tetano
Editor, Senior Moderator
J Pediatric Infect Dis Soc. 2017 Jan 6. pii: piw068. doi: 10.1093/jpids/piw068. [Epub ahead of print]
[h=1]Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized, Controlled Trial.[/h] Jain VK[SUP]1[/SUP], Domachowske JB[SUP]2[/SUP], Wang L[SUP]1[/SUP], Ofori-Anyinam O[SUP]3[/SUP], Rodr?guez-Weber MA[SUP]4[/SUP], Leonardi ML[SUP]5[/SUP], Klein NP[SUP]6[/SUP], Schlichter G[SUP]7[/SUP], Jeanfreau R[SUP]8[/SUP], Haney BL[SUP]9[/SUP], Chu L[SUP]10[/SUP], Harris JS[SUP]11[/SUP], Sarpong KO[SUP]12[/SUP], Micucio AC[SUP]13[/SUP], Soni J[SUP]14[/SUP], Chandrasekaran V[SUP]1[/SUP], Li P[SUP]1[/SUP], Innis BL[SUP]15[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Children under 3 years of age may benefit from a double-dose of inactivated quadrivalent influenza vaccine (IIV4) instead of the standard-dose.
[h=4]METHODS:[/h] We compared the only United States-licensed standard-dose IIV4 (0.25 mL, 7.5 ?g hemagglutinin per influenza strain) versus double-dose IIV4 manufactured by a different process (0.5 mL, 15 ?g per strain) in a phase III, randomized, observer-blind trial in children 6-35 months of age (NCT02242643). The primary objective was to demonstrate immunogenic noninferiority of the double-dose for all vaccine strains 28 days after last vaccination. Immunogenic superiority of the double-dose was evaluated post hoc. Immunogenicity was assessed in the per-protocol cohort (N = 2041), and safety was assessed in the intent-to-treat cohort (N = 2424).
[h=4]RESULTS:[/h] Immunogenic noninferiority of double-dose versus standard-dose IIV4 was demonstrated in terms of geometric mean titer (GMT) ratio and seroconversion rate difference. Superior immunogenicity against both vaccine B strains was observed with double-dose IIV4 in children 6-17 months of age (GMT ratio = 1.89, 95% confidence interval [CI] = 1.64-2.17, B/Yamagata; GMT ratio = 2.13, 95% CI = 1.82-2.50, B/Victoria) and in unprimed children of any age (GMT ratio = 1.85, 95% CI = 1.59-2.13, B/Yamagata; GMT ratio = 2.04, 95% CI = 1.79-2.33, B/Victoria). Safety and reactogenicity, including fever, were similar despite the higher antigen content and volume of the double-dose IIV4. There were no attributable serious adverse events.
[h=4]CONCLUSIONS:[/h] Double-dose IIV4 may improve protection against influenza B in some young children and simplifies annual influenza vaccination by allowing the same vaccine dose to be used for all eligible children and adults.
? The Author 2017. Published by Oxford University Press on behalf of the Pediatric Infectious Diseases Society of America.
[h=4]KEYWORDS:[/h] children; double-dose; inactivated quadrivalent influenza vaccine.
PMID: 28062552 DOI: 10.1093/jpids/piw068
[PubMed - as supplied by publisher]
[h=1]Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized, Controlled Trial.[/h] Jain VK[SUP]1[/SUP], Domachowske JB[SUP]2[/SUP], Wang L[SUP]1[/SUP], Ofori-Anyinam O[SUP]3[/SUP], Rodr?guez-Weber MA[SUP]4[/SUP], Leonardi ML[SUP]5[/SUP], Klein NP[SUP]6[/SUP], Schlichter G[SUP]7[/SUP], Jeanfreau R[SUP]8[/SUP], Haney BL[SUP]9[/SUP], Chu L[SUP]10[/SUP], Harris JS[SUP]11[/SUP], Sarpong KO[SUP]12[/SUP], Micucio AC[SUP]13[/SUP], Soni J[SUP]14[/SUP], Chandrasekaran V[SUP]1[/SUP], Li P[SUP]1[/SUP], Innis BL[SUP]15[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Children under 3 years of age may benefit from a double-dose of inactivated quadrivalent influenza vaccine (IIV4) instead of the standard-dose.
[h=4]METHODS:[/h] We compared the only United States-licensed standard-dose IIV4 (0.25 mL, 7.5 ?g hemagglutinin per influenza strain) versus double-dose IIV4 manufactured by a different process (0.5 mL, 15 ?g per strain) in a phase III, randomized, observer-blind trial in children 6-35 months of age (NCT02242643). The primary objective was to demonstrate immunogenic noninferiority of the double-dose for all vaccine strains 28 days after last vaccination. Immunogenic superiority of the double-dose was evaluated post hoc. Immunogenicity was assessed in the per-protocol cohort (N = 2041), and safety was assessed in the intent-to-treat cohort (N = 2424).
[h=4]RESULTS:[/h] Immunogenic noninferiority of double-dose versus standard-dose IIV4 was demonstrated in terms of geometric mean titer (GMT) ratio and seroconversion rate difference. Superior immunogenicity against both vaccine B strains was observed with double-dose IIV4 in children 6-17 months of age (GMT ratio = 1.89, 95% confidence interval [CI] = 1.64-2.17, B/Yamagata; GMT ratio = 2.13, 95% CI = 1.82-2.50, B/Victoria) and in unprimed children of any age (GMT ratio = 1.85, 95% CI = 1.59-2.13, B/Yamagata; GMT ratio = 2.04, 95% CI = 1.79-2.33, B/Victoria). Safety and reactogenicity, including fever, were similar despite the higher antigen content and volume of the double-dose IIV4. There were no attributable serious adverse events.
[h=4]CONCLUSIONS:[/h] Double-dose IIV4 may improve protection against influenza B in some young children and simplifies annual influenza vaccination by allowing the same vaccine dose to be used for all eligible children and adults.
? The Author 2017. Published by Oxford University Press on behalf of the Pediatric Infectious Diseases Society of America.
[h=4]KEYWORDS:[/h] children; double-dose; inactivated quadrivalent influenza vaccine.
PMID: 28062552 DOI: 10.1093/jpids/piw068
[PubMed - as supplied by publisher]