Study of a Pandemic Influenza Vaccine in Children

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00370864
First received: August 30, 2006
Last updated: November 6, 2008
Last verified: November 2008
  Purpose

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
Influenza
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 CSL Limited:

Primary Outcome Measures:
  • Safety and immunogenicity

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

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

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 ClinicalTrials.gov identifier: NCT00370864

Locations
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
CSL Limited
Investigators
Principal Investigator: Terry M Nolan, Prof Murdoch Childrens Research Institute
  More Information

No publications provided by CSL Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT00370864     History of Changes
Other Study ID Numbers: CSLCT-PAN-05-17
Study First Received: August 30, 2006
Last Updated: November 6, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by CSL Limited:
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

ClinicalTrials.gov processed this record on August 28, 2014