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Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged Between >= 6 Months to < 18 Years
This study is currently recruiting participants.
Verified by CSL Limited, May 2009
First Received: January 15, 2009   Last Updated: May 6, 2009   History of Changes
Sponsored by: CSL Limited
Information provided by: CSL Limited
ClinicalTrials.gov Identifier: NCT00825162
  Purpose

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

MedlinePlus related topics: Flu
Drug Information available for: Fluvirin Influenza Vaccines
U.S. FDA Resources
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

Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • Safety and tolerability by determining the frequency, severity and duration of solicited adverse events, unsolicited adverse events, serious adverse events, and new onset of chronic illness. [ Time Frame: 180 days post-vaccination ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female participants aged ≥ 6 months to < 18 years at the time of vaccination;
  2. Written informed consent to participate in the study and adherence to all protocol requirements. Consent will be obtained from the participant, parent or guardian as appropriate according to the applicable Independent Ethics Committee (IEC) and local requirements. Participant assent will also be obtained if required by the applicable IEC;
  3. Good health, as determined by medical history, and a targeted physical examination;
  4. For participants aged < 9 years, born after a normal gestation period (between 36 and 42 weeks);
  5. Females of childbearing potential (defined as having experienced their first menstrual cycle) must be abstinent or be using adequate contraceptive precautions e.g. intrauterine contraceptive device, oral contraceptive, or equivalent hormonal contraception (e.g., progestogen-only implant, vaginal contraceptive ring, cutaneous hormonal patch or injectable contraceptives) for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrolment.

Exclusion Criteria:

  1. Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine;
  2. Clinical signs of significant active infection and/or an elevated temperature (≥ 38.0°C oral or ≥ 37.5°C axillary) at study entry;
  3. Vaccination against influenza virus in the previous 6 months with a seasonal IVV;
  4. Vaccination with an experimental IVV (e.g. a candidate pandemic IVV or a novel IVV) in the previous 6 months;
  5. Females of child bearing potential, planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of vaccination;
  6. Pregnant or lactating females;
  7. Clinically significant medical or psychiatric conditions, as follows:

    • For acute conditions (active or recent), the condition required hospitalisation within the last month; or
    • For chronic conditions: the Investigator feels that the chronic condition is unstable, such as illness exacerbations within the previous month: i. requiring hospitalisation; ii. with significant organ function deterioration; iii. with major changes to treatment dosages; iv. requiring major new treatments; or
    • The Investigator feels the participant has a clinical condition that may be adversely affected through study participation.
  8. Confirmed or suspected immune deficiency (congenital or acquired, including cancer and human immunodeficiency virus infection);
  9. History of seizures, with the exception of a past history of a single seizure event at any age more than two years previously;
  10. Known history of Guillain-Barré Syndrome;
  11. Current treatment with radiotherapy or cytotoxic drugs, or treatment within the 6 months prior to administration of the Study Vaccine;
  12. 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

  13. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine or during the study;
  14. Current treatment with warfarin or other anticoagulants;
  15. Participation in a clinical trial or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the Study Vaccine or entry into such a study during the on study period;
  16. Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
  17. If, in the Investigator's opinion, the participant should not take part in the clinical study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825162

Contacts
Contact: Dale Cooper, Mr +61 3 9389 1784 dale.cooper@csl.com.au

Locations
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            
Sponsors and Collaborators
CSL Limited
Investigators
Principal Investigator: Peter C Richmond, Dr Princess Margaret Hospital, Canada
  More Information

No publications provided

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

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 May 07, 2009