The Immunogenicity and Safety of 2012-2013 Trivalent Seasonal Influenza Vaccine

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy older people aged > 60 years.

Official Title
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A Single-centered, Open-labeled, Phase 4 Study of 2012-2013 Trivalent Seasonal Influenza Vaccine

Conditions
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Influenza

Intervention / Treatment
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* Biological: 2012-2013 trivalent seasonal influenza vaccine


Participation Criteria
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Eligibility Criteria
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For adults and old people: Inclusion Criteria: Healthy adults aged 18-60 years old, and healthy old people aged >60 years Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years Not participate in any other clinical trials during the study Not receive any immunosuppressive agents during and one month prior to the study Be able to understand and sign the informed consent. Exclusion Criteria: Woman： Who breast-feeding or planning to become pregnant during the study Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Autoimmune disease or immunodeficiency Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases Guillain-Barre Syndrome Women subjects with positive urinary pregnancy test Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) Axillary temperature >37.0 centigrade at the time of dosing Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent. For infants: Inclusion Criteria: Healthy male or female aged between 6 and 35 months Full-term birth, birth weight 2,500 grams or more provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent Exclusion Criteria: Administration of 2012-2013 seasonal vaccine Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Symptoms of acute infection within a week Autoimmune disease or immunodeficiency Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders) Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with Intramuscular injections or blood draws History or family history of convulsions, epilepsy, brain disease and psychiatric Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen Guillain-Barre Syndrome History of any blood products within 3 months Administration of any other investigational research agents within 30 days Administration of any live attenuated vaccine within 30 days Administration of subunit or inactivated vaccines within 14 days Be receiving anti-Tuberculosis prophylaxis or therapy currently Axillary temperature > 37.0 centigrade at the time of dosing Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 85 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trivalent seasonal influenza vaccine<br>2012-2013 trivalent seasonal influenza vaccine in 60 infants with two-dose regimen, 21 days interval trivalent seasonal influenza vaccine in 60 adults and 60 old people with single-dose regimen | Biological: 2012-2013 trivalent seasonal influenza vaccine<br>* trivalent seasonal influenza vaccine with 0.25 ml ⁄ vial, for infants trivalent seasonal influenza vaccine with 0.5 ml ⁄ vial, for adults and old people<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemagglutination inhibition (HI) antibody titer of 2012-2013 trivalent seasonal influenza vaccine | to evaluate the immunogenicity of the vaccine in adults and old people. | 21 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of systemic and local adverse reactions after vaccination | to evaluate the safety of the vaccine in healthy infants, adults, and old people | 0-21 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2012-2013 trivalent seasonal influenza vaccine, immunogenicity,, safety