预约演示

更新于：2026-02-27

Inactivated influenza vaccine(Seqirus Pty Ltd)

更新于：2026-02-27

概要

概要

基本信息

药物类型

灭活疫苗、预防性疫苗、多价疫苗

别名

3 influenza strains: A/Victoria/4897/2022 IVR-238 (an A/Victoria/4897/2022 (H1N1)pdm09-like virus); A/Croatia/10136RV/2023 X-425A (an A/Croatia/10136RV/2023 (H3N2)-like virus); and B/Austria/1359417/2021 BVR-26 (a B/Austria/1359417/2021-like virus)、Afluria、Afluria Quadrivalent

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症

甲型流感病毒感染乙型流感病毒感染流感病毒感染

非在研适应症-

原研机构

Seqirus Pty Ltd.

在研机构

Seqirus Pty Ltd.

Scandinavian Regulatory Services AB

非在研机构

Seqirus GmbH

权益机构-

最高研发阶段批准上市

首次获批日期

丹麦 (1997-12-30),

流感病毒感染

最高研发阶段(中国)-

特殊审评优先审评 (澳大利亚)

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关联

项与 Inactivated influenza vaccine(Seqirus Pty Ltd) 相关的临床试验

NCT05734040

/ Completed临床2期

Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years.

The present study OVX836-006 aims principally to:
* Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms;
* Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ;
* Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response;
* Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response;
* Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies;
* Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.

开始日期2023-05-10

申办/合作机构

Osivax SAS

[+2]

NCT05170399

/ Recruiting临床4期IIT

Vaccine Responses in Patients With B Cell Malignancies

Background:
People with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers.
Objective:
To learn how well vaccines work in people who have certain types of blood cancers.
Eligibility:
Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.
Design:
Participants will get one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine.
Participants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose.
Participants will have pregnancy tests, if needed.
Participants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks.
Participants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional.
Participation will last for up to 5 years after each vaccine series is received.

开始日期2022-09-14

申办/合作机构

National Heart, Lung & Blood Institute

CTRI/2022/05/042514

/ Completed临床3期

A prospective, randomized, two arm, parallel, activecontrolled, multicentre, phase III clinical study tocompare the immunogenicity and safety of InactivatedInfluenza vaccine (split virion) I.P. (Tetravalent) 0.5mlof M/s Cadila Healthcare Limited with Fluarix-Tetra ofM/s GlaxoSmithKline Pharmaceuticals Limited inhealthy children aged 6 to 35 months

开始日期2022-05-15

申办/合作机构-

100 项与 Inactivated influenza vaccine(Seqirus Pty Ltd) 相关的临床结果

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100 项与 Inactivated influenza vaccine(Seqirus Pty Ltd) 相关的转化医学

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100 项与 Inactivated influenza vaccine(Seqirus Pty Ltd) 相关的专利（医药）

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项与 Inactivated influenza vaccine(Seqirus Pty Ltd) 相关的文献（医药）

2020-10-15·AMERICAN FAMILY PHYSICIAN

Influenza Vaccination: Updated 2020-2021 Recommendations from ACIP.

Article

作者: Carrie Armstrong ; Armstrong, Carrie

Updates this year include the antigenic composition of seasonal influenza vaccines available in the United States, the addition of two new influenza vaccines for use in people 65 years and older, and new contraindications and precautions for the use of live attenuated influenza vaccine (LAIV) Because the 2020–2021 influenza season will coincide with the coronavirus disease 2019 (COVID-19) pandemic, vaccination of people six months and older is of particular importance to reduce symptoms that could be confused with those of COVID-19 and to alleviate stress on the health care system Influenza Vaccines—United States, 2020–2021 Influenza Season Trade name Formulation Age indication Hemagglutinin or virus count per vaccine virus (per dose) Route of administration Mercury from thimerosal (mcg per 0 5 mL) IIV4, standard dose, egg based* Afluria Quadrivalent 0 25-mL prefilled syringe† 6 to 35 months 7 5 mcg per 0 25 mL IM‡ — 0 5-mL prefilled syringe† ≥ 3 years 15 mcg per 0 5 mL IM‡ — 5 0-mL multidose vial† ≥ 6 months (needle/syringe) 7 5 mcg per 0 25 mL/15 mcg per 0 5 mL IM‡ 24 5 18 to 64 years (jet injector) Fluarix Quadrivalent 0 5-mL prefilled syringe ≥ 6 months 15 mcg per 0 5 mL IM‡ — Flulaval Quadrivalent 0 5-mL prefilled syringe ≥ 6 months 15 mcg per 0 5 mL IM‡ — Fluzone Quadrivalent 0 5-mL prefilled syringe§ ≥ 6 months 15 mcg per 0 5 mL IM‡ — 0 5-mL single-dose vial ≥ 6 months 15 mcg per 0 5 mL IM‡ — 5 0-mL multidose vial ≥ 6 months 15 mcg per 0 5 mL IM‡ 25 IIV4, standard dose, cell culture based Flucelvax 0 5-mL prefilled syringe ≥ 4 years 15 mcg per 0 5 mL IM‡ — Quadrivalent 5 0-mL multidose vial ≥ 4 years 15 mcg per 0 5 mL IM‡ 25 IIV4, high dose, egg based* Fluzone High-Dose Quadrivalent 0 7-mL prefilled syringe ≥ 65 years 60 mcg per 0 7 mL IM‡ — IIV4, standard dose, egg based* with MF59 adjuvant Fluad Quadrivalent 0 5-mL prefilled syringe ≥ 65 years 15 mcg per 0 5 mL IM‡ — IIV3, standard dose, egg based* with MF59 adjuvant Fluad 0 5-mL prefilled syringe ≥ 65 years 15 mcg per 0 5 mL IM‡ — Recombinant influenza vaccine Flublok Quadrivalent 0 5-mL prefilled syringe ≥ 18 years 45 mcg per 0 5 mL IM‡ — Live attenuated influenza vaccine, egg based* Flumist Quadrivalent 0 2-mL prefilled single-use intranasal sprayer 2 to 49 years 106 5–7 5 fluorescent focus units per 0 2 mL Intranasal — Note: Vaccination providers should consult prescribing information for 2020–2021 influenza vaccines for the most complete and updated information Higher-risk people: ○ Adults 50 years and older ○ American Indians/Alaska Natives ○ Children six to 59 months of age ○ Children up to 18 years of age who are receiving aspirin- or salicylate-containing medications (risk of Reye syndrome after influenza virus infection) ○ Immunocompromised people ○ People with a body mass index of 40 kg per m2 or greater ○ People with chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic, or metabolic disorders other than uncomplicated hypertension ○ Pregnant women ○ Residents of long-term care facilities Household contacts and caregivers of higher-risk people Health care professionals, including students and staff who could be exposed to infectious agents Guideline source:

2019-01-01·Vaccine3区 · 医学

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6–59 months of age: A phase 3, randomized, noninferiority study

3区 · 医学

Article

作者: Sawlwin, Daphne C ; Edelman, Jonathan ; Airey, Jolanta ; Graves Jones, Alison ; Matassa, Vince ; Albano, Frank R ; Heijnen, Esther ; Statler, Victoria A ; Marshall, Gary S

BACKGROUND:

In the Southern Hemisphere 2010 influenza season, Seqirus' split-virion, trivalent inactivated influenza vaccine was associated with increased reports of fevers and febrile reactions in young children. A staged clinical development program of a quadrivalent vaccine (Seqirus IIV4 [S-IIV4]; Afluria® Quadrivalent/Afluria Quad™/Afluria Tetra™), wherein each vaccine strain is split using a higher detergent concentration to reduce lipid content (considered the cause of the increased fevers and febrile reactions), is now complete.

METHODS:

Children aged 6-59 months were randomized 3:1 and stratified by age (6-35 months/36-59 months) to receive S-IIV4 (n = 1684) or a United States (US)-licensed comparator IIV4 (C-IIV4; Fluzone® Quadrivalent; n = 563) during the Northern Hemisphere 2016-2017 influenza season. The primary objective was to demonstrate noninferior immunogenicity of S-IIV4 versus C-IIV4. Immunogenicity was assessed by hemagglutination inhibition (baseline, 28 days postvaccination). Solicited, unsolicited, and serious adverse events were assessed for 7, 28, and 180 days postvaccination, respectively.

RESULTS:

S-IIV4 met the immunogenicity criteria for noninferiority. Adjusted geometric mean titer ratios (C-IIV4/S-IIV4) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 0.79 (95% CI: 0.72, 0.88), 1.27 (1.15, 1.42), 1.12 (1.01, 1.24), and 0.97 (0.86, 1.09), respectively. Corresponding values for differences in seroconversion rates (C-IIV4 minus S-IIV4) were -10.3 (-15.4, -5.1), 2.6 (-2.5, 7.8), 3.1 (-2.1, 8.2), and 0.9 (-4.2, 6.1). Solicited, unsolicited, and serious adverse events were similar between vaccines in both age cohorts, apart from fever. Fever rates were lower with S-IIV4 (5.8%) than C-IIV4 (8.4%), with no febrile convulsions reported with either vaccine during the 7 days postvaccination.

CONCLUSION:

S-IIV4, manufactured with a higher detergent concentration, demonstrated noninferior immunogenicity to the US-licensed C-IIV4, with similar postvaccination safety and tolerability, in children aged 6-59 months. This completes the program demonstrating the immunogenicity and safety of S-IIV4 in participants aged 6 months and older.

FUNDING:

Seqirus Pty Ltd; ClinicalTrials.gov identifier:NCT02914275.

2014-08-01·Lancet (London, England)1区 · 医学

Needle-free jet injection for administration of influenza vaccine: a randomised non-inferiority trial

1区 · 医学

Article

作者: Copeland, Karen ; McAllister, Linda ; Anderson, Jonathan ; Werth, Kristen ; Mendelman, Paul M ; Cho, Iksung ; Le Cam Bouveret, Nancy ; Plant, David ; Cobb, David K

BACKGROUND:

Administration of vaccines by needle-free technology such as jet injection might offer an alternative to needles and syringes that avoids the issue of needle phobia and the risk of needle-stick injury. We aimed to assess the immunogenicity and safety of trivalent influenza vaccine given by needle-free jet injector compared with needle and syringe.

METHODS:

For this randomised, comparator-controlled trial, we randomly assigned (1:1) healthy adults (aged 18-64 years) who attended one of four employee health clinics in the University of Colorado health system, with stratification by site, to receive one dose of the trivalent inactivated influenza vaccine Afluria given either intramuscularly with a needle-free jet injector (Stratis; PharmaJet, Golden, CO, USA) or with needle and syringe. Randomisation was done with a computer-generated randomisation schedule with a block size of 100. Because of the nature of the study, masking of participants was not possible. Immunogenicity was assessed by measurement of the hemagglutination inhibition antibody titres in serum for the three viral strains included in the vaccine. We included six coprimary endpoints: three strain-specific geometric mean titre ratios and the absolute differences in three strain-specific seroconversion rates. The immune response of the jet injector group was regarded as non-inferior to that of the needle and syringe group if both the upper bound of each of the three 95% CIs for the strain-specific geometric mean titre ratios was 1.5 or less, and the upper bound of the three 95% CIs for the strain-specific seroconversion rate differences was less than 10 percentage points. We used t test for group comparison. This study is registered with ClinicalTrials.gov, number NCT01688921.

FINDINGS:

During the 2012-13 influenza season of the northern hemisphere, we allocated 1250 participants to receive vaccination by needle-free jet injector (n=627) or needle and syringe (n=623). In the intention-to-treat immunogenicity population, all participants with two serum samples were included (575 in the jet injector group and 574 in the needle and syringe group). The immune response to Afluria when given by needle-free jet injector met the criteria for non-inferiority for all six coprimary endpoints. The jet injector group met the geometric mean titre criterion for non-inferiority for the A/H1N1, A/H3N2, and B strains (upper bound of the 95% CI for the geometric mean titre ratios were 1·10 for A/H1N1, 1·17 for A/H3N2, and 1·04 for B strains). The jet injector group met the seroconversion rate criterion for non-inferiority for the A/H1N1, A/H3N2, and B strains (upper bound of the 95% CI of the seroconversion rate differences were 6·0% for A/H1N1, 7·0% for A/H3N2, and 5·7% for B strains). We recorded serious adverse events in three participants, none of which were study related.

