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    Clinical Trial Results:
    A phase III randomized, placebo-controlled clinical trial to study the efficacy and safety of V260 in healthy infants in Japan

    Summary
    EudraCT number
    2017-000264-15
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    26 Aug 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    06 May 2017
    First version publication date
    06 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V260-029
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00718237
    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
    26 Aug 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to evaluate whether V260 is effective and well tolerated in healthy Japanese infants.
    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
    20 Aug 2008
    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
    Japan: 762
    Worldwide total number of subjects
    762
    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)
    762
    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
    Healthy Japanese infants with no known history of rotavirus gastroenteritis were enrolled in the study.

    Pre-assignment
    Screening details
    A total of 768 participants were screened and 762 were enrolled in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    RotaTeq™
    Arm description
    Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart beginning on Day 1, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until a total of 30 cases are confirmed (up to approximately 25 months).
    Arm type
    Experimental

    Investigational medicinal product name
    RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent)
    Investigational medicinal product code
    Other name
    V260
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Three 2-mL doses of oral solution administered 28 to 70 days apart

    Arm title
    Placebo
    Arm description
    Three doses of placebo administered 28 to 70 days apart beginning on Day 1, with 14 days of safety follow-up after each vaccination, and follow-up for AGEs until a total of 30 cases are confirmed (up to approximately 25 months).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Three 2-mL doses of oral solution administered 28 to 70 days apart

    Number of subjects in period 1
    RotaTeq™ Placebo
    Started
    381
    381
    Vaccinated at Visit 1
    380
    381
    Vaccinated at Visit 2
    373
    374
    Vaccinated at Visit 3
    371
    369
    Completed
    368
    366
    Not completed
    13
    15
         Physician decision
    1
    -
         Consent withdrawn by subject
    9
    10
         Adverse Event
    1
    3
         Lost to follow-up
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RotaTeq™
    Reporting group description
    Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart beginning on Day 1, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until a total of 30 cases are confirmed (up to approximately 25 months).

    Reporting group title
    Placebo
    Reporting group description
    Three doses of placebo administered 28 to 70 days apart beginning on Day 1, with 14 days of safety follow-up after each vaccination, and follow-up for AGEs until a total of 30 cases are confirmed (up to approximately 25 months).

    Reporting group values
    RotaTeq™ Placebo Total
    Number of subjects
    381 381 762
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    381 381 762
    Age Continuous
    Units: weeks
        arithmetic mean (standard deviation)
    7.6 ± 1.7 7.5 ± 1.6 -
    Gender Categorical
    Units: Subjects
        Female
    173 182 355
        Male
    208 199 407

    End points

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    End points reporting groups
    Reporting group title
    RotaTeq™
    Reporting group description
    Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart beginning on Day 1, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until a total of 30 cases are confirmed (up to approximately 25 months).

    Reporting group title
    Placebo
    Reporting group description
    Three doses of placebo administered 28 to 70 days apart beginning on Day 1, with 14 days of safety follow-up after each vaccination, and follow-up for AGEs until a total of 30 cases are confirmed (up to approximately 25 months).

    Subject analysis set title
    RotaTeq™ Per Protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants randomized to receive RotaTeq™ except those excluded with protocol deviations that may affect the results of the primary efficacy endpoint.

    Subject analysis set title
    Placebo Per Protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants randomized to receive placebo except those excluded with protocol deviations that may affect the results of the primary efficacy endpoint.

    Primary: Incidence Rate of Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With P1A

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    End point title
    Incidence Rate of Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With P1A
    End point description
    Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. The population analyzed was per-protocol participants except those unevaluable due to 1) detection of wild-type rotavirus in stool prior to 14 days Postdose 3, 2) incomplete clinical and/or laboratory results, or 3) stool samples collected out of day range.
    End point type
    Primary
    End point timeframe
    From 14 days Postdose 3 onward
    End point values
    RotaTeq™ Per Protocol Placebo Per Protocol
    Number of subjects analysed
    355
    356
    Units: Participants
    7
    27
    Statistical analysis title
    Vaccine Efficacy
    Statistical analysis description
    Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.
    Comparison groups
    RotaTeq™ Per Protocol v Placebo Per Protocol
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [1]
    Method
    Exact Conditional Test
    Parameter type
    Vaccine Efficacy
    Point estimate
    74.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    39.9
         upper limit
    90.6
    Notes
    [1] - Hypothesis: Efficacy >0%. Based on p< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of participants with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.

    Secondary: Incidence Rate of Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With P1A

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    End point title
    Incidence Rate of Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With P1A
    End point description
    Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe. The population analyzed was per-protocol participants except those unevaluable due to 1) detection of wild-type rotavirus in stool prior to 14 days Postdose 3, 2) incomplete clinical and/or laboratory results, or 3) stool samples collected out of day range.
    End point type
    Secondary
    End point timeframe
    From 14 days Postdose 3 onward
    End point values
    RotaTeq™ Per Protocol Placebo Per Protocol
    Number of subjects analysed
    354
    356
    Units: Participants
    5
    25
    Statistical analysis title
    Vaccine Efficacy
    Statistical analysis description
    Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.
    Comparison groups
    RotaTeq™ Per Protocol v Placebo Per Protocol
    Number of subjects included in analysis
    710
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    Exact Conditional Test
    Parameter type
    Vaccine Efficacy
    Point estimate
    80.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    47.4
         upper limit
    94.1
    Notes
    [2] - Hypothesis: Efficacy >0%. Based on p< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of participants with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.

