The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains Preservative.

Detailed Description
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Influenza Virus Vaccine (Split Virion, Inactivated) that do not contain Preservative. HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B. Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B. This is a randomized, blind phase 3 clinical trial. Total 1200 adults (ages from 6 months to 36 months ) were selected, randomized to two groups [Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600], adults in each group will be vaccinated with two doses of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively,21 days apart.

Official Title
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The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)（Children Forms of Drug）

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influenza Virus Vaccine(no Preservative )
* Biological: Influenza Virus Vaccine(contains Preservative)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, age from 6 months to 35 months ; Adults, parent(s) or guardians are able to understand and sign informed consent for participation; Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; Infants no vaccinated with influenza or other preventive biologicals in recent 7 days; Axillary temperature ≤37℃. Exclusion Criteria: Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy; Low platelet or bleeding disorder do not allow vaccination into the muscle; Have damaged or lower immunological function; Received blood, plasma or immunoglobulin treatment since birth; Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome ); Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV. Exclusion Criteria for doses 2 Have serious anaphylaxis or high fever, convulsion during first dose; Have any circus of Exclusion Criteria after Eligible for study; Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria; Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents; Vaccinated with any other vaccine（except DTP）; Stop observation determined by investigator owing to occurring serious adverse event.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Team 1<br>Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections | Biological: Influenza Virus Vaccine(no Preservative )<br>* Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections<br>|
| Experimental: Team 2<br>Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections | Biological: Influenza Virus Vaccine(contains Preservative)<br>* Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections<br>* Other names: Vaxigrip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug） |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza Virus Vaccine (Split Virion, Inactivated), Influenza