Safety and Immunogenicity of a Subunit Trivalent Influenza Vaccine, Northern Hemisphere Formulation 2013/2014, in Healthy Adults Aged 18 Years and Above

Exclusion Criteria

• •Had behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may have interfered with the subject's ability to participate in the study;
• •Had a serious chronic or acute disease (in the judgment of the investigator) including, but not limited to:
• •* medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years, or localized prostate cancer that had been clinically stable for \>2 years without treatment)
• •* medically significant advanced congestive heart failure (ie, New York Heart Association \[NYHA\] class III and IV)
• •* chronic obstructive pulmonary disease (ie, Global initiative for chronic Obstructive Lung Disease \[GOLD\] stage III and IV)
• •* autoimmune disease (including rheumatoid arthritis and excepting Hashimoto's thyroiditis that has been clinically stable for ≥5 years)
• •* diabetes mellitus type I
• •* poorly controlled diabetes mellitus type II
• •* advanced arteriosclerotic disease
• •* history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (eg, Down's syndrome)
• •* acute or progressive hepatic disease
• •* acute or progressive renal disease
• •* severe neurological (especially Guillain-Barré syndrome) or psychiatric disorder
• •* severe asthma
• •Had a history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine;
• •Had a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
• •* receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study,
• •* receipt of immunostimulants within the past 6 months,
• •* receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within the past 3 months and for the full length of the study, or
• •* suspected or known human immunodeficiency virus (HIV) infection or HIV related disease
• •Had known or suspected drug or alcohol abuse within the past 2 years;
• •Had bleeding diathesis or conditions associated with prolonged bleeding time that, in the investigator's opinion, would interfere with the safety of the subject;
• •Was not able to comprehend and to follow all required study procedures for the whole period of the study;
• •Had a history or any illness that, in the opinion of the investigator, would pose additional risk to the subjects because of participation in the study;
• •Had the following within the past 6 months:
• •* any laboratory confirmed seasonal or pandemic influenza disease
• •* received any seasonal or pandemic influenza vaccine
• •Had received any other vaccine within 4 weeks prior to enrollment in this study or were planning to receive any vaccine during the study;
• •Had acute or chronic infections requiring antiviral therapy within the last 7 days;
• •Had experienced fever (ie, body temperature \[preferably oral\] ≥38.0°C) within the last 3 days of intended study vaccination;
• •Had been participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intends to participate in another clinical study at any time during the conduct of this study;
• •Was part of study personnel or has close family members conducting this study;
• •Had a body mass index (BMI) \>35 kg/m2 (BMI is calculated by dividing the subject's weight in kilograms by the subject's height in meters multiplied by the subject's height in meters).
• •Was pregnant (confirmed by positive urine pregnancy test) or nursing (breastfeeding) or was a female of childbearing potential who refused to use an acceptable method of birth control for the whole duration of the study.