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Study of a Pandemic Influenza Vaccine in Children

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ClinicalTrials.gov Identifier: NCT00370864
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : July 19, 2016
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Biological: H5N1 pandemic influenza vaccine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Phase II Study of a Pandemic Influenza Vaccine in Children
Study Start Date : September 2006
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Safety and immunogenicity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
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

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): 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
Seqirus
Investigators
Principal Investigator: Terry M Nolan, Prof Murdoch Childrens Research Institute
More Information

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
First Posted: September 1, 2006    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