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influenza vaccine (Agriflu / eTIV_a / Begripal)

✓ Approved

Novartis AG · 疫苗 · 疫苗

什么是 influenza vaccine？

influenza vaccine 是一种疫苗，由Novartis AG研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intramuscular (IM) Injection。

药物档案

商品名Agriflu, eTIV_a, Begripal
公司Novartis AG
药物类别疫苗
给药途径Injectable (Others), Intramuscular (IM) Injection
状态Approved
来源： ClinicalTrials.gov, Novartis AG

相关研究文献

PubMedVaccines2026-07-27

Evaluation of Immunogenicity and Cross-Protective Efficacy of a CpG-Adjuvanted Trivalent Inactivated Influenza Vaccine in Ferrets.

Qiu Yanping Y, Zhang Yan Y, He Shuangshuang S, Wang Yutian Y et al.

Background/Objectives: Pandemic influenza remains a persistent global threat, and while vaccination is the primary preventive measure, conventional vaccines often induce narrow, strain-specific immunity. This study evaluated the immunogenicity, protective efficacy, and cross-protective potential of a CpG-adjuvanted trivalent inactivated influenza vaccine (CpG-TIV) administered intramuscularly at high and low doses in ferrets. Methods: Groups of influenza-seronegative ferrets received two intramuscular injections, 3 weeks apart, of high- or low-dose CpG-TIV or a commercial non-adjuvanted trivalent vaccine. Three weeks after the second immunization (Day 42), serum was obtained, and the ferrets were subsequently challenged intranasally with homologous H1N1 and influenza B viruses, as well as a heterologous drifted H3N2 strain. Clinical signs, body weight, nasal viral load, and lung histopathology were monitored following the viral challenge. Results: CpG-TIV induced significantly higher dose-dependent HI and IgG antibodies than the commercial unadjuvanted vaccine. High-dose CpG-TIV markedly reduced weight loss, clinical symptoms, nasal viral load (by up to 99%), and lung pathological damage. Notably, high-dose CpG-TIV provided significant cross-protection against heterologous H3N2, whereas the commercial vaccine showed no protective effect. At Day 42, HI GMTs in the high-dose group reached 500, 254, and 594 against H1N1, H3N2, and B strains, respectively, with a maximal 2.58 log10 reduction in H1N1 viral load. Conclusions: High-dose CpG-TIV demonstrates strong immunogenicity and robust dose-dependent homologous and heterologous cross-protection in ferrets. The combination of a CpG adjuvant and high-dose antigen broadens protection against drifted influenza viruses, overcoming the narrow coverage of conventional vaccines. These data support further clinical development of this broad-spectrum influenza vaccine candidate.

PMID 42506652
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PubMedVaccines2026-07-27

Strain Matching of Seasonal Influenza Vaccines and Emergence of Neuraminidase Inhibitor Resistance in China from 2015 to 2025.

He Peiqing P, Luo Junhao J, Pu Siyu S, Cui Simin S et al.

Background: Influenza remains a major global public health threat, and vaccination is one of the most effective preventive measures. However, frequent antigenic drift and occasional antigenic shift, along with the lead time required for vaccine development and regional differences in the evolution of circulating strains, may lead to mismatches between WHO-recommended vaccine strains and circulating viruses. In addition, antiviral resistance further complicates precise influenza prevention and control. Objectives: This study aimed to evaluate the concordance of vaccine strains with circulating influenza viruses and the emergence of neuraminidase inhibitor (NAI) resistance in China. Methods: Data on antigenic characterization and antiviral susceptibility testing were extracted from weekly influenza surveillance reports published by the Chinese National Influenza Center from 2015 to 2025. Viral evolution, substitutions at key antigenic sites, and resistance-associated mutations were further examined based on sequences of circulating influenza viruses in China. Results: The overall vaccine match rates were 95.72% (95% CI: 94.02-97.43%) for A(H1N1)pdm09, 58.96% (95% CI: 54.93-62.96%) for A(H3N2), 64.45% (95% CI: 59.49-69.41%) for B/Victoria, and 95.19% (95% CI: 91.32-99.05%) for B/Yamagata in China during the 2015-2025 influenza seasons, with marked year-to-year fluctuations observed particularly for A(H3N2) and B/Victoria. The vaccine matching for cell-based A(H3N2) (70.41%, 95% CI: 65.04-75.77%) vaccine reference strains was significantly higher than that for egg-based A(H3N2) (48.09%, 95% CI: 42.63-53.55%) vaccine reference strains. Sequence analysis indicated that circulating A(H3N2) viruses showed the greatest genetic divergence from the matched egg-based vaccine strains (2.71%, 95% CI: 2.66-2.75%). Phenotypic NAI resistance was detected only in A(H1N1)pdm09 viruses, with resistance rates of 0.18% (95% CI: 0.07-0.45%) in 2023, 3.47% (95% CI: 2.63-4.57%) in 2024, and 3.01% (95% CI: 2.46-3.68%) in 2025. Neuraminidase (NA) sequence analysis showed that the key NAI resistance-associated substitution H274Y has been detected in A(H1N1)pdm09 viruses since 2015, at relatively high frequencies observed during 2015-2018. The mutation re-emerged in 2023 and presented increase trends thereafter, although no A(H1N1) pdm09 circulated during the COVID-19 pandemic. Conclusions: Antigenic concordance between vaccine strains and circulating A(H3N2) or B/Victoria viruses showed marked year-to-year fluctuations in China. Cell-based A(H3N2) vaccine reference strains showed higher antigenic concordance than egg-based strains, supporting further consideration of vaccine production platforms in A(H3N2)-predominant seasons. Phenotypic NAI resistance in circulating A(H1N1)pdm09 viruses was detected from 2023 onward in China, whereas resistance-associated NA substitutions had been detected earlier at the sequence level.

PMID 42506623
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PubMedVaccines2026-07-27

Site-Specific Glycosylation Profiling of Protein Subunit and Inactivated Virus Vaccines.

Goecker Zachary C ZC, Burke Meghan C MC, Liu Yi Y, Mirokhin Yuri A YA et al.

Background/Objectives: Glycosylation can affect vaccine antigen structure and function, making site-specific glycan characterization relevant to antigen quality and comparability. However, quantitative approaches for comparing glycan microheterogeneity remain limited. This study evaluated the utility of the glycopeptide abundance distribution spectra framework for measuring similarity among site-specific glycosylation profiles in vaccines and antigen reference reagents across manufacturing conditions. Methods: Intact N-linked glycopeptides were characterized by nanoflow liquid chromatography-tandem mass spectrometry with stepped-energy fragmentation. Products included monovalent and quadrivalent influenza antigens produced in embryonated eggs, Madin-Darby canine kidney cells, or Spodoptera frugiperda cells, together with a SARS-CoV-2 spike vaccine produced in Spodoptera frugiperda cells and a Chinese hamster ovary cell-produced varicella-zoster virus glycoprotein E vaccine. Site-specific glycan distributions were represented as distribution spectra and compared using NIST MS Search software. Dot-product scores ranging from 0 to 999 quantified similarity. Results: Across measured glycosylation sites, distributions clustered into six recurrent classes. Similarity was high for replicate analyses, conserved influenza components across annual formulations, and matched components from different suppliers within the same production platform (similarity scores = 978, 961, and 960, respectively). Similarity was lower between sites within the same protein, between influenza strains, and between production sources (similarity scores = 554, 540, and 209, respectively). Among production-source comparisons, egg- and Madin-Darby canine kidney-derived profiles were most similar, and the overall ordering of glycosylation similarity was consistent with broad phylogenetic relatedness among production hosts. Conclusions: Distribution spectra-based similarity scoring of vaccine glycoproteins provides a quantitative, reusable approach for documenting site-specific glycosylation microheterogeneity. Using this method, we can conclude that production source is the dominant contributor to variation, whereas replicates, annual formulations, and suppliers within the same production platform are highly consistent.

PMID 42506681
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PubMedVaccines2026-07-27

Influenza B Vaccines: Current Landscape and Novel Development Strategies.

Kotlyarov Roman Y RY, Ravin Nikolai V NV, Mardanova Eugenia S ES

Influenza B virus (IBV) represents a significant global health threat, contributing 20-30% of annual influenza cases and causing substantial morbidity and mortality across all age groups. Current seasonal vaccines demonstrate variable effectiveness, highlighting the urgent need for next-generation approaches that provide enhanced and sustained protection against both IBV lineages. Moreover, continuous antigenic drift of circulating viruses progressively reduces the match between vaccine-induced antibodies and contemporary strains, necessitating broad-spectrum protection strategies. This review discusses influenza B virus control strategies, encompassing both conventional approaches and emerging vaccine technologies. While antiviral therapy, epidemiological surveillance, diagnostics, and non-pharmaceutical public-health measures are integral components of influenza B control, the present review focuses specifically on vaccine-based strategies. By critically appraising the available evidence, this review evaluates the extent to which these strategies may improve the effectiveness of IBV vaccines and, in the longer term, inform the prospect of reducing the burden of-or potentially eliminating-influenza B virus, a goal that remains hypothetical and requires clinical validation.

PMID 42506610
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PubMedVaccines2026-07-27

Influenza Vaccination Status and Associated Factors Among Older Adults in Suzhou, China: A Comparative Cross-Sectional Survey.

Du Ningning N, Shao Shuai S, Zhang Yuanyuan Y, Liu Cheng C et al.

