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A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)

Primary Purpose

Healthy, Pneumococcal Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V110, pneumococcal vaccine polyvalent
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Males and females in good health, ages 20-40, with no history of pneumococcal vaccination Exclusion Criteria: Subjects with a recent febrile illness Known or suspected immune dysfunction, conditions associated with immunosuppression, and receipt of immunosuppressive chemotherapy, including long-term corticosteroid therapy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Immunogenicity

    Secondary Outcome Measures

    Safety

    Full Information

    First Posted
    August 2, 2005
    Last Updated
    January 28, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00127153
    Brief Title
    A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)
    Official Title
    A Comparative Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of V110 Formulated With Either All New Process Polysaccharides or All Current Process Polysaccharides
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    May 2005 (Actual)
    Study Completion Date
    May 2005 (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 this trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    130 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    V110, pneumococcal vaccine polyvalent
    Primary Outcome Measure Information:
    Title
    Immunogenicity
    Secondary Outcome Measure Information:
    Title
    Safety

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Males and females in good health, ages 20-40, with no history of pneumococcal vaccination Exclusion Criteria: Subjects with a recent febrile illness Known or suspected immune dysfunction, conditions associated with immunosuppression, and receipt of immunosuppressive chemotherapy, including long-term corticosteroid therapy
    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

    A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)

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