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    Clinical Trial Results:
    A phase IIIb open study to assess the long-term efficacy and safety of GlaxoSmithKline (GSK) Biologicals' oral live attenuated human rotavirus (HRV) vaccine approximately three years after vaccination in healthy infants aged 6-12 weeks at the time of first vaccination in the Rota-036 study (102247) in Finland

    Summary
    EudraCT number
    		 2006-006552-36
    Trial protocol
    		 FI  
    Global end of trial date
    08 Aug 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Jun 2023
    First version publication date
    23 Jul 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    109810
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00420316
    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, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Aug 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To assess the efficacy of GSK Biologicals’ HRV vaccine with respect to any rotavirus gastroenteritis (RV GE) episodes caused by the circulating wild-type RV strains during the follow-up period.
    Protection of trial subjects
    All subjects in the primary study (2004-001175-19) were supervised for 30 minutes after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Feb 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 1613
    Worldwide total number of subjects
    1613
    EEA total number of subjects
    1613
    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)
    1613
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rotarix Group
    Arm description
    		 Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Live attenuated human rotavirus (HRV) vaccine
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral administration of 2 doses of Rotarix vaccine in the primary study. No vaccine was administered during this extension study.

    Arm title
    		 Placebo Group
    Arm description
    		 Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Live attenuated human rotavirus (HRV) vaccine
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Oral administration of 2 doses of placebo in the primary study. No vaccine was administered during this extension study.

    Number of subjects in period 1
    		Rotarix Group Placebo Group
    Started
    1082
    531
    Completed
    1070
    522
    Not completed
    12
    9
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    12
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    		 Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

    Reporting group values
    		 Rotarix Group Placebo Group Total
    Number of subjects
    		 1082 531 1613
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 1082 531 1613
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 31.2 ( 1.12 ) 31.3 ( 1.19 ) -
    Gender categorical
    Units: Subjects
        Female
    		 510 266 776
        Male
    		 572 265 837

    End points

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    End points reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    		 Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

    Primary: Number of subjects with any rotavirus gastroenteritis (RVGE)

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    End point title
    		 Number of subjects with any rotavirus gastroenteritis (RVGE)
    End point description
    Occurence of any rotavirus gastroenteritis caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.
    End point type
    Primary
    End point timeframe
    During the study period for the long-term follow-up (i.e. 6 months)
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    1065
    525
    Units: Subjects
    4
    3
    Statistical analysis title
    		 Vaccine efficacy with respect to any RVGE
    Statistical analysis description
    Vaccine efficacy with respect to any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.
    Comparison groups
    Rotarix Group v Placebo Group
    Number of subjects included in analysis
    1590
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.691
    Method
    		 Fisher exact
    Parameter type
    		 Percent reduction
    Point estimate
    34.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -348.7
         upper limit
    		 88.9

    Secondary: Number of subjects with severe rotavirus gastroenteritis (RVGE)

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    End point title
    		 Number of subjects with severe rotavirus gastroenteritis (RVGE)
    End point description
    Number of rotavirus gastroenteritis episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥)11 were labeled as severe.
    End point type
    Secondary
    End point timeframe
    During the study period for the long-term follow-up (i.e. 6 months)
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    1065
    525
    Units: Subjects
    1
    1
    Statistical analysis title
    		 Vaccine efficacy with respect to severe RVGE
    Statistical analysis description
    Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.
    Comparison groups
    Rotarix Group v Placebo Group
    Number of subjects included in analysis
    1590
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.551
    Method
    		 Fisher exact
    Parameter type
    		 Percent reduction
    Point estimate
    50.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3769.6
         upper limit
    		 99.4

    Secondary: Number of subjects with any rotavirus gastroenteritis (RVGE) with G1 serotype

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    End point title
    		 Number of subjects with any rotavirus gastroenteritis (RVGE) with G1 serotype
    End point description
    Occurence of any rotavirus gastroenteritis caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis.
    End point type
    Secondary
    End point timeframe
    During the study period for the long-term follow-up (i.e. 6 months)
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    1065
    525
    Units: Subjects
        Any RVGE
    0
    2
    Statistical analysis title
    		 Vaccine efficacy with respect to any RVGE
    Statistical analysis description
    Vaccine efficacy with respect to any rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of serotype G1. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.
    Comparison groups
    Rotarix Group v Placebo Group
    Number of subjects included in analysis
    1590
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.109
    Method
    		 Fisher exact
    Parameter type
    		 Percent reduction
    Point estimate
    100
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -162.5
         upper limit
    		 100

    Secondary: Number of subjects with severe rotavirus gastroenteritis (RVGE) with G1 serotype

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    End point title
    		 Number of subjects with severe rotavirus gastroenteritis (RVGE) with G1 serotype
    End point description
    Number of rotavirus gastroenteritis episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores ≥11 were labeled as severe.
    End point type
    Secondary
    End point timeframe
    During the study period for the long-term follow-up (i.e. 6 months)
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    1065
    525
    Units: Subjects
        Severe RVGE
    0
    1
    Statistical analysis title
    		 Vaccine efficacy with respect to severe RVGE
    Statistical analysis description
    Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of serotype G1. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.
    Comparison groups
    Rotarix Group v Placebo Group
    Number of subjects included in analysis
    1590
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.33
    Method
    		 Fisher exact
    Parameter type
    		 Percent reduction
    Point estimate
    100
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1822.5
         upper limit
    		 100

    Secondary: Number of subjects with any rotavirus gastroenteritis (RVGE) with non-G1 serotype

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    End point title
    		 Number of subjects with any rotavirus gastroenteritis (RVGE) with non-G1 serotype
    End point description
    Occurence of any rotavirus gastroenteritis caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.
    End point type
    Secondary
    End point timeframe
    During the study period for the long-term follow-up (i.e. 6 months)
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    1065
    525
    Units: Subjects
        Any RVGE
    4
    1
    Statistical analysis title
    		 Vaccine efficacy with respect to any RVGE
    Statistical analysis description
    Vaccine efficacy with respect to any rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.
    Comparison groups
    Rotarix Group v Placebo Group
    Number of subjects included in analysis
    1590
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Parameter type
    		 Percent reduction
    Point estimate
    -97.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9610.8
         upper limit
    		 80.5

    Secondary: Number of subjects with severe rotavirus gastroenteritis (RVGE) with non-G1 serotype

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    End point title
    		 Number of subjects with severe rotavirus gastroenteritis (RVGE) with non-G1 serotype
    End point description
    Number of rotavirus gastroenteritis episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores ≥ 11 were labeled as severe.
    End point type
    Secondary
    End point timeframe
    During the study period for the long-term follow-up (i.e. 6 months)
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    1065
    525
    Units: Subjects
        Severe RVGE
    1
    0
    Statistical analysis title
    		 Vaccine efficacy with respect to severe RVGE
    Statistical analysis description
    Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.
    Comparison groups
    Placebo Group v Rotarix Group
    Number of subjects included in analysis
    1590
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Parameter type
    		 Percent reduction
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 98.7

    Secondary: Number of subjects with severe gastroenteritis (GE)

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    End point title
    		 Number of subjects with severe gastroenteritis (GE)
    End point description
    Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.
    End point type
    Secondary
    End point timeframe
    During the study period for the long-term follow-up (i.e. 6 months)
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    1065
    525
    Units: Subjects
    15
    6
    Statistical analysis title
    		 Vaccine efficacy with respect to severe GE
    Statistical analysis description
    Vaccine efficacy with respect to severe gastroenteritis (GE).Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.
    Comparison groups
    Rotarix Group v Placebo Group
    Number of subjects included in analysis
    1590
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.817
    Method
    		 Fisher exact
    Parameter type
    		 Percent reduction
    Point estimate
    -23.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -287.7
         upper limit
    		 54.8

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

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs)
    End point description
    An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    During the study period for the long-term follow-up (i.e. 6 months)
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    1082
    531
    Units: Subjects
    4
    7
    No statistical analyses for this end point

    Secondary: Number of subjects reporting intussusception (IS)

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    End point title
    		 Number of subjects reporting intussusception (IS)
    End point description
    Intussusception is defined as the telescoping of the intestine.
    End point type
    Secondary
    End point timeframe
    During the period starting from the end of the second follow-up period up to the start of the study (up to 6 months)
    End point values
    		 Rotarix Group Placebo Group
    Number of subjects analysed
    1082
    531
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)
    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
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Rotarix Group
    Reporting group description
    		 Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The were no non-serious adverse events recorded for this study.
    Serious adverse events
    		 Rotarix Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 1082 (0.37%)
    7 / 531 (1.32%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Febrile convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 1082 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 1082 (0.09%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 1082 (0.09%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 1082 (0.00%)
    2 / 531 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 1082 (0.09%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 1082 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 1082 (0.09%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 1082 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 1082 (0.00%)
    0 / 531 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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.

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