Influenza H1N1 Immunogenicity study

The emergence of a new pandemic influenza virus will give many deaths and
serious complications in vulnerable populations. The World Health Organisation
(WHO) declared on June 11, 2009 the first influenza pandemic in 41 years (1).
Up till the 23th of October a total of 205 patients are hospitalized and 6
patients died of the new influenza H1N1 in The Netherlands. Sixty-one % of the
hospitalized patients suffered from an underlying medical condition (2).
Influenza virus causes a specific clinical picture characterized by sudden
onset of fever, headache, malaise, myalgias, cough and other respiratory
complaints. Adults >= 65 years, pregnant woman, people with underlying medical
conditions and children <= 1 year are at greater risk of developing
complications (3, 4). Preliminary reports show also a greater risk of
complications in the age group of 5 till 14 years (2). Secondary bacterial
pneumonia, exacerbations of underlying pulmonary and cardiac disease are
examples of possible complications of influenza (3). People born before 1950
seem to have some pre-existing immunity against the influenza virus H1N1 (2009)
(5).
Vaccination is the most important tool for reducing morbidity, mortality, virus
transmission and preventing infection. The vaccine currently used in the
Netherlands is Focetria ® (Novartis). This Influenza A(H1N1) 2009 monovalent
vaccine is an inactivated influenza virus vaccine, containing the influenza
virus A/California/7/2009 (H1N1)v like strain (X-179A) and the MF59 adjuvant.
MF59, an oil-in-water emulsion, is an adjuvant developed to improve the
performance of vaccines in general (6) and has been shown to improve immune
response to seasonal influenza vaccines, even in children (7, 8).
The aim of this confirmatory (phase IV)-study is to determine the humoral and
cellular immunity before and after vaccination with the Influenza A virus
(H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine ( Focetria ®, Novartis, a
vaccine registered by EMEA). In addition, the study will reveal data on the
need of giving a second dose of the vaccine.

Primary Objectives:
• To determine the basic immunity against influenza H1N1 (2009) in the
population.
• To determine the humoral and cellular immunity after a single vaccination
with Influenza A virus (H1N1) 2009 Monovalent MF59- Adjuvanted Vaccine.
• To determine the humoral and cellular immunity after the second vaccination
with Influenza A virus (H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine.
• To study the impact of earlier seasonal vaccination on the immune response
against the influenza virus H1N1 (2009).

Secondary Objective(s):
• To determine the requirement of a second vaccination with Influenza A virus
(H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine.

Multi-center study from November 2009 through December 2009. 200 subjects will
be enrolled in this study.
The study will take place in the St. Elisabeth Hospital (EZ) and the TweeSteden
Hospital (TS).

- Cohort study
± 100 subjects will be asked to give 1 blood sample (1 blood tube) each time
before
vaccination the with influenza virus H1N1(2009) first dose, second dose and
seasonal
vaccination to determine their immunity against influenza H1N1 (2009).
- Subset: Case control study
Influence of seasonal vaccination on the gained immunity for influenza virus
H1N1.
100 subjects will be asked to give a blood sample (2 blood tubes) each
time before
vaccination with H1N1(2009) first dose, second dose and seasonal vaccination
to
determine the influence of seasonal vaccination on the immunity for influenza
H1N1(2009). The 100 subjects will be divided into two groups.
Group 1: 50 subjects who received annually the seasonal vaccine and Group 2:
50
subject who never received the seasonal vaccine.

There are no personal benefits or risks entering this study. There is only a
small burden in having venapunctions and only once a very short questionnaire
has to be filled in (duration approximately 2 minutes).