Randomized, Age-stratified, Double Blind, Controlled Phase 3 Study Comparing a Vero Cell-derived Trivalent Seasonal Influenza Vaccine Made by the Modified Manufacturing Process With Vaccine Made by the Current Manufacturing Process and a Licensed Trivalent Influenza Vaccine in Healthy Adults Aged 18 Years and Older

The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process:
induces immune responses comparable to that produced by the current manufacturing process
has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine
demonstrates consistency of immune response among three different lots.

开始日期2013-01-01

申办/合作机构

Baxter Healthcare Ltd

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100 项与 Inactivated Split Virus Seasonal Influenza Vaccine(Baxter Healthcare Corporation) 相关的专利（医药）

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项与 Inactivated Split Virus Seasonal Influenza Vaccine(Baxter Healthcare Corporation) 相关的文献（医药）

2017-05-01·Vaccine3区 · 医学

Nile Red fluorescence spectrum decomposition enables rapid screening of large protein aggregates in complex biopharmaceutical formulations like influenza vaccines

3区 · 医学

Article

作者: Kayser, Veysel ; Akkoc, Senem ; Haines, Jonathan ; Sahin, Ziya ; Neeleman, Ronald

The extensive presence of large (high molecular weight) protein aggregates in biopharmaceutical formulations is a concern for formulation stability and possibly safety. Tests to screen large aggregate content in such bioformulations are therefore needed for rapid and reliable quality control in industrial settings. Herein, non-commercial seasonal influenza split-virus vaccine samples, produced using various strains and extracted from selected industrial processing steps, were used as model complex bioformulations. Orthogonal characterization through transmission electron microscopy, UV-Vis absorption spectroscopy, fluorescence emission spectroscopy, high-performance liquid chromatography and single-radial immunodiffusion revealed that large, amorphous protein aggregates are formed after virus splitting and their presence is linked mainly, albeit not only, to surfactant (Triton X-100) content in a sample. Importantly, the presence of large virus aggregates in purified whole virus samples and large protein aggregates in vaccine samples was found to correlate with broadening/shouldering in Nile Red fluorescence spectra. Accordingly, decomposition of Nile Red spectra into components allowed the development of a novel, rapid, reliable and user-friendly test with high-throughput potential for screening large aggregate content in influenza split-virus vaccines. The test can be adapted for screening other complex biopharmaceutical formulations, provided relevant controls are done for informed decomposition of fluorescence spectra into their components.

2013-07-01·Influenza and Other Respiratory Viruses3区 · 医学

A Meta‐analysis of intradermal versus intramuscular influenza vaccines: Immunogenicity and Adverse Events

3区 · 医学

ReviewOA

作者: Flora Young ; Kathryn Richardson ; Fawziah Marra ; Carlo A. Marra

Please cite this paper as: Marra et al. (2012) A Meta‐analysis of intradermal versus intramuscular influenza vaccines: immunogenicity and adverse events. Influenza and Other Respiratory Viruses 7(4), 584–603.Objective To determine immunogenicity and safety of intradermal (ID) influenza vaccines compared with intramuscular (IM) administration and effect of dose and age.Design Meta‐anlysis.Setting Systematic review and meta‐analysis of randomized controlled trials on influenza vaccines.Sample Randomized, controlled trials comparing ID seasonal split‐virus influenza vaccines with 15 μg IM control in subjects 18 years of age or older and assessed antibody response at 21–28 days post‐vaccination were considered for inclusion.Results A total of 13 trials were included. The pooled immunogenicity outcomes did not differ significantly between the IM and ID vaccine groups for the H1N1 (ratio of GMTR: 0·92, 95% confidence interval 0·77–1·09; seroconversion: 0·94, 0·86–1·02; seroprotection: 0·97, 0·94–1·00) and B strains (GMTR: 0·93, 0·80–1·08; seroconversion: 0·91, 0·80–1·04; seroprotection: 0·97, 0·91–1·03). For the H3N2 strain, there was no significant difference in GMTR (0·97, 0·80–1·18); however, there was a lower pooled seroconversion (0·89, 0·80–0·99) and seroprotection rate (0·98, 0·96–0·99) for ID recipients. There was a statistically significant association between increasing doses of the ID vaccination with increasing immunogenicity response (P = 0·01). There were no differences in adverse event rates within 3 days post‐vaccination for ID versus IM. But for adverse events occurring 7 days post‐vaccination, ID vaccination was associated with a greater incidence of local events but not systemic events.Conclusions There was no significant difference in immunologic response when comparing ID with IM administration of the influenza vaccination in the overall population, but higher doses of ID vaccine in the older adult population produced a better response.

2012-01-01·Influenza and Other Respiratory Viruses3区 · 医学

Quantitative review of antibody response to inactivated seasonal influenza vaccines

3区 · 医学

ReviewOA

作者: Jessica C. Seidman ; Stephanie A. Richard ; Cécile Viboud ; Mark A. Miller

Please cite this paper as: Seidman et al. (2012) Quantitative review of antibody response to inactivated seasonal influenza vaccines. Influenza and Other Respiratory Viruses 6(1), 52–62.Background Seasonal influenza epidemics are associated with significant morbidity and mortality each year, particularly amongst young children and the elderly. Seasonal influenza vaccines have been available for decades, yet influenza remains a major public health threat in the US, sparking interest in studies evaluating the effectiveness of vaccination.Objectives We sought to identify determinants of serological responses to inactivated seasonal influenza vaccines including number of doses, adjuvant, and subject characteristics.Methods We reviewed 60 articles published between 1987 and 2006. We used weighted multiple logistic regression and random‐effects models to evaluate how seroconversion and seroprotection rates varied with host and vaccine factors.Results Both children and seniors tended to have poorer immune responses compared to adults whereas use of adjuvant and a second vaccine dose tended to improve immune response. Pre‐vaccination serological status had a large impact on the immune response to vaccination. We found substantial heterogeneity among studies, even with similar population settings and vaccination regimen.Conclusions Future studies should stratify their results by pre‐vaccination serological status in an effort to produce more precise summary estimates of vaccine response.

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