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    Clinical Trial Results:
    A phase II, randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted pandemic H1N1 influenza candidate vaccine following a 0-28 day or 0-4 month vaccination schedule in subjects aged 8 to 12 weeks.

    Summary
    EudraCT number
    2009-015174-35
    Trial protocol
    NO  
    Global end of trial date
    25 Nov 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Apr 2016
    First version publication date
    13 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    113629
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01003418
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.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
    25 Nov 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2010
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety and reactogenicity of the H1N1 candidate vaccine in terms of solicited local and general symptoms, unsolicited adverse events (AEs) and serious adverse events (SAEs) two weeks post Dose 1.
    Protection of trial subjects
    The vaccinees were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of anaphylaxis following the administration of vaccines.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Nov 2009
    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
    Norway: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    8
    Children (2-11 years)
    0
    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
    Only 8 subjects were enrolled in the study as the study was prematurely terminated for logistic reasons.

    Pre-assignment
    Screening details
    During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    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
    Flu A Group
    Arm description
    Subjects received 2 primary doses of H1N1 vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10.
    Arm type
    Experimental

    Investigational medicinal product name
    Pandemrix™
    Investigational medicinal product code
    GSK2340272A
    Other name
    A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03, Split virion, inactivated A/California/7/2009 (H1N1)v-like
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 primary doses of H1N1 vaccine administered intramuscularly in the anterolateral region of the left thigh at Day 0 and right thigh at Day 28.

    Investigational medicinal product name
    Infanrix™ -IPV+HIB
    Investigational medicinal product code
    Other name
    DTPa-IPV/Hib
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly at Day 14, Month 3 and Month 10 in anterolateral region of right thigh.

    Investigational medicinal product name
    Prevenar™
    Investigational medicinal product code
    Other name
    7-valent pneumococcal conjugate vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly in the anterolateral region of left thigh at at Day 14, Month 3 and Month 10.

    Arm title
    Flu B Group
    Arm description
    Subjects received 2 primary doses of H1N1 vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10.
    Arm type
    Experimental

    Investigational medicinal product name
    Pandemrix™
    Investigational medicinal product code
    GSK2340272A
    Other name
    A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03, Split virion, inactivated A/California/7/2009 (H1N1)v-like
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 primary doses of H1N1 vaccine administered intramuscularly in the anterolateral region of the left thigh at Day 0 and right thigh at Month 4.

    Investigational medicinal product name
    Infanrix™ -IPV+HIB
    Investigational medicinal product code
    Other name
    DTPa-IPV/Hib
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly at Day 14, Month 3 and Month 10 in anterolateral region of right thigh.

    Investigational medicinal product name
    Prevenar™
    Investigational medicinal product code
    Other name
    7-valent pneumococcal conjugate vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly in the anterolateral region of left thigh at at Day 14, Month 3 and Month 10.

    Number of subjects in period 1
    Flu A Group Flu B Group
    Started
    5
    3
    Completed
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Flu A Group
    Reporting group description
    Subjects received 2 primary doses of H1N1 vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10.

    Reporting group title
    Flu B Group
    Reporting group description
    Subjects received 2 primary doses of H1N1 vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10.

    Reporting group values
    Flu A Group Flu B Group Total
    Number of subjects
    5 3 8
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Standard deviation data was not available.
    Units: weeks
        arithmetic mean (standard deviation)
    9 ± 0 8 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    4 2 6
        Male
    1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Flu A Group
    Reporting group description
    Subjects received 2 primary doses of H1N1 vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10.

    Reporting group title
    Flu B Group
    Reporting group description
    Subjects received 2 primary doses of H1N1 vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10.

    Primary: Number of subjects with any, grade 3 and related unsolicited adverse events (AEs).

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    End point title
    Number of subjects with any, grade 3 and related unsolicited adverse events (AEs). [1]
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination. The data was not analyzed as the study was prematurely terminated and due to recruitment issues.
    End point type
    Primary
    End point timeframe
    2 weeks post-Dose 1 (Day 0 and Day 13)
    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: The study was terminated prematurely for logistic reasons not related to safety or efficacy of the vaccine; only eight subjects were enrolled in the study. Therefore, no statistical analyses were conducted.
    End point values
    Flu A Group Flu B Group
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Number
    Notes
    [2] - The data was not analyzed as the study was prematurely terminated and due to recruitment issues.
    [3] - The data was not analyzed as the study was prematurely terminated and due to recruitment issues.
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related unsolicited AEs

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    End point title
    Number of subjects with any, grade 3 and related unsolicited AEs
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any AE reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 28-day (Days 0-27) follow-up period after each H1N1 vaccine administration.
    End point values
    Flu A Group Flu B Group
    Number of subjects analysed
    5
    3
    Units: Subjects
        Any AE(s)
    3
    2
        Grade 3 AE(s)
    0
    0
        Related AE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs).

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    End point title
    Number of subjects with serious adverse events (SAEs).
    End point description
    SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 - Month 11)
    End point values
    Flu A Group Flu B Group
    Number of subjects analysed
    5
    3
    Units: Subjects
        Any SAE(s)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited AEs: Within 28-day follow-up period after each H1N1 vaccination. SAEs: Throughout the entire study (Day 0 to Month 11).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Flu A Group
    Reporting group description
    Subjects received 2 primary doses of H1N1 vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10.

    Reporting group title
    Flu B Group
    Reporting group description
    Subjects received 2 primary doses of H1N1 vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10.

    Serious adverse events
    Flu A Group Flu B Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Flu A Group Flu B Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    2 / 3 (66.67%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    1
    Tracheal inflammation
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    2
    Conjunctivitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2009
    On request of Paediatric Committee (PDCO)/Committee for Medicinal Products for Human Use (CHMP), reporting of vaccine effectiveness and vaccine failure were incorporated. One telephone contact per group was added after the second dose to monitor fever, based on previous paediatric study results.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 Nov 2010
    The study was terminated prematurely for logistic reasons not related to safety or efficacy of the vaccine; only eight subjects were enrolled in the study.
    -

    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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