Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine

Study Overview
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Brief Summary
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A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).

Official Title
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Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza (H5N1)Vaccine in Two-Dose Primed Healthy Adults: A Single Center, Non-Randomized Clinical Trial

Conditions
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Pandemic Influenza Vaccine, Prevention, Pandemic Influenza

Intervention / Treatment
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* Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
* Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
* Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
* Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Had received two-dose priming vaccination in previous phase I trial Be able to show legal identity card for the sake of recruitment 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 to vaccines or eggs Autoimmune disease or immunodeficiency Diabetes mellitus (type I or II), with the exception of gestational diabetes Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study 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 History of any blood products administration within 3 months before the dosing Administration of any other investigational research agents within 30 days before the dosing Administration of any live attenuated vaccine within 30 days before the dosing Administration of subunit or inactivated vaccines, e.g. pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing Be receiving anti-TB prophylaxis or therapy currently 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: 19 Years
Maximum Age: 61 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No.1: 1.25 ug<br> | Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)<br>* pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection<br>|
| Experimental: No.2: 2.5 ug<br> | Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)<br>* pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection<br>|
| Experimental: No.3: 5.0 ug<br> | Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)<br>* pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection<br>|
| Experimental: No. 4: 10 ug<br> | Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)<br>* pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HI antibody Neutralization antibody |  | 15 and 30 days after the booster dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local adverse reactions systemic adverse reactions temperature |  | 3 days after booster dose |