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    Clinical Trial Results:
    A phase III, double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy, immunogenicity and safety of two doses of GSK Biologicals’ oral live attenuated liquid human rotavirus (HRV) vaccine in healthy Chinese infants.

    Summary
    EudraCT number
    2012-005200-18
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    12 May 2012

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

    Trial information

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    Trial identification
    Sponsor protocol code
    113808
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01171963
    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 Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, 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 May 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of two doses of GSK Biologicals’ liquid HRV vaccine against severe RV GE caused by the circulating wild-type RV strains during the efficacy follow-up period. Criteria: The primary objective will be reached if the lower limit of the 95% Confidence Interval (CI) on vaccine efficacy is at least 10%
    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 vaccines.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Aug 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: 3340
    Worldwide total number of subjects
    3340
    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)
    3340
    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
    Duration of the study was of a maximum of 21 months, with the enrolment of subjects starting in August 2010, and subjects being followed up to May 2012 (study Month 21 and Study End), end of the rotavirus season in China.

    Pre-assignment
    Screening details
    Subjects were assigned to 2 sub-cohorts (1:1 ratio). Sub-cohort 1 and Sub-cohort 2 subjects received their OPV and Infanrix™ EPI vaccination respectively independently of, and concomitantly with their Rotarix™/placebo vaccination. 3340 subjects were allocated study subject number allocated and 3333 subjects were vaccinated.

    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
    Rotarix Group
    Arm description
    Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
    Arm type
    Experimental

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two doses administered orally.

    Investigational medicinal product name
    Infanrix™
    Investigational medicinal product code
    Other name
    DTPa
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly in the left anterolateral thigh.

    Investigational medicinal product name
    Oral poliovirus vaccine (OPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    3 doses administered orally.

    Arm title
    Placebo Group
    Arm description
    Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 2 doses of placebo at Day 0 and at Month 1, administered orally.

    Investigational medicinal product name
    Infanrix™
    Investigational medicinal product code
    Other name
    DTPa
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly in the left anterolateral thigh.

    Investigational medicinal product name
    Oral poliovirus vaccine (OPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    3 doses administered orally

    Number of subjects in period 1 [1]
    Rotarix Group Placebo Group
    Started
    1666
    1667
    Completed
    1518
    1499
    Not completed
    148
    168
         Not willing to participate in the EFU-visit 7
    59
    83
         Migrated/moved from study area
    23
    24
         Adverse event, serious fatal
    6
    7
         Adverse event, non-fatal
    4
    8
         Consent withdrawn by subject
    55
    46
         Diarrhea
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 3340 subjects were allocated study subject number allocated and 3333 subjects were vaccinated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.

    Reporting group values
    Rotarix Group Placebo Group Total
    Number of subjects
    1666 1667 3333
    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)
    9.5 ± 2.64 9.7 ± 2.59 -
    Gender categorical
    Units: Subjects
        Female
    795 836 1631
        Male
    871 831 1702

    End points

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    End points reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.

    Primary: Number of subjects with severe episode(s) of rotavirus gastroenteritis (RVGE) caused by the circulating wild type (WT) strains

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    End point title
    Number of subjects with severe episode(s) of rotavirus gastroenteritis (RVGE) caused by the circulating wild type (WT) strains [1]
    End point description
    A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RV GE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system.
    End point type
    Primary
    End point timeframe
    From Month 1 ½ to Month 21
    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
    Rotarix Group Placebo Group
    Number of subjects analysed
    1575
    1573
    Units: Subjects
        Subjects with severe WT RVGE
    21
    75
    No statistical analyses for this end point

    Secondary: Number of subjects with any episode(s) of rotavirus gastroenteritis (RVGE) caused by the circulating wild-type strains

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    End point title
    Number of subjects with any episode(s) of rotavirus gastroenteritis (RVGE) caused by the circulating wild-type strains
    End point description
    A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.
    End point type
    Secondary
    End point timeframe
    From Month 1 ½ to Month 21
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    1575
    1573
    Units: Subjects
        Subjects with WT RVGE
    70
    167
    No statistical analyses for this end point

    Secondary: Number of subjects with any episode(s) of rotavirus gastroenteritis (RVGE) of any type.

