Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study.

ABSTRACT

BACKGROUND: Cell culture-derived inactivated influenza vaccines (TIVc) are necessary for scale and predictability of production to meet global demand. This study compared the safety and tolerability of TIVc with an egg-derived trivalent influenza vaccine (TIVf) in 4-17 yearolds. METHODS: A Phase 3 observer blind, multicenter study enrolled 2055 healthy participants randomized 21 to receive either TIVc or TIVf, respectively (1372 TIVc and 683 TIVf evaluable subjects). Participants received one dose each on Days 1 and 28 (4-8 year-olds not previously vaccinated [NPV]) or one dose on Day 1 (4-8 and 9-17 yearolds previously vaccinated [PV]). Solicited adverse events (AEs) occurring within 7 days after each vaccination were assessed; participants were followed up for 6 months after their last dose for safety. RESULTS: Most solicited and unsolicited AEs were mild to moderate with <1% in the severe category. No withdrawals due to AEs, deaths or vaccine-related SAEs were reported. TIVc and TIVf were similar in percentages of participants reporting solicited reactions in 4-8 years NPV group after the 1st dose local reactions, TIVc 48%, TIVf 43%; systemic reactions, TIVc 34%, TIVf 32%; percentages were lower following the 2nd dose in TIVc; local reactions TIVc 40%; TIVf 43%; systemic reactions TIVc 21%; TIVf 22%. In 4-17 years PV group, solicited reactions were lower following TIVf, local reactions TIVc 53%; TIVf 43%; systemic reactions TIVc 37%, TIVf 30%. Injection-site pain was the most common solicited reaction, and was similar following TIVc and TIVf in 4-8 yearolds (TIVc 56%; TIVf 55%), and lower following TIVf in 9-17 years group (TIVc 52%; TIVf 42%). Reporting of unsolicited AEs was similar for TIVc and TIVf across the two age groups. CONCLUSION: TIVc was well tolerated and had a safety and reactogenicity profile similar to that of TIVf in healthy 4-17 yearolds (NCT01857206).