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    Clinical Trial Results:
    A Phase I, double-blind, randomised, placebo controlled study to evaluate the reactogenicity and safety of a single oral dose of GlaxoSmithKline (GSK) Biologicals’ live attenuated liquid human rotavirus (HRV) vaccine in healthy children aged 2 to 6 years in China.

    Summary
    EudraCT number
    2015-001547-37
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    16 Apr 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Apr 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    113552
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01086436
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalsupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, 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
    28 Jul 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the reactogenicity of a single oral dose of GSK Biologicals’ liquid HRV vaccine when compared to placebo group, in terms of solicited AEs in healthy children aged 2 to 6 years
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of anaphylaxis following the administration of the vaccine.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Mar 2010
    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
    China: 50
    Worldwide total number of subjects
    50
    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)
    0
    Children (2-11 years)
    50
    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
    -

    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
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    HRV Group
    Arm description
    Subjects received a single oral dose of GSK Biologicals’ oral live attenuated liquid human rotavirus vaccine (HRV) vaccine at Day 0
    Arm type
    Experimental

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    One dose of HRV vaccine administered orally at Day 0.

    Arm title
    Placebo Group
    Arm description
    Subjects received a single oral dose of placebo at Day 0
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Oral use
    Dosage and administration details
    One dose of placebo administered orally at Day 0

    Number of subjects in period 1
    HRV Group Placebo Group
    Started
    25
    25
    Completed
    25
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HRV Group
    Reporting group description
    Subjects received a single oral dose of GSK Biologicals’ oral live attenuated liquid human rotavirus vaccine (HRV) vaccine at Day 0

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects received a single oral dose of placebo at Day 0

    Reporting group values
    HRV Group Placebo Group Total
    Number of subjects
    25 25 50
    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
    Units: years
        arithmetic mean (standard deviation)
    3.7 ± 0.89 3.9 ± 0.97 -
    Gender categorical
    Units: Subjects
        Female
    9 16 25
        Male
    16 9 25

    End points

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    End points reporting groups
    Reporting group title
    HRV Group
    Reporting group description
    Subjects received a single oral dose of GSK Biologicals’ oral live attenuated liquid human rotavirus vaccine (HRV) vaccine at Day 0

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects received a single oral dose of placebo at Day 0

    Primary: Number of subjects reporting any, grade 3 and related solicited general symptoms

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    End point title
    Number of subjects reporting any, grade 3 and related solicited general symptoms [1]
    End point description
    Assessed solicited general symptoms were cough, diarrhea, irritability, loss of appetite, fever (According to Chinese scale and GSK scale) and vomiting. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination. Grade 3 Cough = Cough/runny nose which prevented daily activity. Grade 3 Diarrhea = ≥ 6 looser than normal stools/day. Grade 3 Irritability = Crying that could not be comforted/ prevented normal activity. Grade 3 Loss of appetite = Did not eat at all. Grade 3 fever (axillary temperature) = >39.0°C according to both the Chinese and GSK scales. Grade 3 Vomiting = ≥ 3 episodes of vomiting/day. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Primary
    End point timeframe
    During the 8-day (Days 0-7) post-vaccination period
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    HRV Group Placebo Group
    Number of subjects analysed
    25
    25
    Units: Subjects
        Any Cough
    10
    12
        Grade 3 Cough
    0
    0
        Related Cough
    0
    1
        Any Diarrhea
    1
    1
        Grade 3 Diarrhea
    0
    1
        Related Diarrhea
    1
    0
        Any Irritability
    3
    2
        Grade 3 Irritability
    0
    0
        Related Irritability
    0
    0
        Any Loss of appetite
    2
    3
        Grade 3 Loss of appetite
    0
    0
        Related Loss of appetite
    0
    0
        Any temperature (Chinese scale)
    4
    5
        Grade 3 temperature (Chinese scale)
    0
    0
        Related temperature (Chinese scale)
    0
    1
        Any temperature (GSK scale)
    1
    2
        Grade 3 temperature (GSK scale)
    0
    0
        Related temperature (GSK scale)
    0
    1
        Any Vomiting
    1
    0
        Grade 3 Vomiting
    0
    0
        Related Vomiting
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse event (AE)

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    End point title
    Number of subjects reporting any unsolicited adverse event (AE)
    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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study period of one month (Day 0 – Day 30). Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    Within 31 days (Day 0 - Day 30) after the HRV vaccine/placebo dose
    End point values
    HRV Group Placebo Group
    Number of subjects analysed
    25
    25
    Units: Subjects
        Any AE(s)
    11
    13
    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
    Serious adverse events (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 to Month 1)
    End point values
    HRV Group Placebo Group
    Number of subjects analysed
    25
    25
    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
    Solicited symptoms were collected during the 8-day (Days 0-7) post vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post vaccination period. SAEs were collected during the entire study period (Day 0 - Month 1).
    Adverse event reporting additional description
    The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    HRV Group
    Reporting group description
    Subjects received a single oral dose of GSK Biologicals’ oral live attenuated liquid human rotavirus vaccine (HRV) vaccine at Day 0

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects received a single oral dose of placebo at Day 0

    Serious adverse events
    HRV Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    HRV Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 25 (100.00%)
    25 / 25 (100.00%)
    Respiratory, thoracic and mediastinal disorders
    Cough (unsolicited)
         subjects affected / exposed
    3 / 25 (12.00%)
    5 / 25 (20.00%)
         occurrences all number
    3
    5
    Rhinorrhoea
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Cough (solicited)
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 25 (40.00%)
    12 / 25 (48.00%)
         occurrences all number
    10
    12
    Diarrhea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 25 (8.00%)
         occurrences all number
    3
    2
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 25 (12.00%)
         occurrences all number
    2
    3
    Fever (Chinese scale)
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 25 (16.00%)
    5 / 25 (20.00%)
         occurrences all number
    4
    5
    Fever (GSK scale)
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Pyrexia
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 25 (4.00%)
         occurrences all number
    3
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 25 (12.00%)
    4 / 25 (16.00%)
         occurrences all number
    3
    4

    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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