Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants

Inclusion criteria

• Healthy male or female aged between 6 and 35 months
• Full-term birth, birth weight 2,500 grams or more
• provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent

Exclusion criteria

• Cases, cured cases and close contact of influenza A (H1N1) virus
• Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• Symptoms of acute infection within a week
• Autoimmune disease or immunodeficiency
• Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
• Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
• Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
• History or family history of convulsions, epilepsy, brain disease and psychiatric
• Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
• Guillain-Barre Syndrome
• Administration of 2009-2010 seasonal vaccine
• History of any blood products within 3 months
• Administration of any other investigational research agents within 30 days
• Administration of any live attenuated vaccine within 30 days
• Administration of subunit or inactivated vaccines within 14 days
• Be receiving anti-TB prophylaxis or therapy currently
• Axillary temperature > 37.0 centigrade at the time of dosing
• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent