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    Clinical Trial Results:
    A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™

    Summary
    EudraCT number
    		 2012-001611-23
    Trial protocol
    		 ES   SE   FI   CZ   PL   DK  
    Global end of trial date
    25 Mar 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Jul 2020
    First version publication date
    13 Jun 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    updating/correcting to indicate Art 46 applicable study

    Trial information

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    Trial identification
    Sponsor protocol code
    V260-035
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01600092
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    25 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Apr 2013
    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
    Spain: 118
    Country: Number of subjects enrolled
    Sweden: 57
    Country: Number of subjects enrolled
    United States: 237
    Country: Number of subjects enrolled
    Canada: 103
    Country: Number of subjects enrolled
    Czech Republic: 78
    Country: Number of subjects enrolled
    Denmark: 49
    Country: Number of subjects enrolled
    Finland: 138
    Country: Number of subjects enrolled
    Israel: 80
    Country: Number of subjects enrolled
    Mexico: 73
    Country: Number of subjects enrolled
    Poland: 87
    Worldwide total number of subjects
    1020
    EEA total number of subjects
    527
    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)
    1020
    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
    		 A total of 1039 participants were screened

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RotaTeq™ Experimental Formulation
    Arm description
    		 Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 was administered between 6 and 12 weeks of age and the third vaccination was administered before 32 weeks of age. Each vaccination was separated from the next by ≥ 4 weeks (28 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    RotaTeq™ Experimental Formulation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 was administered between 6 and 12 weeks of age and the third vaccination was administered before 32 weeks of age. Each vaccination was separated from the next by ≥ 4 weeks (28 days).

    Arm title
    		 RotaTeq™ Existing Formulation
    Arm description
    		 Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 was administered between 6 and 12 weeks of age and the third vaccination was administered before 32 weeks of age. Each vaccination was separated from the next by ≥ 4 weeks (28 days).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    RotaTeq™ Existing Formulation
    Investigational medicinal product code
    Other name
    V260
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 was administered between 6 and 12 weeks of age and the third vaccination was administered before 32 weeks of age. Each vaccination was separated from the next by ≥ 4 weeks (28 days).

    Number of subjects in period 1
    		RotaTeq™ Experimental Formulation RotaTeq™ Existing Formulation
    Started
    513
    507
    Received at least 1 vaccination
    510
    504
    Received all 3 vaccinations
    500
    494
    Completed
    495
    491
    Not completed
    18
    16
         Physician decision
    1
    1
         Adverse event, non-fatal
    2
    -
         Randomized but not vaccinated
    3
    3
         Lost to follow-up
    4
    6
         Withdrawal by parent/guardian
    8
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RotaTeq™ Experimental Formulation
    Reporting group description
    		 Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 was administered between 6 and 12 weeks of age and the third vaccination was administered before 32 weeks of age. Each vaccination was separated from the next by ≥ 4 weeks (28 days).

    Reporting group title
    RotaTeq™ Existing Formulation
    Reporting group description
    		 Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 was administered between 6 and 12 weeks of age and the third vaccination was administered before 32 weeks of age. Each vaccination was separated from the next by ≥ 4 weeks (28 days).

    Reporting group values
    		 RotaTeq™ Experimental Formulation RotaTeq™ Existing Formulation Total
    Number of subjects
    		 513 507 1020
    Age categorical
    Units: Subjects
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 8.4 ( 1.4 ) 8.3 ( 1.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 232 240 472
        Male
    		 281 267 548

    End points

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    End points reporting groups
    Reporting group title
    RotaTeq™ Experimental Formulation
    Reporting group description
    		 Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 was administered between 6 and 12 weeks of age and the third vaccination was administered before 32 weeks of age. Each vaccination was separated from the next by ≥ 4 weeks (28 days).

    Reporting group title
    RotaTeq™ Existing Formulation
    Reporting group description
    		 Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 was administered between 6 and 12 weeks of age and the third vaccination was administered before 32 weeks of age. Each vaccination was separated from the next by ≥ 4 weeks (28 days).