Background: Influenza poses a serious threat to the health of older adults, and vaccination is a key strategy for prevention. As an economically developed city, Suzhou has a rapidly aging population, yet the influenza vaccination rate among older adults remains substantially lower than that in developed countries. There is an urgent need to understand the current vaccination status and its associated factors to inform future strategies for improving vaccination coverage. Objectives: To compare influenza- and vaccine-related knowledge, attitudes, practices, and information access channels between vaccinated and unvaccinated older adults (≥60 years) in Suzhou, and to identify factors associated with vaccination behavior in economically developed areas. Methods: A comparative cross-sectional survey was conducted from April to August 2024 across six districts or county-level cities randomly selected from Suzhou's ten county-level administrative divisions. Participants were divided into vaccinated and unvaccinated groups based on their influenza vaccination status during the 2023-2024 influenza season. A two-stage sampling method was employed: the six districts were selected as primary sampling units; within each district, eligible older adults (aged ≥60 years) were randomly selected from two independent sampling frames-the vaccination information system for the vaccinated group and the basic public health service system for the unvaccinated group. Face-to-face structured interviews were conducted using a questionnaire consisting of four sections; data were entered using EpiData 13.1 and analyzed using SPSS 27.0. The χ2 test, t-test, and multivariable logistic regression were used for statistical analysis. Results: Among 4622 valid older adults (vaccinated: n = 2007; unvaccinated: n = 2615), the vaccinated group scored significantly higher on influenza-related knowledge (4.06 ± 2.21 vs. 3.16 ± 2.33, p < 0.001), vaccine-related knowledge (2.10 ± 1.18 vs. 0.67 ± 1.07, p < 0.001), and perceived influenza risk scores (2.72 ± 1.42 vs. 2.26 ± 1.64, p < 0.001). Vaccine safety and efficacy endorsement were also markedly higher among the vaccinated group (70.3% vs. 22.0%; 49.7% vs. 9.3%). Regarding information sources, the vaccinated group relied more on healthcare institutions (54.56% vs. 46.92%), whereas the unvaccinated group relied more on television (60.34% vs. 51.17%). Multivariable logistic regression revealed that awareness of the influenza vaccine (aOR = 9.151, 95%CI: 6.32-13.25), having a planned vaccination site (aOR = 2.66, 95%CI: 2.01-3.54), and perceiving the vaccine as safe (aOR = 1.81, 95%CI: 1.31-2.49) were positively associated with vaccination, while rural household registration (aOR = 0.76, 95%CI: 0.63-0.93), full-time employment (aOR = 0.41, 95%CI: 0.28-0.60), and hypertension (aOR = 0.79, 95%CI: 0.65-0.94) were inversely associated. Conclusions: Compared with the unvaccinated group, the vaccinated group demonstrated significantly better influenza- and vaccine-related knowledge, risk perception, and recognition of vaccine safety and efficacy, and relied more on healthcare institutions for information. Multivariable regression analysis identified awareness of the influenza vaccine as the strongest associated factor. These findings suggest that vaccination coverage could be improved by strengthening vaccine knowledge promotion through healthcare professionals and increasing awareness of vaccination policies that integrate medical insurance reimbursement.

PMID 42506682
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PubMedVaccines2026-07-27

Yellow Fever Vaccination in an Individual with Confirmed Egg Protein Allergy: A Case Report.

Otte Nelly N, Kahaki Amir Maleki AM, Wurpts Gerda G, Kraus Thomas T et al.

Yellow fever vaccination is recommended for travelers visiting endemic regions in South America and Africa. The live-attenuated vaccine (Stamaril®, Sanofi Pasteur) is produced in embryonated chicken eggs and contains residual ovalbumin, posing a challenge for individuals with egg protein allergy. We report the case of a 35-year-old male disaster relief worker with confirmed egg protein allergy and moderate sensitization but no history of anaphylaxis. Under normal circumstances, a statement confirming that vaccination is not possible would be sufficient for entry. However, due to his work-related duties and the relevant guidelines from his employer, there was an urgent need for vaccination despite his egg protein allergy. A comprehensive allergy work-up including skin prick testing, serum-specific IgE, and oral provocation testing revealed a moderate allergy without systemic reactions. Following informed consent and risk assessment, a fractional dose (0.1 mL) of the reconstituted yellow fever vaccine was administered under close monitoring. The patient developed a localized dermal reaction without systemic symptoms. Post-vaccination neutralization testing confirmed seroconversion indicating protective immunity. Although yellow fever vaccination is considered contraindicated in individuals with severe egg protein allergy, the literature supports its cautious use in selected cases. Fractional dosing has emerged as an effective dose-sparing strategy. Studies show that even in egg protein-allergic individuals, adverse events are rare. In this case, a fractional yellow fever vaccination was safe and an effective option for an egg-allergic individual in a high-risk occupational setting, supporting a personalized approach based on clinical risk assessment and current evidence.

PMID 42506643
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