Delving into the Latest Updates on Pneumococcal 21-valent Conjugate Vaccine with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Multivalent vaccine, Conjugated vaccine

Synonyms

Pneumococcal 21-valent Conjugate Vaccine, Polyvalent pneumococcal conjugate vaccine Merck Sharp Dohme Corp, Ppcv

+ [4]

Target-

Action-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Invasive streptococcal diseasePneumonia, PneumococcalInfluenza, Human+ [1]

Inactive Indication-

Originator Organization

Merck & Co., Inc.

Active Organization

Merck Sharp & Dohme Corp.Merck Sharp & Dohme (Australia) Pty Ltd.Merck Sharp & Dohme LLC

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (17 Jun 2024),

Invasive streptococcal diseasePneumonia, Pneumococcal

RegulationBreakthrough Therapy (United States), Priority Review (United States)

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This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vaccine response evaluations.

Start Date01 Mar 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

[+1]

CTIS2023-506236-32-00

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease. - V116-013

Start Date02 Apr 2024

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT06177912

/ Active, not recruitingPhase 3

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

Start Date18 Jan 2024

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with Pneumococcal 21-valent Conjugate Vaccine

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100 Translational Medicine associated with Pneumococcal 21-valent Conjugate Vaccine

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100 Patents (Medical) associated with Pneumococcal 21-valent Conjugate Vaccine

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19

Literatures (Medical) associated with Pneumococcal 21-valent Conjugate Vaccine

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Health and economic impact of the 21-valent pneumococcal conjugate vaccine (V116) for adults in Japan: a delta price approach

Article

Author: Cassell, Kelsie ; Owusu-Edusei, Kwame ; Mueller, Peter P. ; Tajima, Atsushi ; Johnson, Kelly D. ; Cossrow, Nicole ; Yi, Zinan ; Matsuki, Taizo

INTRODUCTION:

This study analyzed the health and economic impact of the 21-valent pneumococcal conjugate vaccine (V116) and the 20-valent pneumococcal conjugate vaccine (PCV20), as well as their relative cost-effectiveness, in Japanese adults aged 65 years using a delta pricing approach.

METHODS:

A Markov model was employed to simulate the movement of the Japanese population among four health states: healthy, pneumococcal disease (consisting of invasive pneumococcal disease [IPD] with or without meningitis and non-bacteremic pneumococcal pneumonia [NBPP]), post-meningitis sequelae, and death. The model was populated with publicly available demographic and epidemiologic data, stratified by risk level. Pneumococcal serotype distribution and vaccine effectiveness, as well as direct and indirect treatment costs and health-related utilities, were derived from published sources. The model used a lifetime horizon and 2% discounting of costs and life-years. Costs were adjusted to 2023 values in Japanese yen (¥). Outcomes were cases and deaths, life-years and quality-adjusted life-years (QALYs), vaccination and treatment costs, and incremental cost-effectiveness ratios. The range over which V116 was cost-saving and cost-effective was determined.

RESULTS:

Compared to PCV20, V116 averted an additional 28 cases of IPD, 918 cases of NBPP, 5 deaths from IPD, and 51 deaths from NBPP over the lifetime of a single age 65 cohort. Life-years and QALYs gained were 1,019 and 642, respectively, relative to PCV20; V116 saved ¥733 million in direct medical costs and ¥557 million in indirect costs, compared to PCV20. V116 was found to be cost-saving at price premiums up to ¥1,322 (payer perspective) or ¥2,327 (societal perspective) and remained below a willingness-to-pay threshold of ¥5 million/QALY for premiums up to ¥7,113 (payer perspective) or ¥8,117 (societal perspective).

CONCLUSIONS:

V116 is projected to provide more population health benefits in Japan than PCV20, and to be cost-effective at a variety of price premiums.

28 Jan 2025·mSphere

Establishing a new human pneumococcal standard reference serum, MPRSS-01

Article

Author: Abeygunawardana, Chitrananda ; Schmauch, Jenna ; Green, Tina ; Greway, Rebecca ; Murphy, Rocio D. ; Malinverni, Juliana C. ; Howlett, Adrienne ; Bonhomme, Cyrille J. ; Gowrisankar, Rajam ; Antonello, Joseph M. ; Nolan, Katrina M.

ABSTRACT:

Measuring the immunogenicity of pneumococcal vaccines involves the use of immunoassays to measure serotype-specific immunoglobulin G (IgG) antibody levels post-vaccination with the current Streptococcus pneumoniae human reference serum standard (007sp) for anti-pneumococcal capsule antibodies. Development of new pneumococcal conjugate vaccines (PCVs) with additional serotypes not in 007sp (e.g., V116, a 21-valent PCV) requires a new reference serum. Antibody concentrations to 33 pneumococcal serotypes were assigned in a new Merck Pneumococcal Reference Serum Standard (MPRSS-01; Merck Pneumococcal Reference Serum Standard) using the pneumococcal electrochemiluminescence assay. MPRSS-01 was generated by pooling high-titer serum samples from adults immunized with either 23-valent pneumococcal polysaccharide vaccine (PPSV23) or V116. For the 24 serotypes with established IgG concentrations, the corresponding antibody concentrations in MPRSS-01 were assigned via direct calibration to 007sp, while a cross-standardization approach was used for the nine novel serotypes. Serotype 7F was initially chosen as the reference calibrator for cross-standardization due to parallelism across dilution–response curves demonstrated across all 33 serotypes, and an evaluation of the single-calibrator approach was conducted for the 24 serotypes. Potential systematic bias from using a unique serotype for calibration was identified and addressed by further adjusting the estimated IgG concentrations of the nine novel serotypes. Using the final MPRSS-01 antibody concentration assignments, and the calibration factor relating MPRSS-01 to 007sp, antibody concentration assignments for 007sp were provided for the nine novel serotypes. This proposal was accepted by the Center for Biologics Evaluation and Research (CBER), enabling V116 to bridge old and new human pneumococcal reference sera.

IMPORTANCE:

Immunogenicity of pneumococcal vaccines is measured using post-vaccination serotype-specific immunoglobulin G (IgG) antibodies in serum using enzyme-linked immunoassays with the 007sp reference serum containing serotype-specific IgG for 24 pneumococcal serotypes. With the development of next-generation PCVs, a new S. pneumoniae reference serum standard was needed to include serotypes beyond the existing 24 in 007sp. In this study, antibody concentrations to 33 pneumococcal serotypes were assigned in a new Merck Pneumococcal Reference Serum Standard (MPRSS-01) using the pneumococcal electrochemiluminescence assay, enabling V116 to maintain the link to the historical human pneumococcal standard reference serum while utilizing the new human pneumococcal reference serum.

17 Dec 2024·CLINICAL INFECTIOUS DISEASES

A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine–Experienced Adults 50 Years of Age or Older (STRIDE-6)

Article

Author: Porterfield, Laura ; Chapman, Timothy J ; Jaffuel, Sylvain ; Greenberg, David ; Johnston, William Henry ; Pelayo, Enrique ; Orenstein, Walter A ; Tellier, Guy ; Rosen, Jeffrey Bruce ; Haranaka, Miwa ; Vilella i Morato, Anna ; Grijalva, Carlos G ; Lee, Jacob ; Lee, Dong-Gun ; Scott, Paul ; Dionne, Marc ; Stacey, Helen L ; Castagna, Antonella ; Lenzmeier, Thomas C ; Davis, Karyn ; Girard, Ginette ; Butuk, David J ; Freeman, George Hartley ; Yono, Makoto ; Peer, Avivit ; Darawsha, Mahmud ; Caraco, Yoseph ; Echave-Sustaeta Maria-Tome, Jose Maria ; Chowers, Michal ; Cardona, Jose Francisco ; Song, Joon Young ; Fiel, Thomas ; Nicolas, Jean-Francois ; Dzongowski, Peter ; Choi, Jung Hyun ; Choi, Won Suk ; Li, Jianing ; Huang, Kuo-Chin ; Shi, Hyejin ; Tytus, Richard ; Harper, Charles Harold ; Aumatell, Cristina Masuet ; Stacey, Helen ; Costantino, Claudio ; Ami, Eytan Ben ; Rigonan, Kathryn R ; Martinelli, Domenico ; Gallagher, Nancy ; Platt, Heather L ; Fraser, Neil J ; Perez, Silvia Narejos ; Yang, Yi-Ching ; Bendayan, Daniele ; Zeng, Tiantian ; Fernsler, Doreen ; De luiz Martinez, Gustavo ; Geller, Steven A ; Daboul, Nizar ; Blasi, Francesco Bruno

