiive to pandemrix

    Reporting group values
    ARM1 ARM2 Total
    Number of subjects
    97 157 254
    Age categorical
    Age range
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    97 157 254
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
        LAIV and Pandremix
    0 0 0
        LAIV and Naive
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    46 84 130
        Male
    51 73 124

    End points

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    End points reporting groups
    Reporting group title
    ARM1
    Reporting group description
    Previously vaccinated with pandemrix

    Reporting group title
    ARM2
    Reporting group description
    Naiive to pandemrix

    Primary: Proportion seroconverting to H1N1

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    End point title
    Proportion seroconverting to H1N1
    End point description
    End point type
    Primary
    End point timeframe
    Within three weeks of vaccination
    End point values
    ARM1 ARM2
    Number of subjects analysed
    97
    157
    Units: Percentage
    2
    2
    Statistical analysis title
    Pre planned
    Comparison groups
    ARM1 v ARM2
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.05
    Method
    Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Between recruitment and three weeks after last dose
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    ARM1
    Reporting group description
    -

    Reporting group title
    ARM2
    Reporting group description
    -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: This was an immunogenicity study and not a reactogenicity study.
    Serious adverse events
    ARM1 ARM2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 157 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 157 (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
    ARM1 ARM2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 157 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jun 2014
    Staff changes: . Methodology changes: Addition of assessment of cell mediated immune (CMI) responses through collection of a further 5ml of blood from up to 100 in each group of 9 and 10 year olds – information added in background, summary, objectives, testing of samples and in the patient information sheet and consent form. References: Addition of three extra references with regard to the addition of the CMI work.
    08 Dec 2014
    Addition of nasal swabs in the event of influenza symptoms in children enrolled in the Sniffle2 study (REC ref 14/WM/0159, NRES Committee West Midlands --‐Edgbaston)
    22 May 2015
    Extension of recruitment period into year 2 of the study due to late availability of vaccine in year 1 meaning target of 500 not reached. Planned end date of study remains unchanged i.e. year 2 recruits only participate for two years. This amendment therefore contains amended patient leaflets and consent forms for this purpose. For existing participants in the main study a letter of thanks and a study update is included. All participants in Herts aged 9 years or over in years 2 and 3 will be invited to participate in the optional CMI testing using previously approved information and consent forms. Wording has been updated to reflect this.
    21 Jul 2015
    Addition of nasal swabs in any children living in the same house as the vaccinated child in the event of influenza like illness (ILI).
    18 Aug 2015
    Addition of one box on the consent form for sibling swabbing to say the parent will only proceed if the child agrees at the time of the swab.
    08 Jan 2016
    Addition of the option of home visits
    12 Aug 2016
    Amendment of the schedule for collection of nose swabs for the third year of the study (autumn 2016 – Spring 2017) from whenever children have flu like symptoms to the days following vaccination – up to three swabs in the following week.

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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