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    Clinical Trial Results:
    Post-marketing, Randomized, Open-label Study to Assess the Immunogenicity and Safety of Concomitant Administration of V260 and Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Japanese Healthy Infants

    Summary
    EudraCT number
    		 2017-000277-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Jun 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    V260-060
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01926015
    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
    09 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study evaluated the immunogenicity of DTP-IPV (TetrabikTM) with concomitant administration of RotaTeqTM (V260) in healthy Japanese infants. The hypothesis to be tested was that the antibody response rates to DTP-IPV with concomitant administration of RotaTeqTM were non-inferior to those with staggered administration of RotaTeqTM.
    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
    19 Sep 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
    Japan: 192
    Worldwide total number of subjects
    192
    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)
    192
    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 193 participants’ parents/legal guardians agreed to participate by giving written informed consent for study participation. Of these, a total of 192 participants were randomised and 190 participants received study vaccinations; 2 participants were randomised but did not receive study vaccination.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Concomitant RotaTeqTM + DTP-IPV
    Arm description
    		 RotaTeqTM (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
    Arm type
    		 Experimental

    Investigational medicinal product name
    RotaTeqTM
    Investigational medicinal product code
    Other name
    V260
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains. 2 mL oral administration at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Investigational medicinal product name
    DTP-IPV
    Investigational medicinal product code
    Other name
    TetrabikTM
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule. 0.5 mL subcutaneous injection at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Arm title
    		 Staggered RotaTeqTM + DTP-IPV
    Arm description
    		 RotaTeqTM (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
    Arm type
    		 Experimental

    Investigational medicinal product name
    RotaTeqTM
    Investigational medicinal product code
    Other name
    V260
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains. 2 mL oral administration at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Investigational medicinal product name
    DTP-IPV
    Investigational medicinal product code
    Other name
    TetrabikTM
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule. 0.5 mL subcutaneous injection at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Number of subjects in period 1
    		Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Started
    96
    96
    Received >=1 Vaccination
    94
    96
    Completed
    94
    95
    Not completed
    2
    1
         Withdrawal By Parent/Guardian
    -
    1
         Randomised Not Treated
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Concomitant RotaTeqTM + DTP-IPV
    Reporting group description
    		 RotaTeqTM (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Reporting group title
    Staggered RotaTeqTM + DTP-IPV
    Reporting group description
    		 RotaTeqTM (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Reporting group values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV Total
    Number of subjects
    		 96 96 192
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: weeks
        median (full range (min-max))
    		 8 (6 to 10) 9 (6 to 10) -
    Gender Categorical
    Units: Subjects
        Female
    		 47 41 88
        Male
    		 49 55 104
    Subject analysis sets

    Subject analysis set title
    Concomitant RotaTeqTM + DTP-IPV
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    RotaTeqTM (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Subject analysis set title
    Staggered RotaTeqTM + DTP-IPV
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    RotaTeqTM (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Subject analysis sets values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects
    93
    94
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: weeks
        median (full range (min-max))
    8 (6 to 10)
    9 (6 to 10)
    Gender Categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Concomitant RotaTeqTM + DTP-IPV
    Reporting group description
    		 RotaTeqTM (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Reporting group title
    Staggered RotaTeqTM + DTP-IPV
    Reporting group description
    		 RotaTeqTM (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Subject analysis set title
    Concomitant RotaTeqTM + DTP-IPV
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    RotaTeqTM (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Subject analysis set title
    Staggered RotaTeqTM + DTP-IPV
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    RotaTeqTM (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Primary: Percentage of Participants Who Achieved a Serologic Response for Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Poliovirus (PV) Type 1/2/3

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    End point title
    		 Percentage of Participants Who Achieved a Serologic Response for Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Poliovirus (PV) Type 1/2/3
    End point description
    Participant serum was collected for determination of antibody responses. Threshold levels for serologic response were the following: Diphtheria Toxin, >=0.1 International Units (IU)/mL; Tetanus Toxin, >=0.01 IU/mL; Pertussis Toxin and Pertussis FHA, >=10 Enzyme Units (EU)/mL; Poliovirus Types 1, 2, and 3, neutralising antibody (NA) titer >=8.
    End point type
    Primary
    End point timeframe
    4 to 6 weeks after the third dose of DTP-IPV
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    93
    94
    Units: Percentage of participants
    number (not applicable)
        Diphtheria Toxin >=0.1 IU/mL
    100
    100
        Tetanus Toxin >=0.01 IU/mL
    100
    100
        Pertussis Toxin >=10 EU/mL
    100
    100
        Pertussis FHA >=10 EU/mL
    100
    100
        Poliovirus Type 1 NA >=8
    100
    100
        Poliovirus Type 2 NA >=8
    100
    100
        Poliovirus Type 3 NA >=8
    100
    100
    Statistical analysis title
    		 Compared Seroprotection Against Diphtheria Toxin
    Comparison groups
    Staggered RotaTeqTM + DTP-IPV v Concomitant RotaTeqTM + DTP-IPV
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Serologic Response Rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.99
         upper limit
    		 3.95
    Notes
    [1] - The infection control threshhold level for seroprotection against Diphtheria Toxin is >=0.1 IU/mL. Non-inferiority of concomitant versus staggered administration requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10.
    Statistical analysis title
    		 Compared Seroprotection Against Diphtheria Toxin
    Comparison groups
    Concomitant RotaTeqTM + DTP-IPV v Staggered RotaTeqTM + DTP-IPV
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Serologic Response Rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.99
         upper limit
    		 3.95
    Notes
    [2] - The infection control threshhold level for seroprotection against Tetanus Toxin is >=0.01 IU/mL. Non-inferiority of concomitant versus staggered administration requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10.
    Statistical analysis title
    		 Compared Seroprotection Against Pertussis Toxin
    Comparison groups
    Concomitant RotaTeqTM + DTP-IPV v Staggered RotaTeqTM + DTP-IPV
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Serologic Response Rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.99
         upper limit
    		 3.95
    Notes
    [3] - The infection control threshhold level for seroprotection against Pertussis Toxin is >=10 EU/mL. Non-inferiority of concomitant versus staggered administration requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10.
    Statistical analysis title
    		 Compared Seroprotection Against Pertussis FHA
    Comparison groups
    Concomitant RotaTeqTM + DTP-IPV v Staggered RotaTeqTM + DTP-IPV
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Serologic Response Rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.99
         upper limit
    		 3.95
    Notes
    [4] - The infection control threshhold level for seroprotection against Pertussis FHA is >=10 EU/mL. Non-inferiority of concomitant versus staggered administration requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10.
    Statistical analysis title
    		 Compared Seroprotection Against PV Type 1
    Comparison groups
    Concomitant RotaTeqTM + DTP-IPV v Staggered RotaTeqTM + DTP-IPV
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Serologic Response Rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.99
         upper limit
    		 3.95
    Notes
    [5] - The infection control threshhold level for seroprotection against PV Type 1 is neutralising antibody titer (NA) >=8. Non-inferiority of concomitant versus staggered administration requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10.
    Statistical analysis title
    		 Compared Seroprotection Against PV Type 2
    Comparison groups
    Concomitant RotaTeqTM + DTP-IPV v Staggered RotaTeqTM + DTP-IPV
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Serologic Response Rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.99
         upper limit
    		 3.95
    Notes
    [6] - The infection control threshhold level for seroprotection against PV Type 2 is NA >=8. Non-inferiority of concomitant versus staggered administration requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10.
    Statistical analysis title
    		 Compared Seroprotection Against PV Type 3
    Comparison groups
    Concomitant RotaTeqTM + DTP-IPV v Staggered RotaTeqTM + DTP-IPV
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Serologic Response Rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.99
         upper limit
    		 3.95
    Notes
    [7] - The infection control threshhold level for seroprotection against PV Type 3 is NA >=8. Non-inferiority of concomitant versus staggered administration requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10.

    Secondary: Percentage of Participants Reporting an Adverse Event With Incidence >=1%

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    End point title
    		 Percentage of Participants Reporting an Adverse Event With Incidence >=1%
    End point description
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events with an incidence >=1% in either treatment group were recorded. Each participant was counted only once within a study Period and only once Overall.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after any of the 6 study visits
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    94
    96
    Units: Percentage of participants
        number (not applicable)
    68.1
    86.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Reporting an Adverse Event of Special Interest: Fever

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    End point title
    		 Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
    End point description
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhoea, vomiting, and injection-site adverse events. The safety population included randomised participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was counted only once within a study Period and only once Overall.
    End point type
    Secondary
    End point timeframe
    Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    94
    96
    Units: Percentage of participants
    number (not applicable)
        Period 1 (up to 14 days after V1 or V2) (n=94, 96)
    5.3
    6.3
        Period 2 (up to 14 days after V3 or V4) (n=94, 96)
    1.1
    12.5
        Period 3 (up to 14 days after V5 or V6)(n=94, 95)
    4.3
    6.3
        Overall (up to 14 days after any visit)(n=94, 96)
    10.6
    22.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhoea

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    End point title
    		 Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhoea
    End point description
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events. The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was counted only once within a study Period and only once Overall.
    End point type
    Secondary
    End point timeframe
    Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    94
    96
    Units: Percentage of participants
    number (not applicable)
        Period 1 (up to 14 days after V1 or V2) (n=94, 96)
    17
    31.3
        Period 2 (up to 14 days after V3 or V4) (n=94, 96)
    10.6
    20.8
        Period 3 (up to 14 days after V5 or V6) (n=94, 95)
    7.4
    18.9
        Overall (up to 14 days after any visit)(n=94, 96)
    25.5
    46.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting

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    End point title
    		 Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
    End point description
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhoea, vomiting, and injection-site adverse events. The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was counted only once within a study Period and only once Overall.
    End point type
    Secondary
    End point timeframe
    Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    94
    96
    Units: Percentage of participants
    number (not applicable)
        Period 1 (up to 14 days after V1 or V2) (n=94, 96)
    5.3
    9.4
        Period 2 (up to 14 days after V3 or V4) (n=94, 96)
    3.2
    6.3
        Period 3 (up to 14 days after V5 or V6) (n=94, 95)
    1.1
    4.2
        Overall (up to 14 days after any visit) (n=94, 96)
    8.5
    16.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events

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    End point title
    		 Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
    End point description
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhoea, vomiting, and injection-site adverse events. The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was counted only once within a study Period and only once Overall.
    End point type
    Secondary
    End point timeframe
    Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    94
    96
    Units: Percentage of participants
    number (not applicable)
        Period 1 (up to 14 days after V1 or V2) (n=94, 96)
    2.1
    4.2
        Period 2 (up to 14 days after V3 or V4) (n=94, 96)
    0
    8.3
        Period 3 (up to 14 days after V5 or V6) (n=94, 95)
    0
    2.1
        Overall (up to 14 days after any visit) (n=94, 96)
    2.1
    10.4
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers for Diphtheria Toxin Antibody

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    End point title
    		 Geometric Mean Titers for Diphtheria Toxin Antibody
    End point description
    Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint.
    End point type
    Secondary
    End point timeframe
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    93
    94
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Baseline
    0.025 (0.018 to 0.034)
    0.019 (0.014 to 0.026)
        4 to 6 weeks after the third dose of DTP-IPV
    2.377 (2.032 to 2.78)
    2.493 (2.165 to 2.871)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers for Tetanus Toxin Antibody

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    End point title
    		 Geometric Mean Titers for Tetanus Toxin Antibody
    End point description
    Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint.
    End point type
    Secondary
    End point timeframe
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    93
    94
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Baseline
    0.082 (0.059 to 0.114)
    0.093 (0.067 to 0.128)
        4 to 6 weeks after the third dose of DTP-IPV
    1.001 (0.702 to 1.428)
    1.338 (1.009 to 1.774)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers for Pertussis Toxin Antibody

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    End point title
    		 Geometric Mean Titers for Pertussis Toxin Antibody
    End point description
    Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint.
    End point type
    Secondary
    End point timeframe
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    93
    94
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Baseline
    2.67 (2.143 to 3.328)
    2.757 (2.278 to 3.338)
        4 to 6 weeks after the third dose of DTP-IPV
    198.811 (177.43 to 222.768)
    241.857 (218.225 to 268.049)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers for Pertussis FHA Antibody

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    End point title
    		 Geometric Mean Titers for Pertussis FHA Antibody
    End point description
    Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint.
    End point type
    Secondary
    End point timeframe
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    93 [8]
    94
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Baseline
    7.513 (6.285 to 8.98)
    6.951 (5.703 to 8.472)
        4 to 6 weeks after the third dose of DTP-IPV
    77.386 (67.959 to 88.119)
    88.275 (76.065 to 102.445)
    Notes
    [8] - 6.951
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers for Poliovirus Type 1 Antibody

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    End point title
    		 Geometric Mean Titers for Poliovirus Type 1 Antibody
    End point description
    Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralising antibody (NA) titers. The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint.
    End point type
    Secondary
    End point timeframe
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    93
    94
    Units: NA titer
    geometric mean (confidence interval 95%)
        Baseline
    23.5 (17.21 to 32.05)
    21.1 (15.47 to 28.76)
        4 to 6 weeks after the third dose of DTP-IPV
    1578 (1237.3 to 2012)
    1703 (1314.4 to 2207)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers for Poliovirus Type 2 Antibody

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    End point title
    		 Geometric Mean Titers for Poliovirus Type 2 Antibody
    End point description
    Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralising antibody (NA) titers. The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint.
    End point type
    Secondary
    End point timeframe
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    93
    94
    Units: NA titer
    geometric mean (confidence interval 95%)
        Baseline
    32 (23.97 to 42.72)
    27.8 (20.64 to 37.49)
        4 to 6 weeks after the third dose of DTP-IPV
    2886 (2346.9 to 3547.8)
    3259 (2678.2 to 3965.8)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers for Poliovirus Type 3 Antibody

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    End point title
    		 Geometric Mean Titers for Poliovirus Type 3 Antibody
    End point description
    Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralising (NA) titers. The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint.
    End point type
    Secondary
    End point timeframe
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    End point values
    		 Concomitant RotaTeqTM + DTP-IPV Staggered RotaTeqTM + DTP-IPV
    Number of subjects analysed
    93
    94
    Units: NA titer
    geometric mean (confidence interval 95%)
        Baseline
    3.9 (3.43 to 4.43)
    4.8 (3.92 to 5.85)
        4 to 6 weeks after the third dose of DTP-IPV
    2377 (1973.1 to 2864)
    2671 (2193.5 to 3251.5)
    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 14 days after any study visit; all deaths, vaccine-related serious adverse events, overdoses, and intussusception: up to 26 weeks after Visit 1
    Adverse event reporting additional description
    The safety population included randomised participants who received >=1 dose of study vaccine and had safety follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Staggered RotaTeqTM + DTP-IPV
    Reporting group description
    		 RotaTeqTM (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Reporting group title
    Concomitant RotaTeqTM + DTP-IPV
    Reporting group description
    		 RotaTeqTM (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)

    Serious adverse events
    		 Staggered RotaTeqTM + DTP-IPV Concomitant RotaTeqTM + DTP-IPV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (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
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (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: 5%
    Non-serious adverse events
    		 Staggered RotaTeqTM + DTP-IPV Concomitant RotaTeqTM + DTP-IPV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    79 / 96 (82.29%)
    57 / 94 (60.64%)
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    5 / 96 (5.21%)
    2 / 94 (2.13%)
         occurrences all number
    7
    2
    Pyrexia
         subjects affected / exposed
    22 / 96 (22.92%)
    10 / 94 (10.64%)
         occurrences all number
    27
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    45 / 96 (46.88%)
    24 / 94 (25.53%)
         occurrences all number
    86
    41
    Infantile spitting up
         subjects affected / exposed
    6 / 96 (6.25%)
    0 / 94 (0.00%)
         occurrences all number
    7
    0
    Vomiting
         subjects affected / exposed
    16 / 96 (16.67%)
    8 / 94 (8.51%)
         occurrences all number
    23
    15
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    7 / 96 (7.29%)
    7 / 94 (7.45%)
         occurrences all number
    8
    8
    Upper respiratory tract inflammation
         subjects affected / exposed
    12 / 96 (12.50%)
    9 / 94 (9.57%)
         occurrences all number
    18
    10
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    9 / 96 (9.38%)
    6 / 94 (6.38%)
         occurrences all number
    9
    6
    Eczema infantile
         subjects affected / exposed
    7 / 96 (7.29%)
    7 / 94 (7.45%)
         occurrences all number
    7
    7
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 96 (4.17%)
    5 / 94 (5.32%)
         occurrences all number
    5
    5
    Conjunctivitis
         subjects affected / exposed
    6 / 96 (6.25%)
    2 / 94 (2.13%)
         occurrences all number
    6
    2
    Nasopharyngitis
         subjects affected / exposed
    20 / 96 (20.83%)
    7 / 94 (7.45%)
         occurrences all number
    24
    7
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 96 (12.50%)
    9 / 94 (9.57%)
         occurrences all number
    15
    10

    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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