Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Elderly

Inclusion Criteria:

• Age ≥ 65 years old on the day of screening, having Thai ID card or equivalent
• Able to read and write in Thai and sign written informed consent form
• Able to attend all scheduled visits and to comply with all trial procedures.
• Healthy or medically stable, as established by medical history and physicalexamination. For individuals with medical conditions, symptoms/signs, if present mustbe stable, under control or unchanged for the past three months. If medication is usedto treat the condition, the medication dose must have been stable for at least onemonth preceding vaccination.

Exclusion Criteria:

• Participation in another clinical trial involving any therapy within the previousthree months or planned enrollment in such a trial during the period of this study.
• Hypersensitivity after previous administration of any vaccine.
• Having a history of H1N1, H3N2 or FluB infection within 3 months preceding enrollmentto the trial
• Vaccination against influenza in the past 6 months preceding enrollment to the trial
• Receipt of any non-study vaccine within four weeks prior to enrollment or refusal topostpone receipt of such vaccines until after the Day 28 visit.
• History of bronchial asthma, chronic lung diseases, chronic rhinitis
• History of immunodeficiency state
• History of immunosuppression < 6 months prior to immunization
• History of anaphylactic or other allergic reactions to influenza vaccine or anyvaccine component or excipient (e.g. egg proteins, gentamicin or thimerosal)
• History of Guillain-Barré Syndrome or cerebrovascular events
• Having acute infection with fever > 38 degree Celsius or noninfectious diseases (within 72 hours) preceding enrollment in the trial
• Volunteers who have been taking immunoglobulin products or have had a bloodtransfusion during past 3 months before the beginning of the trial or planned receiptof such products prior to the Day 28 visit.
• Current alcohol abuse or drug addiction that might interfere with the ability tocomply with trial procedures
• Any condition that in the opinion of the investigator would pose a health risk to thesubject if enrolled, or could interfere with the evaluation of the vaccine
• Study site employees who are involved in the protocol and/or may have direct access tostudy related area