NCT00556062

Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

The Clinical Trial for Three Consecutive Lots of Influenza Split Vaccine Anflu by Randomized, Double-Blind and Controlled Design

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 566 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	seasonal split influenza vaccine	0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
BIOLOGICAL	seasonal split influenza vaccine	0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
BIOLOGICAL	seasonal split influenza vaccine	0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
BIOLOGICAL	seasonal split influenza vaccine	0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

Timeline

• Start date: 2007-09-01
• Completion: 2007-11-01
• First posted: 2007-11-09
• Last updated: 2007-11-09