Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

Study Overview
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Brief Summary
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To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.

Official Title
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The Clinical Trial for Three Consecutive Lots of Influenza Split Vaccine Anflu by Randomized, Double-Blind and Controlled Design

Conditions
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Influenza

Intervention / Treatment
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* Biological: seasonal split influenza vaccine
* Biological: seasonal split influenza vaccine
* Biological: seasonal split influenza vaccine
* Biological: seasonal split influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged 18-60 years old 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Lot 1<br> | Biological: seasonal split influenza vaccine<br>* 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime<br>|
| Experimental: 2: Lot 2<br> | Biological: seasonal split influenza vaccine<br>* 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime<br>|
| Experimental: 3: Lot 3<br> | Biological: seasonal split influenza vaccine<br>* 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime<br>|
| Active Comparator: 4: control vaccine<br> | Biological: seasonal split influenza vaccine<br>* 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B |  | 0, 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local and systematic adverse reactions after vaccination |  | within 3 days after vaccination |