A Phase II, Observer-Blind, Parallel Groups, Single Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine in the Previous V70P2 Study.

The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. To evaluate the safety and tolerability of a single 0.25mL IM of injection influenza vaccines in healthy children aged up to 35 months; to evaluate the safety and tolerability of a single 0.50mL IM injection of influenza vaccines in healthy children aged up to 48 months.

开始日期2007-11-01

申办/合作机构-

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项与鼻喷剂型季节性流感疫苗(Advagene Biopharma) 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Epidemiological analysis of influenza vaccination coverage in Pudong New Area, Shanghai (2013-2023): Implications for influenza vaccination strategies

Article

作者: Zheng, Bo ; Xue, Caoyi ; Deng, Pengfei ; Yang, Tian ; Fei, Yi ; Yang, Laibao ; Liu, Wenmin

Seasonal influenza remains a significant public health concern globally, with annual vaccinations as the most effectively preventive measure. This study examines influenza vaccination coverage rates across different age groups in Pudong New Area, Shanghai, China, from 2013 to 2023. This study extracted influenza vaccination data from the Shanghai Immunization Planning Information System (SIPIS) of the Center for Disease Control and Prevention Shanghai's Pudong New Area from 2013 to 2023. The analysis utilized weighted linear regression to compare vaccination rates over the study period. From 2013 to 2023, a cumulative total of 1,421,295 influenza vaccinations were administered in Pudong New Area, with the quadrivalent inactivated influenza vaccines (IIV4) and trivalent inactivated influenza vaccines (IIV3) comprising 56.8% and 42.9%, respectively. The overall average influenza vaccine coverage rate was 2.27% (95% CI: 2.26, 2.28). The 0-4 years group exhibited the highest average annual coverage rate of 22.52% (95% CI: 22.47, 22.57) among different age groups, in stark contrast to that of the 20-24 years age group, which had the lowest at 0.32% (95% CI: 0.31, 0.33). In terms of repeat vaccinations, a significant majority (86.87%) of recipients received only 1-2 doses, while just 13.13% received 3 or more doses. Although influenza vaccination coverage among preschool children in Pudong New Area is relatively high, it falls significantly short of WHO recommendations. Enhance the level of awareness of influenza vaccine among adults and provide a free influenza vaccination strategy for specific groups such as doctors, which is helpful to increase influenza vaccination rates among populations.

2024-09-01·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Relative vaccine effectiveness of MF59-adjuvanted vs high-dose trivalent inactivated influenza vaccines for prevention of test-confirmed influenza hospitalizations during the 2017–2020 influenza seasons

Article

作者: Chastek, Benjamin ; Haag, Mendel D M ; Imran, Mahrukh ; Bancroft, Tim ; Pelton, Stephen I ; Webb, Noah ; McGovern, Ian

OBJECTIVES:

This study evaluated relative vaccine effectiveness (rVE) of MF59-adjuvanted trivalent inactivated influenza vaccine (aTIV) vs high-dose trivalent inactivated influenza vaccine (HD-TIV) for prevention of test-confirmed influenza emergency department visits and/or inpatient admissions ("ED/IP") and for IP admissions alone pooled across the 2017-2020 influenza seasons. Exploratory individual season analyses were also performed.

METHODS:

This retrospective test-negative design study included United States (US) adults age ≥65 years vaccinated with aTIV or HD-TIV who presented to an ED or IP setting with acute respiratory or febrile illness during the 2017-2020 influenza seasons. Test-positive cases and test-negative controls were grouped by vaccine received. The rVE of aTIV vs HD-TIV was evaluated using a combination of inverse probability of treatment weighting and logistic regression to adjust for potential confounders.

RESULTS:

Pooled analyses over the three seasons found no significant differences in the rVE of aTIV vs HD-TIV for prevention of test-confirmed influenza ED/IP (-2.5% [-19.6, 12.2]) visits and admissions or IP admissions alone (-1.6% [-22.5, 15.7]). The exploratory individual season analyses also showed no significant differences.

CONCLUSIONS:

Evidence from the 2017-2020 influenza seasons indicates aTIV and HD-TIV are comparable for prevention of test-confirmed influenza ED/IP visits in US adults age ≥65 years.

2024-08-16·The Journal of infectious diseases

A Multiseason Randomized Controlled Trial of Advax-Adjuvanted Seasonal Influenza Vaccine in Participants With Chronic Disease or Older Age

Article

作者: Chew, Derek ; Toson, Barbara ; Honda-Okubo, Yoshikazu ; Petrovsky, Nikolai ; Sajkov, Dimitar ; Woodman, Richard ; Barbara, Jeffrey

Abstract:

Background:

The aim of the current study was to determine the safety and immunogenicity of trivalent inactivated influenza vaccine (TIV) alone or formulated with Advax delta inulin adjuvant in those who were older (aged >60 years) or had chronic disease.

Methods:

Over 4 consecutive years from 2008 through 2011, adult participants with chronic disease or >60 years of age were recruited into a randomized controlled study to assess the safety, tolerability and immunogenicity of Advax-adjuvanted TIV (TIV + Adj) versus standard TIV. The per-protocol population with ≥1 postbaseline measurement of influenza antibodies comprised 1297 participants, 447 in the TIV and 850 in the TIV + Adj) group.

Results:

No safety issues were identified. Variables negatively affecting vaccine responses included obesity and diabetes mellitus. Advax adjuvant had a positive impact on anti-influenza immunoglobulin M responses and on H3N2 and B strain seropositivity as assessed by hemagglutination inhibition.

Conclusions:

TIV + Adj was safe and well tolerated in individuals with chronic disease. There is an ongoing need for research into improved influenza vaccines for high-risk populations.

Clinical Trials Registration:

Australia New Zealand Clinical Trial Registry: ACTRN 12608000364370.

项与鼻喷剂型季节性流感疫苗(Advagene Biopharma) 相关的新闻（医药）

2023-10-24

·FiercePharma

AstraZeneca's self-administered nasal flu vaccine gets one step closer to FDA approval

A self-administered nasal flu vaccine could be available by the 2024-2025 flu season. AstraZeneca has submitted for FDA approval of FluMist to be administered at home by people ages 18 to 49. On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. The FDA has accepted AZ’s supplemental biologics license application (sBLA) for self-administered FluMist Quadrivalent. The company expects a decision in the first quarter of next year and is making plans to launch the product in the 2024-2025 flu season. The needle-free vaccine, already endorsed for patients ages 2 to 49, could be self-administered by people between the ages of 18 and 49. Adults could also administer FluMist to children ages 2 to 17. Healthcare practitioners are the only ones currently authorized to administer the spray. Since it was approved by the FDA in 2003, FluMist has remained the lone nasal flu vaccine on the market. So why now after 20 years? With the uptake of flu vaccines declining during the coronavirus pandemic, AZ saw an opportunity to attract potential users, Lisa Glasser, AZ’s head of U.S. medical affairs for vaccines and immune therapies, said in an interview. “We viewed this as an opportunity to provide a convenient way for people to get access to flu vaccine,” Glasser said. “Indeed, the pandemic provided us with a lot of difficulties but also a lot of opportunities to realize people really can take care of themselves. They can test themselves for COVID, with a swab in their nose.” If approved, the FluMist would become available through an online pharmacy request system. The vaccine would be shipped to homes in temperature-controlled packages. Despite the CDC recommending seasonal flu vaccinations for everyone older than 6 months, less than half of the U.S. population complies. In rural areas, not even a third of adults were vaccinated in the 2021-2022 flu season. AZ expects that the self-administered vaccine would gain users who currently receive flu shots and would be attracted to the convenience. The longer-range hope, Glasser said, is that it would also draw new people to flu vaccination and increase overall uptake. Backing AZ’s application is a usability study that confirmed that people older than age 18 could administer the product without guidance when given instructions for use. In previous studies, FluMist has been shown to have comparable efficacy and safety profiles to other flu vaccines. AZ has had a bumpy ride with sales of FluMist. They reached $288 million in 2015 before the CDC recommended against its use in the 2016-17 flu season. Sales bottomed out in 2017 at $78 million, as the company had difficulty making the product in bulk after the World Health Organization tweaked its guidelines for manufacturing flu vaccines. The pandemic sparked a resurgence in sales, which reached $295 million in 2020. Last year, the company reported $175 million in revenue from FluMist, with $151 million coming in Europe.