NCT01640691

Immunogenicity and Safety of Pandemic Influenza Vaccine in Healthy Adults

A Clinical Study to Evaluate the Immunogenicity and Safety of Pandemic Influenza Vaccine, AdimFlu-W (H5N1), in Healthy Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Adimmune Corporation · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The objectives of this single arm study are to evaluate the immune response and safety profiles of two injections of an inactivated whole-virion vaccine containing aluminum hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.

Conditions

• Pandemic Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Pandemic Influenza Vaccine (H5N1)	Inactivated whole-virion vaccine 1. Administration route: Intramuscular Injection 2. Dosing schedule: 2 injections - at Day 1 and Day 22 separately 3. Dose(s): Each dose (0.5 mL) contains the 15 mcg hemagglutinin (HA) of influenza A (A/Vietnam/1194/2004)

Timeline

• Start date: 2012-07-10
• Primary completion: 2013-01-02
• Completion: 2013-06-01
• First posted: 2012-07-16
• Last updated: 2018-07-16

Locations

1 site across 1 country: Taiwan