immunogenicity and safety of influenza virus vaccine, adimflu-s (a/h1n1), in pediatric population

Conditions: Influenza

Summary: this is a laboratory-blinded study in healthy toddlers, children, and teenagers designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza h1n1 vaccine (adimflu-s). there are 3 age strata, and each contains at least 50 subjects: greater than or equal to 1 year to less than 3 years, greater than or equal to 3 years to less than 6 years, and greater than or equal to 6 years to less than 18 years. in each age strata, all eligible subjects received 2 injections of adimflu-s (a/h1n1) at a designated dosage level (7.5 μg, 15 μg and 15 μg for 1\~\<3, 3\~\<6 and 6\~\<18 years, respectively) at 3 weeks apart. following immunization, safety is measured by assessment of adverse events for 6 weeks following the first vaccination, serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination, and reactogenicity to the vaccines for 7 days following each vaccination. immunogenicity testing includes hemagglutination inhibition (hai) testing on serum obtained before first vaccination, and three and six weeks after first vaccination.


Eligibility criteria:
inclusion criteria: * boys or girls aged ≧ 1 year old to 18 years old on the day of first vaccination; * subject and/or parents(s)/legal guardian(s) was willing to comply with planned study procedures and be available for all study visits; * subject was in good physical health on the basis of medical history, physical examination; * subject and/or parents(s)/legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure. exclusion criteria: * subject ever received influenza vaccine within the previous 6 months; * history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication (adimflu-s (a/h1n1)); * personal or family history of guillain-barré syndrome; * an acute febrile illness within the last 72 hours prior to vaccination; * subject with bleeding disorder or has any coagulation disorder that needs receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection; * subjects with influenza-like illness as defined by the presence of fever (temperature ≧38.5℃ ) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough; * female subjects who are pregnant, lactating or likely to become pregnant during the study; women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, iud, barrier device or abstinence) throughout the study; * treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent; * immunodeficiency, immunosuppressive or household contact with immunosuppression; * history of wheezing or bronchodilator use within 3 months prior to study vaccine; * receipt of live virus vaccine within 1 month prior to study vaccination or expected receipt within 2 months after first study vaccination; * receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination within 3 weeks after the immunogenicity evaluation period; * receipt of any blood products, including immunoglobulin in the prior 3 months; * underlying condition in the investigator's opinion may be inappropriate for vaccination; * significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.

Keywords: influenza h1n1 vaccine immunogenicity