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Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)

Primary Purpose

Rotavirus Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
RotaTeq™ (V260)
DTP-IPV
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus Disease

Eligibility Criteria

6 Weeks - 11 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Japanese participant
  • Age 6 weeks through <11 weeks (42 to 76 days from date of birth) at Visit 1

Exclusion Criteria:

  • History of hypersensitivity and/or anaphylaxis to any of the product ingredients in V260 or DTP-IPV
  • Gastrointestinal disorder, growth retardation, or failure to thrive
  • History of intussusception
  • Untreated congenital gastrointestinal disorder (such as Meckel diverticulum)
  • Known or suspected impairment of immunological function, including severe immunodeficiency (SCID)
  • Cardiovascular, renal, liver, or blood disease
  • History of convulsion
  • Undergoing immunosuppressive therapy or living with a close relative with congenital immune deficiency
  • Prior vaccination with rotavirus vaccine and/or DTP-IPV vaccine
  • Live vaccine received within 28 days or inactivated vaccine received within 7 days
  • At high risk for tuberculosis exposure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Concomitant RotaTeq™ and DTP-IPV

    Staggered RotaTeq™ and DTP-IPV

    Arm Description

    RotaTeq™ (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).

    RotaTeq™ (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).

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
    Participant serum was collected for determination of antibody responses. Threshold levels for seroresponse 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, neutralizing antibody (NA) titer >=8.

    Secondary Outcome Measures

    Percentage of Participants Reporting an Adverse Event With Incidence >=1%
    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.
    Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
    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.
    Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
    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.
    Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
    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.
    Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
    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.
    Geometric Mean Titers for Diphtheria Toxin Antibody
    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
    Geometric Mean Titers for Tetanus Toxin Antibody
    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
    Geometric Mean Titers for Pertussis Toxin Antibody
    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
    Geometric Mean Titers for Pertussis FHA Antibody
    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
    Geometric Mean Titers for Poliovirus Type 1 Antibody
    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 neutralizing antibody (NA) titers.
    Geometric Mean Titers for Poliovirus Type 2 Antibody
    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 neutralizing antibody (NA) titers.
    Geometric Mean Titers for Poliovirus Type 3 Antibody
    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 neutralizing antibody (NA) titers.

    Full Information

    First Posted
    August 16, 2013
    Last Updated
    October 19, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01926015
    Brief Title
    Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 19, 2013 (Actual)
    Primary Completion Date
    June 6, 2014 (Actual)
    Study Completion Date
    June 6, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with staggered administration of RotaTeq™.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotavirus Disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    192 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Concomitant RotaTeq™ and DTP-IPV
    Arm Type
    Experimental
    Arm Description
    RotaTeq™ (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 Title
    Staggered RotaTeq™ and DTP-IPV
    Arm Type
    Active Comparator
    Arm Description
    RotaTeq™ (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).
    Intervention Type
    Biological
    Intervention Name(s)
    RotaTeq™ (V260)
    Other Intervention Name(s)
    RotaTeq™
    Intervention Description
    Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
    Intervention Type
    Biological
    Intervention Name(s)
    DTP-IPV
    Other Intervention Name(s)
    Tetrabik™, BIKEN
    Intervention Description
    Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
    Description
    Participant serum was collected for determination of antibody responses. Threshold levels for seroresponse 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, neutralizing antibody (NA) titer >=8.
    Time Frame
    4 to 6 weeks after the third dose of DTP-IPV
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Reporting an Adverse Event With Incidence >=1%
    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.
    Time Frame
    Up to 14 days after any of the 6 study visits
    Title
    Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
    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.
    Time Frame
    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)
    Title
    Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
    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.
    Time Frame
    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)
    Title
    Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
    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.
    Time Frame
    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)
    Title
    Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
    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.
    Time Frame
    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)
    Title
    Geometric Mean Titers for Diphtheria Toxin Antibody
    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
    Time Frame
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    Title
    Geometric Mean Titers for Tetanus Toxin Antibody
    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
    Time Frame
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    Title
    Geometric Mean Titers for Pertussis Toxin Antibody
    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
    Time Frame
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    Title
    Geometric Mean Titers for Pertussis FHA Antibody
    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
    Time Frame
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    Title
    Geometric Mean Titers for Poliovirus Type 1 Antibody
    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 neutralizing antibody (NA) titers.
    Time Frame
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    Title
    Geometric Mean Titers for Poliovirus Type 2 Antibody
    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 neutralizing antibody (NA) titers.
    Time Frame
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    Title
    Geometric Mean Titers for Poliovirus Type 3 Antibody
    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 neutralizing antibody (NA) titers.
    Time Frame
    Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Weeks
    Maximum Age & Unit of Time
    11 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Japanese participant Age 6 weeks through <11 weeks (42 to 76 days from date of birth) at Visit 1 Exclusion Criteria: History of hypersensitivity and/or anaphylaxis to any of the product ingredients in V260 or DTP-IPV Gastrointestinal disorder, growth retardation, or failure to thrive History of intussusception Untreated congenital gastrointestinal disorder (such as Meckel diverticulum) Known or suspected impairment of immunological function, including severe immunodeficiency (SCID) Cardiovascular, renal, liver, or blood disease History of convulsion Undergoing immunosuppressive therapy or living with a close relative with congenital immune deficiency Prior vaccination with rotavirus vaccine and/or DTP-IPV vaccine Live vaccine received within 28 days or inactivated vaccine received within 7 days At high risk for tuberculosis exposure
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    28140752
    Citation
    Tanaka Y, Yokokawa R, Rong HS, Kishino H, Stek JE, Nelson M, Lawrence J. Concomitant administration of diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine derived from Sabin strains (DTaP-sIPV) with pentavalent rotavirus vaccine in Japanese infants. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-7. doi: 10.1080/21645515.2017.1279769. Epub 2017 Jan 31.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=V260-060&kw=V260-060&tab=access

    Learn more about this trial

    Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)

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