Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart, in infants between 6 and 12 months of age.

Official Title
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Clinical Study Protocol Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011， in Infants Aged Between 6-12months Old

Conditions
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Influenza

Intervention / Treatment
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* Biological: AdimFlu-S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Boys or girls and aged >= 6 months old to <= 12 months old on the day of first vaccination; Subject's parent(s) or 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's parent(s) or legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure. Exclusion Criteria: Subjects had received influenza vaccine; History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication; Personal or family history of Guillain- Barre' 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 >= 38'C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent; Immunodeficiency, immunosuppressive or significant chronic illness not suitable for inactivated influenza vaccination; 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: AdimFlu-S|0.25mL per injection 2 injections at 4 weeks apart|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HA antibody titers will be determined using the WHO HAI reference technique. |  | Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Safety data will consist of reactogenicity, serious and non-serious adverse events. Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after each vaccination. The events included fever (≥38.0°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions were also evaluated, including soreness/pain, swelling, redness, ecchymosis and limitation of arm motion. | (4 weeks after two doses of study vaccine, 4 weeks apart), Physical examination will be performed at each visit. Reactogenicity will be recorded for 7 days after each vaccination. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccine, Immunogenicity