tetano
Editor, Senior Moderator
Vaccine. 2018 Sep 14. pii: S0264-410X(18)31158-7. doi: 10.1016/j.vaccine.2018.08.032. [Epub ahead of print]
[h=1]Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-na?ve children in a randomized clinical trial in rural Senegal.[/h] Diallo A[SUP]1[/SUP], Victor JC[SUP]2[/SUP], Feser J[SUP]3[/SUP], Ortiz JR[SUP]4[/SUP], Kanesa-Thasan N[SUP]5[/SUP], Ndiaye M[SUP]6[/SUP], Diarra B[SUP]7[/SUP], Cheikh S[SUP]6[/SUP], Diene D[SUP]6[/SUP], Ndiaye T[SUP]8[/SUP], Ndiaye A[SUP]6[/SUP], Lafond KE[SUP]9[/SUP], Widdowson MA[SUP]10[/SUP], Neuzil KM[SUP]11[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]INTRODUCTION:[/h] Effective, programmatically suitable influenza vaccines are needed for low-resource countries.
[h=4]MATERIALS AND METHODS:[/h] This phase II, placebo-controlled, randomized safety and immunogenicity trial (NCT01819155) was conducted in Senegal using the 2012-2013 Northern Hemisphere trivalent influenza vaccine (TIV) formulation. Participants were allocated in a 2:2:1 ratio to receive TIV (full-dose for all age groups), adjuvanted TIV (aTIV), or placebo. Participants were stratified into age groups: 6-11, 12-35, and 36-71 months. All participants were vaccine-na?ve and received two doses of study vaccine 4 weeks apart. The two independent primary objectives were to estimate the immunogenicity of TIV and of aTIV as the proportion of children with a hemagglutination inhibition (HI) antibody titer of ≥1:40 to each vaccine strain at 28 days post-dose two. Safety was evaluated by solicited local and systemic reactions, unsolicited adverse events, and serious adverse events.
[h=4]RESULTS:[/h] 296 children received TIV, aTIV, or placebo, and 235 were included in the final analysis. After two doses, children aged 6-11, 12-35, and 36-71 months receiving TIV had HI titers ≥1:40 against A/H1N1 (73.1%, 94.1%, and 97.0%), A/H3N2 (96.2%, 100.0%, and 100.0%), and B (80.8%, 97.1%, and 97.0%), respectively. After two doses, 100% children aged 6-11, 12-35, and 36-71 months receiving aTIV had ≥1:40 titers against A/H1N1, A/H3N2, and B. After a single dose, the aTIV response was comparable to or greater than the TIV response for all vaccine strains. TIV and aTIV reactogenicity were similar, except for mild elevation in temperature (37.5-38.4 ?C) which occurred more frequently in aTIV than TIV after each vaccine dose. TIV and aTIV had similarly increased pain/tenderness at the injection site compared to placebo.
[h=4]CONCLUSIONS:[/h] Both aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6-71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings.
Copyright ? 2018 Elsevier Ltd. All rights reserved.
[h=4]KEYWORDS:[/h] Africa; Children; Immunogenicity; Inactivated Influenza vaccine; MF59 adjuvant; Safety
PMID: 30224199 DOI: 10.1016/j.vaccine.2018.08.032
[h=1]Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-na?ve children in a randomized clinical trial in rural Senegal.[/h] Diallo A[SUP]1[/SUP], Victor JC[SUP]2[/SUP], Feser J[SUP]3[/SUP], Ortiz JR[SUP]4[/SUP], Kanesa-Thasan N[SUP]5[/SUP], Ndiaye M[SUP]6[/SUP], Diarra B[SUP]7[/SUP], Cheikh S[SUP]6[/SUP], Diene D[SUP]6[/SUP], Ndiaye T[SUP]8[/SUP], Ndiaye A[SUP]6[/SUP], Lafond KE[SUP]9[/SUP], Widdowson MA[SUP]10[/SUP], Neuzil KM[SUP]11[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]INTRODUCTION:[/h] Effective, programmatically suitable influenza vaccines are needed for low-resource countries.
[h=4]MATERIALS AND METHODS:[/h] This phase II, placebo-controlled, randomized safety and immunogenicity trial (NCT01819155) was conducted in Senegal using the 2012-2013 Northern Hemisphere trivalent influenza vaccine (TIV) formulation. Participants were allocated in a 2:2:1 ratio to receive TIV (full-dose for all age groups), adjuvanted TIV (aTIV), or placebo. Participants were stratified into age groups: 6-11, 12-35, and 36-71 months. All participants were vaccine-na?ve and received two doses of study vaccine 4 weeks apart. The two independent primary objectives were to estimate the immunogenicity of TIV and of aTIV as the proportion of children with a hemagglutination inhibition (HI) antibody titer of ≥1:40 to each vaccine strain at 28 days post-dose two. Safety was evaluated by solicited local and systemic reactions, unsolicited adverse events, and serious adverse events.
[h=4]RESULTS:[/h] 296 children received TIV, aTIV, or placebo, and 235 were included in the final analysis. After two doses, children aged 6-11, 12-35, and 36-71 months receiving TIV had HI titers ≥1:40 against A/H1N1 (73.1%, 94.1%, and 97.0%), A/H3N2 (96.2%, 100.0%, and 100.0%), and B (80.8%, 97.1%, and 97.0%), respectively. After two doses, 100% children aged 6-11, 12-35, and 36-71 months receiving aTIV had ≥1:40 titers against A/H1N1, A/H3N2, and B. After a single dose, the aTIV response was comparable to or greater than the TIV response for all vaccine strains. TIV and aTIV reactogenicity were similar, except for mild elevation in temperature (37.5-38.4 ?C) which occurred more frequently in aTIV than TIV after each vaccine dose. TIV and aTIV had similarly increased pain/tenderness at the injection site compared to placebo.
[h=4]CONCLUSIONS:[/h] Both aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6-71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings.
Copyright ? 2018 Elsevier Ltd. All rights reserved.
[h=4]KEYWORDS:[/h] Africa; Children; Immunogenicity; Inactivated Influenza vaccine; MF59 adjuvant; Safety
PMID: 30224199 DOI: 10.1016/j.vaccine.2018.08.032