Abstract:

Background:

Pneumococcal diseases cause considerable morbidity and mortality in adults. V116 is an investigational 21-valent pneumococcal conjugate vaccine (PCV) specifically designed to protect adults from pneumococcal serotypes responsible for the majority of residual pneumococcal diseases. This phase 3 study evaluated safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine–experienced adults aged ≥50 years.

Methods:

A total of 717 adults were enrolled to receive a single dose of pneumococcal vaccine as follows: cohort 1 (n = 350) previously received 23-valent pneumococcal polysaccharide vaccine (PPSV23) and were randomized 2:1 to receive V116 or PCV15, respectively; cohort 2 (n = 261) previously received PCV13 and were randomized 2:1 to receive V116 or PPSV23, respectively; cohort 3 (n = 106) previously received PPSV23 + PCV13, PCV13 + PPSV23, PCV15 + PPSV23, or PCV15 and all received open-label V116. Immunogenicity was evaluated 30 days postvaccination using opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) for all V116 serotypes. Safety was evaluated as the proportion of participants with adverse events (AEs).

Results:

V116 was immunogenic across all 3 cohorts as assessed by serotype-specific OPA GMTs and IgG GMCs postvaccination for all 21 serotypes. V116 elicited comparable immune responses to serotypes shared with PCV15 (cohort 1) or PPSV23 (cohort 2), and higher immune responses to serotypes unique to V116. The proportions of participants with solicited AEs were generally comparable across cohorts.

Conclusions:

V116 is well tolerated with a safety profile comparable to currently licensed pneumococcal vaccines and generates IgG and functional immune responses to all V116 serotypes, regardless of prior pneumococcal vaccine received.

Clinical Trials Registration:

NCT05420961; EudraCT 2021-006679-41.

73

News (Medical) associated with Pneumococcal 21-valent Conjugate Vaccine

05 Feb 2025

·www.echemi.com

Merck Reports 2024 Revenue of $64.168 Billion Driven by Keytruda and Innovative Products

On February 4, Merck & Co. announced its 2024 financial results, revealing total revenue of $64.168 billion, marking a 7% increase year-on-year. The pharmaceutical segment alone generated $57.400 billion, also reflecting a 7% growth. However, research and development (R&D) spending dropped significantly to $17.938 billion, a decline of 41%. In a concerning trend, revenue from the Chinese market fell by 20% to $5.394 billion, representing 9.4% of Merck's global pharmaceutical sales. Despite these challenges, Merck's flagship product, Keytruda (pembrolizumab), set new sales records, achieving $29.482 billion in revenue, an 18% increase that accounted for nearly 46% of the company’s total revenue. As Keytruda continues to thrive, Merck is actively working to maximize its clinical and commercial value. This includes expanding early indications, exploring combination therapies, and developing a subcutaneous formulation. In November 2024, the subcutaneous formulation's Phase III study was successfully completed, reducing administration time to just 2-3 minutes compared to intravenous infusion. Other oncology products also performed well, with the world’s first HIF-2α inhibitor, Welireg, generating $509 million in sales, up 133% year-on-year. This drug received approval in China in November 2024. Additionally, Lynparza (olaparib) contributed $1.311 billion to the revenue. Merck's HPV vaccine, Gardasil/Gardasil 9, reported sales of $8.583 billion, a 3% decrease from the previous year. The decline was largely attributed to reduced demand in China, exacerbated by intense competition from domestic nine-valent vaccines and price wars involving two-valent HPV vaccines. In response, Merck has begun targeting the male market for HPV vaccination. In January 2025, Gardasil was approved in China for use in males aged 9-26, marking it as the first HPV vaccine approved for this demographic. Merck has also been proactive in updating its vaccine portfolio. In June 2024, it launched the 21-valent pneumococcal conjugate vaccine, Capvaxive, enhancing its product lineup alongside Pneumovax 23 and Vaxneuvance. In the cardiovascular sector, the new pulmonary arterial hypertension (PAH) drug Winrevair has emerged as a star product. Approved in March 2024, it has quickly generated $419 million in sales within its first year. The drug has also been submitted for approval in China. Looking ahead, Merck is optimistic about its pipeline, which includes oral PCSK9 inhibitors and dual agonists for GLP-1R/GCGR expected to yield critical research data in 2025. The company is also ramping up efforts in infectious diseases and ophthalmology, with Clesrovimab submitted for U.S. approval as a single-dose RSV monoclonal antibody. Merck's business development activities have intensified, particularly in China, with several strategic acquisitions aimed at expanding its innovative capabilities. These include a $700 million acquisition of CD3/CD19 bispecific antibodies and a $588 million agreement for a PD-1/VEGF bispecific antibody project. Robert M. Davis, Merck’s Chairman and CEO, expressed confidence in the company’s long-term growth potential, stating, “Our strong growth in 2024 reflects the market demand for our innovative product portfolio, including Keytruda, Winrevair, and our robust animal health business.” Looking forward to 2025, Merck anticipates global sales between $64 billion and $65.6 billion.

