Recruitment

Recruitment Status
Completed
Estimated Enrollment
Same as current

Summary

Conditions
Influenza
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Younger than 635 years
Gender
Both males and females

Description

Influenza Virus Vaccine (Split Virion, Inactivated) that do not contain Preservative. HA contents 7.5?g/0.5ml per dose include H1N1?H3N2 and B. Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 7.5?g/0.5ml per dose include H1N1?H3N2 and B. This is a randomized, blind...

Influenza Virus Vaccine (Split Virion, Inactivated) that do not contain Preservative. HA contents 7.5?g/0.5ml per dose include H1N1?H3N2 and B. Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 7.5?g/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.

Tracking Information

NCT #
NCT01551823
Collaborators
Hebei CDC ,China
Investigators
Principal Investigator: Guoyang Liao, Ph. D Chinese Academy of Medical Sciences Principal Investigator: Yuliang Zhao, MD Hubei Provincial Center for Disease Control and Prevention