    Primary: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

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    End point title
    		 Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
    End point description
    The population included participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint
    End point type
    Primary
    End point timeframe
    42 days after vaccination 3 (up to 185 days)
    End point values
    		 RotaTeq™ Experimental Formulation RotaTeq™ Existing Formulation
    Number of subjects analysed
    480
    482
    Units: Titer
    geometric mean (confidence interval 95%)
        Serotype G1
    99.8 (89.7 to 111.1)
    106.1 (94.6 to 119)
        Serotype G2
    30 (27 to 33.3)
    26.3 (23.7 to 29.1)
        Serotype G3
    82.8 (74.2 to 92.5)
    25.2 (22.6 to 28.1)
        Serotype G4
    78.9 (72.3 to 86.1)
    71.5 (65.4 to 78.1)
        Serotype P1A[8]
    106.9 (96.5 to 118.4)
    90.1 (80.2 to 101.2)
    Statistical analysis title
    		 Non-inferiority Serotype G1
    Statistical analysis description
    GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups. Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is >0.67. Since the model used all available data at both baseline and postvaccination, the number of participants included in the analysis was 983 (962 participants had postvaccination data).
    Comparison groups
    RotaTeq™ Experimental Formulation v RotaTeq™ Existing Formulation
    Number of subjects included in analysis
    962
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio (Experimental/Existing)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.07
    Statistical analysis title
    		 Non-inferiority Serotype G2
    Statistical analysis description
    GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups. Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is >0.67. Since the model used all available data at both baseline and postvaccination, the number of participants included in the analysis was 983 (962 participants had postvaccination data).
    Comparison groups
    RotaTeq™ Experimental Formulation v RotaTeq™ Existing Formulation
    Number of subjects included in analysis
    962
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio (Experimental/Existing)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.33
    Statistical analysis title
    		 Non-inferiority Serotype G3
    Statistical analysis description
    GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups. Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is >0.67. Since the model used all available data at both baseline and postvaccination, the number of participants included in the analysis was 983 (962 participants had postvaccination data).
    Comparison groups
    RotaTeq™ Experimental Formulation v RotaTeq™ Existing Formulation
    Number of subjects included in analysis
    962
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio (Experimental/Existing)
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.75
         upper limit
    		 3.74
    Statistical analysis title
    		 Non-inferiority Serotype G4
    Statistical analysis description
    GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups. Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is >0.67. Since the model used all available data at both baseline and postvaccination, the number of participants included in the analysis was 983 (962 participants had postvaccination data).
    Comparison groups
    RotaTeq™ Experimental Formulation v RotaTeq™ Existing Formulation
    Number of subjects included in analysis
    962
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio (Experimental/Existing)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.2
    Statistical analysis title
    		 Non-inferiority Serotype P1A[8]
    Statistical analysis description
    GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups. Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is >0.67. Since the model used all available data at both baseline and postvaccination, the number of participants included in the analysis was 983 (962 participants had postvaccination data).
    Comparison groups
    RotaTeq™ Experimental Formulation v RotaTeq™ Existing Formulation
    Number of subjects included in analysis
    962
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio (Experimental/Existing)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.35

    Secondary: Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability

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    End point title
    		 Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability
    End point description
    The population included participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability.
    End point type
    Secondary
    End point timeframe
    Up to 7 days after any vaccination (up to 147 days)
    End point values
    		 RotaTeq™ Experimental Formulation RotaTeq™ Existing Formulation
    Number of subjects analysed
    509
    505
    Units: Participants
        Diarrhea
    144
    128
        Vomiting
    84
    92
        Elevated temperature
    217
    223
        Irritability
    58
    64
    No statistical analyses for this end point

    Secondary: Number of Participants With Tier-1 Adverse Events: Intussusception

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    End point title
    		 Number of Participants With Tier-1 Adverse Events: Intussusception
    End point description
    The population included participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.
    End point type
    Secondary
    End point timeframe
    Up to Day 185
    End point values
    		 RotaTeq™ Experimental Formulation RotaTeq™ Existing Formulation
    Number of subjects analysed
    509
    505
    Units: Participants
    2
    0
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A

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    End point title
    		 Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A
    End point description
    The population included participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint
    End point type
    Secondary
    End point timeframe
    42 days after vaccination 3 (up to 185 days)
    End point values
    		 RotaTeq™ Experimental Formulation RotaTeq™ Existing Formulation
    Number of subjects analysed
    474
    474
    Units: Titer
        geometric mean (confidence interval 95%)
    240.5 (210.4 to 274.8)
    235.5 (204.1 to 271.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

