COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Study of a Pandemic Influenza Vaccine in Children

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

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

Layout table for study information
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
Actual Study Completion Date : July 2007

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.

Layout table for eligibility information
Ages Eligible for Study:   6 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT00370864

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Terry M Nolan, Prof Murdoch Childrens Research Institute
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr Russell Basser, CSL Limited Identifier: NCT00370864    
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:
Prevention of Pandemic Influenza
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases