NCT00660257

Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine

Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza (H5N1)Vaccine in Two-Dose Primed Healthy Adults: A Single Center, Non-Randomized Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 61 Years
• Healthy volunteers: Accepted

Summary

A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).

Conditions

• Pandemic Influenza Vaccine
• Prevention
• Pandemic Influenza

Interventions

Type	Name	Description
BIOLOGICAL	pandemic influenza vaccine (H5N1 strain NIBRG-14)	pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
BIOLOGICAL	pandemic influenza vaccine (H5N1 strain NIBRG-14)	pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection
BIOLOGICAL	pandemic influenza vaccine (H5N1 strain NIBRG-14)	pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
BIOLOGICAL	pandemic influenza vaccine (H5N1 strain NIBRG-14)	pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-03-01
• Completion: 2008-03-01
• First posted: 2008-04-17
• Last updated: 2008-04-17

Locations

1 site across 1 country: China