Publications by authors named "J J Oberye"

This US-based, prospective observational cohort study evaluated the safety of a quadrivalent inactivated influenza vaccine (IIV4; Afluria Quadrivalent) in pregnant persons immunized over four influenza seasons between 2017 and 2021. Pregnancy outcomes included live birth, stillbirth, spontaneous abortion, and elective termination. Infant events of interest were major congenital malformations (MCMs), preterm birth (<37 weeks gestational age), and low birth weight (LBW).

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Background: Pediatric adjuvanted seasonal influenza vaccines induce higher immune responses and have the potential to confer better protection against influenza among young vaccine-naïve children. Limited data describe benefits and risks of repeated administration of adjuvanted influenza vaccines in children. Two revaccination studies assess the safety and immunogenicity of repeated exposure to an MF59-adjuvanted quadrivalent influenza vaccine (aQIV; Fluad®) compared to routine non-adjuvanted quadrivalent influenza vaccine (QIV).

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Article Synopsis
  • Vaccination against seasonal influenza is important for children at increased risk due to medical conditions, and using an adjuvanted quadrivalent flu vaccine (aIIV4) may improve immune response.
  • A phase III study involving 10,644 children aged 6 months to 5 years showed that aIIV4 produced higher antibody levels in high-risk children compared to a standard, nonadjuvanted vaccine.
  • Both the aIIV4 and nonadjuvanted vaccines had comparable safety profiles, with slightly more minor side effects noted in the aIIV4 group, but overall the vaccines were safe for both healthy and high-risk children.
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Objective: To demonstrate the potential of an MF59-adjuvanted inactivated trivalent seasonal influenza vaccine (aIIV3; Fluad™) to improve the immune response in young children, we review the immunogenicity, efficacy, and safety/tolerability of aIIV3 from a comprehensive clinical development program in a pediatric population with a specific need for improved influenza vaccines.

Methods: Data were analyzed from a series of 1 phase Ib, 3 phase II, and 2 phase III studies involving 11,942 children aged 6 months through 5years.

Results: The clinical data showed that aIIV3 had statistically significantly greater immunogenicity and efficacy in the prevention of influenza compared to conventional inactivated trivalent seasonal influenza vaccines (IIV3s).

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Article Synopsis
  • The study aimed to evaluate the safety and immune response of a specific flu vaccine (aIIV3) in young children (6 months to 5 years) at risk for severe influenza complications.
  • Out of 10,784 children analyzed, about 3% were at risk; adverse events (AEs) were common, with respiratory issues being the main risk factor, but serious AEs were rare and not related to the vaccine.
  • The aIIV3 showed a stronger immune response compared to the standard inactivated influenza vaccine (IIV3), indicating it might be a better option for at-risk children.
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