Phase II Study of Pandemic Influenza Vaccine

Phase 2CompletedNCT00320346

Seqirus400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

400

Conditions

Influenza

Interventions

Pandemic Influenza VaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

CMAX, a division of IDT Australia

Adelaide, South Australia, Australia

Murdoch Childrens Research Institute

Melbourne, Victoria, Australia

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Outcomes

Primary Outcomes

Safety and Immunogenicity

Secondary Outcomes

Lot to Lot Consistency

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.