Safety and Immunogenicity Study of Split Influenza Virus Vaccine in Different Age Groups

Study Overview
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Brief Summary
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The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.

Detailed Description
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Observational Objectives: To describe the safety of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months,6th to 12th birthday and ≥ 60th birthday. To describe the immunogenicity of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months, 6th to 12th birthday and ≥ 60rd birthday.

Official Title
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Evaluation of Safety and Immunogenicity Among Different Age-groups Receiving Different Split Influenza Vaccines

Conditions
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Influenza

Intervention / Treatment
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* Biological: evaluated vaccine
* Biological: imported compared vaccine
* Biological: domestic compared vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants were enrolled (toddlers: 6 months to 3 years; school-aged children: 6 to 12 years and older adults: ≥60 years） Eligible participants were generally healthy or had stable chronic medical conditions (for older adults only) Exclusion Criteria: History of allergic reaction to any component of the study vaccines or previous influenza vaccine History of systemic hypersensitivity to hens' eggs History of Guillain Barré syndrome following administration of any influenza vaccine Any immunodeficient or immunocompromised conditions Receipt of cytotoxic or immunosuppressive drugs within the past 6 months Receipt of blood-derived product within the past 3 months Receipt of any vaccine within one month prior to study entry with exception of paediatric routine vaccination Receipt of non-study 2010-2011 seasonal TIV Participation in any other study with a non-approved drug during the study Acute febrile disease and other self-limiting illness were the temporary exclusion criteria

Ages Eligible for Study
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Minimum Age: 6 Months

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: evaluated vaccine<br>0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) | Biological: evaluated vaccine<br>* 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)<br>Biological: imported compared vaccine<br>* 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)<br>Biological: domestic compared vaccine<br>* 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)<br>|
| Active Comparator: imported compared vaccine<br>0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) | Biological: evaluated vaccine<br>* 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)<br>Biological: imported compared vaccine<br>* 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)<br>Biological: domestic compared vaccine<br>* 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)<br>|
| Active Comparator: domestic compared vaccine<br>0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) | Biological: evaluated vaccine<br>* 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)<br>Biological: imported compared vaccine<br>* 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)<br>Biological: domestic compared vaccine<br>* 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the immunogenicity of evaluated vaccine | The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs. | 6 months | 
| To evaluate the safety | The incidence of adverse events was analyzed statistically | 4 months |