INTERPRETATION:

The immune response to influenza vaccine given with the jet injector device was non-inferior to the immune response to influenza vaccine given with needle and syringe. The device had a clinically acceptable safety profile, but was associated with a higher frequency of local injection site reactions than was the use of needle and syringe. The Stratis needle-free jet injector device could be used as an alternative method of administration of Afluria trivalent influenza vaccine.

FUNDING:

Biomedical Advanced Research and Development Authority (BARDA), PATH, bioCSL, and PharmaJet.

项与 Inactivated influenza vaccine(Seqirus Pty Ltd) 相关的新闻（医药）

2025-12-22

·生物制品圈

2024–2025年美国市场可用流感疫苗

摘要：2024-2025流感季标志着美国流感疫苗接种策略的一个重要转折点，所有疫苗均调整为三价配方（推荐阅读：美国两款鸡胚"亚单位"流感疫苗退市,一场疫苗技术暗战浮出水面），以应对B/Yamagata谱系病毒的实际消失。尽管疫苗供应充足且技术多样，但针对高风险人群（尤其是老年人）的疫苗有效性（VE）仍面临挑战，且针对免疫功能低下个体的高质量效力数据依然稀缺。本文结论强调，未来疫苗研发需继续聚焦于提升对脆弱人群的保护力，并加强针对特殊人群的实时效力监测与研究。第一章：流感疫苗的年度演化与2024-2025季的战略调整流感作为一种急性呼吸道传染病，每年在全球造成严重的疾病负担、住院和死亡。疫苗接种是预防流感及其并发症最有效、最经济的公共卫生干预措施。美国的流感疫苗市场由私营制药公司主导，其配方需每年根据世界卫生组织（WHO）和FDA疫苗及相关生物制品咨询委员会（VRBPAC）对全球流行病毒株的监测和预测进行更新。 1.1 从四价到三价：基于流行病学证据的范式转变 2024-2025流感季最显著的特征是所有在美国上市的流感疫苗均从往年的四价（quadrivalent）统一更改为三价（trivalent）。这一根本性调整并非偶然，而是基于坚实的流行病学监测数据。乙型流感病毒Yamagata谱系自2020年3月以来在全球范围内未被有效监测到，其自然循环可能已中断。继续在疫苗中包含该组分不仅缺乏公共卫生必要性，还可能因疫苗病毒在鸡胚中传代产生不必要的潜在风险。因此，全球监管机构和疫苗生产商一致决定，2024-2025季及以后的疫苗将仅包含两种甲型流感病毒（H1N1和H3N2）和一种乙型流感病毒（Victoria谱系）。这一转变简化了疫苗生产流程，并使其更精准地针对实际流行的病毒威胁。 1.2 2024-2025季疫苗成分更新基于2024年初的病毒监测，2024-2025季流感疫苗的抗原成分进行了针对性更新。具体而言：甲型H1N1组分： A/Victoria/4897/2022(H1N1)pdm09-like病毒，与上一季相比保持不变。甲型H3N2组分：更新为A/Thailand/8/2022(H3N2)-like病毒，这是本季的新组分。乙型Victoria谱系组分： B/Austria/1359417/2021(Victoria lineage)-like病毒，与上一季保持一致。值得注意的是，疫苗成分的具体病毒株会根据生产技术（鸡蛋培养、细胞培养或重组技术）进行微调，以优化其抗原匹配性和免疫原性。 1.3 市场供应与生产概况美国的流感疫苗完全由私营制造商生产，供应量取决于各公司的生产能力与市场策略。对于2024-2025季，预计总供应量约为1.48亿剂，能够充分满足国内需求。在疫苗制剂方面，行业持续向更安全的配方发展：预计94% 的疫苗为无硫柳汞或低硫柳汞制剂，同时约有20% 的疫苗为无鸡胚疫苗（即细胞培养或重组疫苗），这为对鸡蛋严重过敏者提供了安全选择。主要的生产商包括赛诺菲（Sanofi）、葛兰素史克（GSK）、Seqirus（CSL集团旗下）等国际制药巨头。第二章：2024-2025年美国流感疫苗的产品矩阵与技术平台美国市场提供了基于多种技术平台的流感疫苗，以满足不同年龄、健康状况和偏好的需求。这些技术平台在抗原生产方式、免疫原性和适用人群上各有特点。 2.1 基于鸡蛋的灭活流感疫苗这是最传统、应用最广泛的生产技术。病毒在鸡胚中培养、灭活后纯化制成疫苗。