NCT00320346

Phase II Study of Pandemic Influenza Vaccine

A Double-Blind, Randomised, Multi-Centre Study to Evaluate the Safety, Tolerability, Immunogenicity and Lot to Lot Consistency of Two Formulations of CSL Limited's Inactivated Prototype Pandemic Influenza Vaccine in a Healthy Adult Population (≤18 Years to ≥64 Years of Age).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (planned)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Pandemic Influenza Vaccine

Timeline

• Start date: 2006-07-01
• Completion: 2006-09-01
• First posted: 2006-05-03
• Last updated: 2016-07-19

Locations

3 sites across 1 country: Australia