ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of a Pandemic Influenza Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00136331
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : July 19, 2016
Sponsor:
Information provided by:
Seqirus

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 avian influenza pandemic. This study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in healthy adults.

Condition or disease Intervention/treatment Phase
Influenza Biological: Pandemic influenza vaccine Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Phase Ia Study of a Pandemic Influenza Vaccine
Study Start Date : October 2005
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot




Primary Outcome Measures :
  1. Safety and immunogenicity


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • History of Guillain-Barre syndrome or active neurological disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136331


Locations
Australia, South Australia
CMAX, a division of IDT Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Murdoch Childrens Research Institute
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Seqirus
Investigators
Principal Investigator: Terry M Nolan Murdoch Childrens Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT00136331     History of Changes
Other Study ID Numbers: CSLCT-PAN-05-12
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: November 2008

Keywords provided by Seqirus:
Pandemic
Influenza
Prevention
Vaccine
Prevention of Pandemic Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs