The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）

Influenza Virus Vaccine (Split Virion, Inactivated) that do not contain Preservative. HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B.

Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B.

This is a randomized, blind phase 3 clinical trial. Total 1200 adults (ages from 6 months to 36 months ) were selected, randomized to two groups [Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600], adults in each group will be vaccinated with two doses of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively,21 days apart.

Inclusion criteria

• Males and females, age from 6 months to 35 months ;
• Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
• Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
• Infants no vaccinated with influenza or other preventive biologicals in recent 7 days;
• Axillary temperature ≤37℃.

Exclusion criteria

• Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy;
• Low platelet or bleeding disorder do not allow vaccination into the muscle;
• Have damaged or lower immunological function;
• Received blood, plasma or immunoglobulin treatment since birth; Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
• Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.

Exclusion criteria

for doses 2

• Have serious anaphylaxis or high fever, convulsion during first dose;
• Have any circus of Exclusion Criteria after Eligible for study;
• Have serious adverse event which related to previous vaccination;
• Withdrawal and Discontinuance Criteria;
• Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
• Vaccinated with any other vaccine（except DTP）;
• Stop observation determined by investigator owing to occurring serious adverse event.