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J Pediatric Infect Dis Soc. 2017 Jan 6. pii: piw068. doi: 10.1093/jpids/piw068. [Epub ahead of print]
Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized, Controlled Trial.
Jain VK1, Domachowske JB2, Wang L1, Ofori-Anyinam O3, Rodr?guez-Weber MA4, Leonardi ML5, Klein NP6, Schlichter G7, Jeanfreau R8, Haney BL9, Chu L10, Harris JS11, Sarpong KO12, Micucio AC13, Soni J14, Chandrasekaran V1, Li P1, Innis BL15.
Author information
Abstract
BACKGROUND:
Children under 3 years of age may benefit from a double-dose of inactivated quadrivalent influenza vaccine (IIV4) instead of the standard-dose.
METHODS:
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).
RESULTS:
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.
CONCLUSIONS:
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.
KEYWORDS:
children; double-dose; inactivated quadrivalent influenza vaccine.
PMID: 28062552 DOI: 10.1093/jpids/piw068
[PubMed - as supplied by publisher]
Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized, Controlled Trial.
Jain VK1, Domachowske JB2, Wang L1, Ofori-Anyinam O3, Rodr?guez-Weber MA4, Leonardi ML5, Klein NP6, Schlichter G7, Jeanfreau R8, Haney BL9, Chu L10, Harris JS11, Sarpong KO12, Micucio AC13, Soni J14, Chandrasekaran V1, Li P1, Innis BL15.
Author information
Abstract
BACKGROUND:
Children under 3 years of age may benefit from a double-dose of inactivated quadrivalent influenza vaccine (IIV4) instead of the standard-dose.
METHODS:
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).
RESULTS:
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.
CONCLUSIONS:
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.
KEYWORDS:
children; double-dose; inactivated quadrivalent influenza vaccine.
PMID: 28062552 DOI: 10.1093/jpids/piw068
[PubMed - as supplied by publisher]