Clinical trial NCT01356342: Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Healthy Subjects Aged Over 6 Months Old to 18 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Vaccine
Immunogenicity
Lead sponsor: Adimmune Corporation
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 181
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: 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.
timeFrame: 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.
Other outcomes:
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Study officials:
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