Influenza Clinical Trial
Official title:
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).
NCT number | NCT00700193 |
Other study ID # | CSLCT-FLU-04-05 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | June 17, 2008 |
Last updated | July 17, 2016 |
Start date | March 2005 |
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.
Status | Completed |
Enrollment | 298 |
Est. completion date | |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 8 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | Murdoch Childrens Research Institute | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Seqirus |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 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 | Yes | |
Secondary | 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 | 30 days after each vaccine dose | No |
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