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    Clinical Trial Results:
    A phase III, double-blind, randomised, placebo-controlled, multi-country and multi-center study to assess the efficacy, immunogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine expanded program on immunisation (EPI) vaccinations including oral poliovirus vaccine (OPV) in healthy infants.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2015-001540-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Mar 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    07 May 2016
    First version publication date
    28 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results

    Trial information

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    Trial identification
    Sponsor protocol code
    444563/024
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00139347
    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
    12 Oct 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Mar 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Mar 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if two doses of GSK Biologicals’ HRV vaccine given concomitantly with routine EPI vaccinations including OPV can prevent severe rotavirus gastroenteritis (RV GE) caused by the circulating wild-type RV strains during the period starting from 2 weeks after Dose 2 until one year of age.
    Protection of trial subjects
    Subjects were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Dec 2003
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Honduras: 450
    Country: Number of subjects enrolled
    Brazil: 485
    Country: Number of subjects enrolled
    Dominican Republic: 450
    Country: Number of subjects enrolled
    Colombia: 1674
    Country: Number of subjects enrolled
    Argentina: 2618
    Country: Number of subjects enrolled
    Panama: 891
    Worldwide total number of subjects
    6568
    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)
    6568
    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
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HRV Group
    Arm description
    		 Subjects received 2 doses of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine according to a 0, 1 to 2-month schedule with the routine EPI vaccinations.
    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
    Two oral doses of HRV vaccine administered to healthy infants who are 6-12 weeks of age.

    Arm title
    		 Placebo Group
    Arm description
    		 Subjects received 2 doses of placebo according to a 0, 1 to 2-month schedule with the routine EPI vaccinations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two oral doses of plavebo administered to healthy infants who are 6-12 weeks of age.

    Number of subjects in period 1
    		HRV Group Placebo Group
    Started
    4376
    2192
    Completed
    4234
    2115
    Not completed
    142
    77
         Adverse event, serious fatal
    11
    3
         Consent withdrawn by subject
    60
    33
         Adverse event, non-fatal
    1
    -
         Migrated/moved from study area
    48
    24
         Unspecified
    3
    -
         Lost to follow-up
    18
    16
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HRV Group
    Reporting group description
    		 Subjects received 2 doses of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine according to a 0, 1 to 2-month schedule with the routine EPI vaccinations.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 2 doses of placebo according to a 0, 1 to 2-month schedule with the routine EPI vaccinations.

    Reporting group values
    		 HRV Group Placebo Group Total
    Number of subjects
    		 4376 2192 6568
    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)
    		 8.6 ( 1.3 ) 8.6 ( 1.33 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2198 1090 3288
        Male
    		 2178 1102 3280

    End points

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    End points reporting groups
    Reporting group title
    HRV Group
    Reporting group description
    		 Subjects received 2 doses of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine according to a 0, 1 to 2-month schedule with the routine EPI vaccinations.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 2 doses of placebo according to a 0, 1 to 2-month schedule with the routine EPI vaccinations.

    Primary: Number of subjects with severe rotavirus gastroenteritis (RV GE) caused by the wild-type RV strain

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    End point title
    		 Number of subjects with severe rotavirus gastroenteritis (RV GE) caused by the wild-type RV strain [1]
    End point description
    Severe RV GE episodes were defined as an episode of severe gastroenteritis occurring at least two weeks after the full vaccination course in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible but not later than 7 days after admission to the hospital or medical facility
    End point type
    Primary
    End point timeframe
    From 2 weeks after Dose 2 up to study end
    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
    4211
    2099
    Units: Subjects
        RV GE episodes
    7
    19
    No statistical analyses for this end point

    Secondary: Number of subjects with severe RV GE caused by the wild RV strain of serotype G1

