Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase III, double-blind, randomised, placebo-controlled, multi-centre study in Japan to assess the efficacy, safety, reactogenicity and immunogenicity of the lyophilised formulation of GlaxoSmithKline (GSK) Biologicals’ live attenuated human rotavirus (HRV) vaccine, given as a two-dose primary vaccination course, in healthy infants previously uninfected with HRV.

    Summary
    EudraCT number
    		 2015-001543-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Nov 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 Apr 2021
    First version publication date
    18 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections in safety section.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    107625
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00480324
    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
    23 Mar 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if two doses of the lyophilised formulation of GSK Biologicals’ HRV vaccine can prevent any RV GE leading to a medical intervention and caused by the circulating wild-type RV strains during the efficacy follow-up period.
    Protection of trial subjects
    The 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 the HRV vaccine/placebo.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jun 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason
    Long term follow-up duration
    		 17 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 765
    Worldwide total number of subjects
    765
    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)
    765
    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

    		 Close Top of page
    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 Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    The parents/guardians of the subjects, the study personnel and the investigator were unaware of the study vaccine administered (HRV vaccine or placebo). Blinding was maintained for the whole study period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rotarix Group
    Arm description
    		 Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
    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-dose oral vaccination.

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

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two-dose oral administration.

    Number of subjects in period 1
    		Rotarix Group Placebo Group
    Started
    508
    257
    Completed
    476
    241
    Not completed
    32
    16
         Consent withdrawn by subject
    14
    5
         Adverse event, non-fatal
    1
    1
         Protocol Violation
    -
    1
         Lost to follow-up
    17
    8
         Subject’s mother pregnant
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    		 Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.

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

    Reporting group values
    		 Rotarix Group Placebo Group Total
    Number of subjects
    		 508 257 765
    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)
    		 7.7 ± 1.99 7.7 ± 2.05 -
    Gender categorical
    Units: Subjects
        Female
    		 229 134 363
        Male
    		 279 123 402

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    		 Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.

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

    Primary: Number of subjects reporting any rotavirus (RV) gastroenteritis (GE) leading to medical intervention and caused by the circulating wild-type RV strains

    		 Close Top of page
    End point title
    		 Number of subjects reporting any rotavirus (RV) gastroenteritis (GE) leading to medical intervention and caused by the circulating wild-type RV strains [1]
    End point description
    Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
    End point type
    Primary
    End point timeframe
    From 2 weeks after Dose 2 up to 2 years of age
    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
    498
    250
    Units: Subjects
    14
    34
    No statistical analyses for this end point

    Secondary: Number of subjects reporting severe rotavirus (RV) gastroenteritis (GE) leading to medical intervention and caused by the circulating wild-type RV strains

    		 Close Top of page
    End point title
    		 Number of subjects reporting severe rotavirus (RV) gastroenteritis (GE) leading to medical intervention and caused by the circulating wild-type RV strains
    End point description
    A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).
    End point type
    Secondary
    End point timeframe
    From 2 weeks after Dose 2 up to 2 years of age
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    498
    250
    Units: Subjects
    2
    12
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any rotavirus (RV) gastroenteritis (GE) and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains of G1 type

    		 Close Top of page
    End point title
    		 Number of subjects reporting any rotavirus (RV) gastroenteritis (GE) and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains of G1 type
    End point description
    Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
    End point type
    Secondary
    End point timeframe
    From 2 weeks after Dose 2 up to 2 years of age
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    498
    250
    Units: Subjects
        Any RV GE
    4
    13
        Severe RV GE
    1
    6
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any rotavirus (RV) gastroenteritis (GE) and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains of non-G1 types

    		 Close Top of page
    End point title
    		 Number of subjects reporting any rotavirus (RV) gastroenteritis (GE) and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains of non-G1 types
    End point description
    Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
    End point type
    Secondary
    End point timeframe
    From 2 weeks after Dose 2 up to 2 years of age
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    498
    250
    Units: Subjects
        Any RV GE
    10
    21
        Severe RV GE
    1
    6
    No statistical analyses for this end point

    Secondary: Number of subjects hospitalized due to rotavirus (RV) gastroenteritis (GE) caused by the circulating wild-type RV strains

    		 Close Top of page
    End point title
    		 Number of subjects hospitalized due to rotavirus (RV) gastroenteritis (GE) caused by the circulating wild-type RV strains
    End point description
    Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
    End point type
    Secondary
    End point timeframe
    From 2 weeks after Dose 2 up to 2 years of age
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    498
    250
    Units: Subjects
    1
    2
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any rotavirus (RV) gatroenteritis (GE) and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains

    		 Close Top of page
    End point title
    		 Number of subjects reporting any rotavirus (RV) gatroenteritis (GE) and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains
    End point description
    Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
    End point type
    Secondary
    End point timeframe
    From Dose 1 up to 2 years of age
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    508
    257
    Units: Subjects
        Any RV GE
    14
    36
        Severe RV GE
    2
    13
    No statistical analyses for this end point