Drug ApprovalAcquisitionPhase 3VaccineFinancial Statement

05 Feb 2025

·pmlive.com

Merck’s adult-specific pneumococcal vaccine Capvaxive recommended by CHMP

Merck & Co’s – known as MSD outside the US and Canada – adult-specific 21-valent pneumococcal conjugate vaccine has been recommended for approval by the European Medicines Agency’s human medicines committee. The Committee for Medicinal Products for Human Use (CHMP) has recommended that Capvaxive be used to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals aged 18 years and older. Diseases caused by Streptococcus pneumoniae bacteria are currently considered a “major public health problem” by the World Health Organization (WHO). There are more than 100 different types of pneumococcal bacteria and Merck’s Capvaxive, which is administered in a single dose, is specifically designed to help protect against the ones that are responsible for the majority of adult invasive pneumococcal disease, including eight strains not covered by any other approved pneumococcal vaccine. The CHMP’s recommendation was based on results from the late-stage STRIDE-3 trial, which compared Capvaxive to Pfizer’s 20-valent vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine. Capvaxive elicited non-inferior immune responses compared to PCV20 for all ten serotypes common to both vaccines in adults aged 50 years and older, and generated superior immune responses for ten of its 11 unique serotypes. Additionally, Merck’s vaccine elicited non-inferior immune responses in adults aged 18 to 49 years compared to those aged 50 to 64 years and had a safety profile comparable to PCV20. The recommendation was also supported by results from the phase 3 STRIDE-4, STRIDE-5, STRIDE-6, STRIDE-7 and STRIDE-10 trials. The European Commission (EC) will now review the positive opinion as it makes a final decision on Capvaxive, which is expected by the second quarter of 2025. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories, said: “This positive opinion is yet another testament to the clinical profile of Capvaxive and brings us a step closer to helping protect adults in the EU against pneumococcal disease. “Invasive pneumococcal disease can lead to serious consequences, including hospitalisation, organ damage and even death. We are pleased with the CHMP recommendation and look forward to the EC’s decision.”

Clinical ResultPhase 3VaccineDrug Approval

04 Feb 2025

·www.fiercepharma.com

Pfizer harnesses COVID fluctuations to clinch Q4 gains as RSV vaccine sales plummet

The company's full-year 2024 sales totaled $63.6 billion. After a period of unsteady sales for its key COVID-19 products, Pfizer now sees COVID-related revenue volatility as “largely in the past.” In an investor presentation (PDF) Tuesday, the company made that declaration and added that its COVID-related uncertainties have “diminished" as of late.In the fourth quarter, a larger-than-expected sales haul of $4.1 billion from Pfizer's COVID vaccine Cominaty and its antiviral Paxlovid helped drive the company’s total revenue of $17.8 billion, which was ahead of consensus estimates, Leerink analysts wrote in a note to clients.Other products such as Eliquis, Nurtec, Vyndaqel and Ibrance helped drive the sales beat, as well. On the flip side, vaccines Prevnar and Abrysvo underperformed expectations. RSV vaccine Abrysvo specifically floundered in the fourth quarter. The product's sales fell 62% year over year to $198 million, a performance Pfizer attributed to the narrowing market opportunity afforded by new vaccination recommendations from the CDC.Last year, the agency recommended RSV vaccines for people 75 years and older and those ages 60 to 74 with a higher risk of severe disease. Previously, RSV vaccines were recommended for all adults ages 60 and older upon consultation with a doctor.Outside of the new recommendations, both Abrysvo and Prevnar face heavy-hitting competition. GSK’s Arexvy has been leading the charge in the RSV vaccine sales race so far. Elsewhere, Merck’s 21-serotype pneumococcal disease vaccine Capvaxive stands to edge in on Prevnar's turf in that field.However, with its $43 billion Seagen acquisition firmly under its belt, Pfizer has solid footing in the hot antibody-drug conjugate (ADC) market, Edward Jones healthcare analyst John Boylan pointed out in a note to clients. Boylan sees Pfizer as poised to return to “predictable growth” thanks to its new products and “significant” cost-reducing measures while COVID sales should eventually fluctuate based on the severity of the season.As it stands, the current COVID trends show the company's portfolio sustainability, Pfizer said. Paxlovid utilization remains “steady and consistent” with successive COVID waves, while the latest U.S. COVID vaccine administration figures remain “largely aligned” with last year's numbers, according to the presentation.Now, the “stage is set” for profit margin expansion, buoyed by commercial execution and cost-savings efforts, Pfizer added. Beyond its ongoing commercial efforts, this year the company expects four regulatory decisions, nine phase 3 readouts and 13 potential pivotal program starts from its pipeline.In 2024, Pfizer collected $63.6 billion in total revenues, representing 12% operational growth across non-COVID products. For 2025, the company is forecasting revenue in a range between $61 billion and $64 billion.

VaccineAcquisitionmRNA

100 Deals associated with Pneumococcal 21-valent Conjugate Vaccine

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Invasive streptococcal disease	United States	Merck Sharp & Dohme LLC	17 Jun 2024
Pneumonia, Pneumococcal	United States	Merck Sharp & Dohme LLC	17 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	United States	Merck Sharp & Dohme Corp.	23 Sep 2022
Pneumococcal Infections	Phase 3	United States	Merck Sharp & Dohme Corp.	13 Jul 2022
Pneumococcal Infections	Phase 3	Australia	Merck Sharp & Dohme Corp.	13 Jul 2022
Pneumococcal Infections	Phase 3	Belgium	Merck Sharp & Dohme Corp.	13 Jul 2022
Pneumococcal Infections	Phase 3	Chile	Merck Sharp & Dohme Corp.	13 Jul 2022
Pneumococcal Infections	Phase 3	Germany	Merck Sharp & Dohme Corp.	13 Jul 2022
Pneumococcal Infections	Phase 3	New Zealand	Merck Sharp & Dohme Corp.	13 Jul 2022
Pneumococcal Infections	Phase 3	Puerto Rico	Merck Sharp & Dohme Corp.	13 Jul 2022
Pneumococcal Infections	Phase 3	South Africa	Merck Sharp & Dohme Corp.	13 Jul 2022
Pneumococcal Infections	Phase 3	Sweden	Merck Sharp & Dohme Corp.	13 Jul 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05696080 (V116-008 \| STRIDE-8, CTgov)	Phase 3	Pneumococcal Infections	518	Placebo+V116 (V116 + Placebo)	hqfgmxtjzk(wdivtqtljq) = vraeezxwzz gmbmvdswqo (kqkxxyqzvb, xuehhfzbrz - ilzxnorzeo) View more	-	26 Feb 2025
				PPSV23+PCV15 (PCV15 + PPSV23)	hqfgmxtjzk(wdivtqtljq) = heltpxfvfx gmbmvdswqo (kqkxxyqzvb, nqoclrbxuf - gxjdaoeyqq) View more
NCT05569954 (V116-010 \| STRIDE-10, CTgov)	Phase 3	Pneumococcal Infections	1,484	V116 (V116)	dablspwyno(cvmoyudnxh) = dvjaspbaat glrsygbfwt (oafrejzzwy, ktzsjtrkwc - mjpbzhhqmz) View more	-	31 Oct 2024
				PPSV23 (PPSV23)	dablspwyno(cvmoyudnxh) = uhfzfxnqal glrsygbfwt (oafrejzzwy, whtqubrzty - dorrvdspxl) View more
NCT05526716 (V116-005, CTgov)	Phase 3	Pneumonia, Pneumococcal \| Influenza, Human	1,080	QIV+V116 (Concomitant Group (V116 + QIV Followed by Placebo))	tcgckfchgf(tnvpfqsahj) = hjyojppmhw hjstwjsfmj (jlxeutqdqi, askipwglst - tuifouimmd) View more	-	05 Sep 2024
				QIV+V116 (Sequential Group (Placebo + QIV Followed by V116))	tcgckfchgf(tnvpfqsahj) = dwgkzjjwyi hjstwjsfmj (jlxeutqdqi, nmdhnjfswp - galhqzcaqg) View more
NCT05393037 (V116-007, CTgov)	Phase 3	Pneumococcal Infections	313	Placebo+V116+PCV15 - Part B (V116 + Placebo)	nsgauwvkrv(ktkaiofbqk) = qhdgjqdvvw wyqkubrlmt (efkcntxkwe, flnacvcdsl - dzazoumbdv) View more	-	25 Jul 2024
				PPSV23+PCV15 (PCV15 + PPSV23)	nsgauwvkrv(ktkaiofbqk) = eiasgozpih wyqkubrlmt (efkcntxkwe, kezsjauwol - lhwccxwtwf) View more
NCT05420961 (V116-006 \| STRIDE-6, CTgov)	Phase 3	Pneumonia, Pneumococcal	717	V116 (Cohort 1: V116)	geeffcwewt(epnpobjsfg) = ixxvnfypdg vrkawiccxt (bimbarpypu, dizjpikelv - ryxlybssgp) View more	-	01 May 2024
				PCV15 (Cohort 1: PCV15)	geeffcwewt(epnpobjsfg) = gahvbaaowd vrkawiccxt (bimbarpypu, ukbvnczhzt - jcdfclttpp) View more
NCT05569954 (STRIDE-10, Biospace) Manual	Phase 3	Pneumococcal Infections	1,484	V116	utnpxiduyy(ktgsaufdcq) = V116 had a comparable safety profile to PPSV23. dnaomozjqw (oqdolavxiw )	Non-inferior	29 Apr 2024
				PPSV23
NCT05425732 (STRIDE-3, NEWS) Manual	Phase 3	Pneumonia, Pneumococcal \| Invasive streptococcal disease	-	V116 (50 岁及以上)	wbjkbqkjtd(ttaxpaxqku) = 在 50 岁及以上的成年人中（队列 1），与 PCV20 相比，V116 对两种疫苗中常见的全部10种血清型都能引起非劣效免疫反应。与50 - 64岁的成年人相比，在18 - 49岁的成年人(队列2)中，V116引发了非劣势免疫反应(免疫桥接)。 vfrzoavpfk (kikpyvfybj ) View more	Positive	29 Nov 2023
				PCV20 (50 岁及以上)
Pubmed \| Hum Vaccin Immunother	Phase 1	-	102	V116	kaaibcjabn(gxhhkvtdsg) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE krzmsvxfss (snuyqqfois ) View more	Positive	01 Aug 2023
				23-valent pneumococcal polysaccharide vaccine (PPSV23)
NCT05420961 (V116-006 \| STRIDE-6, Corporate Publications) Manual	Phase 3	Pneumonia, Pneumococcal \| IRAK4 Deficiency	717	V116	qtbjnchwoy(mrcjpmsyih) = V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study frsbwhzrhw (slhhazpwxb ) Met	Positive	27 Jul 2023
				PCV15
NCT05425732 (STRIDE-3 \| V116-003, Corporate Publications) Manual	Phase 3	Pneumonia, Pneumococcal \| IRAK4 Deficiency	2,600	V116	orbaohccyj(jtprfrjgso) = demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination. Positive immune responses were also observed for serotypes unique to V116. ckmtvungya (vsgslnrrhd ) Met	Positive	27 Jul 2023
				PCV20