tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2019 Aug;38(8):866-872. doi: 10.1097/INF.0000000000002387.
[h=1]Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine.[/h] Danier J[SUP]1[/SUP], Rivera L[SUP]2[/SUP], Claeys C[SUP]3[/SUP], Dbaibo G[SUP]4[/SUP], Jain VK[SUP]5[/SUP], Kosalaraksa P[SUP]6[/SUP], Woo W[SUP]1[/SUP], Yanni E[SUP]1[/SUP], Zaman K[SUP]7[/SUP], Acosta B[SUP]8[/SUP], Amanullah A[SUP]1[/SUP], Ariza M[SUP]9[/SUP], Luisa Arroba Basanta M[SUP]10[/SUP], Bavdekar A[SUP]11[/SUP], Carmona A[SUP]12[/SUP], Cousin L[SUP]13[/SUP], Diaz A[SUP]14[/SUP], Diez-Domingo J[SUP]15[/SUP], Cagri Dinleyici E[SUP]16[/SUP], Faust SN[SUP]17[/SUP], Garcia-Sicilia J[SUP]18[/SUP], Gomez-Go GD[SUP]19[/SUP], Antionette Gonzales L[SUP]20[/SUP], Hacimustafaoglu M[SUP]21[/SUP], Hughes SM[SUP]22[/SUP], Izu A[SUP]1[/SUP], Jackowska T[SUP]23[/SUP], Kant S[SUP]24[/SUP], Lucero M[SUP]25[/SUP], Mares Bermudez J[SUP]26[/SUP], Martin?n-Torres F[SUP]27[/SUP], Montellano M[SUP]19[/SUP], Prymula R[SUP]28[/SUP], Puthanakit T[SUP]29[/SUP], Ruzkova R[SUP]30[/SUP], Sadowska-Krawczenko I[SUP]31[/SUP], Soni J[SUP]32[/SUP], Szymanski H[SUP]33[/SUP], Ulied A[SUP]34[/SUP], Schuind A[SUP]1[/SUP], Innis BL[SUP]5[/SUP]; Flu4VEC Study Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] In an exploratory analysis of an inactivated quadrivalent influenza vaccine (IIV4) trial in children 6-35 months without risk factors for influenza, we evaluated clinical presentation of influenza illness and vaccine impact on health outcomes.
[h=4]METHODS:[/h] This phase III trial was conducted in 13 geographically diverse countries across 5 influenza seasons (2011-2014). Children were randomized 1:1 to IIV4 or control. Active surveillance was performed for influenza-like episodes (ILE); influenza was confirmed by reverse transcription polymerase chain reaction (RT-PCR). The total vaccinated cohort was evaluated (N = 12,018).
[h=4]RESULTS:[/h] 5702 children experienced ≥1 ILE; 356 (IIV4 group) and 693 (control group) children had RT-PCR-confirmed influenza. Prevalence of ILE was similar in RT-PCR-positive and RT-PCR-negative cases regardless of vaccination. Breakthrough influenza illness was attenuated in children vaccinated with IIV4; moderate-to-severe illness was 41% less likely to be reported in the IIV4 group than the control group [crude odds ratio: 0.59 (95% confidence intervals: 0.44-0.77)]. Furthermore, fever >39?C was 46% less frequent following vaccination with IIV4 than with control [crude odds ratio: 0.54 (95% confidence intervals: 0.39-0.75)] in children with breakthrough illness. Health outcome analysis showed that, each year, IIV4 would prevent 54 influenza cases per 1000 children and 19 children would need to be vaccinated to prevent 1 new influenza case.
[h=4]CONCLUSIONS:[/h] In addition to preventing influenza in 50% of participants, IIV4 attenuated illness severity and disease burden in children who had a breakthrough influenza episode despite vaccination.
PMID: 31306399 DOI: 10.1097/INF.0000000000002387
[h=1]Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine.[/h] Danier J[SUP]1[/SUP], Rivera L[SUP]2[/SUP], Claeys C[SUP]3[/SUP], Dbaibo G[SUP]4[/SUP], Jain VK[SUP]5[/SUP], Kosalaraksa P[SUP]6[/SUP], Woo W[SUP]1[/SUP], Yanni E[SUP]1[/SUP], Zaman K[SUP]7[/SUP], Acosta B[SUP]8[/SUP], Amanullah A[SUP]1[/SUP], Ariza M[SUP]9[/SUP], Luisa Arroba Basanta M[SUP]10[/SUP], Bavdekar A[SUP]11[/SUP], Carmona A[SUP]12[/SUP], Cousin L[SUP]13[/SUP], Diaz A[SUP]14[/SUP], Diez-Domingo J[SUP]15[/SUP], Cagri Dinleyici E[SUP]16[/SUP], Faust SN[SUP]17[/SUP], Garcia-Sicilia J[SUP]18[/SUP], Gomez-Go GD[SUP]19[/SUP], Antionette Gonzales L[SUP]20[/SUP], Hacimustafaoglu M[SUP]21[/SUP], Hughes SM[SUP]22[/SUP], Izu A[SUP]1[/SUP], Jackowska T[SUP]23[/SUP], Kant S[SUP]24[/SUP], Lucero M[SUP]25[/SUP], Mares Bermudez J[SUP]26[/SUP], Martin?n-Torres F[SUP]27[/SUP], Montellano M[SUP]19[/SUP], Prymula R[SUP]28[/SUP], Puthanakit T[SUP]29[/SUP], Ruzkova R[SUP]30[/SUP], Sadowska-Krawczenko I[SUP]31[/SUP], Soni J[SUP]32[/SUP], Szymanski H[SUP]33[/SUP], Ulied A[SUP]34[/SUP], Schuind A[SUP]1[/SUP], Innis BL[SUP]5[/SUP]; Flu4VEC Study Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] In an exploratory analysis of an inactivated quadrivalent influenza vaccine (IIV4) trial in children 6-35 months without risk factors for influenza, we evaluated clinical presentation of influenza illness and vaccine impact on health outcomes.
[h=4]METHODS:[/h] This phase III trial was conducted in 13 geographically diverse countries across 5 influenza seasons (2011-2014). Children were randomized 1:1 to IIV4 or control. Active surveillance was performed for influenza-like episodes (ILE); influenza was confirmed by reverse transcription polymerase chain reaction (RT-PCR). The total vaccinated cohort was evaluated (N = 12,018).
[h=4]RESULTS:[/h] 5702 children experienced ≥1 ILE; 356 (IIV4 group) and 693 (control group) children had RT-PCR-confirmed influenza. Prevalence of ILE was similar in RT-PCR-positive and RT-PCR-negative cases regardless of vaccination. Breakthrough influenza illness was attenuated in children vaccinated with IIV4; moderate-to-severe illness was 41% less likely to be reported in the IIV4 group than the control group [crude odds ratio: 0.59 (95% confidence intervals: 0.44-0.77)]. Furthermore, fever >39?C was 46% less frequent following vaccination with IIV4 than with control [crude odds ratio: 0.54 (95% confidence intervals: 0.39-0.75)] in children with breakthrough illness. Health outcome analysis showed that, each year, IIV4 would prevent 54 influenza cases per 1000 children and 19 children would need to be vaccinated to prevent 1 new influenza case.
[h=4]CONCLUSIONS:[/h] In addition to preventing influenza in 50% of participants, IIV4 attenuated illness severity and disease burden in children who had a breakthrough influenza episode despite vaccination.
PMID: 31306399 DOI: 10.1097/INF.0000000000002387