tetano
Editor, Senior Moderator
Vaccine. 2015 Nov 28. pii: S0264-410X(15)01682-5. doi: 10.1016/j.vaccine.2015.11.040. [Epub ahead of print]
[h=1]Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multi-center, observer-blind study.[/h] Nolan T[SUP]1[/SUP], Chotpitayasunondh T[SUP]2[/SUP], Capeding MR[SUP]3[/SUP], Carson S[SUP]4[/SUP], Senders SD[SUP]5[/SUP], Jaehnig P[SUP]6[/SUP], de Rooij R[SUP]7[/SUP], Chandra R[SUP]8[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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 year-olds.
[h=4]METHODS:[/h] A Phase 3 observer blind, multicentre study enrolled 2055 healthy participants randomized 2:1 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 year-olds 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.
[h=4]RESULTS:[/h] 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 year-olds (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.
[h=4]CONCLUSION:[/h] TIVc was well tolerated and had a safety and reactogenicity profile similar to that of TIVf in healthy 4-17 year-olds (NCT01857206).
Copyright ? 2015. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Cell-culture; Children; Influenza; Safety
PMID: 26643931 [PubMed - as supplied by publisher]
[h=1]Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multi-center, observer-blind study.[/h] Nolan T[SUP]1[/SUP], Chotpitayasunondh T[SUP]2[/SUP], Capeding MR[SUP]3[/SUP], Carson S[SUP]4[/SUP], Senders SD[SUP]5[/SUP], Jaehnig P[SUP]6[/SUP], de Rooij R[SUP]7[/SUP], Chandra R[SUP]8[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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 year-olds.
[h=4]METHODS:[/h] A Phase 3 observer blind, multicentre study enrolled 2055 healthy participants randomized 2:1 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 year-olds 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.
[h=4]RESULTS:[/h] 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 year-olds (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.
[h=4]CONCLUSION:[/h] TIVc was well tolerated and had a safety and reactogenicity profile similar to that of TIVf in healthy 4-17 year-olds (NCT01857206).
Copyright ? 2015. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Cell-culture; Children; Influenza; Safety
PMID: 26643931 [PubMed - as supplied by publisher]