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    End point title
    		 Number of subjects with severe RV GE caused by the wild RV strain of serotype G1
    End point description
    Severe GE episode was defined as a gastroenteritis episode requiring hospitalization and/or re-hydration therapy (equivalent to WHO plan B or C) in a medical facility.
    End point type
    Secondary
    End point timeframe
    From 2 weeks after Dose 2 until one year of age
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    4211
    2099
    Units: Subjects
        G1 wild type +P8 wild type
    0
    1
        G2+P4
    1
    2
        G9+P8 wild type
    6
    16
        Pooled Non G1 (G2, G9)
    7
    18
    No statistical analyses for this end point

    Secondary: Number of subjects with severe RV GE due to non-G1 serotypes

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    End point title
    		 Number of subjects with severe RV GE due to non-G1 serotypes
    End point description
    Severe GE episode was defined as a gastroenteritis episode requiring hospitalization and/or re-hydration therapy (equivalent to WHO plan B or C) in a medical facility.
    End point type
    Secondary
    End point timeframe
    From 2 weeks after Dose 2 until one year of age
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    4376
    2192
    Units: Subjects
        Severe RV GE
    8
    23
    No statistical analyses for this end point

    Secondary: Number of subjects with severe RV GE episode, by isolated RV types

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    End point title
    		 Number of subjects with severe RV GE episode, by isolated RV types
    End point description
    Severe GE episode was defined as a gastroenteritis episode requiring hospitalization and/or re-hydration therapy (equivalent to WHO plan B or C) in a medical facility.
    End point type
    Secondary
    End point timeframe
    From Dose 1 up to study end
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    4376
    2192
    Units: Subjects
        G1 wild type +P8 wild type
    0
    1
        G2+P4
    1
    3
        G9+P8 wild type
    7
    19
        Pooled Non G1 (G2, G9)
    8
    22
    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 event was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, an important medical events that may not be immediately life-threatening or resulted in death or hospitalization but may have jeopardized the subject or required medical or surgical intervention to prevent one of the other outcomes.
    End point type
    Secondary
    End point timeframe
    Throughout the study period (Month 0 to Month 10)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    4376
    2192
    Units: Subjects
        Any SAE(s)
    505
    265
    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
    Antibody concentrations were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. This analysis was performed on a subset of 300 subjects enrolled in year 2003-2004.
    End point type
    Secondary
    End point timeframe
    At one to two months after the second study vaccine dose (at Visit 3)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    89
    176
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti- IgA
    18 (13.1 to 24.6)
    66 (49.9 to 87.2)
    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
    Antibody titers were summarized by Geometric Mean Titers (GMTs) with their 95% CIs. This analysis was performed on a subset of 300 subjects enrolled in year 2003-2004.
    End point type
    Secondary
    End point timeframe
    At one to two months after the second dose of routine EPI vaccinations (at Visit 3)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    168
    83
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1 (N= 168, 80)
    710.6 (549.9 to 918.3)
    1064.8 (803.2 to 1411.6)
        Anti-polio 2 (N= 165, 83)
    819.6 (651.7 to 1030.8)
    1326.5 (1020.4 to 1724.5)
        Anti-polio 3 (N= 164, 81)
    117.5 (89 to 155)
    162.7 (109.7 to 241.2)
    No statistical analyses for this end point

    Secondary: Number of subjects seroprotected for anti-polio type 1, type 2 and type 3 antibodies

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    End point title
    		 Number of subjects seroprotected for anti-polio type 1, type 2 and type 3 antibodies
    End point description
    A seroprotected subject was defined as a subject with antibody concentration/titer greater than or equal to the seroprotection level. This analysis was performed on a subset of 300 subjects enrolled in year 2003-2004.
    End point type
    Secondary
    End point timeframe
    At one to two months after the second dose of routine EPI vaccinations (at Visit 3)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    168
    83
    Units: Subjects
        Anti-polio 1 (N= 168, 80)
    163
    80
        Anti-polio 2 (N= 165, 83)
    160
    82
        Anti-polio 3 (N= 164, 81)
    138
    70
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti- polyribosyl ribitol phosphate (PRP) antibodies

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    End point title
    		 Antibody concentrations for anti- polyribosyl ribitol phosphate (PRP) antibodies
    End point description
    Antibody concentrations were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. This analysis was performed on a subset of 300 subjects enrolled in year 2003-2004.
    End point type
    Secondary
    End point timeframe
    At one to two months after the third dose of routine EPI vaccinations (at Visit 4)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    179
    91
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    20.426 (17.183 to 24.281)
    18.99 (14.134 to 25.514)
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.