    Secondary: Incidence Rate of Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With P1A

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    End point title
    Incidence Rate of Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With P1A
    End point description
    Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe. The population analyzed was per-protocol participants except those unevaluable due to 1) detection of wild-type rotavirus in stool prior to 14 days Postdose 3, 2) incomplete clinical and/or laboratory results, or 3) stool samples collected out of day range.
    End point type
    Secondary
    End point timeframe
    From 14 days Postdose 3 onward
    End point values
    RotaTeq™ Per Protocol Placebo Per Protocol
    Number of subjects analysed
    354
    355
    Units: Participants
    0
    10
    Statistical analysis title
    Vaccine Efficacy
    Statistical analysis description
    Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.
    Comparison groups
    RotaTeq™ Per Protocol v Placebo Per Protocol
    Number of subjects included in analysis
    709
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [3]
    Method
    Exact Conditional Test
    Parameter type
    Vaccine Efficacy
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.4
         upper limit
    100
    Notes
    [3] - Hypothesis: Efficacy >0%. Based on p< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of participants with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14-day period following each vaccination. Any death, Vaccine related serious adverse events (AEs) and Intussusception were collected during the study period.
    Adverse event reporting additional description
    Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) up to 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of participants exposed is the number of participants who received study treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    At least one dose of placebo administered 28 to 70 days apart, beginning on Day 1.

    Reporting group title
    RotaTeq™
    Reporting group description
    At least one dose of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, beginning on Day 1.

    Serious adverse events
    Placebo RotaTeq™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 381 (2.36%)
    7 / 380 (1.84%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Congenital, familial and genetic disorders
    Congenital absence of bile ducts
         subjects affected / exposed
    1 / 381 (0.26%)
    0 / 380 (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
    Asphyxia
         subjects affected / exposed
    0 / 381 (0.00%)
    1 / 380 (0.26%)
         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 / 381 (0.26%)
    0 / 380 (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
    Lymphadenitis
         subjects affected / exposed
    1 / 381 (0.26%)
    0 / 380 (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
    Infantile spasms
         subjects affected / exposed
    1 / 381 (0.26%)
    0 / 380 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 381 (0.26%)
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychomotor retardation
         subjects affected / exposed
    1 / 381 (0.26%)
    0 / 380 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 381 (0.26%)
    0 / 380 (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
    Bronchitis
         subjects affected / exposed
    0 / 381 (0.00%)
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    0 / 381 (0.00%)
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 381 (0.26%)
    0 / 380 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 381 (0.26%)
    0 / 380 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis coxsackie viral
         subjects affected / exposed
    0 / 381 (0.00%)
    1 / 380 (0.26%)
         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 / 381 (0.00%)
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 381 (0.00%)
    2 / 380 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urinary tract infection
         subjects affected / exposed
    1 / 381 (0.26%)
    0 / 380 (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: 1%
    Non-serious adverse events
    Placebo RotaTeq™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    175 / 381 (45.93%)
    179 / 380 (47.11%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    4 / 381 (1.05%)
    1 / 380 (0.26%)
         occurrences all number
    4
    1
    Cough
         subjects affected / exposed
    8 / 381 (2.10%)
    1 / 380 (0.26%)
         occurrences all number
    10
    1
    Rhinorrhoea
         subjects affected / exposed
    6 / 381 (1.57%)
    5 / 380 (1.32%)
         occurrences all number
    7
    5
    Upper respiratory tract inflammation
         subjects affected / exposed
    16 / 381 (4.20%)
    27 / 380 (7.11%)
         occurrences all number
    16
    32
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 381 (0.79%)
    7 / 380 (1.84%)
         occurrences all number
    3
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    31 / 381 (8.14%)
    29 / 380 (7.63%)
         occurrences all number
    40
    33
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    7 / 381 (1.84%)
    11 / 380 (2.89%)
         occurrences all number
    7
    11
    Diarrhoea
         subjects affected / exposed
    47 / 381 (12.34%)
    46 / 380 (12.11%)
         occurrences all number
    65
    64
    Infantile spitting up
         subjects affected / exposed
    2 / 381 (0.52%)
    6 / 380 (1.58%)
         occurrences all number
    3
    11
    Vomiting
         subjects affected / exposed
    29 / 381 (7.61%)
    31 / 380 (8.16%)
         occurrences all number
    39
    53
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    6 / 381 (1.57%)
    9 / 380 (2.37%)
         occurrences all number
    7
    11
    Eczema
         subjects affected / exposed
    12 / 381 (3.15%)
    14 / 380 (3.68%)
         occurrences all number
    12
    15
    Eczema infantile
         subjects affected / exposed
    10 / 381 (2.62%)
    7 / 380 (1.84%)
         occurrences all number
    10
    7
    Rash
         subjects affected / exposed
    4 / 381 (1.05%)
    2 / 380 (0.53%)
         occurrences all number
    4
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    8 / 381 (2.10%)
    7 / 380 (1.84%)
         occurrences all number
    9
    7
    Gastroenteritis
         subjects affected / exposed
    14 / 381 (3.67%)
    27 / 380 (7.11%)
         occurrences all number
    16
    38
    Nasopharyngitis
         subjects affected / exposed
    37 / 381 (9.71%)
    37 / 380 (9.74%)
         occurrences all number
    46
    43
    Respiratory syncytial virus infection
         subjects affected / exposed
    2 / 381 (0.52%)
    4 / 380 (1.05%)
         occurrences all number
    2
    4
    Rhinitis
         subjects affected / exposed
    8 / 381 (2.10%)
    0 / 380 (0.00%)
         occurrences all number
    9
    0
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 381 (2.36%)
    4 / 380 (1.05%)
         occurrences all number
    10
    4

    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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