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

Institute of Medical Biology, Chinese Academy of Medical Sciences1,200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,200

Conditions

Influenza

Interventions

Influenza Virus Vaccine(no Preservative )BIOLOGICAL

Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections

Influenza Virus Vaccine(contains Preservative)BIOLOGICAL

Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 35 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Dingxing Center for Disease Prevention and Control

Shijiazhuang, Hebei, China

Outcomes

Primary Outcomes

To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）

Time frame: six months

Data from ClinicalTrials.gov

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