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    End point title
    		 Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.
    End point description
    Antibody concentrations were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. This analysis was performed on a subset of 300 subjects enrolled in year 2003-2004.
    End point type
    Secondary
    End point timeframe
    At one to two months after the third dose of routine EPI vaccinations (at Visit 4)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    181
    90
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D
    0.656 (0.534 to 0.805)
    0.696 (0.52 to 0.932)
        Anti-T
    2.988 (2.582 to 3.459)
    2.669 (2.16 to 3.297)
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti-Bordetella pertussis toxoids (anti-BPT) antibodies.

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    End point title
    		 Antibody concentrations for anti-Bordetella pertussis toxoids (anti-BPT) antibodies.
    End point description
    Antibody concentrations were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. This analysis was performed on a subset of 300 subjects enrolled in year 2003-2004.
    End point type
    Secondary
    End point timeframe
    At one to two months after the third dose of routine EPI vaccinations (at Visit 4)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    181
    90
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-BPT
    68.2 (60 to 77.6)
    58.6 (48.3 to 71.1)
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti-hepatitis B surface antigen (anti-HBs) antibodies.

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    End point title
    		 Antibody concentrations for anti-hepatitis B surface antigen (anti-HBs) antibodies.
    End point description
    Antibody concentrations were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. This analysis was performed on a subset of 300 subjects enrolled in year 2003-2004.
    End point type
    Secondary
    End point timeframe
    At one to two months after the third dose of routine EPI vaccinations (at Visit 4)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    176
    90
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs
    1007.8 (813.2 to 1248.9)
    899.6 (659.1 to 1227.7)
    No statistical analyses for this end point

    Secondary: Antibody titers against poliovirus type 1, 2 and 3.

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    End point title
    		 Antibody titers against poliovirus type 1, 2 and 3.
    End point description
    Antibody titers were summarized by Geometric Mean Titers (GMTs) with their 95% CIs. This analysis was performed on a subset of 300 subjects enrolled in year 2003-2004.
    End point type
    Secondary
    End point timeframe
    At one to two months after the third dose of routine EPI vaccinations (at Visit 4)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    177
    90
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1 (N= 173, 86)
    989.5 (796.9 to 1228.7)
    967.8 (742.9 to 1261)
        Anti-polio 2 (N= 174, 90)
    792 (665.7 to 942.2)
    898.2 (724.8 to 1113.2)
        Anti-polio 3 (N= 177, 90)
    156.3 (127.1 to 192.3)
    154 (122.7 to 193.4)
    No statistical analyses for this end point

    Secondary: Number of subjects seropositive for anti-BPT antibodies

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    End point title
    		 Number of subjects seropositive for anti-BPT antibodies
    End point description
    A seropositive subject was defined as a subject whose titer was greater than or equal to the cut-off value ( ≥ 15 EL. U/mL). This analysis was performed on a subset of 300 subjects enrolled in year 2003-2004.
    End point type
    Secondary
    End point timeframe
    At one to two months after the third dose of routine EPI vaccinations (at Visit 4)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    181
    90
    Units: Subjects
        Anti-BPT ≥ 15 EL.U/mL
    171
    83
    No statistical analyses for this end point

    Secondary: Antibody titers against poliovirus type 1, 2 and 3.

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    End point title
    		 Antibody titers against poliovirus type 1, 2 and 3.
    End point description
    Antibody titers were summarized by Geometric Mean Titers (GMTs) with their 95% CIs. This analysis was performed on a subset of 900 subjects enrolled in year 2005.
    End point type
    Secondary
    End point timeframe
    At one month after each dose of routine EPI vaccinations (at Month 1, Month 3 and Month 5)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    522
    251
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1; M1 (N= 487, 243)
    221.3 (184.6 to 265.2)
    313.3 (243.4 to 403.2)
        Anti-polio 1; M3 (N= 506, 242)
    908.8 (782.2 to 1055.8)
    1417.4 (1193.3 to 1683.6)
        Anti-polio 1; M5 (N= 491, 236)
    1259.3 (1109.7 to 1429.1)
    1495.8 (1282.2 to 1745)
        Anti-polio 2; M1 (N= 458, 224)
    289.6 (251.7 to 333.3)
    257.1 (208 to 317.8)
        Anti-polio 2; M3 (N= 494, 228)
    1290.8 (1149.4 to 1449.6)
    1472.4 (1263.4 to 1715.9)
        Anti-polio 2; M5 (N= 494, 243)
    1246.3 (1122.5 to 1383.8)
    1216.9 (1064.3 to 1391.4)
        Anti-polio 3; M1 (N= 522, 251)
    17.6 (14.8 to 20.9)
    20.4 (16 to 26)
        Anti-polio 3; M3 (N= 499, 234)
    132.4 (113.1 to 154.9)
    172.6 (139.2 to 214.1)
        Anti-polio 3; M5 (N= 513, 251)
    232.2 (207.6 to 259.8)
    267.7 (229.1 to 312.7)
    No statistical analyses for this end point

    Secondary: Number of subjects seroprotected for anti-polio type 1, type 2 and type 3 antibodies

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    End point title
    		 Number of subjects seroprotected for anti-polio type 1, type 2 and type 3 antibodies
    End point description
    A seroprotected subject was defined as a subject with antibody concentration/titer greater than or equal to the seroprotection level. This analysis was performed on a subset of 900 subjects enrolled in year 2005.
    End point type
    Secondary
    End point timeframe
    At one month after each dose of routine EPI vaccinations (at Month 1, Month 3 and Month 5)
    End point values
    		 HRV Group Placebo Group
    Number of subjects analysed
    522
    251
    Units: Subjects
        Anti-polio 1; M1 (N= 487, 243)
    445
    230
        Anti-polio 1; M3 (N= 506, 242)
    491
    240
        Anti-polio 1; M5 (N= 491, 236)
    487
    236
        Anti-polio 2; M1 (N= 458, 224)
    445
    214
        Anti-polio 2; M3 (N= 494, 228)
    491
    228
        Anti-polio 2; M5 (N= 494, 243)
    494
    243
        Anti-polio 3; M1 (N= 522, 251)
    222
    120
        Anti-polio 3; M3 (N= 499, 234)
    434
    213
        Anti-polio 3; M5 (N= 513, 251)
    504
    248
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    HRV Group
    Reporting group description
    		 Subjects received 2 doses of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine according to a 0, 1 to 2-month schedule with the routine EPI vaccinations.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 2 doses of placebo according to a 0, 1 to 2-month schedule with the routine EPI vaccinations.

    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: No non-serious adverse events were reported.
    Serious adverse events
    		 HRV Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    505 / 4376 (11.54%)
    265 / 2192 (12.09%)
         number of deaths (all causes)
    10
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neuroblastoma
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 4376 (0.14%)
    3 / 2192 (0.14%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Child abuse
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
         subjects affected / exposed
    25 / 4376 (0.57%)
    13 / 2192 (0.59%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    10 / 4376 (0.23%)
    6 / 2192 (0.27%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyper reactivity
         subjects affected / exposed
    3 / 4376 (0.07%)
    3 / 2192 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    2 / 4376 (0.05%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnea
         subjects affected / exposed
    2 / 4376 (0.05%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    2 / 4376 (0.05%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 4376 (0.02%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurocutaneous fistula
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    15 / 4376 (0.34%)
    6 / 2192 (0.27%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    2 / 4376 (0.05%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 4376 (0.00%)
    2 / 2192 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 4376 (0.02%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic brain injury
         subjects affected / exposed
    1 / 4376 (0.02%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental exposure
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental poisoning
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaesthetic complication
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug toxicity
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye injury
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Sickle cell anemia
         subjects affected / exposed
    2 / 4376 (0.05%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital syphilis
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Aortic valve stenosis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyanosis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    4 / 4376 (0.09%)
    9 / 2192 (0.41%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    7 / 4376 (0.16%)
    4 / 2192 (0.18%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 4376 (0.05%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infantile spasms
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic epilepsy
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    2 / 4376 (0.05%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolysis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anemia
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    6 / 4376 (0.14%)
    4 / 2192 (0.18%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    4 / 4376 (0.09%)
    2 / 2192 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diarrhea
         subjects affected / exposed
    3 / 4376 (0.07%)
    2 / 2192 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastro esophageal reflux disease
         subjects affected / exposed
    3 / 4376 (0.07%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 4376 (0.05%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal hemorrhage
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis atopic
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (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
    Bronchiolitis
         subjects affected / exposed
    148 / 4376 (3.38%)
    64 / 2192 (2.92%)
         occurrences causally related to treatment / all
    0 / 148
    0 / 64
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    95 / 4376 (2.17%)
    65 / 2192 (2.97%)
         occurrences causally related to treatment / all
    1 / 95
    0 / 65
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    91 / 4376 (2.08%)
    47 / 2192 (2.14%)
         occurrences causally related to treatment / all
    0 / 91
    0 / 47
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    41 / 4376 (0.94%)
    22 / 2192 (1.00%)
         occurrences causally related to treatment / all
    0 / 41
    0 / 22
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    20 / 4376 (0.46%)
    10 / 2192 (0.46%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    13 / 4376 (0.30%)
    8 / 2192 (0.36%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    15 / 4376 (0.34%)
    5 / 2192 (0.23%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 4376 (0.18%)
    3 / 2192 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    7 / 4376 (0.16%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    5 / 4376 (0.11%)
    2 / 2192 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    5 / 4376 (0.11%)
    2 / 2192 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    2 / 4376 (0.05%)
    5 / 2192 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    2 / 4376 (0.05%)
    3 / 2192 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngotracheo bronchitis
         subjects affected / exposed
    3 / 4376 (0.07%)
    2 / 2192 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    3 / 4376 (0.07%)
    2 / 2192 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    4 / 4376 (0.09%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abscess
         subjects affected / exposed
    2 / 4376 (0.05%)
    2 / 2192 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    4 / 4376 (0.09%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 4376 (0.05%)
    2 / 2192 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    3 / 4376 (0.07%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 4376 (0.00%)
    3 / 2192 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    2 / 4376 (0.05%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Otitis media
         subjects affected / exposed
    3 / 4376 (0.07%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 4376 (0.02%)
    2 / 2192 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 4376 (0.05%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteremia
         subjects affected / exposed
    2 / 4376 (0.05%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    2 / 4376 (0.05%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    2 / 4376 (0.05%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 4376 (0.02%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngotracheitis
         subjects affected / exposed
    1 / 4376 (0.02%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    1 / 4376 (0.02%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    2 / 4376 (0.05%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 4376 (0.05%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 4376 (0.02%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rhinitis
         subjects affected / exposed
    1 / 4376 (0.02%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acarodermatitis
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bullous impetigo
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parasitic infection intestinal
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perianal abscess
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scarlet fever
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    0 / 4376 (0.00%)
    1 / 2192 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral diarrhea
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    7 / 4376 (0.16%)
    7 / 2192 (0.32%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    3 / 4376 (0.07%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactose intolerance
         subjects affected / exposed
    2 / 4376 (0.05%)
    0 / 2192 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 4376 (0.02%)
    0 / 2192 (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
    0 / 4376 (0.00%)
    0 / 2192 (0.00%)

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 May 2004
    • The procedures for the surveillance of the hospital and/or medical facilities in the involved study areas were re-aligned across countries to take into consideration of the operating reality of the different study settings. Complementary surveillance procedures were expected to improve timely identification of severe GE cases. • The active hospital surveillance for severe GE case collection were complemented by subject surveillance, when needed. • In the same context the interval window for stool collection was widened to 7 days after admission to a medical facility or hospital. • The safety data obtained in studies with GSK Biologicals’ HRV vaccine were updated.

    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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