tetano
Editor, Senior Moderator
J Pediatric Infect Dis Soc. 2015 Sep;4(3):242-51. doi: 10.1093/jpids/piu098. Epub 2014 Oct 20.
[h=1]Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.[/h] Langley JM[SUP]1[/SUP], Wang L[SUP]2[/SUP], Aggarwal N[SUP]3[/SUP], Bueso A[SUP]4[/SUP], Chandrasekaran V[SUP]2[/SUP], Cousin L[SUP]4[/SUP], Halperin SA[SUP]1[/SUP], Li P[SUP]2[/SUP], Liu A[SUP]2[/SUP], McNeil S[SUP]1[/SUP], Mendez LP[SUP]5[/SUP], Rivera L[SUP]5[/SUP], Innis BL[SUP]2[/SUP], Jain VK[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Influenza attack rates are high in 6- to 35-month-old children; vaccines containing both lineages of influenza B (Yamagata and Victoria), in addition to the H3N2 and H1N1 antigens, may improve protection rates.
[h=4]METHODS:[/h] In a randomized double-blind controlled trial, the immunogenicity and reactogenicity of an inactivated quadrivalent influenza vaccine (QIV) and a trivalent control vaccine (TIV) were assessed.
[h=4]RESULTS:[/h] Six hundred one children (QIV, n = 299; TIV, n = 302) were enrolled at 8 sites in 3 countries. The primary immunogenicity objective was met: the lower limit (LL) of the 2-sided 95% confidence interval (CI) for the seroconversion rate in QIV recipients ranged from 66.6% to 81.3%, which was ≥40% against all 4 strains. The immunogenic superiority of the additional B/Victoria strain in the QIV compared to that in the TIV was confirmed: the LL of the 2-sided 95% CI of the geometric mean titer ratio (QIV/TIV) (6.28 [95% CI, 5.32-7.41]) was greater than 1.5, and the LL of the 2-sided 95% CI for the difference in the seroconversion rate (QIV - TIV) (64.19% [95% CI, 57.65%-69.95%]) was greater than 10%. Injection-site pain and irritability/fussiness were the most commonly reported solicited injection-site and general adverse events, respectively, from days 0 to 6 and were similar in frequency between the groups.
[h=4]CONCLUSIONS:[/h] In children aged 6 to 35 months, a QIV has superior immunogenicity for the added B strain and acceptable immunogenicity for shared strains, with no notable difference in reactogenicity and safety when compared to a TIV.
[h=4]KEYWORDS:[/h] children; immunogenicity; influenza vaccine
PMID: 26336604 [PubMed - in process] PMCID: PMC4554197 Free PMC Article
[h=1]Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.[/h] Langley JM[SUP]1[/SUP], Wang L[SUP]2[/SUP], Aggarwal N[SUP]3[/SUP], Bueso A[SUP]4[/SUP], Chandrasekaran V[SUP]2[/SUP], Cousin L[SUP]4[/SUP], Halperin SA[SUP]1[/SUP], Li P[SUP]2[/SUP], Liu A[SUP]2[/SUP], McNeil S[SUP]1[/SUP], Mendez LP[SUP]5[/SUP], Rivera L[SUP]5[/SUP], Innis BL[SUP]2[/SUP], Jain VK[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Influenza attack rates are high in 6- to 35-month-old children; vaccines containing both lineages of influenza B (Yamagata and Victoria), in addition to the H3N2 and H1N1 antigens, may improve protection rates.
[h=4]METHODS:[/h] In a randomized double-blind controlled trial, the immunogenicity and reactogenicity of an inactivated quadrivalent influenza vaccine (QIV) and a trivalent control vaccine (TIV) were assessed.
[h=4]RESULTS:[/h] Six hundred one children (QIV, n = 299; TIV, n = 302) were enrolled at 8 sites in 3 countries. The primary immunogenicity objective was met: the lower limit (LL) of the 2-sided 95% confidence interval (CI) for the seroconversion rate in QIV recipients ranged from 66.6% to 81.3%, which was ≥40% against all 4 strains. The immunogenic superiority of the additional B/Victoria strain in the QIV compared to that in the TIV was confirmed: the LL of the 2-sided 95% CI of the geometric mean titer ratio (QIV/TIV) (6.28 [95% CI, 5.32-7.41]) was greater than 1.5, and the LL of the 2-sided 95% CI for the difference in the seroconversion rate (QIV - TIV) (64.19% [95% CI, 57.65%-69.95%]) was greater than 10%. Injection-site pain and irritability/fussiness were the most commonly reported solicited injection-site and general adverse events, respectively, from days 0 to 6 and were similar in frequency between the groups.
[h=4]CONCLUSIONS:[/h] In children aged 6 to 35 months, a QIV has superior immunogenicity for the added B strain and acceptable immunogenicity for shared strains, with no notable difference in reactogenicity and safety when compared to a TIV.
[h=4]KEYWORDS:[/h] children; immunogenicity; influenza vaccine
PMID: 26336604 [PubMed - in process] PMCID: PMC4554197 Free PMC Article