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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
298
2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
Murdoch Childrens Research Institute
Melbourne, Victoria, Australia
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.