Study of the Safety, Tolerability and Immunogenicity of an Intranasal Influenza Vaccine Administered to Healthy Adults

Inclusion criteria

• Non-smoking adult aged between 20-40 years old;
• Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest X-rays, ophthalmoscopy, cardiac echo, and electrocardiogram;
• Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]);
• Normal hematology, biochemistry and urinalysis determinations;
• Subject is willing and able to comply with study procedures and sign informed consent

Exclusion criteria

• Subject with serious underlying chronic illness;
• Documented evidence of allergic rhinitis;
• Subject with acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to enrollment;
• Immunosuppressed subjects as result of illness or treatment;
• Female subject of childbearing potential who:

• is lactating; or
• has positive urine pregnancy test at Visit 2 or Visit 3; or
• refuse to adopt reliable method of contraception during the study;
• Subject received blood products or immunoglobulin within 3 months prior enrollment;
• Subjects with long-term use of steroids, including parenteral steroids or high dose inhaled steroids within 28 days prior to enrollment;
• Subject has received any intranasal medication or nasal topical treatment within 7 days prior to enrollment;
• Subject has received any investigational agent within 28 days or 5 half- lives, whichever is longer, prior to the first dose of investigational product;
• Subject has previously experienced anaphylaxis;
• Subject has allergy to eggs or prior influenza vaccine;
• Subject with laboratory-confirmed influenza or has been vaccinated against influenza within 6 months prior to enrollment;
• Subject with acute respiratory illness or administered antibiotics or antivirals within 7 days prior to enrollment;
• Subject with body temperature high than 38°C within 3 days prior to enrollment;
• Subject with documented history of Bell's palsy or neurological disorder.
• Subject with documented history of diarrhea within one month prior to study enrollment
• A positive test for HIV antibody.
• Subject has received Chinese medication or herbal medication within 28 days prior to enrollment