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

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

The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains Preservative.

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.