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Consistency Lots Vaccine Study (V260-009)

Primary Purpose

Rotavirus Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rotavirus vaccine, live, oral, pentavalent
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus Infections

Eligibility Criteria

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

Inclusion Criteria: Healthy infants Exclusion Criteria: History of abdominal disorders from a birth defect, intussusception, or abdominal surgery Known or suspected problems with the immune system Fever at time of immunization Prior administration of a rotavirus vaccine History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    RotaTeq™ Lot 1

    RotaTeq™ Lot 2

    RotaTeq™ Lot 3

    Placebo

    Arm Description

    ~8.81 X 10^7 IU/Dose of RotaTeq™

    ~8.01 X 10^7 IU/Dose of RotaTeq™

    ~6.91 X 10^7 IU/Dose of RotaTeq™

    Outcomes

    Primary Outcome Measures

    Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
    Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8]

    Secondary Outcome Measures

    Full Information

    First Posted
    September 22, 2004
    Last Updated
    September 18, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092456
    Brief Title
    Consistency Lots Vaccine Study (V260-009)
    Official Title
    Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2003 (undefined)
    Primary Completion Date
    August 2004 (Actual)
    Study Completion Date
    August 2004 (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
    This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    RotaTeq™ Lot 1
    Arm Type
    Experimental
    Arm Description
    ~8.81 X 10^7 IU/Dose of RotaTeq™
    Arm Title
    RotaTeq™ Lot 2
    Arm Type
    Experimental
    Arm Description
    ~8.01 X 10^7 IU/Dose of RotaTeq™
    Arm Title
    RotaTeq™ Lot 3
    Arm Type
    Experimental
    Arm Description
    ~6.91 X 10^7 IU/Dose of RotaTeq™
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    rotavirus vaccine, live, oral, pentavalent
    Other Intervention Name(s)
    V260, RotaTeq™
    Intervention Description
    Three oral doses (~8.81 X 10^7 IU/Dose for Lot 1; ~8.01 X 10^7 IU/Dose for Lot 2; and ~6.91 X 10^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
    Primary Outcome Measure Information:
    Title
    Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
    Description
    Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8]
    Time Frame
    42 days following the 3rd vaccination
    Other Pre-specified Outcome Measures:
    Title
    Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).
    Description
    Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA
    Time Frame
    42 days following the 3rd vaccination
    Title
    Number of Subjects With Clinical Adverse Experiences (CAEs)
    Description
    Subjects in this study were followed for all CAEs, including intussusception. A CAE 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
    Time Frame
    Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
    Title
    Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)
    Description
    Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
    Time Frame
    Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
    Title
    Number of Subjects With Vaccine-Related Clinical AEs (CAEs)
    Description
    CAE 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. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment.
    Time Frame
    Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
    Title
    Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)
    Description
    Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose
    Time Frame
    Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
    Title
    Number of Subjects Discontinued Due to Clinical Adverse Experiences
    Description
    A CAE 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.
    Time Frame
    Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
    Title
    Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)
    Description
    CAE 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. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment.
    Time Frame
    Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
    Title
    Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)
    Description
    SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
    Time Frame
    Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
    Title
    Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)
    Description
    Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
    Time Frame
    Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first

    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 infants Exclusion Criteria: History of abdominal disorders from a birth defect, intussusception, or abdominal surgery Known or suspected problems with the immune system Fever at time of immunization Prior administration of a rotavirus vaccine History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.
    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

    Learn more about this trial

    Consistency Lots Vaccine Study (V260-009)

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