tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2018 Nov 2. doi: 10.1097/INF.0000000000002227. [Epub ahead of print]
[h=1]Safety and Immunogenicity of a Full-Dose Split-Virion Inactivated Quadrivalent Influenza Vaccine in Healthy Children 6 to 35 Months of Age: A Randomized Controlled Clinical Trial.[/h] Robertson CA[SUP]1[/SUP], Mercer M[SUP]1[/SUP], Selmani A[SUP]1[/SUP], Klein NP[SUP]2[/SUP], Jeanfreau R[SUP]3[/SUP], Greenberg DP[SUP]1,[/SUP][SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] For children aged < 3 years, a half dose of inactivated influenza vaccine (7.5 ?g hemagglutinin/strain) has been used for more than 30 years, but several studies indicate that a full dose (15 ?g hemagglutinin/strain) can be used in this population without increasing the rate of fever or other reactions. Here we compare the safety and immunogenicity of full and half doses of quadrivalent split-virion inactivated influenza vaccine (IIV4) in children aged 6 to 35 months.
[h=4]METHODS:[/h] In this phase IV, randomized, observer-blinded, multi-center study, healthy children aged 6 to 35 months were randomized 1:1 to be vaccinated with a half or full dose of IIV4 (NCT02915302). The primary objective was to demonstrate that the rate of any fever (≥ 38.0?C) up to 7 days after a full dose of IIV4 was non-inferior to the rate of fever after a half dose.
[h=4]RESULTS:[/h] The study included 1950 children. Non-inferiority in the rate of fever was demonstrated for the full dose vs. the half dose of IIV4 (difference in rate = 0.84% [95% confidence interval, -2.13%-3.80%]). Solicited reactions and unsolicited adverse events were similar between the dose groups. No vaccine-related serious adverse events were reported. Non-inferiority of both hemagglutination inhibition geometric mean titers and seroconversion rates was demonstrated for all four vaccine strains for the full dose vs. the half dose.
[h=4]CONCLUSIONS:[/h] In children aged 6 to 35 months, a full dose of IIV4 was immunogenic and had a safety profile comparable to that of a half dose, with no new safety concerns observed.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
PMID: 30395011 DOI: 10.1097/INF.0000000000002227
[h=1]Safety and Immunogenicity of a Full-Dose Split-Virion Inactivated Quadrivalent Influenza Vaccine in Healthy Children 6 to 35 Months of Age: A Randomized Controlled Clinical Trial.[/h] Robertson CA[SUP]1[/SUP], Mercer M[SUP]1[/SUP], Selmani A[SUP]1[/SUP], Klein NP[SUP]2[/SUP], Jeanfreau R[SUP]3[/SUP], Greenberg DP[SUP]1,[/SUP][SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] For children aged < 3 years, a half dose of inactivated influenza vaccine (7.5 ?g hemagglutinin/strain) has been used for more than 30 years, but several studies indicate that a full dose (15 ?g hemagglutinin/strain) can be used in this population without increasing the rate of fever or other reactions. Here we compare the safety and immunogenicity of full and half doses of quadrivalent split-virion inactivated influenza vaccine (IIV4) in children aged 6 to 35 months.
[h=4]METHODS:[/h] In this phase IV, randomized, observer-blinded, multi-center study, healthy children aged 6 to 35 months were randomized 1:1 to be vaccinated with a half or full dose of IIV4 (NCT02915302). The primary objective was to demonstrate that the rate of any fever (≥ 38.0?C) up to 7 days after a full dose of IIV4 was non-inferior to the rate of fever after a half dose.
[h=4]RESULTS:[/h] The study included 1950 children. Non-inferiority in the rate of fever was demonstrated for the full dose vs. the half dose of IIV4 (difference in rate = 0.84% [95% confidence interval, -2.13%-3.80%]). Solicited reactions and unsolicited adverse events were similar between the dose groups. No vaccine-related serious adverse events were reported. Non-inferiority of both hemagglutination inhibition geometric mean titers and seroconversion rates was demonstrated for all four vaccine strains for the full dose vs. the half dose.
[h=4]CONCLUSIONS:[/h] In children aged 6 to 35 months, a full dose of IIV4 was immunogenic and had a safety profile comparable to that of a half dose, with no new safety concerns observed.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
PMID: 30395011 DOI: 10.1097/INF.0000000000002227