Healthy
Conditions
Keywords
Cell-derived subunit influenza vaccine, Safety, Reactogenicity
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.
Interventions
BIOLOGICALSeasonal cell-derived influenza vaccine
0.5 mL im, single dose
BIOLOGICALPlacebo Comparator
0.5 mL im, single dose
Sponsors
Solvay Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination. | 3 weeks |
| Long-term safety | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| HI antibody titers | 3 weeks |
Outcome results
None listed