Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine

Study Overview
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Brief Summary
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Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May, 2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza vaccine of Hualanbio has obtained production permission and marketing authorization in May, 2008. In order to further investigate the safety and immunogenicity of the vaccine in the market, The clinical observation was planned to be conducted in Mianyang city (Yanting County), Sichuan Province, China.

Detailed Description
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Dosage and administration route in this clinical trial: Subjects age 3 years or older was vaccinated following a single 0.5ml dose immunization regime. The preferred site of injection was the at the skin near outboard deltoid muscle of the upper arm. The administration route is after the sanitization with 75% alcohol, intramuscularly inject the test vaccine or the control vaccines when the skin was slightly dried for those subjects complied with the inclusion requirements. Safety indicators: Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reaction within 30 minutes ; Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reactions through 6 hours to the 29th day ; Summarize the adverse events/severe adverse events and the incidence levels from the inclusion of the subjects to the completion of the clinical trial. Immunogenicity indicators: Evaluate the Post-vaccination immunogenicity of the test and the control influenza vaccines in persons age 3 years and older by its HI antibody level on Day 28. Take 1:10 serum dilution as the minimum dilutability. The seroconversion in this trial was defined as the post-vaccination HI antibody titer ≥ 1:40 when the HI antibody < 1:10 before the vaccination or the post-vaccination HI antibody titer quadruply increased when HI antibody ≥ 1:10 before the vaccination. The Immunogenicity criteria set for this clinical trial is the seroconversion shall be > 40% after 14 days of the vaccination.

Official Title
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Post-marketing Clinical Observation of Hualan's Inactivated Influenza Vaccine: A Single Center, Parallelled, Controlled, Randomised Clinical Trial

Conditions
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Human Influenza

Intervention / Treatment
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* Biological: Inactivated Influenza Vaccine
* Biological: Inactivated Influenza Vaccine of Pasteur
* Biological: Inactivated Influenza Vaccine of GSK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female age 3 and older, volunteers or their guardians are able to understand and sign the informed consent; Healthy male or female by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product; Be able to comply with the requirement of clinical trial protocol; Have no history of vaccination within the past 6 months and vaccination with other product within the latest 1 week; Axillary temperature <37.1℃. Exclusion Criteria: Subject that was allergic to eggs and any component of the vaccine, or has history of other allergy; Fever, acute disease or acute onset of chronic disease and influenza; Guillain-Barre Syndrome

Ages Eligible for Study
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Minimum Age: 3 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inactivated Influenza Vaccine<br>15μg HA/strain/0.5ml/syringe, Hualan Biologicals | Biological: Inactivated Influenza Vaccine<br>* 200 subjects were randomly assigned (60 children, 100 adults and 40 elders) to receive Inactivated Influenza Vaccine (Split virion) of Hualan Biologicals, 15ug HA/strain/0.5ml/syringe, one dose regime<br>* Other names: Hualan Biologicals;|
| Active Comparator: Inactivated Influenza Vaccine of Pasteur<br>15ug HA/strain/0.5ml/syringe, Sanofi Pasteur | Biological: Inactivated Influenza Vaccine of Pasteur<br>* 200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive the Inactivated Influenza Vaccine of Sanofi Pasteur, 15ug HA/strain/0.5 ml/syringe, one dose regime,<br>* Other names: VAXIGRIP;|
| Active Comparator: Inactivated Influenza Vaccine of GSK<br>15ug HA/strain/0.5ml/syringe, GSK | Biological: Inactivated Influenza Vaccine of GSK<br>* 200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive Inactivated Influenza Vaccine (Split virion) of GSK, 15ug HA/strain/0.5ml/syringe, one dose regime<br>* Other names: Fluarix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse reactions as a measure of safety study | Local reactions, systemic reactions, severity degree and AEFI correlation | 28 days after the vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation of the immunological effect | HI antibody seroconversion ratios | 28 days after the immunization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Tract Infections; Orthomyxoviridae Infections