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Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)

Primary Purpose

Rotavirus, Gastroenteritis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
Comparator: Comparator: Placebo (unspecified)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus focused on measuring Gastroenteritis, Rotavirus

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age

Exclusion Criteria:

  • History Of Known Prior Rotavirus Gastroenteritis
  • Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    RotaTeq™

    Placebo

    Outcomes

    Primary Outcome Measures

    Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
    Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition

    Secondary Outcome Measures

    Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
    Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype 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.
    Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
    Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype 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.

    Full Information

    First Posted
    July 16, 2008
    Last Updated
    March 16, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00718237
    Brief Title
    Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
    Official Title
    A Phase III Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of V260 in Healthy Infants in Japan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    762 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    RotaTeq™
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Biological
    Intervention Name(s)
    Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
    Other Intervention Name(s)
    RotaTeq™, V260
    Intervention Description
    Rotateq orally administered 3 times
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Comparator: Placebo (unspecified)
    Intervention Description
    Placebo orally administered 3 times
    Primary Outcome Measure Information:
    Title
    Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
    Description
    Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition
    Time Frame
    At least 14 days following the 3rd vaccination
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
    Description
    Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype 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.
    Time Frame
    At least 14 days following the 3rd vaccination
    Title
    Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
    Description
    Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype 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.
    Time Frame
    At least 14 days following the 3rd vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Weeks
    Maximum Age & Unit of Time
    12 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age Exclusion Criteria: History Of Known Prior Rotavirus Gastroenteritis Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    23732903
    Citation
    Iwata S, Nakata S, Ukae S, Koizumi Y, Morita Y, Kuroki H, Tanaka Y, Shizuya T, Schodel F, Brown ML, Lawrence J. Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. Hum Vaccin Immunother. 2013 Aug;9(8):1626-33. doi: 10.4161/hv.24846. Epub 2013 May 31.
    Results Reference
    result

    Learn more about this trial

    Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)

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