tetano
Editor, Senior Moderator
Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccines in participants >/=3 years of age: A double-blind, randomized, parallel-controlled phase III clinical trial in China
Expert Rev Vaccines. 2017 Sep 5. doi: 10.1080/14760584.2017.1374181. [Epub ahead of print]
[h=1]Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccines in participants >/=3 years of age: A double-blind, randomized, parallel-controlled phase III clinical trial in China.[/h] Wang SY[SUP]1[/SUP], Shu-Zhen L[SUP]2[/SUP], Chu K[SUP]3[/SUP], Zhao Y[SUP]4[/SUP], Zhu FC[SUP]3[/SUP], Hu YM[SUP]3[/SUP], Meng FY[SUP]3[/SUP], Li JX[SUP]3[/SUP], Luo L[SUP]1[/SUP], Yang JY[SUP]1[/SUP], Liu P[SUP]1[/SUP], Yu J[SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Viruses from two antigenically distinct influenza B strains have co-circulated since the mid-1980s, yet inactivated trivalent influenza vaccines (TIVs) with either the Victoria or Yamagata lineage could only provide limited protection from influenza B strain. Quadrivalent influenza vaccine (QIV) including both influenza B lineages can improve protection against circulating influenza B viruses.
[h=4]METHODS:[/h] Participants >/= 3 years of age were recruited, stratified by age, and then randomly allocated at a ratio of 2:1:1 to receive one-injection of the experimental QIV, TIV-Victoria (Vic) or TIV-Yamagata (Yam). The primary objective of this study was to demonstrate that the hemagglutination-inhibition (HI) antibodies induced by the QIV candidate are not inferior to the licensed TIVs.
[h=4]RESULTS:[/h] First, 3661 participants (1829 in QIV group and 916 in each TIV control group) received the inoculation. The QIV was found to be non-inferior to TIVs in terms of the geometric mean titers (GMTs) and seroconversion rates (SCRs) of the HI antibodies against shared strains 28 days after completion of inoculation, and was superior to the TIVs against the alternate B strain, which is absent from the TIVs. The occurrences of adverse events (AEs) post-vaccination were similar across the treatment groups, except for a lower incidence of fevers observed in TIV-Vic group(4.37%) compared to the QIV(7.88%) and TIV-Yam (7.93%) groups in participants above 60 years of age. A total of 37 serious adverse events (SAEs) were noted during the 6-month follow up, of which 18(0.98%) were reported from QIV group and 13(1.41%), 6 (0.66%)were reported in the TIV-Yam and TIV-Vic groups, respectively; however, none of the SAEs were considered to be related to the study vaccines.
[h=4]CONCLUSION:[/h] The experimental QIV showed good immunogenicity and an acceptable safety profile.
[h=4]KEYWORDS:[/h] Clinical trial; Immunogenicity; Quadrivalent influenza vaccine; Safety; Seasonal influenza; Victoria lineage; Yamagata lineage
PMID: 28870140 DOI: 10.1080/14760584.2017.1374181
Expert Rev Vaccines. 2017 Sep 5. doi: 10.1080/14760584.2017.1374181. [Epub ahead of print]
[h=1]Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccines in participants >/=3 years of age: A double-blind, randomized, parallel-controlled phase III clinical trial in China.[/h] Wang SY[SUP]1[/SUP], Shu-Zhen L[SUP]2[/SUP], Chu K[SUP]3[/SUP], Zhao Y[SUP]4[/SUP], Zhu FC[SUP]3[/SUP], Hu YM[SUP]3[/SUP], Meng FY[SUP]3[/SUP], Li JX[SUP]3[/SUP], Luo L[SUP]1[/SUP], Yang JY[SUP]1[/SUP], Liu P[SUP]1[/SUP], Yu J[SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Viruses from two antigenically distinct influenza B strains have co-circulated since the mid-1980s, yet inactivated trivalent influenza vaccines (TIVs) with either the Victoria or Yamagata lineage could only provide limited protection from influenza B strain. Quadrivalent influenza vaccine (QIV) including both influenza B lineages can improve protection against circulating influenza B viruses.
[h=4]METHODS:[/h] Participants >/= 3 years of age were recruited, stratified by age, and then randomly allocated at a ratio of 2:1:1 to receive one-injection of the experimental QIV, TIV-Victoria (Vic) or TIV-Yamagata (Yam). The primary objective of this study was to demonstrate that the hemagglutination-inhibition (HI) antibodies induced by the QIV candidate are not inferior to the licensed TIVs.
[h=4]RESULTS:[/h] First, 3661 participants (1829 in QIV group and 916 in each TIV control group) received the inoculation. The QIV was found to be non-inferior to TIVs in terms of the geometric mean titers (GMTs) and seroconversion rates (SCRs) of the HI antibodies against shared strains 28 days after completion of inoculation, and was superior to the TIVs against the alternate B strain, which is absent from the TIVs. The occurrences of adverse events (AEs) post-vaccination were similar across the treatment groups, except for a lower incidence of fevers observed in TIV-Vic group(4.37%) compared to the QIV(7.88%) and TIV-Yam (7.93%) groups in participants above 60 years of age. A total of 37 serious adverse events (SAEs) were noted during the 6-month follow up, of which 18(0.98%) were reported from QIV group and 13(1.41%), 6 (0.66%)were reported in the TIV-Yam and TIV-Vic groups, respectively; however, none of the SAEs were considered to be related to the study vaccines.
[h=4]CONCLUSION:[/h] The experimental QIV showed good immunogenicity and an acceptable safety profile.
[h=4]KEYWORDS:[/h] Clinical trial; Immunogenicity; Quadrivalent influenza vaccine; Safety; Seasonal influenza; Victoria lineage; Yamagata lineage
PMID: 28870140 DOI: 10.1080/14760584.2017.1374181