Influenza
Conditions
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 vaccination, in a paediatric population equal to or greater than 6 months to less than 9 years old.
Interventions
BIOLOGICALInfluenza 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
Sponsors
Seqirus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
Australia
Outcome results
None listed