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    End point title
    		 Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
    End point description
    The population included participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had baseline and follow-up results for the endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and 42 days after vaccination 3 (up to 185 days)
    End point values
    		 RotaTeq™ Experimental Formulation RotaTeq™ Existing Formulation
    Number of subjects analysed
    480
    481
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype G1
    56 (51.5 to 60.5)
    53.8 (49.3 to 58.4)
        Serotype G2
    30.4 (26.3 to 34.7)
    26.8 (22.9 to 31)
        Serotype G3
    65.8 (61.4 to 70.1)
    33.3 (29.1 to 37.7)
        Serotype G4
    58.3 (53.8 to 62.8)
    49.7 (45.1 to 54.3)
        Serotype P1A[8]
    49.6 (45 to 54.2)
    42.6 (38.2 to 47.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185
    Adverse event reporting additional description
    The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    RotaTeq™ Existing Formulation
    Reporting group description
    		 Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 was administered between 6 and 12 weeks of age and the third vaccination was administered before 32 weeks of age. Each vaccination was separated from the next by ≥ 4 weeks (28 days).

    Reporting group title
    RotaTeq™ Experimental Formulation
    Reporting group description
    		 Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 was administered between 6 and 12 weeks of age and the third vaccination was administered before 32 weeks of age. Each vaccination was separated from the next by ≥ 4 weeks (28 days).

    Serious adverse events
    		 RotaTeq™ Existing Formulation RotaTeq™ Experimental Formulation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 499 (2.40%)
    20 / 508 (3.94%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 499 (0.20%)
    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 haematoma
         subjects affected / exposed
    1 / 499 (0.20%)
    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
    Hypersomnia
         subjects affected / exposed
    0 / 499 (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
    Loss of consciousness
         subjects affected / exposed
    0 / 499 (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
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 499 (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
    Intussusception
         subjects affected / exposed
    0 / 499 (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
    Umbilical hernia
         subjects affected / exposed
    1 / 499 (0.20%)
    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
    Restlessness
         subjects affected / exposed
    1 / 499 (0.20%)
    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
    Anal abscess
         subjects affected / exposed
    1 / 499 (0.20%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 499 (0.20%)
    3 / 508 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 499 (0.20%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 499 (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
    Gastroenteritis viral
         subjects affected / exposed
    1 / 499 (0.20%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 499 (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
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 499 (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
    Pneumonia
         subjects affected / exposed
    0 / 499 (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
    Pyelonephritis
         subjects affected / exposed
    1 / 499 (0.20%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 499 (0.20%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 499 (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
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 499 (0.20%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 499 (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 infection
         subjects affected / exposed
    0 / 499 (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
    Urinary tract infection
         subjects affected / exposed
    1 / 499 (0.20%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 499 (0.20%)
    1 / 508 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 RotaTeq™ Existing Formulation RotaTeq™ Experimental Formulation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    385 / 499 (77.15%)
    398 / 508 (78.35%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    152 / 499 (30.46%)
    151 / 508 (29.72%)
         occurrences all number
    231
    211
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    22 / 499 (4.41%)
    30 / 508 (5.91%)
         occurrences all number
    29
    33
    Diarrhoea
         subjects affected / exposed
    156 / 499 (31.26%)
    173 / 508 (34.06%)
         occurrences all number
    276
    307
    Vomiting
         subjects affected / exposed
    107 / 499 (21.44%)
    102 / 508 (20.08%)
         occurrences all number
    180
    175
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    44 / 499 (8.82%)
    36 / 508 (7.09%)
         occurrences all number
    50
    39
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    77 / 499 (15.43%)
    65 / 508 (12.80%)
         occurrences all number
    113
    98
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    25 / 499 (5.01%)
    27 / 508 (5.31%)
         occurrences all number
    25
    35
    Nasopharyngitis
         subjects affected / exposed
    83 / 499 (16.63%)
    79 / 508 (15.55%)
         occurrences all number
    113
    106
    Otitis media
         subjects affected / exposed
    29 / 499 (5.81%)
    20 / 508 (3.94%)
         occurrences all number
    33
    26
    Rhinitis
         subjects affected / exposed
    40 / 499 (8.02%)
    42 / 508 (8.27%)
         occurrences all number
    56
    53
    Upper respiratory tract infection
         subjects affected / exposed
    67 / 499 (13.43%)
    78 / 508 (15.35%)
         occurrences all number
    87
    97

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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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