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    Clinical Trial Results:
    An open, single group, multi-centric, post marketing surveillance (PMS) to monitor the reactogenicity and safety of oral live attenuated human rotavirus (HRV) vaccine, Rotarix™ when administered according to the Prescribing Information (PI) to Indian infants

    Summary
    EudraCT number
    2017-000451-14
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    23 Apr 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Dec 2017
    First version publication date
    20 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    112896
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00938327
    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, +((44)2089 904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, +((44)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
    23 Apr 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the reactogenicity of Rotarix in terms of occurrence of at least one Grade “2” or Grade “3” fever, vomiting or diarrhoea within the 8-day (Day 0-Day 7) follow-up period after any Rotarix vaccination
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of vaccine, with appropriate medical treatment readily available in case of a rare anaphylactic reaction
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Aug 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
    India: 332
    Worldwide total number of subjects
    332
    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)
    332
    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
    -

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    332
    Number of subjects completed
    332

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

    Arms
    Arm title
    Rotarix Group
    Arm description
    Subjects who had received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
    Arm type
    Experimental

    Investigational medicinal product name
    Rotarix™
    Investigational medicinal product code
    Other name
    GSK Biologicals’ oral live attenuated HRV vaccine
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two doses of Rotarix administered orally. First dose administered from the age of 6 weeks. Second dose administered at least 4 weeks after Dose 1. Vaccination course completed by 24 weeks of age

    Number of subjects in period 1
    Rotarix Group
    Started
    332
    Completed
    272
    Not completed
    60
         Protocol deviation
    1
         2nd dose received outside of the study
    7
         Vaccine not received as out of stock
    9
         Adverse event, non-fatal
    2
         Consent withdrawn by subject
    4
         Lost to follow-up
    37

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    Subjects who had received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.

    Reporting group values
    Rotarix Group Total
    Number of subjects
    332
    Age categorical
    Units: Subjects
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    10.4 ± 4.27 -
    Gender categorical
    Units: Subjects
        Female
    155 155
        Male
    177 177

    End points

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    End points reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    Subjects who had received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.

    Primary: Number of subjects reporting Grade 2 or 3 symptoms (fever, vomiting or diarrhoea)

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    End point title
    Number of subjects reporting Grade 2 or 3 symptoms (fever, vomiting or diarrhoea) [1]
    End point description
    Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day.
    End point type
    Primary
    End point timeframe
    During the 8-day (Day 0 – Day 7) follow-up period after each 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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    Rotarix Group
    Number of subjects analysed
    332
    Units: subjects
        subjects
    42
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general symptoms

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    End point title
    Number of subjects reporting solicited general symptoms
    End point description
    Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day
    End point type
    Secondary
    End point timeframe
    During the 8-day (Day 0 – Day 7) follow-up period after each vaccination
    End point values
    Rotarix Group
    Number of subjects analysed
    332
    Units: subjects
        Cough
    43
        Diarrhoea
    14
        Irritability
    81
        Loss of appetite
    46
        Temperature (axillary)
    24
        Vomiting
    67
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events (AEs)

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    End point title
    Number of subjects reporting unsolicited adverse events (AEs)
    End point description
    Unsolicited AE covers any AE 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.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0 – Day 30) follow-up period after each vaccination
    End point values
    Rotarix Group
    Number of subjects analysed
    332
    Units: subjects
        subjects
    23
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAEs)

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    End point title
    Number of subjects reporting serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    Throughout the study period (from Day 0 up to Day 30)
    End point values
    Rotarix Group
    Number of subjects analysed
    332
    Units: subjects
        subjects
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events: throughout the study period (Day 0-Day 30). Other adverse avents: during the 8-day (Day 0-Day 7) follow-up period after each vaccination.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.

    Serious adverse events
    Rotarix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 332 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Rotarix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    133 / 332 (40.06%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    45 / 332 (13.55%)
         occurrences all number
    55
    Rhinorrhoea
         subjects affected / exposed
    2 / 332 (0.60%)
         occurrences all number
    2
    Nervous system disorders
    Hypersomnia
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    Lethargy
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    General disorders and administration site conditions
    Inflammation
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    25 / 332 (7.53%)
         occurrences all number
    28
    Psychiatric disorders
    Decreased activity
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    Irritability
         subjects affected / exposed
    81 / 332 (24.40%)
         occurrences all number
    97
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    3 / 332 (0.90%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    16 / 332 (4.82%)
         occurrences all number
    18
    Flatulence
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    Tongue discolouration
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    67 / 332 (20.18%)
         occurrences all number
    83
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    2 / 332 (0.60%)
         occurrences all number
    2
    Rash vesicular
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    46 / 332 (13.86%)
         occurrences all number
    54
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 332 (0.90%)
         occurrences all number
    3
    Otitis media acute
         subjects affected / exposed
    1 / 332 (0.30%)
         occurrences all number
    1

    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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