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    End point title
    Number of subjects with any episode(s) of rotavirus gastroenteritis (RVGE) of any type.
    End point description
    A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.
    End point type
    Secondary
    End point timeframe
    From Month 1 ½ to Month 21
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    1575
    1573
    Units: Subjects
        Subjects with G1WT RVGE
    22
    46
        Subjects with G2 RVGE
    42
    105
        Subjects with G3 RVGE
    1
    12
        Subjects with G9 RVGE
    1
    5
        Subjects with GX RVGE
    6
    8
        Subjects with P4 RVGE
    43
    107
        Subjects with P8WT RVGE
    25
    59
        Subjects with P9 RVGE
    0
    1
        Subjects with PX RVGE
    4
    1
        Subjects with Pooled Non-G1WT RVGE
    49
    129
    No statistical analyses for this end point

    Secondary: Number of subjects with severe episode(s) of rotavirus gastroenteritis (RVGE) of any type

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    End point title
    Number of subjects with severe episode(s) of rotavirus gastroenteritis (RVGE) of any type
    End point description
    A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RVGE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.
    End point type
    Secondary
    End point timeframe
    From Month 1 ½ to Month 21
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    1575
    1573
    Units: Subjects
        Subjects with severe G1WT RVGE
    9
    25
        Subjects with severe G2 RVGE
    11
    43
        Subjects with severe G3 RVGE
    0
    3
        Subjects with severe G9 RVGE
    0
    3
        Subjects with severe GX RVGE
    1
    6
        Subjects with severe P4 RVGE
    12
    43
        Subjects with severe P8WT RVGE
    9
    31
        Subjects with severe PX RVGE
    1
    1
        Subjects with severe Pooled Non-G1WT RVGE
    12
    54
    No statistical analyses for this end point

    Secondary: Number of subjects with episodes of rotavirus gastroenteritis (RVGE) caused by the circulating wild type (WT) strains requiring hospitalization

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    End point title
    Number of subjects with episodes of rotavirus gastroenteritis (RVGE) caused by the circulating wild type (WT) strains requiring hospitalization
    End point description
    A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating WT RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.
    End point type
    Secondary
    End point timeframe
    From Month 1 ½ to Month 21
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    1575
    1573
    Units: Subjects
        Subjects with RVGE requiring hospitalization
    4
    21
    No statistical analyses for this end point

    Secondary: Number of subjects with any and severe gastroenteritis (GE) due to any cause

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    End point title
    Number of subjects with any and severe gastroenteritis (GE) due to any cause
    End point description
    Severe GE was defined as an episode of GE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system. This outcome measure concerns results for GE episodes due to any cause.
    End point type
    Secondary
    End point timeframe
    From Month 1 ½ to Month 21
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    1575
    1573
    Units: Subjects
        Subjects with any GE
    728
    759
        Subjects with any severe GE
    187
    206
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited general symptoms following vaccination with the Rotarix™ vaccine/placebo

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    End point title
    Number of subjects with any solicited general symptoms following vaccination with the Rotarix™ vaccine/placebo
    End point description
    Assessed solicited general symptoms were fever,defined as axillary temperature (T) above or equal to [>=] 37.5 degrees Celsius [°C] (if GSK scale) or >= 37.1°C (if Chinese scale), fussiness/irritability, loss of appetite, cough/runny nose, diarrhea and vomiting. Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 1, who received the EPI vaccination independently of study vaccination with the Rotarix™ vaccine/placebo.
    End point type
    Secondary
    End point timeframe
    Within the 8-day (Days 0–7) follow-up periods after any dose of Rotarix™ vaccine/placebo
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    1513
    1514
    Units: Subjects
        Any cough/runny nose
    313
    366
        Any diarrhoea
    127
    123
        Any Irritability/Fussiness
    415
    448
        Any Loss of appetite
    253
    250
        Any Fever – Chinese scale: Axillary T >= 37.1°C
    302
    313
        Any Fever – GSK scale: Axillary T >= 37.5°C
    83
    104
        Any Vomiting
    213
    232
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited general symptoms following administration of the co-administered EPI vaccines

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    End point title
    Number of subjects with any solicited general symptoms following administration of the co-administered EPI vaccines
    End point description
    Solicited general symptoms assessed following administration of the co-administered EPI vaccines were drowsiness, gastrointestinal symptoms, fussiness/irritability, loss of appetite, and fever, defined as axillary temperature (T) above or equal to [>=] 37.5 degrees Celsius [°C] (if GSK scale) or >= 37.1°C (if Chinese scale ). Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.
    End point type
    Secondary
    End point timeframe
    Within the 8-day (Days 0–7) follow-up periods following Doses 1 and 2 of the OPV vaccine and Dose 1 of the Infanrix™ vaccine
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    153
    153
    Units: Subjects
        Any Drowsiness
    44
    38
        Any Gastrointestinal
    43
    38
        Any Irritability/Fussiness
    56
    52
        Any Loss of appetite
    43
    32
        Any Fever – Chinese scale: Axillary T >= 37.1°C
    18
    20
        Any Fever – GSK scale: Axillary T >= 37.5°C
    6
    7
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited local symptoms following Dose 2 of the Rotarix™ vaccine/placebo

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    End point title
    Number of subjects with any solicited local symptoms following Dose 2 of the Rotarix™ vaccine/placebo
    End point description
    Solicited local symptoms assessed following administration of the co-administered EPI vaccines were pain, swelling, and redness. Any = any occurrence of the specified solicited local symptom regardless of the intensity grade. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.
    End point type
    Secondary
    End point timeframe
    Within the 8-day (Days 0–7) follow-up periods following Dose 2 of the Rotarix™ vaccine/placebo
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    150
    151
    Units: Subjects
        Any Pain
    14
    9
        Any Redness
    20
    13
        Any Swelling
    13
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with any unsolicited adverse events (AEs)

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    End point title
    Number of subjects with any unsolicited adverse events (AEs)
    End point description
    An unsolicited AE is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of the intensity grade or relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0–30) follow-up periods following any dose of the Rotarix™ vaccine or placebo
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    1666
    1667
    Units: Subjects
        Any unsolicited AE(s)
    310
    368
    No statistical analyses for this end point

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

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    End point title
    Number of subjects with any 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, or result in disability/incapacity. Any = occurrence of an SAE regardless of the intensity grade or relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    Throughout the entire study period (from Day 0 to Study End at Month 21)
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    1666
    1667
    Units: Subjects
        Any SAE(s)
    183
    246
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies in Immunogenicity sub-cohort 1

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    End point title
    Number of seroconverted subjects for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies in Immunogenicity sub-cohort 1
    End point description
    A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.
    End point type
    Secondary
    End point timeframe
    At Month 2 and at 12 months of age
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    257
    254
    Units: Subjects
        Anti-RV IgA - Month 2 [N=257;254]
    192
    9
        Anti-RV IgA – 12 months of age [N=246;252]
    176
    118
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies in Immunogenicity sub-cohort 2

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    End point title
    Number of seroconverted subjects for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies in Immunogenicity sub-cohort 2
    End point description
    A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.
    End point type
    Secondary
    End point timeframe
    At Month 2 and at 12 months of age
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    134
    139
    Units: Subjects
        Anti-RV IgA - Month 2 [N=134;139]
    86
    13
        Anti-RV IgA – 12 months of age [N=124;133]
    62
    29
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies

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    End point title
    Number of seroconverted subjects for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies
    End point description
    A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.
    End point type
    Secondary
    End point timeframe
    At Month 2 and at 12 months of age
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    391
    393
    Units: Subjects
        Anti-RV IgA - Month 2 [N=391;393]
    278
    22
        Anti-RV IgA – 12 months of age [N=370;385]
    238
    147
    No statistical analyses for this end point

