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

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]

NCT03547271

/ CompletedPhase 3

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Primary objective:
This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old
Secondary objectives:
This study aimed to demonstrate the non-inferiority of the antibody (Ab) response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old.
- This study aimed to describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.

Start Date14 Dec 2018

Sponsor / Collaborator

Sanofi Pasteur SA

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)

421

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 Oct 2025·Infectious Diseases and Therapy

Effectiveness of a Single Dose of Pneumococcal Conjugate Vaccine Against Invasive Pneumococcal Disease in Children: A Systematic Literature Review

Review

Author: Jodar, Luis ; Gessner, Bradford D ; Althouse, Benjamin M ; Hayford, Kyla ; Hong, Linge ; Dunne, Eileen M ; Theilacker, Christian

INTRODUCTION:

While pneumococcal conjugate vaccines (PCVs) are typically administered to infants using a three- or four-dose regimen, children may receive less immunogenic regimens due to missed doses or alternative schedules. The level of direct protection in children vaccinated with a single dose of PCV remains unclear.

METHODS:

We performed a systematic review of observational studies published during 2000-2024 on vaccine effectiveness (VE) of a single dose of PCV7, PCV10, or PCV13 against vaccine-type invasive pneumococcal disease (IPD) in children. Results were stratified by vaccine and age at administration, and meta-analysis performed to generate pooled VE estimates.

RESULTS:

Twenty-seven studies met the inclusion criteria: nine reported VE for PCV7, four for PCV10, seven for PCV13, and seven reported VE separately for more than one PCV. For PCV7, pooled VE was 64.6% (95% CI 47.3, 76.2) when administered < 12 months or age unspecified and 81.6% (95% CI 72.5, 87.7) when given ≥ 12 months. For PCV10, pooled VE was 73.0% (95% CI - 29.4, 94.4) when age at vaccination was unspecified, and one study reported 68.0% (95% CI 17.6, 87.6) VE when administered ≥ 12 months. For PCV13, pooled VE was 56.8% (95% CI 44.1, 66.6) when administered < 12 months or age unspecified, and 79.2% (95% CI 65.5, 87.5) when given ≥ 12 months.

CONCLUSIONS:

Available evidence demonstrates that a single dose of PCV provides protection against vaccine-type IPD, especially when administered after age 12 months. While complete vaccination according to licensed schedules provides optimal protection, our findings support single-dose catch-up programs for toddlers. Potential single-dose strategies for infants in humanitarian emergencies warrant further exploration.

01 Oct 2025·VACCINE

Pneumococcal carriage prevalence, serotype distribution, and vaccine coverage in Ethiopia 12 years after pneumococcal vaccine introduction

Article

Author: Dessie, Yadeta ; Scott, J Anthony G ; Deressa, Merga ; Gardiner, Elizabeth ; Marami, Dadi ; Solomon, Esrael ; Gallagher, Katherine E ; Kebede, Yohannes ; Karani, Angela ; Bizuayehu, Hiwot Yigzaw

INTRODUCTION:

Ethiopia introduced the 10-valent pneumococcal conjugate vaccine (PCV10, GlaxoSmithKline plc.) in 2011 and switched to 13-valent vaccine (PCV13, Pfizer Inc.) in 2020. In 2023, we conducted a study in four settings in Ethiopia to determine the vaccine coverage, residual vaccine-type carriage prevalence, serotype distribution, and factors associated with carriage across all age groups.

METHODS:

A cross-sectional survey was conducted in urban and rural areas of eastern and southwest Ethiopia in 2023. In total, 50 participants in each of 10 age groups (<1, 1-2, 3-4, 5-9, 10-14, 15-19, 20-39, 40-49, 50-59, and ≥ 60 years) were randomly selected using population registers in Harar, Kersa and Gilgel Gibe demographic surveillance systems, and using random GPS points for Jimma city. After informed consent, data on socioeconomic characteristics and vaccine coverage were collected. A single nasopharyngeal swab was collected and cultured for pneumococci. Pneumococci were serotyped using latex agglutination and confirmatory Quellung reaction.

RESULTS:

A total of 2006 participants were enrolled. The age-standardized population prevalence of pneumococcal carriage (all serotypes) in rural settings was 56 % (95 %CI 48-64 %) in the east and 26 % (95 %CI 20-31 %) in the southwest, and in urban settings, 15 % (95 %CI 11-20 %) in the east and 16 % (95 %CI 12-19 %) in the southwest. PCV13 serotype carriage prevalence among children aged <5 years ranged from 7.4 to 9.3 % in the urban areas, to 16-22 % in the rural areas. Coverage of the third dose of PCV, recorded in vaccination cards of participants aged <5 years, was 49 %-87 % in the urban areas; it was much lower at 13-22 % in the rural areas.

CONCLUSIONS:

There is considerable residual circulation of vaccine serotypes in Ethiopia, particularly in rural areas and the east, and low vaccine coverage. Pneumococcal epidemiology varies by geographical region and urban/rural setting, implying an unequal burden of pneumococcal disease across the country 12 years post-PCV introduction.

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 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
Pneumonia, Pneumococcal	Phase 3	Mexico	GSK Plc	03 Jul 2007
Community Acquired Pneumonia	Phase 3	Argentina	GSK Plc	28 Jun 2007
Community Acquired Pneumonia	Phase 3	Colombia	GSK Plc	28 Jun 2007
Community Acquired Pneumonia	Phase 3	Panama	GSK Plc	28 Jun 2007
Streptococcal Infections	Phase 3	Philippines	GSK Plc	07 Aug 2006
Streptococcal Infections	Phase 3	Poland	GSK Plc	07 Aug 2006

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)	wxzwcetwwg(vereuxwcnt) = xeqdzspwff fdnyltxork (logrwfvlur, byskbvaggc - shbobqihls) View more	-	29 Nov 2019
				DTPa (DTPa Group)	wxzwcetwwg(vereuxwcnt) = xvrgnrhffy fdnyltxork (logrwfvlur, pvnovshljk - raklgtpsvu) View more
NCT01175083 (CTgov)	Phase 3	Streptococcal Infections	300	GSK1024850A+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6S Group)	pebvuapgqf(ztholhzwom) = ovamjxgwqr olsxufvpqf (ewwcqpnwuz, dncabtkzly - ulplrjiluq) View more	-	06 Jun 2019
				GSK1024850A+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6NS Group)	pebvuapgqf(ztholhzwom) = ghtzxuhxhl olsxufvpqf (ewwcqpnwuz, paclukinni - souzreeprt) View more
NCT00496015 (CTgov)	Phase 3	Streptococcal Infections	750	Pneumococcal conjugate vaccine GSK1024850A.+Paracetamol.+Infanrix hexa. (Synflorix I Group)	kavcosceqd = auluxdjzhj epsoilvcvn (pniardbbjv, grdirfbsrl - jtknpjiwvp) View more	-	18 Jan 2019
				Pneumococcal conjugate vaccine GSK1024850A.+Infanrix hexa. (Synflorix II Group)	kavcosceqd = wlkkkfxlun epsoilvcvn (pniardbbjv, eohahnbzdj - mpqpldlelb) View more
NCT00345358 (CTgov)	Phase 3	Streptococcal Infections	600	Synflorix+Infanrix IPV/Hib (Synflorix <6M Group)	krqpcuvxkf = wgovtierls szupqgwams (gctvpsbigx, lhzbnuingx - drmbjethkm) View more	-	15 Jan 2019
				Synflorix (Synflorix 7-11M Group)	krqpcuvxkf = apvutbatmi szupqgwams (gctvpsbigx, eqzebgjddh - wfaqukfijj) View more
NCT00547248 (CTgov)	Phase 3	Streptococcal Infections	756	Synflorix+Tritanrix-HepB+Hiberix+Polio Sabin (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group)	emycdijvoh = rcvelehtkt bdqdfvrluq (rrngyxvzuu, odnojulsjx - tkyyznhaxm) View more	-	14 Jan 2019
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	emycdijvoh = gnwkfbjoup bdqdfvrluq (rrngyxvzuu, snphsgjtpd - frlekzdcpf) View more
NCT00390910 (CTgov)	Phase 3	Streptococcal Infections	286	Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group III)	fukpauchwf = vfefdbkgeo xmyjbzviqx (kegborhixz, xszhgiydfl - bqccicseik) View more	-	17 Dec 2018
				Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group I)	bnftyzhdvy = wootvivqma iszcapbixt (zkkktggvms, vccvrinttr - xlapexicsa) View more
NCT00985465 (CTgov)	Phase 3	Streptococcal Infections	218	Synflorix (Synflorix Primed Group)	fqsyyzgcyv = nestewdzjh bzgpwmpkzb (rfrmirsyeq, ksovwyoofa - ofphnoxfkb) View more	-	14 Dec 2018
				Synflorix™ vaccine (Synflorix Unprimed Group)	olksgjwszk = sxukferoyw bvyvketnqg (mxjmzwcycy, olkdtlxnjg - uixunfnvca) View more
NCT00652951 (CTgov)	Phase 3	Streptococcal Infections	780	GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)+Infanrix™ hexa. (Synflorix + Infanrix Hexa Group)	bubgbbskye(wwcwkdvipb) = hpyyacpefl dxktewodtt (bjlogdjrnm, rbtdlfjfqn - hfybuufbti) View more	-	14 Dec 2018
				GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)+Pediacel™ (Synflorix + Pediacel Group)	bubgbbskye(wwcwkdvipb) = cpufeahmga dxktewodtt (bjlogdjrnm, dlqtdldnjb - vqwoispewo) View more
NCT00370396 (CTgov)	Phase 3	Streptococcal Infections	1,200	Synflorix+Infanrix hexa (Synflorix-Synflorix Group)	jicdztwnxf = gqnysckgrg emzydzyqby (mfcfoyiakc, xrlekegqmx - csmfuicgpw) View more	-	26 Nov 2018
				Infanrix hexa+Prevenar (Prevenar-Prevenar Group)	jicdztwnxf = bbsbpsbdyh emzydzyqby (mfcfoyiakc, jqvfdxesth - djxxanrqgw) View more
NCT00758264 (CTgov)	Phase 3	Meningococcal Infections	363	Synflorix+Nimenrix (Nimenrix + Synflorix Group)	atsecxyfqb(pqfvdagtac) = wgishajogj nnaqmazrno (wbzobwermc, zelbmrpsnd - esiehvxxjr) View more	-	09 May 2018
				Synflorix booster vaccine (Nimenrix Group)	atsecxyfqb(pqfvdagtac) = cfwaqnushl nnaqmazrno (wbzobwermc, mfsicohlnc - ywiklvmfhv) View more

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Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

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