The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg
* Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg
* Biological: split-virion, non-adjuvanted H1N1 vaccine of 45 μg
* Biological: Placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Different age groups from 18 to 60 years, with normal intelligence and health. Volunteers (or their guardians) are well informed of the situation and sign the consent Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy Requests of clinical research program can be obeyed No other protective product is inoculated in last week Axillary temperature below 37 degrees Celsius Exclusion Criteria: Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg History of progressive or severe neurologic disorder Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws History of thyroidectomy or thyroid disease that required medication within the past 12 months Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years Guillain-Barre Syndrome Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination Any conditions may influence the evaluation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: split-virion, non-adjuvanted vaccine of 15 μg<br>split-virion, non-adjuvanted H1N1 vaccine of 15 μg. | Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg<br>* 120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.<br>|
| Experimental: split-virion, non-adjuvanted vaccine of 30 μg<br>split-virion, non-adjuvanted H1N1 vaccine of 30 μg. | Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg<br>* 120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.<br>|
| Experimental: split-virion, non-adjuvanted vaccine of 45 μg<br>split-virion, non-adjuvanted H1N1 vaccine of 45 μg. | Biological: split-virion, non-adjuvanted H1N1 vaccine of 45 μg<br>* 120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.<br>|
| Placebo Comparator: Placebo control<br>Placebo control | Biological: Placebo control<br>* 120 adults were assigned to receive 1 dose of placebo.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemagglutination inhibition antibody titer |  | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of solicited local and systemic adverse events after vaccination |  | Days 0-42 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
H1N1, Vaccine, Immunogenicity, Safety