Immunogenicity and safety of a multi-dose quadrivalent inactivated influenza vaccine in individuals aged 6 months to 17 years: a randomized phase III trial

Ojeda, Joyce; Arredondo, José Luis; Salcedo, Perla; Paredes‐Paredes, Mercedes; Dupuy, Martin; Petit, Céline; Chabanon, Anne Laure; Rivas, Enrique; Gurunathan, Sanjay; Bruijn, Iris De; Pépin, Stéphanie

doi:10.1080/21645515.2019.1697595

Cited by 4 publications

(5 citation statements)

References 16 publications

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“…However, poor vaccination responses were not associated with high pre-vaccination antibody titers in the present study. Recent clinical trials demonstrate that inactivated influenza vaccines are immunogenic and effective in previously-naïve infants [ 64 , 65 , 66 , 67 ], indicating that these vaccines can prime naïve B cells. However, memory B cells are intrinsically programed to out-compete naïve B cells upon B cell receptor engagement [ 68 , 69 , 70 ], and it has been proposed that this could account for the observation that antibody responses to A(H1N1pdm09) vaccines were highly focused on epitopes shared with previously encountered A(H1N1) viruses in selected age groups [ 41 , 71 , 72 , 73 ].…”

Section: Discussionmentioning

confidence: 99%

Opposing Effects of Prior Infection versus Prior Vaccination on Vaccine Immunogenicity against Influenza A(H3N2) Viruses

Fox

Carolan

Leung

et al. 2022

Viruses

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Prior vaccination can alternately enhance or attenuate influenza vaccine immunogenicity and effectiveness. Analogously, we found that vaccine immunogenicity was enhanced by prior A(H3N2) virus infection among participants of the Ha Nam Cohort, Viet Nam, but was attenuated by prior vaccination among Australian Health Care Workers (HCWs) vaccinated in the same year. Here, we combined these studies to directly compare antibody titers against 35 A(H3N2) viruses spanning 1968–2018. Participants received licensed inactivated vaccines containing A/HongKong/4801/2014 (H3N2). The analysis was limited to participants aged 18–65 Y, and compared those exposed to A(H3N2) viruses circulating since 2009 by infection (Ha Nam) or vaccination (HCWs) to a reference group who had no recent A(H3N2) infection or vaccination (Ha Nam). Antibody responses were compared by fitting titer/titer-rise landscapes across strains, and by estimating titer ratios to the reference group of 2009–2018 viruses. Pre-vaccination, titers were lowest against 2009–2014 viruses among the reference (no recent exposure) group. Post-vaccination, titers were, on average, two-fold higher among participants with prior infection and two-fold lower among participants with 3–5 prior vaccinations compared to the reference group. Titer rise was negligible among participants with 3–5 prior vaccinations, poor among participants with 1–2 prior vaccinations, and equivalent or better among those with prior infection compared to the reference group. The enhancing effect of prior infection versus the incrementally attenuating effect of prior vaccinations suggests that these exposures may alternately promote and constrain the generation of memory that can be recalled by a new vaccine strain.

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Section: Discussionmentioning

confidence: 99%

Opposing Effects of Prior Infection versus Prior Vaccination on Vaccine Immunogenicity against Influenza A(H3N2) Viruses

Fox

Carolan

Leung

et al. 2022

Viruses

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“…Lo studio di fase III di Ojeda et al [ 35 ] randomizzato, in aperto, è stato condotto per valutare l’immunogenicità e la sicurezza di un vaccino QIVe in formato multi dose ( multi-dose vial , MDV), contenente tiomersale rispetto al formato a dose singola ( pre-filled syringe , PFS) senza tiomersale. Lo studio ha arruolato 302 soggetti (121 soggetti di età compresa tra 6 e 35 mesi, 59 di età compresa tra 3 e 8 anni e 122 di età compresa tra 9 e 17 anni) tra il 19 dicembre 2017 e il 19 gennaio 2018.…”

