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

Launched by SINOVAC BIOTECH CO., LTD · Jan 11, 2010

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male or female aged between 6 and 35 months
• • 2. Full-term birth, birth weight 2,500 grams or more
• • 3. provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent
• Exclusion Criteria:
• • 1. Cases, cured cases and close contact of influenza A (H1N1) virus
• • 2. 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
• • 3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• • 4. Symptoms of acute infection within a week
• • 5. Autoimmune disease or immunodeficiency
• • 6. Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
• • 7. 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
• • 8. 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
• • 9. History or family history of convulsions, epilepsy, brain disease and psychiatric
• • 10. Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
• • 11. Guillain-Barre Syndrome
• • 12. Administration of 2009-2010 seasonal vaccine
• • 13. History of any blood products within 3 months
• • 14. Administration of any other investigational research agents within 30 days
• • 15. Administration of any live attenuated vaccine within 30 days
• • 16. Administration of subunit or inactivated vaccines within 14 days
• • 17. Be receiving anti-TB prophylaxis or therapy currently
• • 18. Axillary temperature \> 37.0 centigrade at the time of dosing
• • 19. 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