代表品牌：Afluria® (Seqirus), FLUARIX® (GSK), Fluzone® (Sanofi)。特点：生产技术成熟，产能大，成本相对较低。但病毒在鸡胚中传代可能发生适应性变异，导致疫苗株与流行株出现抗原性差异（即“蛋适应性变化”），可能影响疫苗效果。推荐阅读：美国两款鸡胚"亚单位"流感疫苗退市,一场疫苗技术暗战浮出水面 2.2 基于细胞培养的灭活流感疫苗使用哺乳动物细胞系（如Madin-Darby犬肾细胞，MDCK）培养病毒，避免了鸡蛋适应性变异问题。代表品牌：Flucelvax® (Seqirus Inc.)。特点：生产周期更可控，抗原性与流行病毒株匹配可能更佳。适用于对鸡蛋严重过敏者。 2.3 重组流感疫苗采用重组DNA技术，将流感病毒血凝素（HA）基因插入杆状病毒表达系统，在昆虫细胞中大量生产HA蛋白。代表品牌：Flublok® (Sanofi Pasteur Inc.) 。特点：完全不使用流感病毒或鸡蛋，生产过程高度标准化，能快速响应疫情。其HA蛋白含量是标准疫苗的3倍，旨在诱发更强的免疫反应。特别适用于对鸡蛋严重过敏者。 2.4 佐剂疫苗与高剂量疫苗专为65岁及以上老年人设计，旨在克服其免疫系统随年龄增长而衰退（免疫衰老）的问题。佐剂疫苗：在疫苗中添加佐剂（如MF59，一种水包油型乳剂），以增强和拓宽免疫反应。代表品牌：Fluad® (Seqirus, Inc.)。高剂量疫苗：含有比标准疫苗多4倍的抗原量，以刺激产生更强的免疫应答。代表品牌：Fluzone High-Dose (Sanofi)。 CDC建议：对于65岁及以上成年人，优先推荐使用这三种增强型疫苗中的任何一种，而非标准剂量疫苗。 2.5 减毒活流感疫苗通过鼻腔喷雾接种，含有经冷适应和温度敏感处理的减毒活病毒，能在上呼吸道复制并诱发免疫反应，但不引起疾病。代表品牌：FluMist® (由阿斯利康AstraZeneca生产)。批准状态与适用人群：搜索结果显示，对于2024-2025流感季，FluMist® 是美国市场上唯一可用的LAIV，且已调整为三价配方（LAIV3）。它被批准用于2至49岁的健康、非孕妇人群。然而，其使用历史存在波折，曾因效力问题被ACIP暂停推荐数年，后恢复。对于免疫功能低下者、孕妇等特定人群，LAIV是禁忌的。 2.6 疫苗类型总结表第三章：CDC官方建议与疫苗接种策略美国疾病控制与预防中心（CDC）通过其免疫实践咨询委员会（ACIP）制定并发布流感疫苗接种的官方建议，这些建议是临床实践和公共卫生政策的基石。 3.1 普遍接种建议 CDC的核心建议明确且一贯：所有年龄在6个月及以上、没有疫苗禁忌症的人，每年都应接种季节性流感疫苗。这一建议在2024年6月发布的更新中再次得到重申，强调了疫苗接种在降低流感感染风险、减轻疾病严重程度、减少并发症、住院和死亡方面的关键作用。 3.2 针对特定人群的建议老年人（≥65岁）：如前所述，ACIP明确建议该年龄组应优先接种高剂量疫苗、佐剂疫苗或重组疫苗，而非标准剂量疫苗，以获取更强的保护。儿童和青少年：从6月龄开始接种。对于首次接种流感疫苗的6个月至8岁儿童，某些情况下需要接种2剂（间隔至少4周）才能获得充分保护。免疫功能低下者：强烈建议每年接种流感疫苗。但必须使用灭活疫苗或重组疫苗，严禁使用减毒活疫苗，因为后者对免疫功能低下者存在潜在风险。对于实体器官移植受者等特定群体，建议使用高剂量或佐剂疫苗。孕妇：流感疫苗对孕妇安全且至关重要，既能保护孕妇本人（孕期患重症流感风险高），也能通过抗体传输为新生儿提供出生后几个月的被动保护。 3.3 疫苗接种时机 CDC建议在流感病毒开始在社区传播之前完成接种，理想时间是9月或10月。但对于在整个流感季节（通常持续到次年3月甚至更晚）尚未接种者，任何时候接种都是有益的。第四章：疫苗有效性监测与证据分析疫苗有效性（Vaccine Effectiveness, VE）是衡量疫苗在真实世界中预防疾病能力的核心指标。CDC通过多个监测网络（如US Flu VE Network, VISION, IVY, NVSN）持续收集和分析数据。截至2025年12月，关于2024-2025季的VE数据主要是初步（preliminary）或中期（interim）估计，最终总结报告可能尚未完全发布或正在最后定稿中。 4.1 总体有效性结论综合多个来源的初步数据，CDC的总体结论是：接种2024-2025季流感疫苗显著降低了流感相关的门诊就诊和住院风险。一项中期分析指出，疫苗在预防任何流感相关急性呼吸道感染的门诊就诊方面，有效性估计在36%至54% 之间这与其他季节的观察范围基本一致。 4.2 按年龄组分层的有效性数据儿科人群（6个月-17岁）：来自CDC网络的初步数据显示，疫苗对儿童和青少年的保护作用较为显著。预防门诊就诊：在门诊设置中，不同网络估计的VE范围为32%至60%。其中US Flu VE网络报告的门诊VE为32% (95% CI: 1 to 54) 。预防住院：针对流感相关住院的保护效果更高，估计在63%至78% 之间。这再次印证了疫苗在预防重症方面的核心价值。成年人，特别是老年人（≥65岁）：这是有效性数据最受关注且存在一定复杂性的群体。历史与普遍认知：由于免疫衰老，流感疫苗在老年人中的效果通常低于年轻成人。2023-2024季的数据显示，≥65岁人群的门诊VE在41%至51% 之间。 2024-2025季的争议点：一份搜索结果引用了一项中期分析，其中“US Flu VE (outpatient)”网络针对“Adults aged ≥65 yrs”的VE估计值为18%，但置信区间极宽（–69 to 60），表明不确定性非常大，该点估计值可靠性低。这与CDC整体上“疫苗降低了老年人住院风险”的结论以及增强型疫苗的推荐逻辑似乎存在表面冲突。深度分析认为：首先，不同监测网络、不同研究设计（门诊vs住院）、不同流感亚型（H1N1 vs H3N2）的VE结果可能存在差异。其次，18%这个点估计可能反映了该特定网络在特定时间段、针对特定流行株（可能是当时占主导且与疫苗匹配度较差的H3N2病毒）的观察结果，不能代表整个流感季或所有老年人群的最终效果。最后，它恰恰凸显了老年人免疫应答的脆弱性和对更有效疫苗的迫切需求。因此，不能将18%视为2024-2025季老年人流感疫苗有效性的权威或最终数字，需等待CDC更完整、更稳定的数据分析。年轻及中年成人（18-64岁）：通常表现出介于儿童和老年人之间的疫苗有效性。 4.3 针对免疫功能低下个体的有效性证据：一个显著的证据缺口这是当前研究和临床实践中的一个关键薄弱环节。搜索结果的共识非常明确：关于流感疫苗在免疫功能低下个体中的有效性，高质量、大规模的真实世界证据和临床试验数据严重缺乏。现有研究的局限性：多数研究样本量小，统计效力不足，且免疫功能低下状态异质性极高（如血液肿瘤、实体器官移植、HIV感染、使用生物制剂等），导致难以得出普适性结论。有效性可能降低：有限的数据表明，与免疫功能正常者相比，疫苗在免疫功能低下者中诱发的免疫反应较弱，有效性可能显著降低。一项研究甚至显示VE仅为5%，而对照组为41%。临床建议基于理论风险和间接证据：尽管直接效力证据不足，但基于流感对免疫功能低下者的高风险性，以及疫苗的安全性，ACIP和IDSA（美国传染病学会）仍强烈建议该人群每年接种灭活或重组流感疫苗。接种的主要目标可能从“完全预防感染”部分转向“减轻疾病严重程度、降低并发症风险”。 2025年新研究？：搜索结果未能明确指向2025年发表的、针对美国免疫功能低下人群流感疫苗有效性的新的重磅同行评审研究。这表明该领域的研究进展依然缓慢，是需要优先填补的科学空白。第五章：关键争议、挑战与未来展望 5.1 关于疫苗有效性数字的解读与沟通如前所述，像“18%”这样的低点估计值在公众和媒体中极易引起误解和“疫苗无效”的质疑。公共卫生机构面临如何科学、透明且负责任地沟通VE数据的挑战。必须强调置信区间、亚组分析、预防重症与预防轻症的区别，以及疫苗接种的群体免疫效益。 5.2 疫苗技术创新的持续需求老年人VE的挑战凸显了对下一代流感疫苗的需求。研究方向包括：通用流感疫苗：针对流感病毒相对保守的区域（如茎部），提供对不同毒株的长期、广泛保护，减少每年接种的必要性。新型佐剂和递送系统：进一步优化对脆弱人群的免疫应答。 mRNA技术平台：在COVID-19疫苗中验证成功后，mRNA流感疫苗正在快速研发中，其优势在于研发周期短、易于针对新毒株更新。Moderna和辉瑞等公司正在推进相关临床试验。 5.3 疫苗接种覆盖率与健康公平即使疫苗有效，其公共卫生 impact 也取决于接种率。数据显示，2024-2025季某些人群（如成年人）的接种率仍有提升空间。确保所有人群，特别是医疗资源不足的社区和种族/族裔少数群体，能够公平地获得和接种推荐的疫苗，是消除健康差距的关键。 5.4 联合疫苗接种策略随着COVID-19的常态化流行，CDC已建议在符合条件的情况下，可同时接种流感疫苗和更新的COVID-19疫苗。这提高了接种便利性，但也对接种服务提供和公众教育提出了新要求。第六章：结论 2024-2025年美国流感疫苗市场处于一个重要的过渡与整合期。三价配方成为新标准，这是基于病毒进化流行病学做出的合理简化。市场提供了多元化的技术选择，从传统的鸡胚疫苗（推荐阅读：美国两款鸡胚"亚单位"流感疫苗退市,一场疫苗技术暗战浮出水面）到先进的重组和细胞培养疫苗，再到专门为老年人设计的增强型疫苗，为临床医生和公众提供了丰富的选项。 CDC的普遍接种建议坚定不移，并针对高风险人群给出了细化指导。来自监测网络的初步有效性数据证实了本季疫苗在减少流感相关医疗负担方面的总体价值，尤其是在预防儿童住院方面效果明确。然而，数据也再次揭示了疫苗保护力在老年人群中的局限性，以及针对免疫功能低下者效力证据的严重匮乏，这些是未来科研和疫苗创新的核心靶点。截至2025年12月，CDC可能仍在整合与分析最终数据，但现有证据已足够支持每年接种流感疫苗这一公共卫生实践的持续开展。面对不断演变的流感病毒和复杂的人群免疫状况，持续监测、透明沟通、推动疫苗技术创新并努力提高接种公平性，是构筑更强大呼吸道疾病免疫防线不可或缺的支柱。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

疫苗

2025-07-23

·FiercePharma

RFK Jr. rubber-stamps ACIP recommendation to remove thimerosal from all vaccines in US

Department of Health and Human Services Secretary Robert F. Kennedy Jr. has endorsed a Centers for Disease Control and Prevention advisory committee recommendation banning the use of thimerosal in all vaccines in the U.S. RFK Jr. and other anti-vaccine activists have said that the preservative, which contains mercury, can cause autism, while studies have shown no link. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has signed off on a Centers for Disease Control and Prevention (CDC) advisory committee recommendation to remove the preservative thimerosal from all flu shots distributed in the U.S.Thimerosal, which contains mercury, has been used in vaccines for nearly a century to prevent fungal or bacterial contamination after one dose has been drawn from a multidose vial.In 1999, the HHS, the American Academy of Pediatrics and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure. Two years later, the U.S. recommended that children age 6 and younger not receive vaccines that contain thimerosal.Anti-vaccine activists have claimed that the preservative can cause autism, though multiple studies, including one by the CDC in 2010, have shown that there is no link.Last month, RFK Jr.’s revamped Advisory Committee on Immunization Practices (ACIP) recommended against the use of thimerosal in flu shots. In three separate rounds of voting, the ACIP advised that children, pregnant women and adults should not receive vaccines that contain thimerosal. Each of the votes were 5-1 in favor of removing thimerosal from vaccines, with one committee member abstaining.“After more than two decades of delay, this action fulfills a long-overdue promise to protect our most vulnerable populations from unnecessary mercury exposure,” RFK Jr. said in a release. “Injecting any amount of mercury into children when safe, mercury-free alternatives exist defies common sense and public health responsibility. Today, we put safety first.”Most companies have already removed the preservative from their vaccines. The exceptions are Sanofi, which produces multidose vials of Fluzone in addition to single-dose syringes, and CSL Seqirus, which includes thimerosal in its multidose vials of Afluria and Flucelvax. Each of these flu shots include a 0.01% concentration of thimerosal.“We acknowledge the recommendation of the new (ACIP),” a Sanofi spokesperson said in a brief statement. “We will have sufficient supply of Sanofi flu vaccine to support customer preference for this season.”Meanwhile, a spokesperson from CSL Seqirus said that “delivery of our thimerosal-free flu vaccines for the upcoming season is already underway and we don't expect the ACIP recommendation to have any impact on our vaccine supply or shipment timings." Both companies have said that they provide many more flu shots in single-dose syringes, which don’t contain thimerosal, than they do in multidose vials.Last month, during the ACIP meeting, Tracy Beth Hoeg, M.D., Ph.D., of the FDA, told the committee that fewer than 5% of the flu vaccines administered in the 2024-25 season contained thimerosal.While the decision does not have a major impact on the industry, it does raise concern about the influence of RFK Jr. and his hand-picked panel of ACIP experts, many of whom have expressed anti-vaccine views. Early last month, RFK Jr. dismissed all 17 previous members of the committee. In placing the lone dissenting vote in the ACIP meeting, Cody Meissner, M.D., of Dartmouth’s Geisel School of Medicine, said the "risk from influenza is so much greater than the nonexistent—as far as we know—risk from thimerosal."“I would hate for a person not to receive the influenza vaccine because the only available preparation contains thimerosal. I find that very hard to justify,” Meissner added.Meanwhile, with his decision, RFK Jr. urged "global health authorities to follow this prudent example for the protection of children worldwide."

疫苗

2025-07-18

·生物制品圈

灭活重组流感疫苗：下一代流感防控的核心方向

摘要：本文系统解析了灭活重组流感疫苗的研发进展、技术突破及应用前景。作为应对流感病毒快速变异的关键手段，灭活重组技术结合了基因工程的精准性与灭活工艺的安全性，通过改造病毒抗原（如血凝素 HA）和优化灭活试剂（如β-丙内酯），有望突破传统疫苗的局限。文章对比了现有灭活方法的优劣，详解重组抗原设计策略（如 HA 茎部靶向、计算优化抗原）及新型佐剂的应用，指出灭活重组疫苗是开发通用流感疫苗（UIV）的核心路径。同时，本文也探讨了技术挑战，如生产复杂性、安全性评估等，并展望了其在全球流感防控中的变革性价值。推荐阅读：鸡胚“亚单位”VS杆状病毒重组亚单位流感疫苗：一场“真假亚单位”的科学审视一、流感防控的迫切需求与疫苗技术现状流感病毒是全球公共卫生的 “常驻威胁”，每年导致 300–500 万重症病例和 29–65 万人死亡。其抗原漂移（基因小突变）和抗原转变（基因重配）特性，使得季节性疫苗需每年更新，且常因病毒变异出现 “匹配失效”。例如，2021–2022 季美国 H3N2 疫苗株与流行株不匹配，导致病例激增。目前，美国市场的流感疫苗主要分为三类：灭活流感疫苗（IIV）、减毒活流感疫苗（LAIV）和重组 HA 疫苗（RIV）。其中，IIV 因安全性高、适用人群广（覆盖 6 月龄以上），是全球使用最广泛的类型（表 1）。但传统 IIV 依赖自然病毒株，难以应对快速变异，因此灭活重组流感疫苗成为下一代疫苗的研发焦点 —— 它通过基因工程改造抗原，结合灭活工艺，可诱导更广泛、更持久的保护。二、现有灭活流感疫苗：从全病毒到拆分疫苗的演进1. 疫苗类型的迭代：安全性与免疫原性的平衡全病毒灭活疫苗（WIV）：1940 年代问世，通过鸡胚培养病毒后灭活制成，免疫原性强但副作用明显（如发热、局部肿痛）。拆分灭活疫苗（SIV）：1968 年替代 WIV，通过去污剂（如 Triton X-100）破坏病毒膜结构，降低毒性但保留抗原性。目前 SIV 是市场主流，占美国 IIV 的 80% 以上。尽管 SIV 安全性更高，但免疫原性较弱，尤其对老年人保护不足。相比之下，WIV 能激活更全面的免疫应答（如诱导细胞毒性 T 细胞），但需改进灭活和纯化技术以减少副作用。2. 美国市场流感疫苗概况（表 1）当前美国市场的流感疫苗可分为多种类型，具体如下表所示。其中，四价灭活疫苗（IIV4）覆盖 2 种 A 型（H1N1、H3N2）和 2 种 B 型病毒，是季节性接种的核心选择,其中以MDCK细胞为基质还有昆虫细胞重组HA亚单位疫苗是鸡胚为基质裂解疫苗的下一代新技术。表 1：2023–2024 年美国市场可用流感疫苗三、灭活工艺的核心：甲醛与β- 丙内酯的技术较量灭活是疫苗生产的关键步骤，需在消除病毒感染性的同时保留抗原性。目前主流试剂为甲醛（FA）和β- 丙内酯（BPL），两者机制与效果差异显著。1. 甲醛：传统但有局限的 “老方法”甲醛通过烷基化反应交联病毒蛋白质和核酸（图 1），自 1930 年代起用于疫苗生产。其优势是工艺成熟，但存在明显短板：灭活时间长（2–7℃下需 24 小时），可能破坏 HA 蛋白构象，降低免疫原性；无法有效激活TLR7 通路（天然免疫受体），可能削弱免疫应答；残留甲醛需严格控制，避免副作用。图 1：甲醛与流感病毒 RNA 和蛋白质的反应机制（A）甲醛与病毒 RNA（尿嘧啶）的反应；（B）甲醛与蛋白质氨基酸的反应2. β- 丙内酯：更高效的 “新一代灭活剂”BPL 通过烷基化病毒核酸（图 2）阻断其复制，对蛋白质抗原性的破坏更小 [22]。相比甲醛，其优势显著：灭活更彻底：可完全灭活 H1N1、H3N2、H5N1 等多种亚型，而甲醛对部分毒株灭活不完全；速度更快：室温下 35–170 分钟即可完成，甲醛则需数天；保留更多抗原性：BPL 灭活的 H5N1 疫苗对异源 H1N1 的保护效果优于甲醛灭活疫苗；安全性可控：BPL 半衰期短（25℃下约 3 小时），易通过加热去除残留。目前，美国 FDA 已批准两款 BPL 灭活疫苗（如 Afluria Quadrivalent），但其应用仍受限于生产工艺的监管壁垒。图 2：β- 丙内酯与流感病毒 RNA 的反应机制（Nu 代表亲核分子，展示 BPL 如何通过化学反应阻断病毒核酸功能）四、灭活重组技术：突破传统疫苗的 “变异困境”传统灭活疫苗依赖自然病毒株，难以应对快速变异。灭活重组流感疫苗通过基因工程改造抗原，结合灭活工艺，实现“精准设计”，是开发通用流感疫苗（UIV）的核心策略。1. 反向遗传学：重组病毒的 “制造工厂”反向遗传学技术（1990 年代问世）可通过质粒系统合成病毒，无需依赖自然毒株。最常用的是 “8 质粒系统”（图 3）：图 3：生成重组 A 型流感病毒的 8 质粒系统（6 个质粒来自 A/PR/8/34 的核心基因，2 个质粒携带目标 HA 和 NA 基因，共转染细胞后生成重组病毒）6 个质粒来自高增殖性毒株（如 A/PR/8/34），提供复制骨架；2 个质粒携带目标毒株的血凝素（HA）和神经氨酸酶（NA）基因；共转染细胞后，2–3 天即可生成重组病毒。该技术不仅缩短生产周期（省去传统筛选步骤），还能精准引入突变（如增强 HA 稳定性），为抗原设计提供灵活性。2. 重组抗原设计：靶向病毒的 “保守区域”血凝素（HA）是流感病毒的主要抗原，分为易变异的 “头部” 和保守的 “茎部”。重组疫苗通过设计 HA 蛋白，引导免疫应答靶向保守区域，实现跨株保护：HA 茎部策略：高糖基化：在 HA 头部增加糖基化位点，遮蔽可变区域，迫使免疫系统针对茎部产生抗体。动物实验显示，此类疫苗可使小鼠对异源毒株的存活率从 0 提升至 100%；嵌合 HA（cHA）：保留茎部不变，替换头部为其他毒株序列。Ⅰ期临床试验显示，cHA 疫苗诱导的茎部抗体在 420 天后仍比安慰剂组高 2 倍。HA 头部优化策略：COBRA 技术：通过计算融合不同毒株的头部保守序列，诱导广谱抗体。例如，COBRA-SIV 疫苗可保护雪貂抵御多种 H1N1 和 H3N2 变异株；集中式 HA：选取能代表进化树各分支的毒株，覆盖更多变异类型。五、佐剂的 “助推作用”：增强免疫应答的关键佐剂可增强疫苗的免疫原性，尤其对免疫功能较弱的人群（如老年人）。下一代佐剂不仅能提升抗体水平，还能激活 T 细胞免疫，扩大保护范围：TLR 激动剂：如 TLR7/8 激动剂可激活天然免疫，增强 Th1 型应答，使疫苗对异源毒株的保护率提升 30%–50%；cGAMP：激活cGAS-STING 通路，在老年小鼠中可使疫苗存活率提高 4–5 倍，且无需增加抗原剂量；R-DOTAP：阳离子纳米颗粒，可将抗原递送进细胞，激活细胞毒性 T 细胞（CTL），使 COBRA 疫苗的存活率从 30% 提升至 100%。目前，MF59（一种含角鲨烯的佐剂）已应用于临床，可减少老年人流感相关住院率 58.5%。六、挑战与未来：灭活重组疫苗的 “成长之路”尽管前景广阔，灭活重组流感疫苗仍面临多重挑战：生产复杂性：反向遗传学技术对实验室级别要求高，规模化生产需优化工艺（如细胞培养替代鸡胚）；安全性评估：重组病毒可能因抗原重组改变致病性，需严格评估其生物安全性；成本与可及性：重组抗原和佐剂的加入可能提高价格，需通过技术普及降低成本，惠及低收入地区；病毒进化压力：疫苗可能诱导病毒产生新的逃逸突变，需结合全球监测及时更新疫苗株。未来的突破方向包括：开发多抗原疫苗（同时表达 HA 和 NA），利用 NA 的保守性扩大保护；优化 BPL 灭活工艺与佐剂组合（如 BPL+MF59），平衡安全性和免疫原性；推动通用疫苗的临床转化（如 cHA 疫苗已进入Ⅰ期临床试验）。七、结语灭活重组流感疫苗整合了基因工程的精准设计与灭活工艺的安全优势，是应对流感变异的 “利器”。从 β- 丙内酯灭活技术的应用到 HA 保守区域的靶向设计，再到新型佐剂的开发，每一步突破都让 “通用流感疫苗” 的目标更近。未来，随着技术普及和全球协作的加强，灭活重组疫苗有望终结 “每年一换” 的防控模式，为全人群提供长期、广谱的保护，彻底改变流感防控的格局。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