    Secondary: Number of subjects seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies in Immunogenicity sub-cohort 1

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    End point title
    Number of subjects seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies in Immunogenicity sub-cohort 1
    End point description
    A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0, Month 2 and at 12 months of age
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    257
    254
    Units: Subjects
        Anti-RV IgA – Day 0 [N=257;254]
    0
    0
        Anti-RV IgA - Month 2 [N=257;254]
    192
    9
        Anti-RV IgA – 12 months of age [N=246;252]
    176
    118
    No statistical analyses for this end point

    Secondary: Number of subjects seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies in Immunogenicity sub-cohort 2

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    End point title
    Number of subjects seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies in Immunogenicity sub-cohort 2
    End point description
    A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0, Month 2 and at 12 months of age
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    134
    139
    Units: Subjects
        Anti-RV IgA – Day 0 [N=134;139]
    0
    0
        Anti-RV IgA - Month 2 [N=134;139]
    86
    13
        Anti-RV IgA – 12 months of age [N=124;133]
    62
    29
    No statistical analyses for this end point

    Secondary: Number of subjects seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies

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    End point title
    Number of subjects seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies
    End point description
    A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0, Month 2 and at 12 months of age
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    391
    393
    Units: Subjects
        Anti-RV IgA – Day 0 [N=391;393]
    0
    0
        Anti-RV IgA - Month 2 [N=391;393]
    278
    22
        Anti-RV IgA – 12 months of age [N=370;385]
    238
    147
    No statistical analyses for this end point

    Secondary: Anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibody concentrations in Immunogenicity sub-cohort 1

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    End point title
    Anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibody concentrations in Immunogenicity sub-cohort 1
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL). At Day 0 for Rotarix Group and Placebo Group and Month 2 for the Placebo Group, no subjects had an antibody concentration equal or above to the cut-off (20 U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0, Month 2 and at 12 months of age
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    257
    254
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-RV IgA – Day 0 [N=257;254]
    0 (0 to 0)
    0 (0 to 0)
        Anti-RV IgA - Month 2 [N=257;254]
    90.2 (73.3 to 111.1)
    0 (0 to 0)
        Anti-RV IgA – 12 months of age [N=246;252]
    66.5 (54.6 to 81)
    35.3 (29.3 to 42.5)
    No statistical analyses for this end point

    Secondary: Anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibody concentrations in Immunogenicity sub-cohort 2.

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    End point title
    Anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibody concentrations in Immunogenicity sub-cohort 2.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL). At Day 0 for the Rotarix Group and Placebo Group and Month 2 and 12 months of age for Placebo Group, no subjects had an antibody concentration equal or above to the cut-off (20 U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0, Month 2 and at 12 months of age.
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    134
    139
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-RV IgA – Day 0 [N=134;139]
    0 (0 to 0)
    0 (0 to 0)
        Anti-RV IgA - Month 2 [N=134;139]
    84 (58.9 to 119.8)
    0 (0 to 0)
        Anti-RV IgA – 12 months of age [N=124;133]
    31.3 (24.6 to 39.8)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibody concentrations

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    End point title
    Anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibody concentrations
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL). At Day 0 for Rotarix Group and Placebo Group and at Month 2 for Placebo group, no subjects had an antibody concentration equal or above to the cut-off (20 U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0, Month 2 and at 12 months of age
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    391
    393
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-RV IgA – Day 0 [N=391;393]
    0 (0 to 0)
    0 (0 to 0)
        Anti-RV IgA - Month 2 [N=391;393]
    88 (73.4 to 105.6)
    0 (0 to 0)
        Anti-RV IgA – 12 months of age [N=370;385]
    51.6 (44.1 to 60.5)
    27.4 (23.7 to 31.7)
    No statistical analyses for this end point

