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    Clinical Trial Results:
    A phase III, randomized, open study to assess the immunogenicity, reactogenicity and safety of two different formulations of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, Rotarix, when given as a two-dose primary vaccination, in healthy infants with no previous history of rotavirus illness or vaccination

    Summary
    EudraCT number
    		 2012-001875-35
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Nov 2020
    First version publication date
    30 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    116566
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02141204
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 044 208-990-4466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 208-990-4466, 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
    14 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate non-inferiority of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine in terms of geometric mean concentrations (GMCs) for anti-RV antibodies, one month post dose 2 of HRV liquid vaccine and HRV lyophilized vaccine. Criterion: Non-inferiority will be stated if the lower limit of the two-sided 95% confidence interval (CI) for the ratio of anti RV IgA antibody GMCs between HRV liquid vaccine over the HRV lyophilized vaccine, one month after dose 2 is greater than or equal to 0.5.
    Protection of trial subjects
    All subjects were observed closely for 30 min following the administration of the vaccine, with appropriate medical treatment readily available in case of anaphylaxis. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up for 30 days after the last vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Feb 2019
    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
    India: 451
    Worldwide total number of subjects
    451
    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)
    451
    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
    		 The study was conducted at 8 centers in India.

    Pre-assignment
    Screening details
    		 Out of 451 subjects enrolled in the study, 1 subject did not receive any study treatment and 1 vaccinated subject was eliminated from all analysis due to incorrect impartial witness. 449 subjects were vaccinated and included in the Exposed Set, 419 subjects completed the study.

    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
    		 HRV Liq Group
    Arm description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liquid Human Rotavirus Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two doses administered orally according to a 0, 1-month schedule.

    Arm title
    		 HRV Lyo Group
    Arm description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lyophilized Human Rotavirus Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two doses administered orally according to a 0, 1-month schedule.

    Number of subjects in period 1 [1]
    		HRV Liq Group HRV Lyo Group
    Started
    224
    225
    Completed
    209
    210
    Not completed
    15
    15
         CONSENT WITHDRAWAL NOT DUE TO AE
    1
    2
         NOT WILLING TO PARTICIPATE THIS VISIT
    9
    7
         MIGRATED / MOVED FROM THE STUDY AREA
    3
    5
         Lost to follow-up
    2
    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: Out of 451 subjects enrolled in the study, 1 subject did not receive any study treatment and 1 vaccinated subject was eliminated from all analysis due to incorrect impartial witness. 449 subjects were vaccinated and included in the Exposed Set, 419 subjects completed the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HRV Liq Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.

    Reporting group title
    HRV Lyo Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.

    Reporting group values
    		 HRV Liq Group HRV Lyo Group Total
    Number of subjects
    		 224 225 449
    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)
    		 224 225 449
        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: weeks
        arithmetic mean (standard deviation)
    		 6.8 ± 1.0 6.8 ± 1.1 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 100 120 220
        Male
    		 124 105 229
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 224 225 449

    End points

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    End points reporting groups
    Reporting group title
    HRV Liq Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.

    Reporting group title
    HRV Lyo Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.

    Primary: 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
    Serum anti-RV IgA antibody concentrations were expressed as geometric mean concentrations (GMCs). Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all eligible subjects who received both doses of HRV vaccine, complied with vaccination schedule and for whom immunogenicity data were available at the specified time point.
    End point type
    Primary
    End point timeframe
    At Month 2
    End point values
    		 HRV Liq Group HRV Lyo Group
    Number of subjects analysed
    189
    192
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-RV IgA
    90.25 (67.28 to 121.06)
    94.16 (70.29 to 126.13)
    Statistical analysis title
    		 Anti-RV IgA GMCs (non-inferiority)
    Statistical analysis description
    Non-inferiority comparison between GSK Biologicals' HRV liquid vaccine (HRV Liq Group) and GSK Biologicals' HRV lyophilized vaccine (HRV Lyo Group) in terms of geometric mean concentrations (GMCs) for anti-RV antibodies, one month after the administration of the second dose of study vaccine.
    Comparison groups
    HRV Liq Group v HRV Lyo Group
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 ANCOVA
    Parameter type
    		 GMC ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.34
    Notes
    [1] - Lower limit (LL) of the two-sided 95% confidence interval (CI) for the ratio of anti-RV IgA antibody GMCs between HRV Liq Group over the HRV Lyo Group should be greater than or equal to (≥) 0.5.

    Secondary: Percentage of seroconverted subjects for anti-RV IgA antibodies

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    End point title
    		 Percentage of seroconverted subjects for anti-RV IgA antibodies
    End point description
    Seroconversion is defined as: - for subjects with a pre-vaccination anti-RV IgA antibody concentration lower than (<) 20 U/mL, seroconversion is achieved when the post-vaccination concentration is greater than or equal to (≥) 20 U/mL and - for subjects with a pre-vaccination anti-RV IgA antibody concentration ≥ 20 U/mL, seroconversion is achieved when the post-vaccination concentration is ≥ 2 times the pre-vaccination concentration. Analysis was performed on PPS for immunogenicity, which included all eligible subjects who received both doses of HRV vaccine, complied with vaccination schedule and for whom immunogenicity data were available at the specified time point.
    End point type
    Secondary
    End point timeframe
    At Month 2
    End point values
    		 HRV Liq Group HRV Lyo Group
    Number of subjects analysed
    189
    192
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-RV IgA
    54.5 (47.1 to 61.7)
    50.0 (42.7 to 57.3)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any solicited general adverse events (AEs)
    End point description
    Solicited general AEs assessed were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination. Analysis was performed on the Exposed Set (ES), which included all subjects with at least one study vaccine administration documented and with the diary card completed.
    End point type
    Secondary
    End point timeframe
    During the 8-day follow-up period after each vaccination (vaccines administered at Day 1 and Month 1)
    End point values
    		 HRV Liq Group HRV Lyo Group
    Number of subjects analysed
    224
    225
    Units: Subjects
        Cough/Runny Nose (Dose 1), Any (N=224;225)
    22
    24
        Cough/Runny Nose (Dose 2), Any (N=214;213)
    17
    23
        Diarrhea (Dose 1), Any (N=224;225)
    4
    2
        Diarrhea (Dose 2), Any (N=214;213)
    3
    3
        Fever (Dose 1), ≥ 38.0°C (N=224;225)
    57
    48
        Fever (Dose 2), ≥ 38.0°C (N=214;213)
    50
    53
        Irritability/Fussiness (Dose 1), Any (N=224;225)
    71
    83
        Irritability/Fussiness (Dose 2), Any (N=214;213)
    56
    61
        Loss of appetite (Dose 1), Any (N=224;225)
    33
    42
        Loss of appetite (Dose 2), Any (N=214;213)
    28
    25
        Vomiting (Dose 1), Any (N=224;225)
    22
    22
        Vomiting (Dose 2), Any (N=214;213)
    15
    13
    No statistical analyses for this end point

    Secondary: Number of subjects with any unsolicited AEs

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    End point title
    		 Number of subjects with any unsolicited AEs
    End point description
    An unsolicited AE is defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, and reported in addition to those solicited during the clinical study and any ‘solicited’ AE with onset outside the specified period of follow-up for solicited AE. Any = occurrence of AE regardless of intensity grade or relation to study vaccination. Analysis was performed on the ES, which included all subjects with at least one study vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    During the 31-day follow-up period across doses (vaccines administered at Day 1 and Month 1)
    End point values
    		 HRV Liq Group HRV Lyo Group
    Number of subjects analysed
    224
    225
    Units: Subjects
        Any AE(s)
    54
    58
    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 included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization and/or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination. Analysis was performed on the ES, which included all subjects with at least one study vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    Throughout the study period (from Day 1 up to Month 2)
    End point values
    		 HRV Liq Group HRV Lyo Group
    Number of subjects analysed
    224
    225
    Units: Subjects
        Any SAE(s)
    7
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    HRV Liq Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.

    Reporting group title
    HRV Lyo Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.

    Serious adverse events
    		 HRV Liq Group HRV Lyo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 224 (3.13%)
    2 / 225 (0.89%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    3 / 224 (1.34%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 224 (0.89%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (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
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (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: 0%
    Non-serious adverse events
    		 HRV Liq Group HRV Lyo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    146 / 224 (65.18%)
    162 / 225 (72.00%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    1 / 224 (0.45%)
    2 / 225 (0.89%)
         occurrences all number
    1
    2
    Injection site pain
         subjects affected / exposed
    10 / 224 (4.46%)
    7 / 225 (3.11%)
         occurrences all number
    12
    9
    Injection site swelling
         subjects affected / exposed
    13 / 224 (5.80%)
    12 / 225 (5.33%)
         occurrences all number
    17
    17
    Pain
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    87 / 224 (38.84%)
    91 / 225 (40.44%)
         occurrences all number
    119
    116
    Ear and labyrinth disorders
    Otorrhoea
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Abnormal faeces
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    6 / 224 (2.68%)
    6 / 225 (2.67%)
         occurrences all number
    8
    8
    Faeces discoloured
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    2 / 224 (0.89%)
    0 / 225 (0.00%)
         occurrences all number
    2
    0
    Oral disorder
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Regurgitation
         subjects affected / exposed
    1 / 224 (0.45%)
    1 / 225 (0.44%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    33 / 224 (14.73%)
    31 / 225 (13.78%)
         occurrences all number
    38
    38
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    37 / 224 (16.52%)
    47 / 225 (20.89%)
         occurrences all number
    44
    58
    Nasal congestion
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 224 (0.45%)
    4 / 225 (1.78%)
         occurrences all number
    1
    4
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    2 / 224 (0.89%)
    0 / 225 (0.00%)
         occurrences all number
    2
    0
    Intertrigo
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Rash papular
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    87 / 224 (38.84%)
    102 / 225 (45.33%)
         occurrences all number
    128
    144
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 224 (0.89%)
    5 / 225 (2.22%)
         occurrences all number
    2
    6
    Respiratory tract infection
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 224 (0.45%)
    1 / 225 (0.44%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 224 (3.13%)
    5 / 225 (2.22%)
         occurrences all number
    8
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    44 / 224 (19.64%)
    53 / 225 (23.56%)
         occurrences all number
    61
    68
    Dehydration
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jul 2013
    NDAC- Vaccines (New Drug Advisory Committee on Vaccines) of Drugs Controller General of India (DCGI) recommended to conduct this study as a Phase IV study instead of phase III as initially planned because Rotarix liquid file application is considered as a line extension of Rotarix Lyophilized formulation. The protocol was amended to adapt the change recommended by NDAC-Vaccines of DCGI.
    31 Oct 2017
    - The phase of this clinical trial is revised from Phase IV to Phase III. - The study objectives have been updated to include a confirmatory primary objective and the study has been powered accordingly. - The statistical considerations have been revised to define the success criteria for the primary objective. - Collection and testing of stool samples from subjects who develop gastroenteritis (GE) during the study period is removed. - The study procedures, list of assays and section on biological samples evaluation have been updated accordingly.
    30 Oct 2019
    - The PPS was modified to include subjects seroposi-tive at baseline. - The statistical method to derive the 95% CI for the GMC group ratio was revised to be an ANCOVA. - The seroconversion threshold was redefined to account for seropositive subjects at pre-vaccination.

    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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