Risk minimisation Information has been updated according to recommendations activities from the RMP evaluation report (see section 5 of this advice). The evaluator has no objection to the changes and recommends to the Delegate that the updated version is implemented (see below). Suggested wording for conditions of registration RMP Implement the Core RMP (version 1.0 data lock point 15 March 2013) with Australian Specific Annex (version 1.1 dated April 2014) and any future updates as a condition of registration. VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations: Quality The quality evaluators recommend that for FluQuadri and FluQuadri Junior 60 µg HA/0.5 mL dose and 30 µg HA/0.25 mL dose, prefilled syringe without needle, with a shelf life of 12 months at 2 to 80C should be approved. The sponsor has agreed to provide target formulation values to the TGA prior to the commencement of each season. Nonclinical The sponsor provided adequate justification for the lack of nonclinical studies for FluQuadri®. There are no nonclinical objections to registration of FluQuadri® and FluQuadri Junior®. Clinical Clinical immunogenicity The three submitted studies are presented involving the different age groups, adults 18 ≥ years, adults 65 years and children 6 months to <9 years. In each of the studies, ≥ assessment of immunogenicity was the primary objective. No efficacy data was presented. Serum antibody responses to the influenza viruses were considered to correlate with protection against infection and serve as valid surrogates of vaccine efficacy. The method used to measure serum antibodies in the clinical studies was the haemagglutination inhibition (HAI) test. Assessment of immunogenicity post vaccination was uniform amongst the studies: Seroprotection was defined as an HAI antibody 40 (l/dil) at pre and ≥ postvaccination Seroconversion was defined as a pre-vaccination titre < 10 (1/dil) and a titre 40 (1/dil), or a pre-vaccination titre 10 (1/dil) and a 4 fold ≥ ≥ ≥ increase in postvaccination titre
Risk minimisation activities Information has been updated according to recommendations from the RMP evaluation report (see section 5 of this advice). The evaluator has no objection to the changes and recommends to the Delegate that the updated version is implemented (see below). Suggested wording for conditions of registration RMP Implement the Core RMP (version 1.0 data lock point 15 March 2013) with Australian Specific Annex (version 1.1 dated April 2014) and any future updates as a condition of registration. VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations: Quality The quality evaluators recommend that for FluQuadri and FluQuadri Junior 60 µg HA/0.5 mL dose and 30 µg HA/0.25 mL dose, prefilled syringe without needle, with a shelf life of 12 months at 2 to 80C should be approved. The sponsor has agreed to provide target formulation values to the TGA prior to the commencement of each season. Nonclinical The sponsor provided adequate justification for the lack of nonclinical studies for FluQuadri®. There are no nonclinical objections to registration of FluQuadri® and FluQuadri Junior®. Clinical Clinical immunogenicity The three submitted studies are presented involving the different age groups, adults ≥ 18 years, adults ≥ 65 years and children 6 months to <9 years. In each of the studies, assessment of immunogenicity was the primary objective. No efficacy data was presented. Serum antibody responses to the influenza viruses were considered to correlate with protection against infection and serve as valid surrogates of vaccine efficacy. The method used to measure serum antibodies in the clinical studies was the haemagglutination inhibition (HAI) test. Assessment of immunogenicity post vaccination was uniform amongst the studies: Seroprotection was defined as an HAI antibody ≥ 40 (l/dil) at pre and postvaccination Seroconversion was defined as a pre-vaccination titre < 10 (1/dil) and a titre ≥ 40 (1/dil), or a pre-vaccination titre ≥ 10 (1/dil) and a ≥ 4 fold increase in postvaccination titre
auspar-influenza-virus-haemagglutinin-150206.docx