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Sponsored by: |
CSL Limited |
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Information provided by: | CSL Limited |
ClinicalTrials.gov Identifier: | NCT00825162 |
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years
Condition | Intervention | Phase |
---|---|---|
Influenza |
Biological: CSL Limited Influenza Virus Vaccine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years |
Estimated Enrollment: | 2025 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 |
Biological: CSL Limited Influenza Virus Vaccine
0.25 mL (one or two doses) or 0.5 mL (one or two doses), as directed by Influenza vaccination guidelines
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Ages Eligible for Study: | 6 Months to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant medical or psychiatric conditions, as follows:
Current (or within the 90 days prior to receiving the Study Vaccine) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows:
• Chronic or long term corticosteroids: i. Age less than 9 years: ≥ 0.5 mg/kg/day of oral prednisolone or equivalent daily; ii. Age 9 years and above: ≥ 15 mg/day of oral prednisolone or equivalent daily;
• Sporadic corticosteroids: i. Age less than 9 years: ≥ 1 mg/kg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days in the 3 months preceding vaccination; ii. Age 9 years and above: ≥ 40 mg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the 3 months preceding vaccination; Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable
Contact: Dale Cooper, Mr | +61 3 9389 1784 | dale.cooper@csl.com.au |
Australia, Australian Capital Territory | |
The Canberra Hospital | Recruiting |
Woden, Australian Capital Territory, Australia, 2606 | |
Contact: Grahan Reynolds, Assoc Prof +61 2 6244 3259 Graham.Reynolds@act.gov.au | |
Principal Investigator: Graham Reynolds | |
Australia, New South Wales | |
Children's Hospital at Westmead | Recruiting |
Westmead, New South Wales, Australia, 2145 | |
Contact: Robert Booy +61 2 9845 1410 robertb2@chw.edu.au | |
Principal Investigator: Robert Booy, Professor | |
Sydney Children's Clinical Trials Centre | Recruiting |
Randwick, New South Wales, Australia, 2031 | |
Contact: Tony Walls, Doctor +61 2 9382 1508 Tony.Walls@SESIAHS.HEALTH.NSW.GOV.AU | |
Principal Investigator: Tony Walls, Dr | |
Australia, Queensland | |
Royal Children's Hospital | Recruiting |
Herston, Queensland, Australia, 4006 | |
Contact: Stephen Lambert, Dr +61 7 3636 5371 sblambert@uq.edu.au | |
Principal Investigator: Stephen Lambert, Dr | |
Australia, South Australia | |
Women's & Children's Hospital Adelaide | Recruiting |
North Adelaide, South Australia, Australia, 5006 | |
Contact: Helen Marshall, Dr +61 407 414 303 Helen.marshall@adelaide.edu.au | |
Principal Investigator: Helen Marshall, Dr | |
Australia, Victoria | |
Murdoch Children's Research Institute | Recruiting |
Melbourne, Victoria, Australia, 3053 | |
Contact: Terry M Nolan +61 3 8344 9137 t.nolan@unimelb.edu.au | |
Principal Investigator: Terry M Nolan, Professor | |
Australia, Western Australia | |
Princess Margaret Hospital | Recruiting |
Subiaco, Western Australia, Australia, 6008 | |
Contact: Peter C Richmond +61 8 9340 8745 prichmond@meddent.uwa.edu.au | |
Principal Investigator: Peter C Richmond, Dr |
Principal Investigator: | Peter C Richmond, Dr | Princess Margaret Hospital, Canada |
Responsible Party: | CSL Limited ( Dale Cooper, Clinical Study Manager ) |
Study ID Numbers: | CSLCT-USF-06-29 |
Study First Received: | January 15, 2009 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00825162 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |