flu influenza
Conditions
Interventions
Vaccination with pandemic influenza vaccine Focetria from Novartis.
Added with reference to the extension:
Voluntary vaccination with seasonal influenza vaccin 2010-2011.
Sponsors
Registratie en Medische Unit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * good self-reported health according to the investigator * willingness and ability to adhere to the study regimen * having a signed informed consent form * age 18 * 52 years
Exclusion criteria
Exclusion criteria: The exclusion criteria with regard to contra-indications for receiving the pandemic influenza vaccine are: * allergy to any of the components of the vaccine or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB). The exclusion criteria with regard to blood collection and the immunological analysis are: * immune deficiencies * haematological disorders * bleeding disorders * usage of anticoagulants, corticosteroids, NSAIDs and/or statins * diabetes mellitus * having had an infectious disease with fever within the last two weeks * previously diagnosed with pandemic H1N1 influenza
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: pandemic influenza virus identification after reporting of influenza-like symptoms by the participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: - The humoral immune response against pandemic influenza vaccine at each of the specified time points. - The cellular immune response against pandemic influenza vaccine at each of the specified time points. - The humoral and cellular, cross-specific and specific immune responses against the pandemic influenza virus in the pre-vaccination samples and in the unvaccinated group. Added with reference to the extension: * the humoral and cellular immune responses against influenza A (H3N2) vaccine. | — |
Countries
Netherlands
Outcome results
None listed