the immunogenicity and safety of 2013-2014 seasonal trivalent influenza vaccine

Conditions: Influenza

Summary: the purpose of this study is to evaluate the immunogenicity and safety of northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged \> 60 years.


Eligibility criteria:
for adults and seniors: inclusion criteria: * healthy adults aged 18-60 years old, and healthy seniors aged \> 60 years old; * without vaccination history of seasonal split influenza vaccine in the recent 3 years * no traveling plan during the study period of this trial; * be able to understand and sign the informed consent; exclusion criteria: * allergic to egg products or any ingredient of the study vaccine; * fever, influenza or acute illness on the vaccination day; * acute stage of chronic illness; * malignant tumor; * immunodeficiency, includes hiv infection; * guillain-barre syndrome; * administration of live attenuated vaccine within the previous 14 days; * administration of subunit or inactivated vaccine within the previous 7 days; * planned to participate in any other clinical trial of drug or vaccine during this study; * received immunesuppressive treatment within the previous month, or planned for such treatment during this study; * pregnant, or planning pregnancy; * axillary temperature \> 37.0℃; * any other factors that, in the judgment of the investigator, is unsuitable for this study; for 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 or legal guardian is able to understand and sign the informed consent; exclusion criteria: * received seasonal influenza vaccine after june 30, 2012; * acute infection within the previous week; * allergy history, or allergic to any ingredient of the study vaccine, such as egg; * history of serious adverse reaction (sar) to vaccine; * autoimmune disease or immune deficiency, or administration of immunosuppressive therapy, cell toxic therapy, or inhaled corticosteroid within the previous 6 months; * congenital malformations, developmental disorder or serious chronic disease; * unstable condition of asthma and administration of corticosteroid in the most recent two years; * coagulation abnormalities or disorders; * history/ family history of infantile convulsion, epilepsy, cerebropathy, or mental disease; * without spleen; * severe neurological diseases, such as guillain-barre syndrome; * administration of blood products or investigational drug within the previous month; * administration of live attenuated vaccine within the previous 14 days; * administration of subunit or inactivated vaccine within the previous 7 days; * received treatment for allergy within the previous 14 days; * on-going anti-tuberculosis therapy; * axillary temperature \> 37.0℃ immediately before vaccination; * any other factors that, in the judgment of the investigator, is unsuitable for this study;

Keywords: seasonal trivalent inactivated influenza vaccine immunogenicity safety cross-reactivity northern hemisphere 2013-2014 formulation