The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-08-31

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) that do not contains Preservative .

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Detailed Description

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Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative. HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.

Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.

This is a randomized, blind phase 3 clinical trial. Total 1200 adults (above ages 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 one dose of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Influenza Virus Vaccine

Influenza Virus Vaccine（no Preservative ) 0.5ml intramuscular injections

Group Type EXPERIMENTAL

Influenza Virus Vaccine

Intervention Type BIOLOGICAL

Influenza Virus Vaccine 0.5ml intramuscular injections

Influenza Virus Vaccine(contains Preservative)

Intervention Type BIOLOGICAL

Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections

Influenza Virus Vaccine(Preservative)

Influenza Virus Vaccine（add Preservative ) 0.5ml intramuscular injections

Group Type EXPERIMENTAL

Influenza Virus Vaccine

Intervention Type BIOLOGICAL

Influenza Virus Vaccine 0.5ml intramuscular injections

Influenza Virus Vaccine(contains Preservative)

Intervention Type BIOLOGICAL

Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections

Interventions

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Influenza Virus Vaccine

Influenza Virus Vaccine 0.5ml intramuscular injections

Intervention Type BIOLOGICAL

Influenza Virus Vaccine(contains Preservative)

Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections

Intervention Type BIOLOGICAL

Other Intervention Names

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Vaxigrip

Eligibility Criteria

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Inclusion Criteria

* Males and females, age above 36 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.

Minimum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes