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    Clinical Trial Results:
    A phase I, double-blind, randomised, placebo-controlled study to assess the reactogenicity and safety of two doses of GlaxoSmithKline Biologicals’ (GSK) oral live attenuated liquid human rotavirus (HRV) vaccine, when administered to healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination according to a 0, 1 month schedule in China.

    Summary
    EudraCT number
    		 2012-001481-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Jun 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    113518
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01107587
    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 Jun 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jun 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the reactogenicity of GSK Biologicals’ liquid HRV vaccine when compared to placebo in terms of grade “3” solicited AEs.
    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 Apr 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)
    50
    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
    		 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 2 oral doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated liquid human rotavirus (HRV)HRV vaccine according to a 0, 1 month schedule
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotarix Oral Suspension
    Investigational medicinal product code
    SUB22357
    Other name
    HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two oral doses of the liquid HRV vaccine administered at Months 0 and 1

    Arm title
    		 Placebo Group
    Arm description
    		 Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two oral doses of placebo administered at Months 0 and 1

    Number of subjects in period 1
    		HRV Group Placebo Group
    Started
    25
    25
    Completed
    23
    22
    Not completed
    2
    3
         Consent withdrawn by subject
    1
    1
         Migrated/moved from study area
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HRV Group
    Reporting group description
    		 Subjects received 2 oral doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated liquid human rotavirus (HRV)HRV vaccine according to a 0, 1 month schedule

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.

    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: weeks
        arithmetic mean (standard deviation)
    		 10.3 ± 2.7 11.8 ± 2.43 -
    Gender categorical
    Units: Subjects
        Female
    		 13 10 23
        Male
    		 12 15 27

    End points

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    End points reporting groups
    Reporting group title
    HRV Group
    Reporting group description
    		 Subjects received 2 oral doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated liquid human rotavirus (HRV)HRV vaccine according to a 0, 1 month schedule

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.

    Primary: Number of subjects reporting grade 3 solicited general symptoms

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    End point title
    		 Number of subjects reporting grade 3 solicited general symptoms [1]
    End point description
    Assessed solicited general symptoms were cough, diarrhoea, irritability, loss of appetite, fever (By GSK scale and Chinese scale) and vomiting. Grade 3 cough = Cough/runny nose that prevented normal everyday activity, Grade 3 diarrhoea = greater than or equal to (≥) 6 looser than normal stools/day, Grade 3 irritability = Crying that could not be comforted/prevented normal activity, Grade 3 loss of appetite = not eating at all, Grade 3 fever = greater than (>) 39.0 degree Celsius (°C) (as defined by GSK Biologicals and the Chinese authorities), Grade 3 vomiting = ≥ 3 episodes of vomiting/day
    End point type
    Primary
    End point timeframe
    Within the 8-day (Day 0-Day 7) follow-up period after each dose of HRV vaccine or placebo
    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
        Grade 3 Cough; Dose 1 [N=25, 25]
    0
    0
        Grade 3 Diarrhoea; Dose 1 [N=25, 25]
    2
    1
        Grade 3 Irritability; Dose 1 [N=25, 25]
    0
    0
        Grade 3 Loss of appetite; Dose 1 [N=25, 25]
    0
    0
        Grade 3 temp (By GSK scale); Dose 1 [N=25, 25]
    0
    0
        Grade 3 temp (By Chinese scale); Dose 1 [N=25, 25]
    0
    0
        Grade 3 Vomiting; Dose 1 [N=25, 25]
    1
    0
        Grade 3 Cough; Dose 2 [N=23, 22]
    0
    0
        Grade 3 Diarrhoea; Dose 2 [N=23, 22]
    1
    1
        Grade 3 Irritability; Dose 2 [N=23, 22]
    0
    0
        Grade 3 Loss of appetite; Dose 2 [N=23, 22]
    0
    0
        Grade 3 temp (By GSK scale); Dose 2 [N=23, 22]
    0
    0
        Grade 3 temp (By Chinese scale); Dose 2 [N=23, 22]
    0
    0
        Grade 3 Vomiting; Dose 2 [N=23, 22]
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and related solicited general symptoms

