A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00700193
First received: June 17, 2008
Last updated: November 6, 2008
Last verified: November 2008

June 17, 2008
November 6, 2008
March 2005
June 2006   (final data collection date for primary outcome measure)
Safety of CSL Influenza Virus Vaccine in a Paediatric population through the assessment of the frequency of Local and general solicited symptoms, Unsolicited Adverse Events (UAE),Serious Adverse Events (SAEs) [ Time Frame: Local & general solicited symptoms for 7 days post each vaccination, UAEs for 30 days post each vaccination, SAEs for 6 months after the last primary vaccination and 6 months after the booster vaccination ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00700193 on ClinicalTrials.gov Archive Site
Evaluate immunogenicity response to CSL Influenza Virus Vaccine in Paediatric population according to the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines [ Time Frame: 30 days after each vaccine dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population
An Open-Label, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of CSL's Influenza Vaccine in a Paediatric Population (= or >6 Months to < 9 Years of Age).

The purpose of this study is to determine the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine in a two dose primary vaccination series, with a 12-month booster vaccination, in a paediatric population equal to or greater than 6 months to less than 9 years old.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
  • Biological: Influenza Virus Vaccine
    2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
  • Biological: Influenza Virus Vaccine
    2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
  • Group A
    Equal to or greater 6 months to less than 3 years old
    Intervention: Biological: Influenza Virus Vaccine
  • Group B
    Equal to or greater 3 years to less than 9 years old
    Intervention: Biological: Influenza Virus Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
298
Not Provided
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Be healthy male or female children, aged = or > 6 months to < 9 years at the time of first study vaccination; Note: = or > 6 refers to 6 calendar months
  2. Parent(s) or Guardian(s) to provide written informed consent to participate in the study;
  3. Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and
  4. Be born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

  1. Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine;
  2. Previous influenza vaccination;
  3. Clinical signs of active infection and/or an axillary temperature of = or >37.5 degrees Celsius or oral temperature of = or >38 degrees Celsius at study entry. Study entry may be deferred for such individuals, at the discretion of the Principal Investigator;
  4. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV);
  5. Current (or within the 90 days prior to receiving the Study Vaccine) treatment with immunosuppressive or immunomodulative medication, including systemic corticosteroids, as follows:

    •Chronic or long term corticosteroids: >0.5mg/kg/day of oral prednisolone or equivalent (Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable).

  6. Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period;
  7. Participation in a clinical study or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use), within the 90 days prior to receiving the Study Vaccine or be planning to enter such a study during the study period;
  8. Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine;
  9. Have a known history of Guillain-Barré Syndrome;
  10. Have a major congenital defect or serious illness and
  11. Have a history of neurologic disorders or seizures
Both
6 Months to 8 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00700193
CSLCT-FLU-04-05
No
Dr Russell Basser, CSL Limited
CSL Limited
Not Provided
Principal Investigator: Terry M Nolan, Prof Murdoch Childrens Research Institute
CSL Limited
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP