Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial

MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment.
Participants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®/Pneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration.
Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.

开始日期2021-04-28

申办/合作机构

Hvidovre University Hospital

NCT04318548

/ Completed临床3期

A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

开始日期2020-08-25

申办/合作机构

GSK Plc

NCT04324606

/ Active, not recruiting临床1/2期IIT

A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers

A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM) into the deltoid region of the arm

开始日期2020-04-23

申办/合作机构

University of Oxford

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项与脑膜炎双球菌(A/C/Y和W-135群)寡糖白喉CRM197结合疫苗(Novartis Pharma AG) 相关的文献（医药）

2025-01-01·VACCINE

Randomized trial showing persistence of hSBA titers elicited by a pentavalent meningococcal MenABCWY vaccine for up to 4 years following a primary series and safety and immunogenicity of a booster dose

Article

作者: Maguire, Jason D ; Maansson, Roger ; O'Neill, Robert ; Drazan, Daniel ; Peyrani, Paula ; Maguire, Jason D. ; Zolotas, Lefteris ; Beeslaar, Johannes ; Gruber, William C ; Gruber, William C. ; Jodar, Luis ; Moughan, Beth ; Anderson, Annaliesa S. ; Peterson, James ; Anderson, Annaliesa S

BACKGROUND:

Vaccination against 5 prominent meningococcal serogroups (A/B/C/W/Y) is necessary for broad disease protection. We report immunopersistence through 4 years after a 2-dose (6-month interval) pentavalent MenABCWY primary vaccine series and safety and immunogenicity of a booster administered 4 years after primary vaccination.

METHODS:

This randomized, active-controlled, observer-blinded study was conducted in the United States and Europe. In stage 1, healthy MenACWY vaccine-naive or -experienced 10- to 25-year-olds were randomized 1:2 to receive MenABCWY and placebo or MenB-fHbp and MenACWY-CRM. Eligible participants were randomly selected to participate in stage 2, which was an open-label immunopersistence and booster extension. Immunogenicity was assessed through serum bactericidal antibody using human complement (hSBA) assays with serogroups A/C/W/Y (MenA/C/W/Y) and 4 primary serogroup B (MenB) test strains. Immunogenicity endpoints included hSBA seroprotection rates through 48 months after primary vaccination and 1 month after the booster. Safety endpoints included booster reactogenicity events and adverse events (AEs).

RESULTS:

Of 1379 eligible participants, 353 entered stage 2; 242 completed the 48-month blood draw after primary vaccination and 240 completed the booster vaccination phase. MenA/C/W/Y seroprotection rates remained high for 4 years following a 2-dose MenABCWY primary series (MenACWY-naive, 62.0 %-100.0 %; MenACWY-experienced, 98.7 %-100.0 %) and trended higher than those after a single MenACWY-CRM dose (MenACWY-naive, 38.1 %-95.2 %; MenACWY-experienced, 89.7 %-100.0 %). Corresponding seroprotection rates against MenB remained stable and generally higher than baseline (MenABCWY, 18.2 %-36.6 %; MenB-fHbp, 16.2 %-31.9 % across strains). Following a booster, seroprotection rates against all 5 serogroups were ≥ 93.8 % across groups. Most booster dose reactogenicity events were mild or moderate in severity, and AEs were infrequent.

CONCLUSIONS:

Immune responses remained high for MenA/C/W/Y and above baseline for MenB through 4 years after the MenABCWY primary series, with robust responses for all 5 serogroups observed following a booster. The MenABCWY booster had an acceptable safety and tolerability profile consistent with the primary series. NCT03135834.

2025-01-01·VACCINE

Impact on meningococcal disease of different vaccination strategies with 4CMenB and MenACWY-CRM197 in infants and adolescents in Argentina

Article

作者: Giglio, Norberto ; Pannunzio, Maria Eugenia ; Karwala, Piotr ; Nocita, Florencia ; Urueña, Analia ; Gómez, Jorge Alberto ; Graña, Maria Gabriela

BACKGROUND:

Invasive meningococcal disease (IMD) is a life-threatening disease, primarily affecting infants and children. Argentina introduced routine meningococcal vaccination in infants and adolescents in 2017, with MenACWY vaccination targeting serogroups A, C, W, and Y (current National Immunization Program [cNIP]). Serogroup B, more prevalent since 2015, became predominant in children. The dynamic trends of IMD epidemiology and availability of a four-component meningococcal B vaccine (4CMenB) call for a reassessment of the best schedule to optimize IMD prevention. The objective was to model the public health impact of routine 4CMenB and/or MenACWY in infants and adolescents, using different vaccination strategies compared with the cNIP in Argentina.

METHODS:

A published dynamic transmission model adapted for Argentina evaluated six vaccination strategies versus the cNIP: infant 4CMenB alone (1), infant 4CMenB with adolescent MenACWY (2), adolescent MenACWY alone (3), infant 4CMenB & MenACWY (4), infant MenACWY alone (5), and infant 4CMenB & MenACWY with adolescent MenACWY (6).

RESULTS:

Strategies including adolescent MenACWY with infant 4CMenB (or 4CMenB plus MenACWY) vaccination had the largest impact on increasing IMD prevention i.e., up to 23 % higher than the cNIP after 25 years. Strategies including 4CMenB (1, 2, 4, 6) had the largest reduction of serogroup B IMD (impact is seen among children 0-4 years old) i.e., a 39 % decrease within the first five years of introducing 4CMenB. Strategies including adolescent MenACWY (cNIP, 2, 3 and 6) had the largest reduction of serogroup ACWY IMD, with near elimination after 30 years (impact seen in all ages, due to herd protection).

CONCLUSIONS:

Adding routine infant 4CMenB (either to the complete cNIP or instead of infant MenACWY) could further reduce IMD cases, sequelae, and deaths in Argentina. In addition, maintaining the adolescent MenACWY program, with its herd immunity benefits, could achieve near elimination of serogroup ACWY IMD over 30 years.

2024-12-01·LANCET INFECTIOUS DISEASES

Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial

Article

作者: Langley, Joanne ; Carter, Robert ; Simon, William ; Jeanfreau, Robert ; Ackerman, Ronald ; Pelayo, Enrique ; Willemsen, Arnold ; Ukkonen, Benita ; Trapani, Mauro ; Freeman, George ; Staben, Jonathan ; Chakerian, Maia ; Vale, Noah ; Rämet, Mika ; Dionne, Marc ; Lattanzi, Maria ; de Looze, Ferdinandus ; Cetin, Benhur Sirvan ; Zemanek, Josef ; Paavola, Pauliina ; Vachon, Marie-Louise ; Athan, Eugene ; Dzongowski, Peter ; Surber, Joseph ; Beran, Jiří ; Cetin, Benhur ; Osowa, Alexander ; Farjo, Rand ; Dinleyici, Ener Cagri ; Silas, Peter ; Ayesu, Kwabena ; Byars, William ; Spaziererova, Martina ; Koski, Susanna ; Tipton, Mary ; Dalebout, Marije ; Meisalu, Sandra ; Lechevin, Isabelle ; Adamovska, Renata ; Ince, Tolga ; Bhusal, Chiranjiwi ; Rouhbakhsh, Rambod ; Raulier, Stefanie ; Tapiero, Bruce ; Laajalahti, Outi ; Finn, Daniel ; Grubb, Paul ; Bernard, David ; Gottfredson, Ryan ; Pavlasek, Miroslav ; Morelle, Danielle ; Kokko, Satu ; Jones, Jake ; Richmond, Peter ; Kiiroja, Kaia ; Toneatto, Daniela ; Dražan, Daniel ; Patel, Minesh ; Rok, Walter ; Bloch, Mark ; Seppä, Ilkka ; Sanchez, Yamirka ; Schear, Martin ; Gupta, Anil ; Tiong, Florence ; Sadarangani, Manish ; Mehta, Hemalini ; Scott, John ; Nolan, Terry ; Richmond, Peter C ; Kellner, James ; Wauters, Dominique ; Ulukol, Betul ; Langley, Joanne M

BACKGROUND:

A multicomponent meningococcal serogroups ABCWY vaccine (MenABCWY) could provide broad protection against disease-causing meningococcal strains and simplify the immunisation schedule. The aim of this trial was to confirm the effect of the licensed meningococcal serogroup B (MenB) vaccine, 4CMenB, against diverse MenB strains, and to assess the breadth of immune response against a panel of 110 MenB strains for MenABCWY containing the antigenic components of 4CMenB and licensed serogroups ACWY vaccine, MenACWY-CRM, the non-inferiority of the immune response with MenABCWY versus 4CMenB and MenACWY-CRM, safety, and MenABCWY lot-to-lot consistency.

METHODS:

We conducted a phase 3 randomised, controlled, observer-blinded trial of healthy adolescents and young adults (age 10-25 years) across 114 centres in Australia, Canada, Czechia, Estonia, Finland, Türkiye, and the USA. Exclusion criteria included previous vaccination with a MenB vaccine or (within the last 4 years) MenACWY vaccine. Participants were randomly allocated (5:5:3:3:3:1 ratio) via a central randomisation system using a minimisation procedure to receive 4CMenB at months 0, 2, and 6 (referred to as 4CMenB 0-2-6 hereafter); or 4CMenB at months 0 and 6 (referred to as 4CMenB 0-6 hereafter); or MenABCWY (three groups, each receiving one production lot of the MenACWY-CRM component) at months 0 and 6; or MenACWY-CRM at month 0. Demonstration in the per-protocol set of the consistency of three MenACWY-CRM component lots of the MenABCWY vaccine was a primary objective (demonstrated with two-sided 95% CIs for the ratio of human serum bactericidal antibody [hSBA] geometric mean titres against each serogroup within predefined criteria [0·5-2·0]). The primary endpoints (breadth of immune response) for the MenB component of MenABCWY and 4CMenB were measured using the endogenous complement hSBA (enc-hSBA) assay against a panel of 110 diverse MenB invasive disease strains. For each serum sample, 35 strains from the 110 MenB strain panel were randomly selected for testing. The 4CMenB breadth of immune response data have been published separately. For MenABCWY, breadth of immune response was assessed in two analyses: a test-based analysis of the percentage of samples (tests) without bactericidal serum activity against MenB strains 1 month after two MenABCWY doses versus the percentage after one MenACWY-CRM dose in the per-protocol set, and a responder-based analysis of the percentage of participants (responders) whose sera killed 70% or more strains at 1 month after two MenABCWY doses in the full analysis set. A lower limit of two-sided 95% CI above 65% would demonstrate breadth of immune response. Other primary outcomes included non-inferiority (5% margin) of two MenABCWY doses versus two 4CMenB doses by enc-hSBA assay in the per-protocol set, non-inferiority (10% margin) of two MenABCWY doses versus one MenACWY-CRM dose in MenACWY vaccine-naive participants by traditional hSBA assay in the per-protocol set, and safety in all vaccinated participants. This trial is registered with ClinicalTrials.gov, NCT04502693, and is complete.

FINDINGS:

Between Aug 14, 2020, and Sept 3, 2021, 3651 participants were enrolled and randomly allocated (900 in the 4CMenB 0-2-6 group and 908 in the 4CMenB 0-6 group, 1666 in the three MenABCWY groups combined, and 177 in the MenACWY-CRM group). All primary objectives for MenABCWY were met. Consistency of immune responses against the three production lots of the MenACWY component of MenABCWY was demonstrated since two-sided 95% CIs for the ratios of hSBA geometric mean titres against serogroups A, C, W, and Y for each pair of lots were within the predefined equivalence criteria. The lot data were pooled for the remainder of MenABCWY endpoints. By enc-hSBA assay, breadth of immune response against the MenB strain panel was 77·9% (95% CI 76·6 to 79·2) in the test-based analysis and 84·1% (81·4 to 86·5; 687 of 817 participants) in the responder-based analysis. Non-inferiority of MenABCWY to 4CMenB was demonstrated by enc-hSBA assay: the difference in percentage of samples with bactericidal serum activity between the MenABCWY group (82·5% [95% CI 82·1 to 83·0]; 21 222 of 25 715) and 4CMenB 0-2 group (83·1% [82·7 to 83·6]; 22 921 of 27 569) was -0·61% (-1·25 to 0·03). Non-inferiority of two-dose MenABCWY to one-dose MenACWY-CRM was demonstrated by traditional hSBA assay, with differences between the MenABCWY group and MenACWY group in percentages of participants with a four-fold rise in hSBA titres of 11·3% (5·9 to 19·0) for serogroup A, 47·2% (38·1 to 56·3) for serogroup C, 35·3% (26·9 to 44·5) for serogroup W, and 27·0% (19·4 to 35·8) for serogroup Y. MenABCWY reactogenicity was mostly of mild or moderate severity and transient, with similar frequencies of adverse events in the MenABCWY and 4CMenB groups and no safety concerns were identified.

INTERPRETATION:

This study demonstrates breadth of immune response against a panel of 110 MenB strains for the MenB component of the investigational MenABCWY vaccine, when administered as a 0-6 months schedule to the target population of adolescents and young adults, with predefined criteria for success met for both breadth of immune response endpoints and for non-inferiority versus 4CMenB. This investigational vaccine could provide broad meningococcal serogroup coverage in a simplified immunisation schedule, thus aiding the public health attempt in preventing invasive meningococcal disease due to five Neisseria meningitidis serogroups in adolescents and young adults.

FUNDING:

GSK.

项与脑膜炎双球菌(A/C/Y和W-135群)寡糖白喉CRM197结合疫苗(Novartis Pharma AG) 相关的新闻（医药）

2025-01-08

·PRNewswire

Clarivate Identifies Eleven Potential Blockbuster and Transformative Drugs in Annual Drugs to Watch Report

Anticipated advancements in obesity, oncology, gene therapy and other areas poised to revolutionize patient care LONDON, Jan. 8, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT) a leading global provider of transformative intelligence, today announced the release of the twelfth annual Drugs to Watch™ report, a trusted guide to the therapies poised to redefine the future of healthcare. This year, the highly anticipated resource highlights 11 drugs projected to achieve blockbuster status or revolutionize treatment paradigms within five years. Since its inception, Drugs to Watch has identified over 98 transformative therapies, cementing its role as an essential resource for navigating the ever-evolving pharmaceutical landscape. This year's report, powered by insights from the Clarivate Cortellis intelligence suite of products, highlights 11 therapies that have recently launched or are set to debut in 2025. These innovations, addressing critical challenges in areas such as obesity, oncology, and gene therapy, are forecast to achieve blockbuster sales by 2030 or dramatically improve patient outcomes on a global scale. The report also explores pivotal trends shaping the industry, including the surging demand for obesity treatments, the transformative potential of gene editing, and the growing impact of regulatory innovation. The report offers an in-depth analysis of the chronic disease market in Mainland China, spotlighting five therapies expected to exceed $1 billion in annual sales over the next five years or deliver transformative outcomes for patients. It also explores critical topics shaping global healthcare, including regulatory advancements, the role of radiopharmaceutical theranostics in oncology, and the growing use of real-world data (RWD) and patient-reported outcomes (PROs) to drive health equity and enhance regulatory submissions. Henry Levy, President, Life Sciences & Healthcare, Clarivate, remarked: "Innovation in the life sciences is reaching unprecedented heights, and this year's Drugs to Watch™ report once again demonstrates the industry's ability to deliver therapies that address unmet medical needs and challenge existing paradigms of care. At Clarivate, we take pride in the precision and reliability of our predictions—last year, we identified 13 molecules as Drugs to Watch, with 12 already approved and launched and one poised for launch. This track record reflects the strength of our comprehensive data and deep expertise. By continuing to provide actionable insights, we empower the sector to navigate opportunities, overcome challenges and drive progress in advancing global health." Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, stated: "2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as AI and machine learning to enhance drug discovery and development. This year's report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities." The 2025 Drugs to Watch™ report highlights key trends reshaping the life sciences landscape, emphasizing the transformative impact of emerging technologies and therapeutic breakthroughs. Advances in AI and machine learning are streamlining drug discovery, clinical trials, and real-world data integration, enabling precision medicine approaches. The obesity market is undergoing a revolution driven by next-generation GLP-1 therapies, while radiopharmaceutical theranostics are redefining cancer treatment with a "see it and treat it" paradigm. Gene editing technologies are unlocking new opportunities in personalized medicine, and evolving regulatory frameworks are fostering greater emphasis on patient-reported outcomes and health equity. Together, these trends showcase the sector's resilience and its ability to navigate challenges while driving innovation to improve patient care worldwide. This year's drugs to watch exemplify the fusion of innovation and dedication to advancing patient care in an increasingly complex healthcare ecosystem. The Drugs to Watch™ 2025 list include: AWIQLI® (LAI 287; insulin icodec) developed by Novo Nordisk | Type 1 and type 2 diabetes mellitus AWIQLI®, the first once-weekly, subcutaneous insulin, has launched in Australia, Canada, the EU, Mainland China, and Japan. Its weekly dosing offers a significant advantage over daily basal insulin, potentially reducing the treatment burden for patients with type 1 or type 2 diabetes (T1DM and T2DM). CagriSema (cagrilintide + semaglutide) developed by Novo Nordisk | Obesity and type 2 diabetes mellitus CagriSema, combining cagrilintide, a long-acting amylin analog, with semaglutide, promises superior efficacy over semaglutide (OZEMPIC/WEGOVY®) and tirzepatide (MOUNJARO/ZEPBOUND®) in treating obesity and type 2 diabetes. This next-generation GLP-1 therapy leverages the benefits of GLP-1s, such as enhanced insulin secretion and appetite reduction, while incorporating amylin's effects, including slowed glucose absorption and release. If approved, CagriSema will be the first fixed-dose combination of amylin and GLP-1 receptor agonists in the obesity and T2DM markets. COBENFY™ (KarXT; xanomeline-trospium) developed by Bristol Myers Squibb | Schizophrenia and psychosis related to Alzheimer's disease Amid setbacks for emerging schizophrenia treatments, the approval of COBENFY marks a transformative milestone as the first drug in over 30 years with a novel mechanism of action for treating schizophrenia. Combining xanomeline and trospium, COBENFY selectively targets M1 and M4 receptors, rather than traditional dopamine pathways, while minimizing cholinergic side effects. While further data is needed to assess its effectiveness in Alzheimer's disease-related psychosis, COBENFY shows strong commercial potential if proven effective in treating AD-related hallucinations and delusions. EBGLYSS™ (lebrikizumab) developed by Eli Lilly and Co and Almirall | Atopic dermatitis EBGLYSS™, the third biologic targeting IL-13 for atopic dermatitis, follows DUPIXENT® (dupilumab) and ADBRY®/ADTRALZA® (tralokinumab) to market. Its less frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position it as a likely first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate. Fitusiran developed by Alnylam® Pharmaceuticals Inc and Sanofi | Hemophilia A and B Fitusiran, shown to be effective in phase 3 trials for both hemophilia A and B, regardless of inhibitor status, has the potential to offer a new approach to hemophilia treatment. This small interfering RNA (siRNA) therapy works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance hemostasis to prevent bleeds. Leveraging Alnylam® Pharmaceuticals' ESC-GalNAc conjugate technology, fitusiran could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval. GSK-3536819 (MenABCWY) developed by GSK plc | Meningococcus GSK plc's GSK-3536819 vaccine candidate, a 5-in-1, first-generation formulation, targets the five groups of Neisseria meningitidis (A, B, C, W, and Y) responsible for most invasive meningococcal disease (IMD) cases worldwide. It combines the antigenic components of GSK's licensed meningococcal vaccines, BEXSERO (MenB) and MENVEO (MenACWY), both of which have established efficacy and safety profiles. IMDELLTRA™ (tarlatamab-dlle) developed by Amgen | Small-cell lung cancer (SCLC) IMDELLTRA™ is a first-in-class immunotherapy for extensive-stage small cell lung cancer (ES-SCLC). Using Amgen's bispecific T cell engager (BiTE®) molecules, it targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to attack and lyse the tumor. DLL3 is expressed on the surface of SCLC cells in more than 85% of patients but is minimally expressed on healthy cells making it an attractive target. This mechanism positions IMDELLTRA as a potential standard of care for previously treated ES-SCLC. mRESVIA (mRNA-1345) developed by Moderna Inc | RSV With its U.S. FDA approval in May 2024, mRESVIA® joined AREXVY and ABRYSVO, both featured in Drugs to Watch 2024, as respiratory syncytial virus (RSV) vaccines currently available for adults ages 60 years and older, helping further support the public health initiative to reduce the RSV-related disease burden. Even with available vaccines, RSV infections continue to be a public health concern, particularly for infants and older adults (65 years and older). SEL-212 developed by Sobi® and Cartesian Therapeutics Inc/Selecta Biosciences Inc | Gout SEL-212 is a novel, once-monthly treatment combining pegylated uricase (pegadricase; SEL-037) with ImmTOR™, an immune tolerance technology designed to inhibit the formation of anti-drug antibodies (ADAs). For this application, ImmTOR consists of SEL-110.36, an inhibitor of uricase-specific ADA. This approach may help overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, such as KRYSTEXXA® (pegloticase), in patients with chronic gout. Vepdegestrant (ARV-471) developed by Arvinas Inc and Pfizer Inc | Breast cancer A global collaboration between Arvinas Inc and Pfizer Inc, vepdegestrant may become the first PROteolysis Targeting Chimera (PROTAC®) protein degrader on the market. Designed to target and degrade the estrogen receptor (ER) protein, early studies suggest PROTAC-induced degradation is more complete than with oral selective estrogen receptor degraders (SERDs). This offers potential for overcoming endocrine resistance in breast cancer. Label expansions, including combination with IBRANCE® (palbociclib), are being explored. Zanzalintinib (XL092) developed by Exelixis Inc | Colorectal cancer, renal cell carcinoma and squamous cell carcinoma of head and neck Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases involved in tumor growth and immunosuppression. Currently in phase 3 trials for non-clear-cell renal cell carcinoma (nccRCC), colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN), the company anticipates one potential zanzalintinib launch per year starting as early as 2026. Compared to CABOMETYX® (cabozantinib), zanzalintinib may offer benefits, including approval for nccRCC histology and a broader patient population. Access the Drugs to Watch 2025 report from Clarivate, here. For more Drugs to Watch updates and analyses throughout the year, visit the Drugs to Watch web page and follow Clarivate for Life Sciences & Healthcare on LinkedIn and X. Join the conversation, using #DrugstoWatch. To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery, development and delivery process, visit here. Methodology for the Clarivate Drugs to Watch 2025 Report To identify this year's Drugs to Watch, Clarivate drew from the expertise of over 160 analysts covering hundreds of diseases, drugs and markets, along with 11 integrated data sets that span the R&D and commercialization lifecycle, including: Cortellis Competitive Intelligence™, Disease Landscape & Forecast, Epidemiology Intelligence, BioWorld™, Cortellis Regulatory Intelligence™, Drug Timeline & Success Rates, Cortellis Clinical Trials Intelligence™, Cortellis Deals Intelligence™, Access & Reimbursement payer studies, Clarivate Real-World Data and Analytics, Web of Science™, Derwent Innovation™, and other industry sources including biopharma company press releases, filings and peer-reviewed publications. Candidate drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched in 2024 were selected for analysis, including both novel treatments and already-marketed drugs pursuing new indications that could be particularly impactful. Drugs launched prior to 2024 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2030. Clarivate experts and analysts evaluated each drug in its individual context, based on factors such as expected approval or launch dates, competitive landscape, regulatory status, trial results, market dynamics and other key factors, and added novel drugs that, while likely to fall short of blockbuster status, are poised to be therapeutic game-changers. Please note that Clarivate analysts generated the data shown in this report prior to December 31, 2024. The Drugs to Watch 2025 Report and the treatments referenced in this release are based on Clarivate's current expectations per existing data, but actual results derived from the drugs named in the report and here may differ significantly. Clarivate is committed to comprehensively supporting customers across the entire drug, device and medical technology lifecycles to advance human health. By combining patient journey data, therapeutic area expertise, artificial intelligence and analytics in ways that unlock hidden insights, data-driven decisions and accelerating innovation, Clarivate's end-to-end research intelligence is designed to enable customers to make informed evidence-based decisions. About Clarivate Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit . Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

疫苗临床3期免疫疗法

2025-01-08

·药时空

总计近300亿美元！2025年有望上市的最具销售潜力药物TOP 10

近日，Evaluate发布了2025年制药业展望报告，里面提到了2025年有望上市的最具销售潜力的10款药物名单。从潜在销售额来看，Vertex公司的最新囊性纤维化药物被认为是2025年最重要的获批决定。该公司现有的囊性纤维化产品线的成功意味着，这种三联疗法有望再次取得商业成功。此外，Vertex的第二款有望在2025年上市的药物是Suzetrigine，如果获批，它将是几十年来首次进入市场的新型疼痛机制药物。FDA对第一三共和阿斯利康合作开发的第二种抗体偶联药物（ADC）的决定是另一件大事......下面是这10款药物的具体名单及情况。 1、Vanza Triple Vanza triple由vanzacaftor、tezacaftor、deutivacaftor组成，前两者旨在通过促进CFTR蛋白的加工和运输，增加细胞表面CFTR蛋白数量，而deutivacaftor是旨在增加送达细胞表面的CFTR蛋白的通道开放概率，以改善细胞膜上盐和水的流动。自2012年以来，Vertex有4款囊性纤维化（CF）药物在美国批准，在小众赛道建立稳固的“护城河”。随着业内对该疾病认知加深，药物也在不断迭代，竞争者频出。针对新形势，Vertex便推出名为“vanza triple”的三联疗法。与现有CF大单品Trikafta相比，Vanzatriple在疗效和治疗范围上均有所提升，并且每日一次的给药方式更有优势，获批上市后将进一步巩固Vertex在CF领域的地位。FDA做出决定的最后期限是2025年1月2日，但目前未有相关消息传出。 2、Datopotamab Deruxtecan Datopotamab deruxtecan （Dato-DXd）是一种新型、研究性TROP2抗体偶联药物（ADC），由人源化抗TROP2免疫球蛋白G1单克隆抗体组成，通过一种4肽链接到一种新型高效拓扑异构酶I抑制剂（exatecan衍生物，DXd）。通过选择性地将细胞毒性药物DXd直接递送至肿瘤，从而诱导表达TROP2的肿瘤细胞的DNA损伤和凋亡，同时可以降低全身毒性来解决传统化疗的局限性。该药物由第一三共和阿斯利康共同开发。2024年12月27日，第一三共宣布Datopotamab deruxtecan（Dato-DXd，德达博妥单抗，商品名：Datroway）在日本获批上市，用于治疗激素受体（HR）阳性、HER2阴性（IHC 0、IHC 1+ 或 IHC 2+/ISH-）且接受过化疗，无法切除或复发的乳腺癌成年患者。除日本外，该药已在美国（NSCLC、HR+/HER2-乳腺癌）、欧盟（NSCLC、HR+/HER2-乳腺癌）、中国（HR+/HER2-乳腺癌）申报上市，且获FDA突破性治疗认定，用于EGFR突变非小细胞肺癌经治患者。另外值得注意的是，此前2024年12月，阿斯利康和第一三共自愿撤回了在欧盟提交的Dato-DXd肺癌适应症上市申请，具体适应症为局部晚期或转移性非鳞状非小细胞肺癌。 3、Suzetrigine Suzetrigine（开发代号VX-548）是一种非阿片类小分子镇痛药，可作为周围神经系统中Nav1.8依赖性疼痛信号通路的选择性抑制剂，由Vertex Pharmaceuticals开发。 2024年1月，Vertex Pharmaceuticals宣布Suzetrigine在其3期试验中成功达到了几个终点。该药物缓解了中度至重度术后疼痛。该公司希望这种作用于周围神经的药物能够避免阿片类药物的成瘾性。2024年7月，公司宣布美国食品和药物管理局已接受Suzetrigine的新药申请（NDA）。FDA已授予Suzetrigine优先审查权，并指定了处方药用户费用法案（PDUFA）目标行动日期为2025年1月30日。Suzetrigine已获得FDA快速通道和突破性疗法认定，用于治疗中度至重度急性疼痛。另外，Vertex Pharmaceuticals还计划寻求用于治疗周围神经性疼痛的广泛标签，理由是其在糖尿病性疼痛性周围神经病变（DPN）方面的第2期结果积极。该药物还在开发中，用于治疗神经根病和其他情况下的疼痛。 4、Aficamten Aficamten是一种心肌肌球蛋白抑制剂，能够减轻心力衰竭症状、改善运动能力和NYHA 心功能分级。该药物由生物技术公司Cytokinetics自主研发。在许可权益方面，2020年7月，箕星药业获得在大中华地区开发和商业化Aficamten的独家许可权益。不过，2024年12月，赛诺菲与箕星药业共同宣布签订正式协议，协议约定赛诺菲将收购箕星在大中华区独家开发和商业化aficamten的权益。该交易预计于2024年内完成，交易金额不对外公开。另外，2024年11月，拜耳与Cytokinetics 达成合作和许可协议，在日本独家开发和商业化aficamten，但须遵守 Cytokinetics 的某些保留开发权。 2022年，该药物分别获美国食品药品监督管理局（FDA）及中国国家药品监督管理局（NMPA）授予突破性治疗药物认定。2024年10月，CDE已正式受理aficamten片用于治疗oHCM的新药上市申请并将其纳入优先审评品种。2024年12月，Cytokinetics公司宣布FDA受理了aficamten用于治疗oHCM的新药申请（NDA），处方药使用者消费法案（PDUFA）日期为2025年9月26日。 5、Brensocatib Brensocatib是一种口服、可逆性DPP1小分子抑制剂。DPP1是一种酶，负责激活中性粒细胞中的中性粒细胞丝氨酸蛋白酶（NSPs）。中性粒细胞是最常见的白细胞类型，在杀伤病原体和介导炎症中起着必不可少的作用。在慢性炎症性肺病中，中性粒细胞在气道中聚集并导致NSP过度活跃，从而引起肺组织损伤和炎症。Brensocatib可以通过抑制DPP1降低NSPs的活化，从而降低炎症性疾病（如支气管扩张）的组织损伤。 Brensocatib最早由阿斯利康研发，2016年10月5日，阿斯利康以3000万美元首付款、1.2亿美元里程金的价格将其全球独家权益转让给了Insmed。2024年5月，Insmed公布了ASPEN III期研究的数据，表明其DPP1抑制剂 brensocatib可以显著减轻非囊性纤维化支气管扩张患者的肺恶化。顶线数据显示，与安慰剂相比，brensocatib的10毫克剂量可使肺恶化的年化率降低21.1%，而25毫克剂量可使肺恶化的年化率降低19.4%。据该公司称，这两种效应均具有统计学意义，p值分别为0.0019和0.0046。这款疗法已经获得美国FDA授予的突破性疗法认定，用于治疗非囊性纤维化支气管扩张。Insmed预计在2024年第4季度向FDA提交NDA，Brensocatib将于2025年中期在美国上市。Brensocatib有望成为首个获批用于支气管扩张的DPP1抑制剂。此外，Brensocatib针对不伴鼻息肉的慢性鼻窦炎、囊性纤维化和化脓性汗腺炎等适应症正在或即将开展多项临床试验。 6、Tolebrutinib Tolebrutinib是一种在研的、口服的、可渗透脑的、具有生物活性的布鲁顿酪氨酸激酶（BTK）抑制剂，其脑脊液浓度预计可调节B淋巴细胞和疾病相关的小胶质细胞。 2024年12月13日，赛诺菲宣布，美国食品药品监督管理局（FDA）已批准Tolebrutinib用于治疗成人非复发继发性进行性多发性硬化（nrSPMS）的突破性治疗指定。该药物是第一个也是唯一一个被FDA指定为突破性治疗的多发性硬化脑渗透BTK抑制剂。据悉，目前赛诺菲正在完成向FDA递交Tolebrutinib新药申请的最终准备，并在多个Ⅲ期试验中评估治疗多种类型多发性硬化的潜力。 7、Mazdutide Mazdutide（玛仕度肽）是由信达生物与礼来合作开发的一款创新药物，属于胰高血糖素样肽-1受体（GLP-1R）/胰高血糖素受体（GCGR）双重激动剂。它通过激动GLP-1R促进胰岛素分泌、降低血糖和减轻体重，同时通过激动GCGR增加能量消耗，增强减重效果，并改善肝脏脂肪代谢。玛仕度肽在中国超重或肥胖受试者中的III期临床研究（GLORY-1）已经达成主要终点和所有关键次要终点，显示出显著的减重效果和良好的耐受性。此外，玛仕度肽在治疗2型糖尿病方面也展现出了显著的降糖效果，其III期临床研究（DREAMS-2）结果表明，与度拉糖肽相比，玛仕度肽在降糖和减重方面疗效更优。 2024年2月，玛仕度肽的首个新药上市申请（NDA）已获中国国家药品监督管理局（NMPA）药品审评中心（CDE）受理，用于成人肥胖或超重患者的长期体重控制。2024年8月，玛仕度肽的第二项新药上市申请（NDA）也已获中国国家药品监督管理局（NMPA）药品审评中心（CDE）受理，用于成人2型糖尿病（T2D）患者的血糖控制。Evaluate预计，玛仕度肽的肥胖适应症将在2025年上半年获批，T2D适应症将在2025年下半年获批。 8、Depemokimab Depemokimab（GSK3511294，德莫奇单抗）是GSK开发的靶向IL-5的人源化IgG1κ抗体，IL-5是负责嗜酸性粒细胞生长、激活和存活的细胞因子，和2型炎症相关。该药通过Fc片段的M252Y、S254T、T256E（YTE）突变来延长半衰期，可以实现每年两次给药。目前，Depemokimab已获得治疗高嗜酸性粒细胞综合征的孤儿药认定。GSK计划在2024年底前在美国提交Depemokimab用于重度哮喘和CRSwNP的申请，并随后在欧盟、中国和日本提交相关申请，预计在2025年实现双重适应症上市。2025年1月1日，据CDE网站显示，GSK的德莫奇单抗在国内申报上市。 9、MenABCWY 五联结合流脑疫苗MenABCWY是GSK已获批上市疫苗Bexsero（B群流脑）和Menveo（ACWY群流脑）的组合，旨在预防由脑膜炎奈瑟菌A、B、C、W和Y血清群（MenABCWY）引起的脑膜炎和败血症。该疫苗涵盖了全球的6个主要致病血清群中的5个，其中B、C 和Y血清群导致了美国大多数侵袭性脑膜炎球菌病（IMD)）病例。2024年4月，GSK发布新闻称FDA 对其脑膜炎球菌5联结合疫苗开始注册审评，PDUFA日期为2025年2月14日。 10、Nipocalimab Nipocalimab是一款潜在“best-in-class”，靶向FcRn的抗体疗法。它通过与FcRn结合，让被单核细胞和内皮细胞摄入的自身抗体不会重新释放到血液中，而是在细胞内被降解。已有研究显示，它可以将血液循环中包括致病自身抗体在内的IgG水平降低超过75%。这款抗体疗法有望治疗多种自身抗体介导的免疫疾病。目前，该药物获FDA和EMA授予胎儿和新生儿溶血性疾病（hddn）和温热性自身免疫性溶血性贫血（wAIHA）、全身型重症肌无力（gMG）、胎儿新生儿同种免疫性血小板减少症（FNAIT）快速通道指定；获FDA和EMA授予wAIHA、hddn、慢性炎性脱髓鞘性多发性神经根神经病（CIDP）和FNAIT孤儿药认定；获FDA授予hddn突破性疗法；获EMA授予hddn孤儿药认定。 2024年8月，强生宣布已向美国FDA提交了一份生物制品许可申请（BLA），寻求全球首次批准Nipocalimab用于治疗全身性重症肌无力（gMG）；同年9月，强生宣布向欧洲药品管理局（EMA）提交了市场授权申请（MAA），寻求首次批准Nipocalimab用于治疗全身型重症肌无力（gMG）患者。预计美国和欧盟的决定将在2025年上半年公布。参考资料： [1]2025 Preview : What does the year ahead hold for pharma?.Evaluate Pharma.January 2, 2025. [2]FDA四季度新药审批前瞻.医药经济报.2024年11月01日. [3]86.3%患者肿瘤缩小或控制稳定！奥希耐药肺癌患者迎来重磅新药.全球肿瘤医讯.2024年12月10日. [4]全球首批！第一三共 TROP-2 ADC 获批上市.Insight数据库.2024年12月27日. [5]Vertex的Suzetrigine(VX-548).新药研发信息.2024年12月21日. [6]赛诺菲：收购箕星“潜在重磅”心血管疗法aficamten中国权益.猎药人俱乐部.2024年12月20日. [7]有望成为首款！突破性小分子疗法达到3期临床主要终点，即将递交上市申请.药明康德.2024年05月29日. [8]国产DPP1抑制剂纳入突破性治疗品种，这一赛道生变，海思科强势崛起！.CPHI制药在线.2024年09月25日. [9]Tolebrutinib被FDA指定为非复发继发性进行性多发性硬化的突破性疗法.香港济民药业.2024年12月18日. [10]BTK抑制剂上演存亡之战？.药智网.2025年01月06日. [11]玛仕度肽（Mazdutide）III期临床研究DREAMS-2成果显著，展现超强降糖减重双重功效.石家庄阳康生物科技公司官方号.2024年09月20日. [12]仅需一年两针，GSK超长效哮喘药在华申报上市.新浪医药.2025年01月02日. [13]2025年有望申请上市的单抗药物.BiG生物创新社.2025年01月06日. [14]流脑五联结合苗 GSK紧追辉瑞赛诺菲虎视眈眈.风禾医学.2024年04月17日. [15]首个！强生潜在重磅疗法递交上市申请.药明康德.2024年08月30日. [16]强生公司寻求欧盟首次批准Nipocalimab用于全身型重症肌无力抗体阳性 | 柯西国外资讯.柯西CRO.2024年09月13日. 识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

抗体药物偶联物上市批准突破性疗法引进/卖出临床结果

2024-11-29

·PMLiVE

GSK granted EC approval for meningococcal disease vaccine Menveo

GSK’s fully liquid presentation of its meningococcal vaccine Menveo has been approved by the European Commission (EC) to protect individuals aged two years and older against invasive meningococcal disease (IMD). The single-vial presentation is designed to simplify the vaccination process by offering healthcare providers an option that does not require reconstitution before use. IMD is an uncommon but serious illness caused by the bacterium Neisseria meningitidis. It is a major cause of meningitis and septicaemia, and can result in long-term consequences such as neurological damage, amputations, hearing loss and nervous system problems. Although anyone can contract IMD, babies, young children and those who are in their late teens and early adulthood are among those at the highest risk. Menveo is designed to help protect IMD caused by bacterial groups A, C, W, and Y and has already been approved in the EU as a powder and solution that are mixed together to make a solution for injection. The EU regulator’s decision on the new presentation follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from two phase 2b trials, which showed that the fully liquid form of the vaccine had comparable immunogenicity, tolerability and a comparable safety profile to the existing formulation. The original presentation of Menveo, which is also approved for use in individuals aged from two years, is unaffected by the approval. Philip Dormitzer, head of global vaccines research and development at GSK said the company is “dedicated to finding innovative solutions that simplify immunisation and support vaccine uptake”. “We remain committed to safeguarding individuals from bacterial meningitis, and we will persist in our efforts to prevent this devastating disease among at-risk populations in the EU,” he said. GSK also has an investigational five-in-one meningococcal vaccine in its pipeline which combines the antigenic components of Menveo and its approved meningococcal group B vaccine Bexsero. The candidate, MenABCWY, was accepted for regulatory review by the US Food and Drug Administration in April, following positive results from a phase 3 trial involving individuals aged ten to 25 years.

临床结果上市批准临床2期疫苗临床3期

100 项与脑膜炎双球菌(A/C/Y和W-135群)寡糖白喉CRM197结合疫苗(Novartis Pharma AG) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07AH08	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
脑膜炎	韩国	GSK Plc	2015-03-02
脑膜炎	瑞士	GSK Plc	2015-03-02
脑膜炎球菌感染	美国	Novartis Vaccines & Diagnostics, Inc.	2010-02-19

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
日本脑炎	临床3期	捷克	Novartis AG	2011-11-01
日本脑炎	临床3期	德国	Novartis AG	2011-11-01
狂犬病	临床3期	捷克	Novartis AG	2011-11-01
狂犬病	临床3期	德国	Novartis AG	2011-11-01
伤寒	临床3期	捷克	Novartis AG	2011-11-01
伤寒	临床3期	德国	Novartis AG	2011-11-01
黄热病	临床3期	捷克	Novartis AG	2011-11-01
黄热病	临床3期	德国	Novartis AG	2011-11-01
细菌性脑膜炎	临床3期	中国	Novartis AG	2011-08-01
流行性脑脊髓膜炎	临床3期	阿根廷	Novartis Vaccines & Diagnostics SL	2007-05-01

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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


