NCT01551810

The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 36 Months
• Healthy volunteers: Accepted

Summary

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

Detailed description

Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative. HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B. Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B. This is a randomized, blind phase 3 clinical trial. Total 1200 adults (above ages 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 one dose of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Virus Vaccine	Influenza Virus Vaccine 0.5ml intramuscular injections
BIOLOGICAL	Influenza Virus Vaccine(contains Preservative)	Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-05-01
• Completion: 2012-08-01
• First posted: 2012-03-13
• Last updated: 2023-10-11

Locations

1 site across 1 country: China