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Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Seasonal cell-derived influenza vaccine
Placebo Comparator
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring Cell-derived subunit influenza vaccine, Safety, Reactogenicity

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy female or male subjects aged ≧18 and ≦49 years
  • Willing and able to give informed consent

Exclusion Criteria:

  • Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent,
  • presence of any significant medical condition,
  • a serious adverse reaction after a previous (influenza) vaccination,
  • underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP),
  • chronic diseases requiring long-term immunosuppressive therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination.
    Long-term safety

    Secondary Outcome Measures

    HI antibody titers

    Full Information

    First Posted
    January 10, 2008
    Last Updated
    June 27, 2008
    Sponsor
    Solvay Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00599443
    Brief Title
    Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years
    Official Title
    Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Solvay Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy
    Keywords
    Cell-derived subunit influenza vaccine, Safety, Reactogenicity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    Seasonal cell-derived influenza vaccine
    Intervention Description
    0.5 mL im, single dose
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo Comparator
    Intervention Description
    0.5 mL im, single dose
    Primary Outcome Measure Information:
    Title
    Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination.
    Time Frame
    3 weeks
    Title
    Long-term safety
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    HI antibody titers
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy female or male subjects aged ≧18 and ≦49 years Willing and able to give informed consent Exclusion Criteria: Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent, presence of any significant medical condition, a serious adverse reaction after a previous (influenza) vaccination, underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP), chronic diseases requiring long-term immunosuppressive therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Global Clinical Director Solvay
    Organizational Affiliation
    Solvay Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years

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