    Secondary: Number of subjects seroprotected against diphtheria and tetanus

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    End point title
    Number of subjects seroprotected against diphtheria and tetanus
    End point description
    A subject seroprotected against diphtheria/tetanus was defined as a subject with an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Month 4
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    133
    139
    Units: Subjects
        Anti-D at Day 0 [N=133;138]
    1
    1
        Anti-D at Month 4 [N=133;139]
    133
    139
        Anti-T at Day 0 [N=133;138]
    0
    1
        Anti-T at Month 4 [N=133;139]
    133
    139
    No statistical analyses for this end point

    Secondary: Anti-Diphtheria (Anti-D) and anti-tetanus (anti-T) antibody concentrations

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    End point title
    Anti-Diphtheria (Anti-D) and anti-tetanus (anti-T) antibody concentrations
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off assay (≥ 0.1 IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Month 4
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    133
    139
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D at Day 0 [N=133;138]
    0.051 (0.049 to 0.052)
    0.05 (0.05 to 0.051)
        Anti-D at Month 4 [N=133;139]
    0.375 (0.326 to 0.432)
    0.334 (0.308 to 0.363)
        Anti-T at Day 0 [N=133;138]
    0.05 (0.05 to 0.05)
    0.05 (0.05 to 0.1)
        Anti-T at Month 4 [N=133;139]
    1.281 (1.253 to 1.309)
    1.343 (1.215 to 1.486)
    No statistical analyses for this end point

    Secondary: Number of subjects seroprotected against poliovirus types 1, 2 and 3

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    End point title
    Number of subjects seroprotected against poliovirus types 1, 2 and 3
    End point description
    A subject seroprotected against poliovirus types 1, 2 and 3 was defined as a subject with anti-poliovirus type 1 (anti-polio 1)/anti-polio 2/anti-polio 3 antibody titer greater than or equal to (≥) 8 estimated doses 50% (ED50). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo (cf. population definition below).
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Month 4
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    136
    139
    Units: Subjects
        Anti-polio 1 at Day 0
    63
    62
        Anti-polio 1 at Month 4
    136
    139
        Anti-polio 2 at Day 0
    52
    39
        Anti-polio 2 at Month 4
    136
    139
        Anti-polio 3 at Day 0
    32
    29
        Anti-polio 3 at Month 4
    135
    138
    No statistical analyses for this end point

    Secondary: Titers for anti-poliovirus type 1 (anti-polio 1), anti-polio 2 and anti-polio 3 antibodies

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    End point title
    Titers for anti-poliovirus type 1 (anti-polio 1), anti-polio 2 and anti-polio 3 antibodies
    End point description
    Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seroprotection cut-off (≥ 8 estimated doses 50% [ED50] for anti-poliovirus type 1 [anti-polio 1]/anti-polio 2/anti-polio 3 antibodies. This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Month 4
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    136
    139
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1 at Day 0
    8.9 (7.5 to 10.5)
    9.1 (7.6 to 11)
        Anti-polio 1 at Month 4
    2101.1 (1734.8 to 2544.8)
    2259.4 (1844.4 to 2767.9)
        Anti-polio 2 at Day 0
    7.6 (6.5 to 9)
    6.2 (5.4 to 7.1)
        Anti-polio 2 at Month 4
    402.5 (334.8 to 483.9)
    425.1 (371 to 487.1)
        Anti-polio 3 at Day 0
    5.6 (4.9 to 6.3)
    5.7 (4.9 to 6.6)
        Anti-polio 3 at Month 4
    426.6 (342.7 to 531)
    360.3 (303 to 428.3)
    No statistical analyses for this end point

    Secondary: Number of subjects seropositive for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibodies

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    End point title
    Number of subjects seropositive for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibodies
    End point description
    Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). A subject seropositive for anti-PT/anti-FHA/anti-PRN antibodies was defined as a subject with an anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Month 4
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    133
    139
    Units: Subjects
        Anti-PT at Day 0 [N=131;139]
    43
    34
        Anti-PT at Month 4 [N=133;139]
    133
    139
        Anti-FHA at Day 0 [N=131;139]
    31
    47
        Anti-FHA at Month 4 [N=133;139]
    133
    139
        Anti-PRN at Day 0 [N=131;139]
    3
    5
        Anti-PRN at Month 4 [N=133;139]
    133
    139
    No statistical analyses for this end point

    Secondary: Concentrations for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin

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    End point title
    Concentrations for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin
    End point description
    Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 5 EL.U/mL) for all antibodies assessed (anti-PT, anti-FHA and anti-PRN). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Month 4
    End point values
    Rotarix Group Placebo Group
    Number of subjects analysed
    133
    139
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT at Day 0 [N=131;139]
    3.4 (3.1 to 3.7)
    3.2 (3 to 3.4)
        Anti-PT at Month 4 [N=133;139]
    88.9 (84.9 to 93.2)
    90.5 (86.4 to 94.8)
        Anti-FHA at Day 0 [N=131;139]
    3.1 (2.9 to 3.3)
    3.5 (3.2 to 3.8)
        Anti-FHA at Month 4 [N=133;139]
    59.5 (55.8 to 63.5)
    65.8 (61.3 to 70.5)
        Anti-PRN at Month 0 [N=133;139]
    2.6 (2.5 to 2.6)
    2.6 (2.5 to 2.7)
        Anti-PRN at Month 4 [N=133;139]
    41.9 (37.6 to 46.5)
    50.8 (44.3 to 58.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms were collected during the 8-day (Days 0-7) post vaccination period. Unsolicited AEs were collected during the 31 day (Days 0-30) post vaccination. SAEs were collected throughout the entire study period (Months 0 to 21).
    Adverse event reporting additional description
    1 subject in the Placebo Group experienced an SAE assessed by the investigators as causally related to study vaccination (Diarrhoea). The number of occurrences reported for solicited symptoms, adverse events & SAEs were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    -

