Yearly Strain Variation Study, 2009/2010
Yearly Strain Variation Study, 2009/2010
The purpose of this study is to verify the immunogenicity and tolerance of a trivalent
 seasonal influenza vaccine with strain composition according to World Heath
 Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly
 licensing application.
Inclusion Criteria:

 -  Subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects
 in age stratum A only)

 -  Subject is 60 years of age or older , inclusive, at the time of screening (for
 subjects in age stratum B only)

 -  Subject has given written informed consent prior to study entry

 -  Subject is generally healthy , as determined by the investigator's clinical judgment
 through collection of medical history and performance of a physical examination, such
 that the investigator would not hesitate to provide routine influenza immunization to
 the subject in the course of routine medical practice

 -  Subject agrees to keep a daily record of symptoms for the duration of the study

 -  If female of childbearing potential, subject presents with a negative urine pregnancy
 test, and agrees to employ adequate birth control measures for the duration of the
 study

 -  Subject is willing and able to comply with the requirements of the protocol

 Exclusion Criteria:

 -  Subject has a history of severe allergic reaction or anaphylaxis

 -  Subject has an oral temperature of >= 37.5°C on the day of vaccination in this study

 -  Subject has a rash or dermatologic condition or tattoos, which may interfere with
 injection site reaction rating

 -  Subject has received a live vaccine within 4 weeks or an inactivated or subunit
 vaccine within 2 weeks of study entry

 -  Subject has received a seasonal influenza vaccine within 6 months of study entry

 -  Subject currently has or had a history of a significant neurological, cardiovascular,
 pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological
 or renal disorder

 -  Subject has any inherited or acquired immunodeficiency

 -  Subject has a disease or is currently undergoing a form of treatment or was undergoing
 a form of treatment within 30 days prior to study entry that can be expected to
 influence immune response. Such treatment includes, but is not limited to, systemic or
 high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent)
 corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.

 -  Subject has a functional or surgical asplenia

 -  Subject has a known or suspected problem with alcohol or drug abuse

 -  Subject is a member of the team conducting this study or is in a dependent
 relationship with one of the study team members. Dependent relationships include close
 relatives (ie, children, partner/spouse, siblings, parents) as well as employees of
 the investigator or site personnel conducting the study

 -  If female, subject is pregnant or lactating at the time of study enrollment