Section: Immunogenicità Efficacia Teorica E Sul Campounclassified

“…Nello studio di Ojeda et al [ 35 ] sono stati riportati i dati di sicurezza di un vaccino QIVe in formato multi dose (QIV-MDV), contenente tiomersale rispetto alla preparazione in dose singola (QIV-PFS) senza tiomersale, in bambini di età compresa tra i 6 mesi e i 18 anni. Nei soggetti di età 6-35 mesi nessun AE immediato non sollecitato è stato segnalato sia nei riceventi QIV-MDV che nei vaccinati con QIV-PFS, le reazioni sollecitate globali sono risultate pari al 72% nei vaccinati con QIV-MDV e al 59,3% negli immunizzati con QIV-PFS, le reazione sollecitate al sito d’iniezione erano pari al 54% nei QIV-MDV e al 48,1% nei QIV-PFS, mentre le reazioni sollecitate sistemiche sono risultate pari al 66% nei QIV-MDV e al 46,3% nei QIV-PFS, mentre le reazioni non sollecitate non gravi globali sono risultate pari al 52,5% nei QIV-MDV e al 43,1% nei QIV-PFS.…”

Section: Sicurezza E Tollerabilitàunclassified

Journal of Preventive Medicine and Hygiene, Vol. 62 No. 2s1 (2021): Health Technology Assessment (HTA) dell’introduzione della vaccinazione antinfluenzale per la popolazione giovanile italiana con il vaccino Fluenz Tetra®

Boccalini

Pariani

Calabrò

et al. 2021

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“…Four of the included studies evaluated quadrivalent influenza vaccines (QIV) in children. 5,[11][12][13] All of the studies reported reactogenicity outcomes and adverse events. One study reported both TIV and QIV vaccines and the results are reported above.…”

Section: Quadrivalent Influenza Vaccinesmentioning

confidence: 99%

“…11 The final trial evaluated Vaxigrip Tetra (15μg/strain) administered to children and adolescents in two different formats. 12 Vaxigrip administered as a single dose using a pre-filled syringe (PFS) was compared to a 10-dose multi-dose vial (MDV). Systemic reactions were reported in more infants aged 6 − 35 months in the MDV group than in the PFS group, however this difference was not clinically significant.…”

Section: Quadrivalent Influenza Vaccinesmentioning

confidence: 99%

Safety and effectiveness of dose-sparing strategies for seasonal influenza vaccine

Antony

2020

Preprint

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Background: The objective of this rapid scoping review was to identify potentially safe and effective dose-sparing strategies for intramuscular administration of seasonal influenza vaccines in healthy individuals of all ages. Methods: Comprehensive literature searches were developed and executed in MEDLINE, EMBASE, and the Cochrane library, and grey literature was searched via international clinical trial registries for relevant studies published in English in the last 20 years. References of relevant systematic reviews and included studies were also scanned. Title/abstract and full-text screening were carried out by pairs of reviewers independently and data charting conducted by a single reviewer and verified by a second reviewer. Results were presented narratively. Results: A total of 13 studies with 10,351 participants were included in the review and all studies were randomized control trials conducted between 2006 and 2019. The most common interventions were the trivalent influenza vaccine (n=10), followed by quadrivalent influenza vaccine (n=4). Nine studies included infants/toddlers 6-36 months old and one of these studies also included children and adolescents. In these nine studies, no clinical effectiveness outcomes were reported and no difference was found in local and systemic reactogenicity between dosing strategies. Of the four adult studies (≥ 18 years), the two studies that reported on effectiveness outcomes found similar results between the half-dose and full-dose vaccination groups and all four studies reported no differences in safety outcomes between groups. Conclusion: The current evidence for the administration of intramuscular influenza vaccines suggests there is no significant difference in safety and clinical effectiveness with the use of low-dose compared to full-dose vaccines, which is promising given the predicted resource constraints in the upcoming influenza season due to the 2019 novel coronavirus. Due to the low number of studies in adults and the lack of studies assessing confirmed influenza and influenza-like illness, there remains a need for further evaluation.

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Immunogenicity and safety of a multi-dose quadrivalent inactivated influenza vaccine in individuals aged 6 months to 17 years: a randomized phase III trial

Abstract: (2020) Immunogenicity and safety of a multidose quadrivalent inactivated influenza vaccine in individuals aged 6 months to 17 years: a randomized phase III trial,

Cited by 4 publications

References 16 publications

Opposing Effects of Prior Infection versus Prior Vaccination on Vaccine Immunogenicity against Influenza A(H3N2) Viruses

Opposing Effects of Prior Infection versus Prior Vaccination on Vaccine Immunogenicity against Influenza A(H3N2) Viruses

Journal of Preventive Medicine and Hygiene, Vol. 62 No. 2s1 (2021): Health Technology Assessment (HTA) dell’introduzione della vaccinazione antinfluenzale per la popolazione giovanile italiana con il vaccino Fluenz Tetra®

Safety and effectiveness of dose-sparing strategies for seasonal influenza vaccine

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