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    Clinical Trial Results:
    A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Rotavirus Reassortant Vaccine in Chinese Healthy Adults, Children and Infants

    Summary
    EudraCT number
    		 2017-000263-32
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Mar 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    V260-028
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00953056
    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 Mar 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study assessed the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations.
    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. The following additional measure defined for this individual study was in place for the protection of trial participants: the primary investigator and the Ethics Review Committee reviewed blinded safety data and decided to move forward to the next cohort (Cohort I, then II, then III) based on their best clinical judgment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 2009
    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
    China: 144
    Worldwide total number of subjects
    144
    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)
    48
    Children (2-11 years)
    48
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    48
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled into 3 cohorts. Randomization ratio was 1:1 (RotaTeq™ (V260):placebo) in each cohort. The study was conducted sequentially: Cohort I followed by Cohort II followed by Cohort III, with the primary investigator and Ethics Review Committee reviewing blinded safety data before the next cohort.

    Pre-assignment
    Screening details
    		 Healthy Chinese participants 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
    		 Investigator, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1 Rotateq™
    Arm description
    		 Adults ages 19 - 47 years randomized to receive a single dose of RotaTeq™
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotateq™
    Investigational medicinal product code
    Other name
    V260, Rotavirus vaccine, live, oral, pentavalent. The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Single 2.0 mL dose of V260 (RotaTeq™) administered orally at enrollment

    Arm title
    		 Cohort I Placebo
    Arm description
    		 Adults ages 19 - 47 years randomized to receive a single dose of placebo
    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
    Single 2.0 mL dose of matching placebo to Rotateq™ administered orally at enrollment

    Arm title
    		 Cohort II RotaTeq™
    Arm description
    		 Children ages 2 - 6 years randomized to receive a single dose of RotaTeq™
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotateq™
    Investigational medicinal product code
    Other name
    V260, Rotavirus vaccine, live, oral, pentavalent. The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Single 2.0 mL dose of V260 (RotaTeq™) administered orally at enrollment

    Arm title
    		 Cohort II Placebo
    Arm description
    		 Children ages 2 - 6 years randomized to receive a single dose of placebo
    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
    Single 2.0 mL dose of matching placebo to Rotateq™ administered orally at enrollment

    Arm title
    		 Cohort III RotaTeq™
    Arm description
    		 Infants ages 6 - 12 weeks randomized to receive RotaTeq™ vaccination administered at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotateq™
    Investigational medicinal product code
    Other name
    V260, Rotavirus vaccine, live, oral, pentavalent. The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    2.0 mL doses of V260 (RotaTeq™) administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

    Arm title
    		 Cohort III Placebo
    Arm description
    		 Infants ages 6 - 12 weeks randomized to receive placebo vaccination administered at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.
    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
    2.0 mL doses of matching placebo to Rotateq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

    Number of subjects in period 1
    		Cohort 1 Rotateq™ Cohort I Placebo Cohort II RotaTeq™ Cohort II Placebo Cohort III RotaTeq™ Cohort III Placebo
    Started
    24
    24
    24
    24
    24
    24
    Completed
    24
    24
    24
    24
    22
    20
    Not completed
    0
    0
    0
    0
    2
    4
         Consent withdrawn by subject
    -
    -
    -
    -
    2
    3
         Serious Adverse Event
    -
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1 Rotateq™
    Reporting group description
    		 Adults ages 19 - 47 years randomized to receive a single dose of RotaTeq™

    Reporting group title
    Cohort I Placebo
    Reporting group description
    		 Adults ages 19 - 47 years randomized to receive a single dose of placebo

    Reporting group title
    Cohort II RotaTeq™
    Reporting group description
    		 Children ages 2 - 6 years randomized to receive a single dose of RotaTeq™

    Reporting group title
    Cohort II Placebo
    Reporting group description
    		 Children ages 2 - 6 years randomized to receive a single dose of placebo

    Reporting group title
    Cohort III RotaTeq™
    Reporting group description
    		 Infants ages 6 - 12 weeks randomized to receive RotaTeq™ vaccination administered at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

    Reporting group title
    Cohort III Placebo
    Reporting group description
    		 Infants ages 6 - 12 weeks randomized to receive placebo vaccination administered at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

    Reporting group values
    		 Cohort 1 Rotateq™ Cohort I Placebo Cohort II RotaTeq™ Cohort II Placebo Cohort III RotaTeq™ Cohort III Placebo Total
    Number of subjects
    		 24 24 24 24 24 24 144
    Age Categorical
    Units: Subjects
        6 weeks to 12 weeks (infants)
    		 0 0 0 0 24 24 48
        2 years to 6 years (children)
    		 0 0 24 24 0 0 48
        19 years to 47 years (adults)
    		 24 24 0 0 0 0 48
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.8 ± 8 36 ± 7.6 3.6 ± 1.1 3.5 ± 1.2 0.169 ± 0.027 0.179 ± 0.029 -
    Gender Categorical
    Units: Subjects
        Female
    		 13 17 10 11 8 11 70
        Male
    		 11 7 14 13 16 13 74
    Region of Enrollment
    Units: Subjects
        China
    		 24 24 24 24 24 24 144

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1 Rotateq™
    Reporting group description
    		 Adults ages 19 - 47 years randomized to receive a single dose of RotaTeq™

    Reporting group title
    Cohort I Placebo
    Reporting group description
    		 Adults ages 19 - 47 years randomized to receive a single dose of placebo

    Reporting group title
    Cohort II RotaTeq™
    Reporting group description
    		 Children ages 2 - 6 years randomized to receive a single dose of RotaTeq™

    Reporting group title
    Cohort II Placebo
    Reporting group description
    		 Children ages 2 - 6 years randomized to receive a single dose of placebo

    Reporting group title
    Cohort III RotaTeq™
    Reporting group description
    		 Infants ages 6 - 12 weeks randomized to receive RotaTeq™ vaccination administered at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

    Reporting group title
    Cohort III Placebo
    Reporting group description
    		 Infants ages 6 - 12 weeks randomized to receive placebo vaccination administered at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

    Primary: Number of Participants with a Serious Adverse Event

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    End point title
    		 Number of Participants with a Serious Adverse Event [1]
    End point description
    An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, 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 sponsor’s product, is also an AE. A serious AE is an AE that results in death, is life threatening, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or may jeopardize the participant and require medical or surgical intervention. The population analyzed included all participants who received at least one dose of study drug and had safety follow-up.
    End point type
    Primary
    End point timeframe
    Up to 14 days post vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or conducted for this endpoint
    End point values
    		 Cohort 1 Rotateq™ Cohort I Placebo Cohort II RotaTeq™ Cohort II Placebo Cohort III RotaTeq™ Cohort III Placebo
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: Participants
    0
    0
    0
    0
    0
    3
    No statistical analyses for this end point

    Primary: Number of Serious Adverse Events

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    End point title
    		 Number of Serious Adverse Events [2]
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, 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 sponsor’s product, is also an AE. A serious AE is an AE that results in death, is life threatening, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or may jeopardize the participant and require medical or surgical intervention. The population analyzed included all participants who received at least one dose of study drug and had safety follow-up.
    End point type
    Primary
    End point timeframe
    Up to 14 days post vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or conducted for this endpoint
    End point values
    		 Cohort 1 Rotateq™ Cohort I Placebo Cohort II RotaTeq™ Cohort II Placebo Cohort III RotaTeq™ Cohort III Placebo
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: Events
    0
    0
    0
    0
    0
    4
    No statistical analyses for this end point

    Secondary: Number of Infants with Fecal Vaccine Virus Shedding

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    End point title
    		 Number of Infants with Fecal Vaccine Virus Shedding [3]
    End point description
    Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose. The population analyzed included participants in Cohort III who received the scheduled dose of vaccination and for whom the stool samples were available for testing. This endpoint applied to Cohort III only.
    End point type
    Secondary
    End point timeframe
    Between Day 3 and Day 7 following each of 3 doses
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint applied to Cohort III only
    End point values
    		 Cohort III RotaTeq™ Cohort III Placebo
    Number of subjects analysed
    24
    24
    Units: Participants
        Postdose 1 (n=23, 24)
    3
    0
        Postdose 2 (n=21, 22)
    2
    0
        Postdose 3 (n=22, 20)
    3
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Cohorts I and II: up to 14 days after vaccination; Cohort III: up to 14 days after any of three vaccinations
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Cohort 1 Rotateq™
    Reporting group description
    		 Adults ages 19 - 47 years randomized to receive a single dose of RotaTeq™

    Reporting group title
    Cohort I Placebo
    Reporting group description
    		 Adults ages 19 - 47 years randomized to receive a single dose of placebo

    Reporting group title
    Cohort II RotaTeq™
    Reporting group description
    		 Children ages 2 - 6 years randomized to receive a single dose of RotaTeq™

    Reporting group title
    Cohort II Placebo
    Reporting group description
    		 Children ages 2 - 6 years randomized to receive a single dose of placebo

    Reporting group title
    Cohort III RotaTeq™
    Reporting group description
    		 Infants ages 6 - 12 weeks randomized to receive RotaTeq™ vaccination administered at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

    Reporting group title
    Cohort III Placebo
    Reporting group description
    		 Infants ages 6 - 12 weeks randomized to receive placebo vaccination administered at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

    Serious adverse events
    		 Cohort 1 Rotateq™ Cohort I Placebo Cohort II RotaTeq™ Cohort II Placebo Cohort III RotaTeq™ Cohort III Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    3 / 24 (12.50%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis viral
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1 Rotateq™ Cohort I Placebo Cohort II RotaTeq™ Cohort II Placebo Cohort III RotaTeq™ Cohort III Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 24 (25.00%)
    2 / 24 (8.33%)
    6 / 24 (25.00%)
    3 / 24 (12.50%)
    18 / 24 (75.00%)
    14 / 24 (58.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    4 / 24 (16.67%)
    2 / 24 (8.33%)
    9 / 24 (37.50%)
    5 / 24 (20.83%)
         occurrences all number
    1
    1
    4
    2
    11
    8
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    13 / 24 (54.17%)
    8 / 24 (33.33%)
         occurrences all number
    1
    0
    1
    2
    23
    19
    Vomiting
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    9 / 24 (37.50%)
    12 / 24 (50.00%)
         occurrences all number
    0
    0
    1
    1
    22
    25
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    2 / 24 (8.33%)
    2 / 24 (8.33%)
         occurrences all number
    1
    0
    1
    1
    3
    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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    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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