tetano
Editor, Senior Moderator
Hum Vaccin Immunother. 2016 Aug 26:0. [Epub ahead of print]
[h=1]Safety and immunogenicity of an intramuscular quadrivalent Influenza vaccine in children 3 to 8 years of age: a phase III randomised controlled study.[/h] Pepin S[SUP]1[/SUP], Szymanski H[SUP]2[/SUP], Roch?n Kobashi IA[SUP]3[/SUP], Villagomez Martinez S[SUP]4[/SUP], Gonz?lez Zamora JF[SUP]5[/SUP], Brzostek J[SUP]6[/SUP], Huang LM[SUP]7[/SUP], Chiu CH[SUP]8[/SUP], Chen PY[SUP]9[/SUP], Ahonen A[SUP]10[/SUP], Forst?n A[SUP]10[/SUP], Sepp? I[SUP]10[/SUP], Quiroz RF[SUP]11[/SUP], Korhonen T[SUP]10[/SUP], Rivas E[SUP]12[/SUP], Monfredo C[SUP]1[/SUP], Hutagalung Y[SUP]13[/SUP], Menezes J[SUP]13[/SUP], Vesikari T[SUP]10[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] A quadrivalent, inactivated, split-virion influenza vaccine containing a strain from both B lineages (IIV4) has been developed, but its safety and immunogenicity in young children has not been described. This was a phase III, randomised, double-blind, active-controlled, multi-centre study to examine the immunogenicity and safety of IIV4 in children 3-8 years of age (EudraCT no. 2011-005374-33). Participants were randomised 5:1:1 to receive the 2013/2014 Northern Hemisphere formulation of IIV4, an investigational trivalent comparator (IIV3) containing the B/Victoria lineage strain, or the licensed Northern Hemisphere IIV3 containing the B/Yamagata lineage strain. Participants who had not previously received a full influenza vaccination schedule received two doses of vaccine 28 days apart; all others received a single dose. 1242 children were included. For all four strains, IIV4 induced geometric mean haemagglutination inhibition titres non-inferior to those induced by the IIV3 comparators. For both B strains, geometric mean antibody titres induced by IIV4 were superior to those induced by the IIV3 with the alternative lineage strain. Similar proportions of participants vaccinated with IIV4 and IIV3 reported solicited injection-site reactions, solicited systemic reactions, and vaccine-related adverse events. A single vaccine-related serious adverse event, thrombocytopenia, was reported 9 days after vaccination with IIV4 and resolved without sequelae. In conclusion, in children aged 3-8 years who received one dose or two doses 28 days apart, IIV4 had an acceptable safety profile, was as immunogenic as IIV3 for the shared strains, and had superior immunogenicity for the additional B strain.
[h=4]KEYWORDS:[/h] Quadrivalent inactivated influenza vaccine; children; haemagglutination inhibition; immunogenicity; phase III clinical trial; safety
PMID: 27565435 DOI: 10.1080/21645515.2016.1212143
[PubMed - as supplied by publisher]
[h=1]Safety and immunogenicity of an intramuscular quadrivalent Influenza vaccine in children 3 to 8 years of age: a phase III randomised controlled study.[/h] Pepin S[SUP]1[/SUP], Szymanski H[SUP]2[/SUP], Roch?n Kobashi IA[SUP]3[/SUP], Villagomez Martinez S[SUP]4[/SUP], Gonz?lez Zamora JF[SUP]5[/SUP], Brzostek J[SUP]6[/SUP], Huang LM[SUP]7[/SUP], Chiu CH[SUP]8[/SUP], Chen PY[SUP]9[/SUP], Ahonen A[SUP]10[/SUP], Forst?n A[SUP]10[/SUP], Sepp? I[SUP]10[/SUP], Quiroz RF[SUP]11[/SUP], Korhonen T[SUP]10[/SUP], Rivas E[SUP]12[/SUP], Monfredo C[SUP]1[/SUP], Hutagalung Y[SUP]13[/SUP], Menezes J[SUP]13[/SUP], Vesikari T[SUP]10[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] A quadrivalent, inactivated, split-virion influenza vaccine containing a strain from both B lineages (IIV4) has been developed, but its safety and immunogenicity in young children has not been described. This was a phase III, randomised, double-blind, active-controlled, multi-centre study to examine the immunogenicity and safety of IIV4 in children 3-8 years of age (EudraCT no. 2011-005374-33). Participants were randomised 5:1:1 to receive the 2013/2014 Northern Hemisphere formulation of IIV4, an investigational trivalent comparator (IIV3) containing the B/Victoria lineage strain, or the licensed Northern Hemisphere IIV3 containing the B/Yamagata lineage strain. Participants who had not previously received a full influenza vaccination schedule received two doses of vaccine 28 days apart; all others received a single dose. 1242 children were included. For all four strains, IIV4 induced geometric mean haemagglutination inhibition titres non-inferior to those induced by the IIV3 comparators. For both B strains, geometric mean antibody titres induced by IIV4 were superior to those induced by the IIV3 with the alternative lineage strain. Similar proportions of participants vaccinated with IIV4 and IIV3 reported solicited injection-site reactions, solicited systemic reactions, and vaccine-related adverse events. A single vaccine-related serious adverse event, thrombocytopenia, was reported 9 days after vaccination with IIV4 and resolved without sequelae. In conclusion, in children aged 3-8 years who received one dose or two doses 28 days apart, IIV4 had an acceptable safety profile, was as immunogenic as IIV3 for the shared strains, and had superior immunogenicity for the additional B strain.
[h=4]KEYWORDS:[/h] Quadrivalent inactivated influenza vaccine; children; haemagglutination inhibition; immunogenicity; phase III clinical trial; safety
PMID: 27565435 DOI: 10.1080/21645515.2016.1212143
[PubMed - as supplied by publisher]