疫苗临床研究

100 项与 Inactivated influenza vaccine(Seqirus Pty Ltd) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BB01	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
甲型流感病毒感染	美国	Seqirus Pty Ltd.	2007-09-28
乙型流感病毒感染	美国	Seqirus Pty Ltd.	2007-09-28
流感病毒感染	丹麦	Scandinavian Regulatory Services AB	1997-12-30
流感病毒感染	芬兰	Scandinavian Regulatory Services AB	1997-12-30
流感病毒感染	荷兰	Scandinavian Regulatory Services AB	1997-12-30
流感病毒感染	瑞典	Scandinavian Regulatory Services AB	1997-12-30

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02255409 (CTgov)	临床3期	流感病毒感染	607	Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)	遞鏇鹹憲糧範構鹹糧顧 = 糧顧餘廠繭鹹願廠蓋淵廠淵遞顧糧糧遞壓糧構 (鹹廠繭鏇艱獵顧醖鏇積, 獵範鹹願鹹壓醖製願獵 ~ 鏇憲構襯憲憲遞艱構鏇) 更多	-	2023-03-15
NCT02914275 (CTgov)	临床3期	流感病毒感染	2,250	Seqirus Quadrivalent Inactivated Influenza Vaccine (Seqirus QIV Cohort A)	製憲繭夢鏇夢艱襯衊鬱(醖蓋艱衊願繭淵蓋壓襯) = 製願壓齋遞廠繭製網醖衊糧網範醖觸夢遞艱醖 (壓齋積構鹹醖築窪網壓, 製襯積網鹽構鬱鬱願遞 ~ 夢範願鬱鹹鑰憲繭鹹顧) 更多	-	2019-01-23
				Seqirus Quadrivalent Inactivated Influenza Vaccine (Seqirus QIV Cohort B)	製憲繭夢鏇夢艱襯衊鬱(醖蓋艱衊願繭淵蓋壓襯) = 鏇鏇選廠製鏇醖鏇構簾衊糧網範醖觸夢遞艱醖 (壓齋積構鹹醖築窪網壓, 選願網壓鑰築製製蓋觸 ~ 簾選築醖鬱蓋鏇憲構夢) 更多
NCT01688921 (JIFI, CTgov)	临床4期	流感病毒感染	1,250	Needle-Syringe+AFLURIA vaccine (2012-2013 formulation)	蓋襯構獵觸膚鏇鹽廠夢(顧獵築範襯鑰繭壓窪網) = 鹽築築鏇壓網憲顧鹹遞觸願觸繭艱齋繭襯鬱築 (構蓋觸範蓋蓋窪鑰網衊, 1.352) 更多	-	2014-10-22
NCT01863433 (CTgov)	临床4期	流感病毒感染	120	Trivalent Influenza Vaccine	築製鹽積鹹衊淵鏇醖醖 = 憲簾遞鑰夢蓋襯襯餘糧範艱簾齋襯鏇築願顧選 (觸膚窪網製膚選壓襯壓, 鬱鏇膚範遞醖淵膚積艱 ~ 製願餘艱觸衊壓簾範壓) 更多	-	2014-01-15
NCT01857297 (CTgov)	临床4期	流感病毒感染	120	CSL Influenza Vaccine (Adults (18 to 59 Years))	繭憲壓憲鑰齋簾夢網鏇 = 膚選蓋範糧選醖獵襯觸鏇夢鏇製鏇壓襯觸構製 (糧襯製餘衊網構膚齋襯, 憲憲鹹鏇憲鏇窪壓夢鏇 ~ 鹽構構簾願觸選願觸鹹) 更多	-	2014-01-15
				CSL Influenza Vaccine (Older Adults (60 Years or Older))	繭憲壓憲鑰齋簾夢網鏇 = 顧顧艱獵遞餘膚範簾壓鏇夢鏇製鏇壓襯觸構製 (糧襯製餘衊網構膚齋襯, 遞廠廠齋艱簾鏇積範鬱 ~ 製鬱鹹廠獵鏇艱夢構夢) 更多
NCT01591837 (CTgov)	临床4期	流感病毒感染	120	CSL Influenza Vaccine (Adults)	鹹壓餘繭壓醖顧觸廠網 = 糧襯顧窪鬱獵製選憲膚繭蓋範簾廠淵積網鹽選 (醖網鏇夢鑰淵選醖鏇願, 艱觸遞蓋構鹽顧鹹醖積 ~ 廠遞鑰廠醖夢鏇襯襯糧) 更多	-	2013-11-18
				CSL Influenza Vaccine (Older Adults)	鹹壓餘繭壓醖顧觸廠網 = 顧糧壓簾觸製糧夢網膚繭蓋範簾廠淵積網鹽選 (醖網鏇夢鑰淵選醖鏇願, 網積廠遞製網願築壓選 ~ 網鑰鏇鬱醖膚蓋蓋壓蓋) 更多
NCT01113580 (CTgov)	临床4期	流感病毒感染	120	Enzira® Vaccine (Adults)	壓齋糧鑰醖範築遞壓窪 = 憲網鏇鑰鑰鏇鑰網襯膚築廠鹹觸膚願鬱廠糧淵 (壓鏇選積構鑰蓋鹽壓糧, 壓積選構糧夢鹹淵鹹願 ~ 鹹獵衊蓋築鹹選憲窪製) 更多	-	2012-07-18
				Enzira® Vaccine (Older Adults)	壓齋糧鑰醖範築遞壓窪 = 鏇願築鏇鏇鏇壓製觸淵築廠鹹觸膚願鬱廠糧淵 (壓鏇選積構鑰蓋鹽壓糧, 醖築餘窪廠鑰鏇觸淵蓋 ~ 醖顧夢鬱觸醖選積壓觸) 更多
NCT00735475 (CTgov)	临床4期	流感病毒感染	1,268	Afluria (Afluria® Group)	齋醖築廠選廠鏇蓋簾鬱(簾選蓋網簾鏇齋餘憲願) = 顧繭憲廠鏇遞衊壓憲觸廠鬱鏇餘蓋醖餘壓鬱觸 (醖顧膚淵襯願淵範製餘, 觸膚鏇積獵簾鹽壓觸繭 ~ 艱製糧壓網鹽網鏇顧夢) 更多	-	2011-09-01
				Fluzone (Fluzone® Group)	齋醖築廠選廠鏇蓋簾鬱(簾選蓋網簾鏇齋餘憲願) = 鬱遞選壓築簾顧窪製廠廠鬱鏇餘蓋醖餘壓鬱觸 (醖顧膚淵襯願淵範製餘, 壓淵顧鹽鬱繭鏇糧構選 ~ 簾築衊膚艱鑰選網夢顧) 更多
NCT00959049 (CTgov)	临床3期	流感病毒感染	1,474	CSL's Influenza Virus Vaccine (Afluria) (Afluria Cohort A)	鬱膚糧範顧鏇膚網壓鬱(製鹽鬱襯構簾鏇廠選鹹) = 願齋積簾獵糧憲襯衊獵廠願淵壓築築膚選範醖 (構願齋餘艱糧襯積繭積, 鬱鬱餘鹹窪簾齋網鑰網 ~ 醖艱築鑰糧憲醖壓鹹鬱) 更多	-	2011-07-29
				Influenza Virus Vaccine (Fluzone) (Fluzone Cohort A)	鬱膚糧範顧鏇膚網壓鬱(製鹽鬱襯構簾鏇廠選鹹) = 觸顧窪繭積膚餘積鬱鹹廠願淵壓築築膚選範醖 (構願齋餘艱糧襯積繭積, 鑰製願鬱範鏇蓋襯製積 ~ 簾觸齋顧網齋製夢襯淵) 更多