    Reporting group title
    Placebo Group
    Reporting group description
    -

    Serious adverse events
    Rotarix Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    183 / 1666 (10.98%)
    246 / 1667 (14.76%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Histiocytosis haematophagic
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Multi-organ failure
         subjects affected / exposed
    1 / 1666 (0.06%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Death
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Drowning
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         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
    Brain contusion
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain herniation
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Skull fracture
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Liver function test abnormal
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocarditis
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Glucose-6-phosphate dehydrogenase deficiency
         subjects affected / exposed
    3 / 1666 (0.18%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart disease congenital
         subjects affected / exposed
    0 / 1666 (0.00%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thalassaemia beta
         subjects affected / exposed
    2 / 1666 (0.12%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    0 / 1666 (0.00%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial septal defect
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cortical dysplasia
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hydrocele
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patent ductus arteriosus
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalassaemia
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Deficiency anaemia
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    2 / 1666 (0.12%)
    3 / 1667 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asphyxia
         subjects affected / exposed
    2 / 1666 (0.12%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    3 / 1666 (0.18%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 1666 (0.06%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 1666 (0.00%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epilepsy
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrapyramidal disorder
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ureteric stenosis
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    44 / 1666 (2.64%)
    73 / 1667 (4.38%)
         occurrences causally related to treatment / all
    0 / 44
    0 / 73
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 1666 (0.24%)
    11 / 1667 (0.66%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 1666 (0.06%)
    3 / 1667 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    1 / 1666 (0.06%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 1666 (0.00%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 1666 (0.06%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (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
    Dermatitis diaper
         subjects affected / exposed
    1 / 1666 (0.06%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (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
    Hypokalaemia
         subjects affected / exposed
    1 / 1666 (0.06%)
    3 / 1667 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acidosis
         subjects affected / exposed
    0 / 1666 (0.00%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 1666 (0.06%)
    3 / 1667 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    74 / 1666 (4.44%)
    98 / 1667 (5.88%)
         occurrences causally related to treatment / all
    0 / 74
    0 / 98
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    58 / 1666 (3.48%)
    61 / 1667 (3.66%)
         occurrences causally related to treatment / all
    0 / 58
    0 / 61
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    14 / 1666 (0.84%)
    14 / 1667 (0.84%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    2 / 1666 (0.12%)
    8 / 1667 (0.48%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    5 / 1666 (0.30%)
    4 / 1667 (0.24%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    4 / 1666 (0.24%)
    4 / 1667 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    5 / 1666 (0.30%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candidiasis
         subjects affected / exposed
    3 / 1666 (0.18%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 1666 (0.12%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    2 / 1666 (0.12%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 1666 (0.06%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 1666 (0.12%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 1666 (0.00%)
    2 / 1667 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    1 / 1666 (0.06%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    2 / 1666 (0.12%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    2 / 1666 (0.12%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial diarrhoea
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system infection
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Otitis media
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shigella infection
         subjects affected / exposed
    0 / 1666 (0.00%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 1666 (0.06%)
    0 / 1667 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 1666 (0.96%)
    26 / 1667 (1.56%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 1666 (0.06%)
    1 / 1667 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Rotarix Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    415 / 1666 (24.91%)
    448 / 1667 (26.87%)
    General disorders and administration site conditions
    Cough/runny nose
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    313 / 1513 (20.69%)
    366 / 1514 (24.17%)
         occurrences all number
    313
    366
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    127 / 1513 (8.39%)
    123 / 1514 (8.12%)
         occurrences all number
    127
    123
    Irritability/Fussiness
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    415 / 1513 (27.43%)
    448 / 1514 (29.59%)
         occurrences all number
    415
    448
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    253 / 1513 (16.72%)
    250 / 1514 (16.51%)
         occurrences all number
    253
    250
    Fever (GSK scale) (Axillary T >= 37.5°C)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    83 / 1513 (5.49%)
    104 / 1514 (6.87%)
         occurrences all number
    83
    104
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    213 / 1513 (14.08%)
    232 / 1514 (15.32%)
         occurrences all number
    213
    232
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    14 / 150 (9.33%)
    9 / 151 (5.96%)
         occurrences all number
    14
    9
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    20 / 150 (13.33%)
    13 / 151 (8.61%)
         occurrences all number
    20
    13
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    13 / 150 (8.67%)
    6 / 151 (3.97%)
         occurrences all number
    13
    6
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    44 / 153 (28.76%)
    38 / 153 (24.84%)
         occurrences all number
    44
    38
    Irritability/Fussiness (OPV and DTPa vaccine)
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    56 / 153 (36.60%)
    52 / 153 (33.99%)
         occurrences all number
    56
    52
    Loss of appetite (OPV and DTPa vaccine)
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    43 / 153 (28.10%)
    32 / 153 (20.92%)
         occurrences all number
    43
    32
    Fever – Chinese scale: Axillary T >= 37.1°C
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    302 / 1513 (19.96%)
    313 / 1514 (20.67%)
         occurrences all number
    302
    313
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    43 / 153 (28.10%)
    38 / 153 (24.84%)
         occurrences all number
    43
    38
    Fever – Chinese scale: Axillary T >= 37.1°C (OPV and DTPa vaccine)
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    18 / 153 (11.76%)
    20 / 153 (13.07%)
         occurrences all number
    18
    20
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    119 / 1666 (7.14%)
    124 / 1667 (7.44%)
         occurrences all number
    119
    124
    Nasopharyngitis
         subjects affected / exposed
    103 / 1666 (6.18%)
    123 / 1667 (7.38%)
         occurrences all number
    103
    123
    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)
    [7] - 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)
    [8] - 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)
    [9] - 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)
    [10] - 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)
    [11] - 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)
    [12] - 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)
    [13] - 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)
    [14] - 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)
    [15] - 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)

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Aug 2011
    Based on the preliminary review of GE episodes reported to date prior to unblinding and complete cleaning of the database, the rotavirus (RV) attack rate seems lower than what was anticipated in the protocol. In order to have the acceptable statistical power for the primary endpoint, the efficacy follow-up was extended till April 2012 (i.e. end of RV season in China).

    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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