infection influenza
Conditions
Interventions
Three treatment arms will be included:
1. Seasonal influenza vaccine (one dose) and a placebo dose
3. Commercial seasonal influenza vaccine (one dose) and a placebo dose.
Blood samples are drawn on screening, day 0, day 21 and on day 42. After each
dose, subjects are requested to complete a diary
Sponsors
Stichting Leveronderzoek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 18 to 49 years Good health according to the investigator
Exclusion criteria
Exclusion criteria: - having had an infectious disease with fever (including influenza) within the last 14 days - present evidence of serious disease(s) demanding medical treatment that might interfere with the results of the study such as diseases which interfere with the immune system - known or suspected allergy to any of the vaccine components: egg components, chicken protein, ovalbumin (by medical history) - known or suspected immune deficiency - history of any neurologic disorder, including epilepsy - females: positive pregnancy test - positive HIV, HBV or HCV serology - previous vaccination with an influenza vaccine in the previous three winter seasons - abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: to assess the safety of seasonal and pandemic inactivated whole virion influenza vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): to assess immunogenicity of seasonal and pandemic inactivated whole virion influenza vaccine, and to compare the safety profile of the whole virion vaccines with a split virion vaccine. | — |
Countries
Netherlands
Outcome results
None listed