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Study of a Pandemic Influenza Vaccine in Children

This study has been completed.
Information provided by:
Seqirus Identifier:
First received: August 30, 2006
Last updated: July 17, 2016
Last verified: November 2008
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic. Children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.

Condition Intervention Phase
Biological: H5N1 pandemic influenza vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase II Study of a Pandemic Influenza Vaccine in Children

Resource links provided by NLM:

Further study details as provided by Seqirus:

Primary Outcome Measures:
  • Safety and immunogenicity

Estimated Enrollment: 220
Study Start Date: September 2006
Study Completion Date: July 2007

Ages Eligible for Study:   6 Months to 8 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy children aged greater or equal to 6 months to less than 9 years
  • Normal gestation period

Exclusion Criteria:

  • History of clinically significant medical conditions
  • History of Guillain Barre syndrome or active neurological disease
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00370864

Australia, Victoria
Murdoch Childrens Research Institute
Melbourne, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Sponsors and Collaborators
Principal Investigator: Terry M Nolan, Prof Murdoch Childrens Research Institute
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Russell Basser, CSL Limited Identifier: NCT00370864     History of Changes
Other Study ID Numbers: CSLCT-PAN-05-17 
Study First Received: August 30, 2006
Last Updated: July 17, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Seqirus:
Prevention of Pandemic Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on October 20, 2016