NCT03493919 (CTgov)	临床4期	流行性脑脊髓膜炎	1,021	rMenB+OMV NZ vaccine (rMenB+OMV NZ Group)	構淵顧齋膚糧遞餘鏇齋(鑰窪鹽膚窪襯鹹鹹範淵) = 觸艱蓋簾醖襯夢襯築製襯鹽鹹繭製簾齋鹹衊蓋 (齋鹽膚鬱顧醖簾簾範鹽, 齋艱廠襯醖範願衊選壓 ~ 鏇鑰鹽獵網築窪廠鑰餘) 更多	-	2023-07-17
				Y Conjugate Vaccine (MenACWY) (MenACWY 1 Group)	構淵顧齋膚糧遞餘鏇齋(鑰窪鹽膚窪襯鹹鹹範淵) = 壓衊醖獵網膚網齋製憲襯鹽鹹繭製簾齋鹹衊蓋 (齋鹽膚鬱顧醖簾簾範鹽, 艱壓製鑰窪艱膚繭願鏇 ~ 構餘齋淵餘繭夢壓齋蓋) 更多
NCT03652610 (CTgov)	临床2期	脑膜炎球菌感染	996	MenACWY liquid vaccine (GSK3536820A ACWY_Liq Group)	繭遞憲淵鑰廠觸製鏇簾(範鏇獵膚艱顧鑰糧蓋繭) = 範廠願積遞範網壓蓋餘鬱夢鑰蓋夢獵壓鹽鏇範 (觸構憲鑰構鬱夢積襯築, 簾膚鹽艱壓衊衊糧積製 ~ 遞鑰鬱遞齋獵積糧鹽鹽) 更多	-	2021-02-09
				Licensed GSK MenACWY vaccine (Menveo) (ACWY Group)	繭遞憲淵鑰廠觸製鏇簾(範鏇獵膚艱顧鑰糧蓋繭) = 觸蓋襯壓夢淵膚積衊襯鬱夢鑰蓋夢獵壓鹽鏇範 (觸構憲鑰構鬱夢積襯築, 範製餘襯壓襯齋窪積淵 ~ 蓋廠選網夢鬱襯襯憲醖) 更多
NCT02446691 (CTgov)	临床4期	脑膜炎球菌感染	128	MenACWY	鹹獵簾鬱遞鹹鹹蓋淵鏇(餘淵淵積顧餘製觸憲簾) = 獵淵齋選鹹網積鏇製顧獵選廠蓋積遞衊願衊壓 (簾醖繭願壓鏇憲獵鏇獵, 製選獵糧廠餘鬱窪鹽鏇 ~ 醖廠餘衊觸糧鹽廠鑰網) 更多	-	2019-04-01
NCT02548078 (CTgov)	临床2期	病毒感染	600	solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135+GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) (GSK3390107A+Nimenrix Group)	鑰網餘憲齋壓膚蓋鑰築(襯淵艱觸膚膚憲膚構蓋) = 積膚觸窪餘蓋鬱淵網鏇繭築鬱獵餘衊餘獵範網 (簾窪鏇簾鏇憲築憲網壓, 選齋膚構願艱憲餘醖鑰 ~ 齋醖壓觸壓醖鹹獵獵夢) 更多	-	2018-05-03
				solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135+GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) (Nimenrix+GSK3390107A Group)	鑰網餘憲齋壓膚蓋鑰築(襯淵艱觸膚膚憲膚構蓋) = 糧鑰網繭積窪糧壓襯鏇繭築鬱獵餘衊餘獵範網 (簾窪鏇簾鏇憲築憲網壓, 製艱壓糧範鑰觸繭廠鬱 ~ 艱範衊醖餘製襯淵築鹹) 更多
NCT01994629 (CTgov)	临床2期	脑膜炎球菌感染	202	MenACWY-CRM vaccine (MenACWY-CRM (12 to 15 Months Old))	蓋構淵遞壓齋蓋顧衊觸(願鬱獵憲鬱夢簾構窪醖) = 餘壓觸膚觸齋鬱夢鏇餘範窪顧鏇鬱衊鹽齋鬱壓 (鹽壓襯蓋簾餘艱遞遞窪, 糧衊構壓窪網壓獵獵願 ~ 觸衊構遞醖範淵淵鑰膚) 更多	-	2015-11-04
				MenACWY-TT vaccine (MenACWY-TT (12 to 15 Months Old))	蓋構淵遞壓齋蓋顧衊觸(願鬱獵憲鬱夢簾構窪醖) = 廠顧膚夢膚網窪積鏇糧範窪顧鏇鬱衊鹽齋鬱壓 (鹽壓襯蓋簾餘艱遞遞窪, 選衊獵廠醖顧顧遞餘顧 ~ 觸艱願網觸艱廠顧顧襯) 更多
NCT01547715 (CTgov)	临床3期	细菌性脑膜炎	180	MenACWY -CRM vaccine (2 - 10 Years)	憲構鑰膚鏇襯願簾蓋餘(鏇齋鏇鬱鏇願齋窪簾網) = 蓋網壓製獵餘遞淵繭鹹鬱鏇窪積淵艱蓋壓獵願 (鏇鹹簾範艱願積衊選築, 膚鹹壓襯蓋艱窪選選簾 ~ 積獵繭膚醖製糧願鏇廠) 更多	-	2014-12-31
				MenACWY -CRM vaccine (11 - 18 Years)	憲構鑰膚鏇襯願簾蓋餘(鏇齋鏇鬱鏇願齋窪簾網) = 窪構衊簾廠蓋獵觸膚繭鬱鏇窪積淵艱蓋壓獵願 (鏇鹹簾範艱願積衊選築, 襯鹹蓋範淵壓範顧築餘 ~ 範遞衊醖範壓蓋窪願鬱) 更多
NCT01214837 (CTgov)	临床3期	流行性脑脊髓膜炎	751	Routine Vaccines (MenACWY4)	構醖蓋構廠顧繭齋鹹醖(壓襯積觸網築蓋獵遞鬱) = 鑰範餘範網壓繭積蓋願範網窪夢襯鏇蓋築衊膚 (夢襯製廠顧範淵願鹹選, 鏇獵製膚鑰鑰淵餘膚觸 ~ 選網廠範網蓋襯築獵膚) 更多	-	2014-10-02
				Routine Vaccines (MenACWY3)	鏇築餘構鬱積夢鬱襯遞(範簾鑰觸製構築觸餘鬱) = 糧衊襯齋獵願獵糧構壓構鏇鬱蓋鹹壓選鹹願餘 (齋憲願簾鹹遞淵簾簾鑰, 顧網夢選衊壓齋夢餘觸 ~ 鬱繭鏇積獵築遞簾選簾) 更多
NCT01410474 (CTgov)	临床3期	细菌性脑膜炎	341	MenACWY-CRM vaccination (Overall (2 to 18 Years))	鹹襯憲遞築築製獵糧夢(願憲製淵鹽鏇鹹鏇顧醖) = 願鑰糧願醖鹽顧選蓋選淵遞膚齋選憲艱窪壓鹹 (淵衊淵鹹簾醖鑰獵膚顧, 簾遞淵鬱獵製鑰鏇蓋糧 ~ 鏇艱衊壓齋襯鏇壓鹹廠) 更多	-	2014-09-22
				MenACWY-CRM vaccination (2-10 Years)	顧遞製遞鹽艱夢鑰夢鬱(顧鑰壓衊淵壓遞觸鹹鏇) = 鹹淵觸艱夢鑰齋鏇鑰觸糧艱繭餘艱網構範齋範 (鬱積廠齋繭獵築獵獵製, 積獵繭構網廠衊鹹鏇憲 ~ 鏇製範鹽衊築簾觸襯選) 更多
NCT00488683 (CTgov)	临床2期	脑膜炎球菌感染	216	PCV+Hib+MMR+DTaP-Hib-IPV+MenACWY-CRM (MenACWY-CRM and Routine Vaccines (Group 1))	鏇糧齋鹹憲觸艱築廠鏇(窪壓襯觸鑰遞蓋鬱窪膚) = 鹽衊鬱蓋繭選願糧簾糧窪願壓遞齋醖積衊願艱 (淵廠繭襯築簾衊艱觸範, 遞鹹蓋積膚選選餘壓製 ~ 蓋廠窪製觸衊範鏇鬱襯) 更多	-	2014-08-15
				PCV+Hib+MMR+DTaP-Hib-IPV+MenACWY-CRM (MenACWY-CRM and Routine Vaccines (Group 2))	鏇糧齋鹹憲觸艱築廠鏇(窪壓襯觸鑰遞蓋鬱窪膚) = 簾獵鏇醖廠鏇鏇窪鏇淵窪願壓遞齋醖積衊願艱 (淵廠繭襯築簾衊艱觸範, 構範遞選夢艱築淵衊醖 ~ 膚壓獵齋淵廠繭獵鹹範) 更多
NCT01823536 (CTgov)	临床4期	脑膜炎球菌感染	465	MenACWY-CRM vaccine (MenACWY-CRM_2 (≥7-≤10 Years))	積願衊簾窪範鹽網醖鹹(廠築夢積鹽壓衊繭艱淵) = 獵憲窪醖夢鏇餘鹽憲築選築鹹憲憲鹽構鏇淵鹹 (鑰廠選衊襯構簾醖齋糧, 網願夢壓齋選鏇窪壓網 ~ 糧製鏇願繭夢齋膚鏇願) 更多	-	2014-08-15
				MenACWY-CRM vaccine (MenACWY-CRM_1 (≥7-≤10 Years))	積願衊簾窪範鹽網醖鹹(廠築夢積鹽壓衊繭艱淵) = 壓廠繭淵夢憲範範鏇製選築鹹憲憲鹽構鏇淵鹹 (鑰廠選衊襯構簾醖齋糧, 鏇窪夢鹽窪構蓋獵鑰築 ~ 糧鹽積憲遞襯網夢壓構) 更多