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Int J Infect Dis. 2015 Nov 13. pii: S1201-9712(15)00264-7. doi: 10.1016/j.ijid.2015.11.004. [Epub ahead of print]
Non-inferiority of mammalian cell-derived quadrivalent subunit influenza virus vaccines compared to trivalent subunit influenza virus in healthy children: a phase III randomized, multicenter, double-blind, clinical trial.
Hartvickson R1, Cruz M2, Ervin J3, Brandon D4, Forleo-Neto E5, Dagnew AF5, Chandra R5, Lindert K5, Mateen AA6.
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Abstract
OBJECTIVES:
We evaluated the safety and immunogenicity of mammalian cell-derived quadrivalent influenza vaccine (QIVc) as compared with trivalent influenza vaccines (TIV1c/TIV2c) in children aged ≥4 to <18 years.
METHODS:
2333 subjects were randomized 2:1:1 to receive either one or two doses of study vaccine depending on previous vaccination status. Hemagglutination inhibition antibody responses for all four influenza strains were performed 3 weeks after last dose. Reactogenicity and safety were also assessed (ClinicalTrials.gov:NCT01992107).
RESULTS:
QIVc met the non-inferiority criteria against all four vaccine strains and demonstrated superiority for both influenza B strains over the unmatched B lineage included in the comparator vaccines, when geometric mean titers and seroconversion rates were compared, 3 weeks after last vaccination. Similar percentages of subjects experienced solicited and unsolicited AEs across all sub-groups. Unsolicited AEs, serious AEs, medically attended AEs, and new onset chronic disease were reported in comparable percentages of subjects in all study groups. No vaccine-related serious AEs or deaths occurred.
CONCLUSIONS:
QIVc demonstrated similar safety profile and immunogenicity responses against all four vaccine strains without signs of immune interference on addition of an alternate lineage B strain compared with TIV1c/TIV2c and may provide broader protection against both influenza B lineages in children.
Copyright ? 2015. Published by Elsevier Ltd.
KEYWORDS:
Influenza; MDCK; pediatric; quadrivalent; trivalent; vaccine
PMID: 26585940 [PubMed - as supplied by publisher] Free full text
Non-inferiority of mammalian cell-derived quadrivalent subunit influenza virus vaccines compared to trivalent subunit influenza virus in healthy children: a phase III randomized, multicenter, double-blind, clinical trial.
Hartvickson R1, Cruz M2, Ervin J3, Brandon D4, Forleo-Neto E5, Dagnew AF5, Chandra R5, Lindert K5, Mateen AA6.
Author information
Abstract
OBJECTIVES:
We evaluated the safety and immunogenicity of mammalian cell-derived quadrivalent influenza vaccine (QIVc) as compared with trivalent influenza vaccines (TIV1c/TIV2c) in children aged ≥4 to <18 years.
METHODS:
2333 subjects were randomized 2:1:1 to receive either one or two doses of study vaccine depending on previous vaccination status. Hemagglutination inhibition antibody responses for all four influenza strains were performed 3 weeks after last dose. Reactogenicity and safety were also assessed (ClinicalTrials.gov:NCT01992107).
RESULTS:
QIVc met the non-inferiority criteria against all four vaccine strains and demonstrated superiority for both influenza B strains over the unmatched B lineage included in the comparator vaccines, when geometric mean titers and seroconversion rates were compared, 3 weeks after last vaccination. Similar percentages of subjects experienced solicited and unsolicited AEs across all sub-groups. Unsolicited AEs, serious AEs, medically attended AEs, and new onset chronic disease were reported in comparable percentages of subjects in all study groups. No vaccine-related serious AEs or deaths occurred.
CONCLUSIONS:
QIVc demonstrated similar safety profile and immunogenicity responses against all four vaccine strains without signs of immune interference on addition of an alternate lineage B strain compared with TIV1c/TIV2c and may provide broader protection against both influenza B lineages in children.
Copyright ? 2015. Published by Elsevier Ltd.
KEYWORDS:
Influenza; MDCK; pediatric; quadrivalent; trivalent; vaccine
PMID: 26585940 [PubMed - as supplied by publisher] Free full text