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