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    End point title
    		 Number of subjects reporting any and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were cough, diarrhoea, irritability, loss of appetite, fever (By GSK scale and Chinese scale) and vomiting. Any = Incidence of any general symptom regardless of intensity grade or relationship to vaccination. Related = symptom assessed by the investigator as related to the vaccination. Any fever =  37.1 °C (as defined by the Chinese authorities) or 37.5°C (as defined by GSK Biologicals).
    End point type
    Secondary
    End point timeframe
    Within the 8-day (Day 0-Day 7) follow-up period after each dose of HRV vaccine or placebo.
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    25
    25
    Units: Subjects
        Any Cough; Dose 1 [N=25, 25]
    3
    5
        Related Cough; Dose 1 [N=25, 25]
    0
    0
        Any Diarrhoea; Dose 1 [N=25, 25]
    4
    2
        Related Diarrhoea; Dose 1 [N=25, 25]
    0
    1
        Any Irritability; Dose 1 [N=25, 25]
    5
    6
        Related Irritability; Dose 1 [N=25, 25]
    0
    0
        Any Loss of appetite; Dose 1 [N=25, 25]
    3
    5
        Related Loss of appetite; Dose 1 [N=25, 25]
    0
    0
        Any temperature (By GSK scale); Dose 1 [N=25, 25]
    1
    0
        Related temp (By GSK scale); Dose 1 [N=25, 25]
    0
    0
        Any temp (By Chinese scale); Dose 1 [N=25, 25]
    1
    2
        Related temp (By Chinese scale); Dose 1 [N=25, 25]
    0
    0
        Any Vomiting; Dose 1 [N=25, 25]
    2
    1
        Related Vomiting; Dose 1 [N=25, 25]
    1
    0
        Any Cough; Dose 2 [N=23, 22]
    3
    4
        Related Cough; Dose 2 [N=23, 22]
    0
    0
        Any Diarrhoea; Dose 2 [N=23, 22]
    4
    4
        Related Diarrhoea; Dose 2 [N=23, 22]
    2
    1
        Any Irritability; Dose 2 [N=23, 22]
    1
    5
        Related Irritability; Dose 2 [N=23, 22]
    0
    2
        Any Loss of appetite; Dose 2 [N=23, 22]
    2
    5
        Related Loss of appetite; Dose 2 [N=23, 22]
    0
    1
        Any temp (By GSK scale); Dose 2 [N=23, 22]
    0
    3
        Related temp (By GSK scale); Dose 2 [N=23, 22]
    0
    1
        Any temp (By Chinese scale); Dose 2 [N=23, 22]
    3
    6
        Related temp (By Chinese scale); Dose 2 [N=23, 22]
    1
    3
        Any Vomiting; Dose 2 [N=23, 22]
    1
    1
        Related Vomiting; Dose 2 [N=23, 22]
    1
    0
    No statistical analyses for this end point

    Secondary: Numbers of subjects reporting any unsolicited adverse events (AEs)

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    End point title
    		 Numbers of subjects reporting any unsolicited adverse events (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. Any was defined as an adverse event (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 was reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Day 0-Day 30) follow-up after any dose of HRV vaccine or placebo
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    25
    25
    Units: Subjects
        any AE(s)
    6
    3
    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 include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Throughout the study period (Day 0 up to Month 2).
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    25
    25
    Units: Subjects
        Any SAE(s)
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-rotavirus IgA antibody concentration above the cut-off value

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    End point title
    		 Number of subjects with anti-rotavirus IgA antibody concentration above the cut-off value
    End point description
    The cut-off value for anti-rotavirus IgA antibody concentration was ≥ 20 U/mL
    End point type
    Secondary
    End point timeframe
    At Day 0 and Month 2
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    15
    17
    Units: Subjects
        Anti-RV.IgA; Day 0
    0
    0
        Anti-RV.IgA; Month 2
    13
    0
    No statistical analyses for this end point

