Safety and immunogenicity of whole virion influenza vaccines.

To increase availability of seasonal and especially pandemic influenza vaccines for developing countries it is important that local vaccine production facilities are established. The Netherlands Vaccine Institute (NVI) has set up an influenza vaccine production process suitable for technology transfer to manufacturers in lower- and middle income countries. The safety and immunogenicity of a monovalent seasonal and a pandemic inactivated whole virion vaccine will be investigated.

1. Assessment of safety of seasonal and pandemic inactivated whole virion influenza vaccines;

2. Assessment of immunogenicity of the whole virion vaccines;

3. Comparison of the safety profile of the whole virion vaccines with a split virion vaccine.

Blood samples are drawn on screening, day 0 (prior to vaccine/placebo administration), day 21 (prior to vaccine/placebo administration), and on day 42.
After each vaccine/placebo dose, subjects are requested to complete a diary for five days to record adverse events.

Four treatment arms will be included:

1. Seasonal influenza vaccine (one dose) and a placebo dose;

2. Pandemic influenza vaccine (two doses);

3. Placebo (two doses);

4. Commercial seasonal influenza vaccine (one dose) and a placebo dose.



Blood samples are drawn on screening, day 0 (prior to vaccine/placebo administration), day 21 (prior to vaccine/placebo administration), and on day 42. After each vaccine/placebo dose, subjects are requested to complete a diary for five days to record adverse events.