Phase II Study of Pandemic Influenza Vaccine

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CMAX, a division of IDT Australia, Adelaide, South Australia, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pandemic influenza vaccine

Biological

Primary outcomes

Safety and Immunogenicity

Secondary outcomes

Lot to Lot Consistency

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Registry information

Official study title

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).

Important dates

Study start: 2006
Study completion: 2006
First posted: May 3, 2006
Registry last updated: Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed