Evaluation of Persistence of Immunogenicity Following an Open-labelled, Randomized Controlled Trial Evaluating Non-inferiority of 1+1 Compared to 2+1 Dosing Schedules of 10-valent and 13-valent Pneumococcal Conjugate Vaccine in South Africa

This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 PCV schedule (6, 14 weeks of age and 9 months of age).

Start Date14 Feb 2020

Sponsor / Collaborator

University of the Witwatersrand

CTRI/2019/03/018215

/ CompletedPhase 3

â??A Phase 3, Randomized, Double-Blind Study to Evaluate the Immunogenicity, Safety and Tolerability of Serum Institute of Indiaâ??s 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSILÂ®) in Healthy Indian Infants.â??

Start Date25 Mar 2019

Sponsor / Collaborator-

NCT03489018

/ CompletedPhase 4IIT

The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines (PCV10 and PCV13) on Immunogenicity and Vaccine-serotype Carriage in Kenyan Infants

Before the introduction of pneumonia vaccines in 2000, between 700,000 - 1 million children died each year as a result of infection with the bacteria Streptococcus pneumoniae and the resulting diseases, namely, meningitis, sepsis and pneumonia. Most of the deaths were in Africa and Asia. Where the vaccines have been introduced, they have been highly effective and have already reduced disease. However, at 10 USD per child, they are not affordable to most low-income countries without financial support from Gavi, the Vaccine Alliance.
This project aims to assess whether lower doses of the two commercially available pneumonia vaccines can protect Kenyan infants as well as the full dose. The results could be used to increase the affordability of the pneumonia vaccine, and enable delivery of the vaccine to continue in the absence of Gavi support.

Start Date21 Mar 2019

Sponsor / Collaborator

London School of Hygiene & Tropical Medicine

[+4]

100 Clinical Results associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

100 Translational Medicine associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

100 Patents (Medical) associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

680

Literatures (Medical) associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

31 Dec 2025·Expert Review of Vaccines

Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study

Article

Author: Cutland, Clare L. ; Madhi, Shabir A. ; Nana, Amit J ; Koen, Anthonet ; Jose, Lisa ; Olwagen, Courtney ; Mutsaerts, Eleanora Aml ; Izu, Alane

BACKGROUND:

Due to high costs of pneumococcal conjugate vaccines (PCV), transitioning from a two (2 + 1) to a single dose (1 + 1) primary series with a booster should be considered. This study evaluated the immune response at 18 months of age following a 1 + 1 compared to a 2 + 1 schedule of 10-valent (PCV10) and 13-valent (PCV13) vaccines.

RESEARCH DESIGN AND METHODS:

A single-center, open-label, randomized trial conducted in Soweto, South Africa, evaluated the immunogenicity of differing dosing schedule for PCV10 and PCV13. Six hundred children were randomly assigned to six study arms (1:1:1:1:1:1). Non-inferiority was concluded when the lower limit of the 96% confidence interval of the ratio of geometric mean concentrations (GMCs) of the 1 + 1 and 2 + 1 schedules was >0.5 for at least 10 and eight of the PCV13 and PCV10 serotypes, respectively.

RESULTS:

GMCs in children who received the PCV13_6w + 1 and PCV13_14w + 1 schedule were non-inferior for 11 and 10 of the PCV13 serotypes, respectively, compared with the PCV13_2 + 1 arm. For PCV10, GMCs for both 1 + 1 schedules were non-inferior to a 2 + 1 schedule for nine of the PCV10 serotypes.

CONCLUSION:

Transitioning to a 1 + 1 schedule should be considered for early immunization programs.

CLINICAL TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is NCT02943902.

01 Feb 2025·VACCINE

Nasopharyngeal carriage of Streptococcus pneumoniae among children and their household members in southern Mozambique five years after PCV10 introduction

Article

Author: Chauque, Alberto ; Mucavele, Helio ; Lessa, Fernanda C ; Moiane, Benild ; da Gloria Carvalho, Maria ; Pimenta, Fabiana C ; Sigauque, Betuel ; Tembe, Nelson ; Mabombo, Viviana ; Massora, Sergio ; Matsinhe, Graca ; Verani, Jennifer ; Kahn, Rebecca ; Sacoor, Charfudin ; Whitney, Cynthia G

BACKGROUND:

Streptococcus pneumoniae is an important cause of pneumonia, sepsis, and meningitis, which are leading causes of child mortality. Pneumococcal conjugate vaccines (PCVs) protect against disease and nasopharyngeal colonization with vaccine serotypes, reducing transmission to and among unvaccinated individuals. Mozambique introduced 10-valent PCV (PCV10) in 2013. In 2017-2019, 13-valent PCV (PCV13) replaced PCV10, and in September 2019 the schedule changed from three primary doses to two primary doses and a booster; the booster-containing schedule may increase indirect effects. We examined pneumococcal carriage in Mozambique to establish a baseline for estimating the impact of policy changes and to estimate the long-term impact of PCV10 in children aged <5 years.

METHODS:

We calculated prevalence of carriage of PCV10 serotypes and the 3 additional PCV13 serotypes ('PCV13-unique') among children aged <5 years and their household members in southern Mozambique, between October 2018 and July 2019. Nasopharyngeal swabs were cultured, and isolates underwent Quellung serotyping. For children, we compared these "long-term post-PCV10" data with prior surveys ("pre-PCV" (2012-2013) and "post-PCV10" (2015-2016)) that used the same methods.

RESULTS:

In 2018-2019, among 1319 children aged under five years, 1064 (80.7 %) were colonized with pneumococcus, among 614 children aged 5- < 18 years, 355 (57.8 %) were colonized, and among 804 adults (aged ≥18 years), 285 (35.4 %) were colonized. The most frequently observed serotypes were 19 A (n = 154, 8.5 % of isolates) and 6 A (n = 107, 5.9 %), both PCV13-unique serotypes. Overall carriage prevalence among children under five years remained stable at approximately 80 % across the carriage studies conducted between 2012 and 2019; between 2015 and 2016 and 2018-2019, the prevalence of PCV10-type carriage declined from 17.7 % to 10.1 %.

CONCLUSIONS:

Despite substantial declines in PCV10-type carriage initially following vaccine introduction, the continued circulation of PCV10 serotypes and relative high prevalence of PCV13-unique serotypes underscore the need to understand the impact of policy changes on pneumococcus transmission.

01 Jan 2025·VACCINE

Changes in population genetic structure of serotype 19A Streptococcus pneumoniae after universal childhood use of the 10-valent pneumococcal conjugate vaccine in Brazil

Article

Author: da Silva, André R A ; da Silva, Amanda B ; Teixeira, Lúcia M ; de Miranda, Filipe M ; Neves, Felipe P G ; da Silva, Lívia D ; Cabral, Amanda S ; Lima, Jailton L C

BACKGROUND:

The introduction of the 10-valent pneumococcal conjugate vaccine (PCV10) for nationwide childhood immunization in 2010 led to a significant reduction in colonization and invasive pneumococcal disease (IPD) by vaccine serotypes in young. However, non-vaccine serotypes have emerged, and serotype 19A is now the leading cause of IPD in Brazil.

METHODS:

We analyzed 32 serotype 19A isolates of Streptococcus pneumoniae recovered from children and adults who attended different health facilities in the state of Rio de Janeiro, Brazil, between 2010 and 2023. The capsular types of the isolates were determined by sequential multiplex PCR or by cpsB gene sequencing. All isolates were subjected to antimicrobial susceptibility testing and MLST.

RESULTS:

Of the 32 serotype 19A isolates, 29 (90.6 %) isolates were recovered from children aged ≤5 years and three (9.4 %) isolates were recovered from adults. Nineteen (59.4 %) isolates were associated with colonization, and 13 (40.6 %) isolates were from diseases. All isolates were susceptible to chloramphenicol, levofloxacin, linezolid, rifampin, and vancomycin. The highest frequencies of non-susceptibility (intermediate + resistant) were observed for sulfamethoxazole-trimethoprim (n = 30; 93.8 %), penicillin (n = 24; 75 %), and erythromycin (n = 23; 71.9 %). Twenty-two (68.8 %) isolates were multidrug resistant (MDR). MICs for penicillin among penicillin-non-susceptible pneumococci (PNSP) ranged from 0.12 to 8.0 μg/mL. MICs for erythromycin ranged from 0.064 to >256 μg/mL. MICs for ceftriaxone ranged from 0.023 to 4 μg/mL. The most common genetic lineages were ST733 (n = 7; 21.9 %), mostly found before and in the early years of PCV10 introduction, and CC320 (n = 25; 78.1 %), mostly found in the late-PCV10 period. All 25 isolates within CC320 were PNSP and mostly (n = 22; 88 %) MDR.

CONCLUSIONS:

We observed a shift in antimicrobial susceptibility profiles and genetic lineages after long-term use of PCV, mostly PCV10, for routine childhood immunization, characterized by clonal expansion of the MDR lineage CC320.

News (Medical) associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

18 Mar 2025

·www.globenewswire.com

Curevo Raises $110 Million to Advance Amezosvatein Shingles Vaccine

-- Amezosvatein has shown excellent immunogenicity and improved tolerability in Phase 2 study -- Medicxi leads round, joined by new investors OrbiMed, HBM Healthcare Investments, and Sanofi Ventures -- Former Chair of GSK’s vaccine business and Chief Scientific Advisor to Operation Warp Speed, Moncef Slaoui, to join Curevo as Board Chair March 17, 2025 -- Curevo Vaccine (Curevo), a privately-held clinical-stage biotechnology company dedicated to developing varicella zoster virus (VZV) vaccines with improved tolerability, today announces the closing of a $110 million Series B round to advance development of amezosvatein, its vaccine for shingles. Leading the round is new investor Medicxi, a European biotech-focused investment firm with significant experience investing in vaccine companies such as Vaxcyte and ViceBio. Joining Medicxi is an international group of investment funds including OrbiMed, HBM Healthcare Investments, and Sanofi Ventures plus existing investors RA Capital Management, Janus Henderson Investors, Adjuvant Capital, and founding investor GC Biopharma. “This Series B round will fund the extension of our successful Phase 2 program into an additional 640 participants, including the key population of adults over age 70, to finalize dose selection ahead of the Phase 3 program,” said Curevo’s CEO, George Simeon, MBA/MPH. “Designed based upon feedback from regulators and other stakeholders, this short extension trial will begin mid-2025 and serve to set the company for clinical, strategic, and regulatory success.” Concurrent with the round, Moncef Slaoui, PhD, will join Curevo as Board Chair. Dr. Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed during the COVID-19 pandemic, helping deliver vaccines against the SARS-CoV-2 virus. He spent nearly 30 years at GlaxoSmithKline, during which he helped shape its vaccine business by contributing to the creation of numerous new vaccines including Shingrix® (shingles), Cervarix® (HPV-induced cervical cancer), Mosquirix® (malaria), Rotarix® (rotavirus gastroenteritis), and Synflorix® (pneumococcal disease). “I have been collaborating with the Curevo team for several weeks now,” stated Dr. Slaoui. “I’m very excited to work with them to help perfect shingles vaccination, adding good tolerability to the exceptional efficacy achieved by the current vaccine. The data so far show Curevo’s adjuvant technology has the attributes to succeed in this endeavor.” Also joining Curevo’s Board of Directors will be Giovanni Mariggi, PhD, co-founder and Partner at Medicxi, an experienced infectious disease investor and board member. “Patients, doctors, and payors are very clear a new shingles vaccine like amezosvatein would be welcome in the global marketplace. Amezosvatein’s activity and improved tolerability profile could allow it to be a significant product in the shingles vaccines market. We are excited to support Curevo’s plan with a streamlined path to approval,” stated Dr. Mariggi. Tal Zaks, MD/PhD, will be joining Curevo’s Board of Directors on behalf of OrbiMed. Dr. Zaks is the former Chief Medical Officer of Moderna, where he led development of their mRNA vaccine against the SARS-CoV-2 virus. He previously held senior leadership positions in drug development at GSK and Sanofi. “OrbiMed has a long history of investing in biotech companies like Curevo seeking to improve healthcare outcomes while creating long-term shareholder value,” said Dr. Zaks. “The fact amezosvatein contains an optimized version of the TLR4 agonist with a known mechanism of action reduces biological risk while providing the competitive advantage of potentially improved tolerability, which should position it as the first choice for people who want to be protected from shingles.” ‘Amezosvatein’ is the assigned non-proprietary name for CRV-101, a non-mRNA adjuvanted subunit vaccine under investigation by Curevo. Like Shingrix, amezosvatein uses a subunit protein antigen called glycoprotein ‘E’ (gE). Targeting the gE antigen is proven to elicit a long-term, protective immune response to prevent shingles. Amezosvatein’s adjuvant contains an optimized version of the TLR4 agonist proven by Shingrix to be biologically active in shingles vaccination. Amezosvatein was engineered to maintain exceptional efficacy and have a best-in-class tolerability profile. The SLA-SE adjuvant formulation was developed at Seattle-based Access to Advanced Health Institute (AAHI) and amezosvatein was licensed from the Mogam Institute for Biomedical Research, a research institute funded by South Korea’s GC Biopharma. Curevo is a privately held, clinical-stage biotechnology company based near Seattle dedicated to reducing the burden of infectious disease by developing vaccines with improved tolerability and accessibility. Curevo’s lead product is amezosvatein, a non-mRNA adjuvanted sub-unit vaccine to prevent shingles, a serious medical condition involving a painful, blistering skin rash where 10-18% of people also develop serious, long-lasting nerve pain. The current $4+ billion shingles vaccine market is characterized by accessibility issues and vaccine hesitancy/dose avoidance related to vaccine tolerability. For more information visit https://curevovaccine.com/. Medicxi is a healthcare-focused investment firm with the mission to create and invest in companies across the full drug development continuum. Leveraging deep expertise in drug development and company creation spanning over two decades, Medicxi invests in early and late-stage therapeutics with a product vision that can fulfill a clear unmet medical need. For more information, please visit: https://www.medicxi.com. OrbiMed is a leading global healthcare investment firm with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, via private equity funds, public equity funds, and royalty/credit funds. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and extensive global team resources to help build world-class healthcare companies. OrbiMed’s team of over 100 professionals is based in New York City, London, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. For more information, please visit www.orbimed.com. Switzerland-based HBM Healthcare Investments focuses on the healthcare sector, holding and managing an international portfolio of promising companies in the human medicine, biotechnology, medical technology, diagnostics, and related areas. Many of these companies have their lead products already available on the market or are at an advanced stage of development. The portfolio companies are closely tracked and actively guided in their strategic direction. This is what makes HBM Healthcare Investments an interesting alternative to investments in big pharma and biotechnology companies. HBM Healthcare Investments has an international shareholder base and is listed on SIX Swiss Exchange (SIX:HBMN). Sanofi Ventures is the corporate venture capital arm of Sanofi, focused on investing in promising early-stage healthcare companies. The firm supports pioneering innovations in biotechnology, digital health, and life sciences aligning with Sanofi’s mission to bring life-changing treatments to patients worldwide. For more information, please visit www.sanofiventures.com. Founded in 2004, RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital creates and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization and beyond. RA Capital's knowledge engine is guided by its TechAtlas internal research division, and Raven, RA Capital's healthcare incubator, offers entrepreneurs and innovators a collaborative and comprehensive platform to explore the novel and the re-imagined. RA Capital has more than 150 employees and over $10 billion in assets under management. Janus Henderson Investors exists to help clients achieve their long-term financial goals. Its active management offers clients the opportunity to outperform passive portfolios over the course of market cycles. With more than 360 investment professionals, Janus Henderson Investors provides access to some of the industry’s most talented and innovative thinkers, spanning equities, fixed income, multi-asset, and alternatives, globally. Its investment teams blend insight, originality, and precision with rigorous analysis, structured processes, and robust risk management. Janus Henderson Investors builds client partnerships on openness and trust, channeling expertise from across the business and communicating the views of its experts in a timely and relevant way. https://www.janushenderson.com/ Headquartered in New York, with offices in Zürich, Adjuvant is a global life science investment fund built to accelerate the development of new technologies for the world's most pressing public health challenges. Backed by prominent healthcare and emerging market investors, Adjuvant draws upon its network of scientists, public health experts, biopharmaceutical industry veterans, and development finance professionals to identify new investment opportunities. Adjuvant invests in companies developing promising new vaccines, therapeutics, diagnostics, and medical devices targeting high-burden infectious diseases, maternal and child health, antimicrobial resistance, and malnutrition, with a commitment to make these interventions accessible globally. For more information, visit http://www.adjuvantcapital.com Founding investor GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yongin, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines and expanded its global presence with the successful USA market entry of ALYGLO™ (intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platforms to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit https://www.gcbiopharma.com/eng/ The content above comes from the network. if any infringement, please contact us to modify.

Vaccine

04 Feb 2025

·ir.arcturusrx.com

Arcturus Therapeutics Announces Appointment of Moncef Slaoui, Ph.D., as Chair Designate

SAN DIEGO --(BUSINESS WIRE)--Feb. 4, 2025-- Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the appointment of Moncef Slaoui , Ph.D., as Chair Designate. Dr. Slaoui has been serving on the Company’s Board of Directors since June 2024 . “Dr. Moncef Slaoui has a long-proven track record in the pharmaceutical and biotechnology industry, and we are delighted to have him as our Chair Designate,” said Joseph Payne , President & Chief Executive Officer of Arcturus. “We look forward to working with him as we enter a transformative year of advancing our pipeline of therapeutics and vaccines.” “Arcturus has deep expertise in mRNA delivery for therapeutics and a validated commercial stage vaccines platform,” said Dr. Moncef Slaoui . “I am excited to work with the company during this potentially transformational time with multiple key data readouts across its pipeline.” About Dr. Moncef Slaoui Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna, Inc. and Lonza Group AG , and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a redesign of GSK’s R&D structure and culture to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world. He served on the Advisory Committee to the Director of the NIH from 2011 to 2016 and has advised the U.S. President's Council of Advisors on Science and Technology . Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles , completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine , and was a Professor of Immunology at the University of Mons , Belgium . He received an accelerated Master of Business Administration from IMD, Switzerland in 1998. About Arcturus Founded in 2013 and based in San Diego, California , Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan , ARCALIS , focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S. , Europe , Japan , China , and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20250204663825/en/ Arcturus Therapeutics Public Relations & Investor Relations Neda Safarzadeh VP, Head of IR/PR/Marketing (858) 900-2682 IR@ArcturusRx.com Source: Arcturus Therapeutics Holdings Inc.

VaccineExecutive ChangemRNA

27 Jul 2023

·firstwordpharma.com

Merck & Co. looks to take on Pfizer’s Prevnar franchise with positive top-line data for V116

Merck & Co. has announced positive top-line results from two Phase III trials evaluating V116, its investigational 21-valent pneumococcal conjugate vaccine in vaccine-naïve and previously vaccinated individuals. The company initiated pivotal-stage studies of the vaccine last summer. Results from the STRIDE-3 trial demonstrated statistically significant immune responses for V116 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. Additionally, results from STRIDE-6 demonstrated that 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. In both studies, V116 had a safety profile comparable to the comparator and results will be shared with the scientific community in the near future. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults, said Merck. According to CDC data from 2019, the 21 serotypes covered by V116 are responsible for 85% of invasive pneumococcal disease in individuals 65 and older and Merck’s vaccine includes eight serotypes not currently covered by approved pneumococcal vaccines. These unique serotypes are thought to be responsible for approximately 30% of invasive pneumococcal disease in individuals 65 and older, based on pre-pandemic data.“Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older,” said Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories.The global market for pneumococcal vaccines is largely dominated by Pfizer’s Prevnar 13 and Prevnar 20 franchises, with smaller share commanded by Merck’s Pneumovax and Vaxneuvance brands which the company is hoping to build on with V116. The third notable player in this space GSK, responsible for marketing the vaccine Synflorix, acquired Affinivax just over a year ago at an upfront cost of $2.1 billion in a bid to also expand its long-term presence in the pneumococcal vaccine market.

VaccineClinical ResultAcquisitionPhase 3Immunotherapy

100 Deals associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)	J07AL52	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Otitis Media	Japan	GSK Plc	17 Apr 2015
Pneumococcal Infections	Japan	Japan Vaccine Co., Ltd.	26 Mar 2015
Pneumonia	Canada	GSK Plc	22 May 2009
Acute otitis media	European Union	GlaxoSmithKline Biologicals SA	29 Mar 2009
Acute otitis media	Iceland	GlaxoSmithKline Biologicals SA	29 Mar 2009
Acute otitis media	Liechtenstein	GlaxoSmithKline Biologicals SA	29 Mar 2009
Acute otitis media	Norway	GlaxoSmithKline Biologicals SA	29 Mar 2009
Invasive streptococcal disease	European Union	GlaxoSmithKline Biologicals SA	29 Mar 2009
Invasive streptococcal disease	Iceland	GlaxoSmithKline Biologicals SA	29 Mar 2009
Invasive streptococcal disease	Liechtenstein	GlaxoSmithKline Biologicals SA	29 Mar 2009
Invasive streptococcal disease	Norway	GlaxoSmithKline Biologicals SA	29 Mar 2009
invasive Streptococcus pneumoniae infection	European Union	GlaxoSmithKline Biologicals SA	29 Mar 2009
invasive Streptococcus pneumoniae infection	Iceland	GlaxoSmithKline Biologicals SA	29 Mar 2009
invasive Streptococcus pneumoniae infection	Liechtenstein	GlaxoSmithKline Biologicals SA	29 Mar 2009
invasive Streptococcus pneumoniae infection	Norway	GlaxoSmithKline Biologicals SA	29 Mar 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Malaria	Phase 3	Burkina Faso	GSK Plc	17 Nov 2011
Malaria	Phase 3	Ghana	GSK Plc	17 Nov 2011
Haemophilus Infections	Phase 3	Germany	GSK Plc	14 May 2009
Haemophilus Infections	Phase 3	Poland	GSK Plc	14 May 2009
Haemophilus Infections	Phase 3	Spain	GSK Plc	14 May 2009
Meningitis	Phase 3	Germany	GSK Plc	14 May 2009
Meningitis	Phase 3	Poland	GSK Plc	14 May 2009
Meningitis	Phase 3	Spain	GSK Plc	14 May 2009
HIV Infections	Phase 3	South Africa	GSK Plc	17 Feb 2009
Meningococcal Infections	Phase 3	Mexico	GSK Plc	30 Oct 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01027845 (CTgov)	Phase 3	Streptococcal Infections	360	Pneumococcal vaccine GSK1024850A+DTPa (10Pn Group)	prdcrghgae(zfvmtyfsaj) = artvkaujji wzjjlrqicp (wuaeddtmav, iwmjundoqc - pogiaecorj) View more	-	29 Nov 2019
				DTPa (DTPa Group)	prdcrghgae(zfvmtyfsaj) = lgatwpwhtw wzjjlrqicp (wuaeddtmav, jhcerahjng - mgiujqvrwj) View more
NCT01175083 (CTgov)	Phase 3	Streptococcal Infections	300	GSK1024850A+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6S Group)	msgkqyawgh(ooyyfizguv) = yjsynanqkx ldurhryhzx (duiutkhnkw, zinbcttggo - qoxwstzlgz) View more	-	06 Jun 2019
				GSK1024850A+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6NS Group)	msgkqyawgh(ooyyfizguv) = kkvnhgqfpb ldurhryhzx (duiutkhnkw, jjivwyrcmk - xfozwospws) View more
NCT00496015 (CTgov)	Phase 3	Streptococcal Infections	750	Pneumococcal conjugate vaccine GSK1024850A.+Paracetamol.+Infanrix hexa. (Synflorix I Group)	evuowgitsx = xbgkwsxbfe uosriytped (jgbmgiipkw, kjxfphknwj - bofamvznzb) View more	-	18 Jan 2019
				Pneumococcal conjugate vaccine GSK1024850A.+Infanrix hexa. (Synflorix II Group)	evuowgitsx = axpilkjdti uosriytped (jgbmgiipkw, cnetcxumej - ilkryomeeh) View more
NCT00345358 (CTgov)	Phase 3	Streptococcal Infections	600	Synflorix+Infanrix IPV/Hib (Synflorix <6M Group)	ibneuwiqru = vweeibrgru doawvymrgc (bmdpstkabl, oqiydghjwi - vvudgyykzl) View more	-	15 Jan 2019
				Synflorix (Synflorix 7-11M Group)	ibneuwiqru = gjzssxniew doawvymrgc (bmdpstkabl, czyaivvadb - oxtxgqurmd) View more
NCT00547248 (CTgov)	Phase 3	Streptococcal Infections	756	Synflorix+Tritanrix-HepB+Hiberix+Polio Sabin (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group)	pehvzcyosi = tshktkovbi xlufbdilrt (pclssipmoq, fhwdxagmdd - kzphwvowhx) View more	-	14 Jan 2019
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	pehvzcyosi = lvxhgnmtfu xlufbdilrt (pclssipmoq, cihjwwxdip - sqddvdaxqy) View more
NCT00390910 (CTgov)	Phase 3	Streptococcal Infections	286	Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group III)	uqcufutraj = fvtvdohkoy ihqyvhxbco (mjxuauapbz, caohfyfojc - pqlocnlxkm) View more	-	17 Dec 2018
				Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group I)	rpybuquejv = iqernrexec pazomgfexi (knbsltrihz, plnypqkcqf - pjiroxrtut) View more
NCT00652951 (CTgov)	Phase 3	Streptococcal Infections	780	GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)+Infanrix™ hexa. (Synflorix + Infanrix Hexa Group)	tthularbqh(cgvyfyobad) = wlmaobdmbq utrmsnasor (cylboqjiqu, csvjtxkcot - bmhrqefixj) View more	-	14 Dec 2018
				GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)+Pediacel™ (Synflorix + Pediacel Group)	tthularbqh(cgvyfyobad) = pdjehwtuiw utrmsnasor (cylboqjiqu, suhpvzzmnl - cqbukpolph) View more
NCT00985465 (CTgov)	Phase 3	Streptococcal Infections	218	Synflorix (Synflorix Primed Group)	fswmjruowb = pnqpqnnztv wclsoilipk (hjmqqonwbl, efbjiszadk - sddgzwxqtk) View more	-	14 Dec 2018
				PD-DIT-032+Synflorix™ vaccine (Synflorix Unprimed Group)	fleseephgb = wulyduacnc zzdfqdhqdv (hckkotkhch, snaxkymrsv - zbwpykvptm) View more
NCT00370396 (CTgov)	Phase 3	Streptococcal Infections	1,200	Synflorix+Infanrix hexa (Synflorix-Synflorix Group)	caesjogvbk = fbuqewedri cvpfhzafgk (palacchall, nkjapetbos - ugpvqiuidt) View more	-	26 Nov 2018
				Infanrix hexa+Prevenar (Prevenar-Prevenar Group)	caesjogvbk = zgbjynlnwz cvpfhzafgk (palacchall, jkhpqcxeov - itawxexwzo) View more
NCT00758264 (CTgov)	Phase 3	Meningococcal Infections	363	Synflorix+Nimenrix (Nimenrix + Synflorix Group)	okprwxxbhk(zzgeozzidm) = viuursxmlw apbfvskuvh (pkfqxndtqw, ccjzllrumo - rqpqwcmfsk) View more	-	09 May 2018
				Synflorix booster vaccine (Nimenrix Group)	okprwxxbhk(zzgeozzidm) = gqyhdcnkfw apbfvskuvh (pkfqxndtqw, jdahtusbzb - pnwnetezmq) View more

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Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

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