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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00320346

Enrollment

400

Registered

2006-05-03

Start date

2006-07-31

Completion date

2006-09-30

Last updated

2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza

Brief 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.

Interventions

BIOLOGICALPandemic Influenza Vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Adults

Exclusion criteria

* Previous vaccination with an influenza Vaccine containing the H5N1 strain * History of clinically significant medical conditions * History of Guillian-Barre Syndrome or active Neurological disease

Design outcomes

Primary

Measure	Time frame
Safety and Immunogenicity	—

Secondary

Measure	Time frame
Lot to Lot Consistency	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026