    Secondary: Serum rotavirus immunoglobulin A (IgA) antibody concentrations

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    End point title
    		 Serum rotavirus immunoglobulin A (IgA) antibody concentrations
    End point description
    Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies. Seroconverted subject is defined as a subject with appearance of anti-rotavirus (RV) IgA antibody concentration ≥ 20 units (U)/millilitre (mL) in subjects initially (i.e. prior to the first dose of HRV vaccine or placebo) seronegative for anti-RV IgA antibody). None of the subjects in the Placebo Group had seroconverted.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Month 2
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    15
    17
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-RV.IgA; Day 0
    0 (99.8 to 746)
    0 (0 to 0)
        Anti-RV.IgA; Month 2
    272.8 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of subjects with RV in stool samples (shedding)

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    End point title
    		 Number of subjects with RV in stool samples (shedding)
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 7 and Day 15 after each HRV vaccine or placebo dose and one month post-Dose 2 (Month 2)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    15
    17
    Units: Subjects
        Dose 1; Day 0
    0
    0
        Dose 1; Day 7
    2
    0
        Dose 1; Day 15
    0
    0
        Dose 2; Day 0
    0
    0
        Dose 2; Day 7
    0
    0
        Dose 2; Day 15
    0
    0
        Month 2; Day 0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited general symptom during the 8-day (Days 0-7) post-vaccination period; Unsolicited AEs within the 31-day (Days 0-30) follow-up after vaccination and SAEs during the entire study period (Day 0 to Month 2)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    HRV Group
    Reporting group description
    		 Subjects received 2 oral doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated liquid human rotavirus (HRV)HRV vaccine according to a 0, 1 month schedule

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.

    Serious adverse events
    		 HRV Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Congenital, familial and genetic disorders
    Heart disease congenital
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (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
    Bronchopneumonia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (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
    		 HRV Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 25 (20.00%)
    6 / 25 (24.00%)
    General disorders and administration site conditions
    Irritability; Dose 1
         subjects affected / exposed
    5 / 25 (20.00%)
    6 / 25 (24.00%)
         occurrences all number
    5
    6
    Loss of appetite; Dose 1
         subjects affected / exposed
    3 / 25 (12.00%)
    5 / 25 (20.00%)
         occurrences all number
    3
    5
    Fever By Chinese scale; Dose 1
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Vomiting; Dose 1
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Diarrhoea; Dose 2
         subjects affected / exposed [1]
    4 / 23 (17.39%)
    4 / 22 (18.18%)
         occurrences all number
    4
    4
    Irritability; Dose 2
         subjects affected / exposed [2]
    1 / 23 (4.35%)
    5 / 22 (22.73%)
         occurrences all number
    1
    5
    Loss of appetite; Dose 2
         subjects affected / exposed [3]
    2 / 23 (8.70%)
    5 / 22 (22.73%)
         occurrences all number
    2
    5
    Fever By GSK scale; Dose 2
         subjects affected / exposed [4]
    0 / 23 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    3
    Fever By Chinese scale; Dose 2
         subjects affected / exposed [5]
    3 / 23 (13.04%)
    6 / 22 (27.27%)
         occurrences all number
    3
    6
    Gastrointestinal disorders
    Diarrhoea; Dose 1
         subjects affected / exposed
    4 / 25 (16.00%)
    2 / 25 (8.00%)
         occurrences all number
    4
    2
    Respiratory, thoracic and mediastinal disorders
    Cough; Dose 1
         subjects affected / exposed
    3 / 25 (12.00%)
    5 / 25 (20.00%)
         occurrences all number
    3
    5
    Cough; Dose 2
         subjects affected / exposed [6]
    3 / 23 (13.04%)
    4 / 22 (18.18%)
         occurrences all number
    3
    4
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 25 (16.00%)
    3 / 25 (12.00%)
         occurrences all number
    4
    3
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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