Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

Inclusion criteria

• Healthy infants aged between 6 and 35 months
• full-term birth with birth weight above 2,500 grams
• Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures

Exclusion criteria

• Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
• Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
• History of progressive or severe neurologic disorder
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
• 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 of thyroidectomy or thyroid disease that required medication within the past 12 months
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
• Guillain-Barre Syndrome
• Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
• Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
• Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
• Any conditions may influence the evaluation