CompletedPhase 4

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Healthy Subjects Aged Over 6 Months Old to 18 Years Old

181 participantsStarted 2010-07

Plain-language summary

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.

Who can participate

Age range6 Months – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

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.

Timeframe: Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination.

Trial details

NCT IDNCT01356342

SponsorAdimmune Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-04