Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants

Study Overview
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Brief Summary
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A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).

Official Title
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A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants

Conditions
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Influenza

Intervention / Treatment
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* Biological: Pandemic influenza A/H1N1 vaccine
* Biological: Pandemic influenza A/H1N1 vaccine
* Biological: Seasonal trivalent vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female aged between 6 and 35 months Full-term birth, birth weight 2,500 grams or more provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent Exclusion Criteria: Cases, cured cases and close contact of influenza A (H1N1) virus Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Symptoms of acute infection within a week Autoimmune disease or immunodeficiency Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders) 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 or family history of convulsions, epilepsy, brain disease and psychiatric Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen Guillain-Barre Syndrome Administration of 2009-2010 seasonal vaccine History of any blood products within 3 months Administration of any other investigational research agents within 30 days Administration of any live attenuated vaccine within 30 days Administration of subunit or inactivated vaccines within 14 days Be receiving anti-TB prophylaxis or therapy currently Axillary temperature > 37.0 centigrade at the time of dosing 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: 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine<br>120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart | Biological: Pandemic influenza A/H1N1 vaccine<br>* Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose<br>|
| Experimental: Group 2 : 15 μg pandemic influenza A/H1N1 vaccine<br>120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart | Biological: Pandemic influenza A/H1N1 vaccine<br>* Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose<br>|
| Sham Comparator: Group 3 : 7.5 μg seasonal trivalent vaccine<br>60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart | Biological: Seasonal trivalent vaccine<br>* Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants |  | 3 months |