Influenza Clinical Trial
Verified date | December 2012 |
Source | Adimmune Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Taiwan Food and Drug Administration |
Study type | Interventional |
This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects aged between 6 months old to 18 years old. All participants will be divided into three age cohorts. First, participants aged 6 through < 36 months will receive 2 doses of 0.25 mL vaccine separated by 4 weeks. Second, participants aged 3 through < 9 years will receive 2 doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through < 18 years will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO haemaglutination inhibition reference technique. The analysis will be observer-blinded. All participants will be followed, either by clinical visit or by telephone contact, for 6 months after the first vaccination for safety reasons.
Status | Completed |
Enrollment | 181 |
Est. completion date | May 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 18 Years |
Eligibility |
Inclusion Criteria: - Boys or girls and aged 6 months old to 18 years old on the day of first vaccination; - Subject and/or parents(s)/legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits; - Subject must be 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: - Subjects received influenza vaccine (Trivalent and/or A(H1N1)) within the previous 6 months; - History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication; - Personal or family history of Guillain-Barré Syndrome; - An acute febrile illness within 1 week prior to vaccination; - Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours; - Subjects with influenza-like illness as defined by the presence of fever (temperature ³38ºC) 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 vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation; - Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation; - Receipt of any blood products, including immunoglobulin in the prior 3 months; - Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine; - Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Adimmune Corporation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2010-2011 season) of the AdimFlu-S manufactured by Adimmune Corporation. | Serum samples will be obtained prior to vaccination, and 4 weeks after each vaccination. Serum samples will be tested for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI), and assays will be performed at Adimmune Corporation designated central laboratory. Subjects will be considered to be seronegative if serum HAI titer<1:10. The seroconversion is defined as the post-vaccination serum at least 40 for whom had negative pre-vaccination or a fourfold or greater increase in HAI titers in subjects who had positive pre-vaccination serum. | Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination. | No |
Secondary | The secondary objective is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation. | Reactogenicity events are pre-specified adverse events systematically recorded on diary cards (a grid of check boxes for each event and each day) during the immediate post-vaccination period by all participants. In general, reactogenicity events will be recorded for 7 days after each vaccination. The selection of the events to be collected systematically is based on events expected to occur with wild-type influenza infection. | Safety data will consist of reactogenicity, serious and non-serious adverse events throughout the study, including 7 days after each dose of study vaccine. Vital signs and physical examination will be performed at each clinic visit. | Yes |
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