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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Equal to or greater 6 months to less than 3 years old |
|
| Group B | Other | Equal to or greater 3 years to less than 9 years old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine | Biological | 2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine;
Previous influenza vaccination;
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;
Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV);
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).
Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period;
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;
Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine;
Have a known history of Guillain-Barré Syndrome;
Have a major congenital defect or serious illness and
Have a history of neurologic disorders or seizures
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| Name | Affiliation | Role |
|---|---|---|
| Terry M Nolan, Prof | Murdoch Childrens Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Murdoch Childrens Research Institute | Melbourne | Victoria | 3052 | Australia |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Influenza Virus Vaccine | Biological | 2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |