Study of a Pandemic Influenza Vaccine in Children

This study has been completed.

First Received: August 30, 2006 Last Updated: November 6, 2008 History of Changes

Sponsored by:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00370864

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of a Pandemic Influenza Vaccine in Children

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

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

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 National Clinical Trials Identifier (NCT ID):

Nolan T, Richmond PC, Formica NT, Höschler K, Skeljo MV, Stoney T, McVernon J, Hartel G, Sawlwin DC, Bennet J, Ryan D, Basser RL, Zambon MC. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine. 2008 Nov 25;26(50):6383-91. Epub 2008 Sep 16.

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

Keywords provided by CSL Limited:

Pandemic
Influenza
Prevention
Vaccine
Prevention of Pandemic Influenza

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on September 09, 2009