Cell-derived flu vaccine noninferior to egg-based vaccine in children, study finds
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The results of a phase 3 trial demonstrated that a cell-derived quadrivalent influenza vaccine was well tolerated and elicited noninferior antibody responses compared with a licensed quadrivalent egg-based vaccine in young U.S. children.
Results of the trial were presented during the virtual Annual Conference on Vaccinology Research sponsored by the National Foundation for Infectious Diseases.
In the study, Marten Heeringa, PhD, senior clinical program scientific lead at Seqirus, and colleagues randomly assigned 2,414 children aged 6 to 47 months in a 2-to-1 ratio to receive either the cell-derived quadrivalent influenza vaccine (QIVc) or the licensed quadrivalent influenza vaccine (QIV). Based on vaccination history, children received either one or two doses, 28 days a part, and were followed for at least 180 days.
“Noninferiority of QIVc compared to QIV was concluded if the upper bound of the two-sided 95% confidence interval for the postvaccination [geometric mean titers] ratio did not exceed 1.5, and if the [seroconversion rate] difference did not exceed 10% for each of the four strains,” the researchers explained in the abstract.
Noninferiority was met for the geometric meant titers ratio and the seroconversion rate for each of the four influenza strains, Heeringa and colleagues reported.
“Geometric mean fold rises of pre- to post-vaccination titers for QIVc by hemagglutination inhibition assays were [more than] fourfold for [influenza] A/H1N1, A/H3N2, and B/Yamagata and 2.65 for B/Victoria,” they wrote.
Solicited adverse events were reported in 64% of participants who received QIVc, and 66% of participants in the QIV arm. The most common reported adverse events, respectively, among both QIVc and QIV groups were tenderness (28% and 30%), erythema at the injection site (26% and 25%), irritability (28% and 30%) and sleepiness (27% and 26%).
Fever was reported in less than 7% of all participants. Additionally, the rate of serious adverse events was less than 1% for both groups, the researchers reported.
Perspective
Back to TopPedro A. Piedra, MD
Compared with the egg-based manufacturing process, the cell-based manufacturing process generally provides a more exact match to the influenza vaccine antigens that are selected annually by the FDA and WHO. Currently, egg-based QIV are the only approved influenza vaccines for children aged 6 months and older. A QIVc is approved for children aged 4 years and older in the United States. Heering and colleagues reported on a phase 3 observer-blind controlled study that was conducted in the U.S. to determine whether a QIVc would elicit a noninferior immune response compared with a U.S.-licensed QIV in children aged 6 to 47 months. Noninferiority was met for the immune response to each of the four influenza vaccine strains for QIVc. Adverse event profiles were comparable between QIVc and QIV, with injection site reactions being the most common adverse event reported. This study provides data for a supplemental Biologics License Application for use of QIVc in children down to 6 months of age.
References:
Goshsopf LA, et al. MMWR Recomm Rep. 2020;doi:10.15585/mmwr.rr69081.
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Heeringa M, et al. Immunogenicity and safety of cell-derived quadrivalent influenza vaccine in children 6 through 47 months of age: A randomized controlled non-inferiority trial. Presented at: NFID Annual Conference on Vaccinology Research; April 26-28, 2021 (virtual meeting).
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