Regulatory Decision Summary for Influvac Tetra

Influenza is a respiratory illness caused by the influenza A and B viruses. It can cause mild to severe illness that can result in hospitalization or death. Certain populations, such as young children and the elderly, may be at higher risk for serious influenza complications. Annual influenza vaccination is the primary means of prevention of influenza and its complications. 

Influvac Tetra is a quadrivalent influenza vaccine. Each 0.5 mL dose contains neuraminidase and 15 mcg of haemagglutinin antigen for each virus strain present in the vaccine. The composition of Influvac Tetra is adapted annually to comply with the World Health Organization (WHO) (northern hemisphere) recommendations.

The authorization was based on a Phase III, Observer-Blind, Randomized, Non-influenza Vaccine Comparator-Controlled, Parallel-Group, Multi-Country Study in Children Aged 6-35 Months to Assess the Safety and Efficacy of Abbott’s Candidate Quadrivalent Influenza Vaccine. Heathy children (n = 2,000) received two 0.5 mL doses of either Quadrivalent Influenza Vaccine (n = 1,005) or a Non-Influenza Vaccine (n = 995) 28 days apart. The study was conducted over three influenza seasons.

The primary efficacy endpoint was first occurrence of reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B illness of any severity due to any circulating seasonal influenza strain occurring between 28 days following the second vaccine administration and the end of the influenza surveillance period. The efficacy of Influvac Tetra in the prevention of symptomatic influenza infection compared with a non-influenza vaccine in children aged 6 months to 35 months was demonstrated with an overall efficacy of 54% for any strain and 68% for the strains contained in the vaccine.

The most frequently reported general adverse reaction after vaccination observed in the clinical study for Influvac Tetra in children from 6 months to 35 months of age was irritability (30.2%). The most frequently reported local adverse reaction after vaccination was vaccination site pain (22.6%). The safety findings were consistent with the previous observations. No new safety concerns were identified in the study.

The recommended dose of Influvac Tetra for children from 6 months of age and older is 0.5 mL. For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 mL should be given after an interval of at least 4 weeks.

The benefit risk ratio for Influvac Tetra remains favourable.