Status:
COMPLETED
A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population
Lead Sponsor:
Seqirus
Conditions:
Influenza
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief Summary
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 vaccinat...
Eligibility Criteria
Inclusion
- 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
- Parent(s) or Guardian(s) to provide written informed consent to participate in the study;
- Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and
- Be born after a normal gestation period (between 36 and 42 weeks).
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT00700193
Start Date
March 1 2005
Last Update
July 19 2016
Active Locations (1)
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1
Murdoch Childrens Research Institute
Melbourne, Victoria, Australia, 3052