    Secondary: Serum anti-rotavirus immunoglobulin A (IgA) antibody concentration

    		 Close Top of page
    End point title
    		 Serum anti-rotavirus immunoglobulin A (IgA) antibody concentration
    End point description
    Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).
    End point type
    Secondary
    End point timeframe
    2 months after Dose 2
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    34
    20
    Units: U/mL
        geometric mean (confidence interval 95%)
    217 (109.9 to 428.6)
    0 (0 to 0)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects seroconverted for anti-rotavirus immunoglobulin A (IgA) antibodies
    End point description
    Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative.
    End point type
    Secondary
    End point timeframe
    2 months after Dose 2
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    34
    20
    Units: Subjects
    29
    1
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms
    End point description
    Solicited general symptoms assessed were cough, diarrhoea, fever, irritability, loss of appetite and vomiting. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 Cough/runny nose = cough/runny nose which prevented daily activity, Grade 3 Diarrhoea = ≥ 6 looser than normal stools/day, Grade 3 Irritability = crying that could not be comforted/prevented normal activity, Grade 3 Loss of appetite = did not eat at all, Grade 3 Vomiting = ≥ 3 episodes of vomiting/day and Grade 3 fever = Temperature axillary > 39.0°C. Related = general symptom assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 8-day follow-up period after each dose and overall.
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    508
    257
    Units: Subjects
        Cough
    184
    92
        Diarrhoea
    43
    14
        Fever
    62
    22
        Irritability
    261
    125
        Loss of appetite
    81
    33
        Vomiting
    74
    36
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects reporting any unsolicited adverse events (AEs)
    End point description
    Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    End point type
    Secondary
    End point timeframe
    During the 31-day follow-up period after each dose
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    508
    257
    Units: Subjects
        any AE (s)
    279
    144
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects reporting serious adverse events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    Up to 2 years of age
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    508
    257
    Units: Subjects
    72
    44
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms during the 8-day (Day 0-7) solicited follow-up period after each dose of HRV vaccine/Placebo, Unsolicited AEs during the 31 days (Day 0-30) after any dose of HRV vaccine/Placebo and SAEs during the entire period (Dose1 up to Visit 5).
    Adverse event reporting additional description
    The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.

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

    Serious adverse events
    		 Placebo Group Rotarix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    44 / 257 (17.12%)
    72 / 508 (14.17%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroma
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Teratoma
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    1 / 257 (0.39%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 257 (0.39%)
    3 / 508 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 257 (1.17%)
    5 / 508 (0.98%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinorrhoea
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         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
    Cryptorchism
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (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
    Febrile convulsion
         subjects affected / exposed
    1 / 257 (0.39%)
    4 / 508 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    2 / 257 (0.78%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (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
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 257 (0.78%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplasia pure red cell
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterocolitis
         subjects affected / exposed
    1 / 257 (0.39%)
    2 / 508 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    2 / 257 (0.78%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 257 (0.00%)
    2 / 508 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         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 / 257 (0.00%)
    1 / 508 (0.20%)
         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
    2 / 257 (0.78%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         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 / 257 (0.39%)
    0 / 508 (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
    Pneumonia
         subjects affected / exposed
    4 / 257 (1.56%)
    12 / 508 (2.36%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 257 (0.00%)
    14 / 508 (2.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 257 (0.78%)
    11 / 508 (2.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    3 / 257 (1.17%)
    5 / 508 (0.98%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    2 / 257 (0.78%)
    6 / 508 (1.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    3 / 257 (1.17%)
    5 / 508 (0.98%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    2 / 257 (0.78%)
    3 / 508 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 257 (0.39%)
    4 / 508 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    2 / 257 (0.78%)
    2 / 508 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    3 / 257 (1.17%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 257 (0.78%)
    2 / 508 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 257 (0.78%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 257 (0.78%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute tonsilitis
         subjects affected / exposed
    1 / 257 (0.39%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    2 / 257 (0.78%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 257 (0.78%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis viral
         subjects affected / exposed
    0 / 257 (0.00%)
    2 / 508 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 257 (0.39%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 257 (0.00%)
    2 / 508 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (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
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema infectiosum
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 257 (0.00%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (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
    1 / 257 (0.39%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (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
    1 / 257 (0.39%)
    3 / 508 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight gain poor
         subjects affected / exposed
    1 / 257 (0.39%)
    0 / 508 (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
    		 Placebo Group Rotarix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    204 / 257 (79.38%)
    411 / 508 (80.91%)
    General disorders and administration site conditions
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    92 / 257 (35.80%)
    184 / 508 (36.22%)
         occurrences all number
    92
    184
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 257 (5.45%)
    43 / 508 (8.46%)
         occurrences all number
    14
    43
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 257 (8.56%)
    62 / 508 (12.20%)
         occurrences all number
    22
    62
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    125 / 257 (48.64%)
    261 / 508 (51.38%)
         occurrences all number
    125
    261
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    33 / 257 (12.84%)
    81 / 508 (15.94%)
         occurrences all number
    33
    81
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    36 / 257 (14.01%)
    74 / 508 (14.57%)
         occurrences all number
    36
    74
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation
         subjects affected / exposed
    16 / 257 (6.23%)
    33 / 508 (6.50%)
         occurrences all number
    16
    33
    Rhinorrhoea
         subjects affected / exposed
    21 / 257 (8.17%)
    19 / 508 (3.74%)
         occurrences all number
    21
    19
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    29 / 257 (11.28%)
    72 / 508 (14.17%)
         occurrences all number
    29
    72
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    25 / 257 (9.73%)
    50 / 508 (9.84%)
         occurrences all number
    25
    50
    Nasopharyngitis
         subjects affected / exposed
    13 / 257 (5.06%)
    31 / 508 (6.10%)
         occurrences all number
    13
    31

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2007
    The protocol has been amended as per the request from Pharmaceutical and Medical Devices Agency (PMDA), Japan.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 06:37:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA