A Phase IV, Open labelled, Randomized, Controlled Study to Assess the Immunogenicity and Effect on Pneumococcal Nasopharyngeal Carriage of reduced two dose schedule (1+1) of Pneumococcal Conjugate Vaccines 10-valent PNEUMOSIL and 14 valent PNEUBEVAX-14 as compared to their recommended three dose schedule (2+1) in Healthy Indian Infants. - NIL

Start Date01 Jan 2025

Sponsor / Collaborator-

NCT06740630 / Not yet recruitingPhase 3

A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age

The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.

Start Date17 Dec 2024

Sponsor / Collaborator

GSK Plc

NCT06622109 / Not yet recruitingNot Applicable

PREVENAR 20 SUSPENSION LIQUID FOR INJECTION SPECIAL INVESTIGATION - Investigation in Infants Starting Vaccination at the Age of 2 Month, Inclusive, to 7 Months, Exclusive -

The purpose of this study is to learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan.
This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time.
Infants aged between two months and six months are normally given four vaccinations. The first three vaccinations are called primary vaccinations and are given with an interval of one month between each vaccination. The fourth vaccination is called the booster and is given between 12 and 15 months of age.
Participants will take part in this study from the day of first vaccination to 28 days after fourth vaccination.
The side effects observed in the participants will be recorded and looked into.

Start Date29 Nov 2024

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with 20-valent Pneumococcal Conjugate Vaccine(Pfizer)

100 Translational Medicine associated with 20-valent Pneumococcal Conjugate Vaccine(Pfizer)

100 Patents (Medical) associated with 20-valent Pneumococcal Conjugate Vaccine(Pfizer)

2,658

Literatures (Medical) associated with 20-valent Pneumococcal Conjugate Vaccine(Pfizer)

01 Jan 2025·VACCINE

Cost-effectiveness of 15-valent or 20-valent pneumococcal conjugate vaccine for U.S. adults aged 65 years and older and adults 19 years and older with underlying conditions

Article

Author: Stoecker, Charles ; Kobayashi, Miwako ; Leidner, Andrew J ; Rosenthal, Melissa ; Pilishvili, Tamara ; Cho, Bo-Hyun

BACKGROUND:

In June 2021, the Advisory Committee on Immunization Practices (ACIP) recommended use of either 20-valent pneumococcal conjugate vaccine (PCV20) alone or 15-valent pneumococcal conjugate vaccine (PCV15) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) for all PCV-unvaccinated adults aged ≥65 years (age-based) and for adults aged 19-64 years with conditions that increase the risk for pneumococcal disease (risk-based). This recommendation replaced a previous recommendation for PPSV23 with or without 13-valent pneumococcal conjugate vaccine (PCV13) for these groups.

OBJECTIVE:

We conducted a cost-effectiveness analysis of age-based and risk-based use of either PCV15 in series with PPSV23 or PCV20 alone when compared to previous recommendations.

METHODS:

We utilized probabilistic cohort models of all 65-year-olds (age-based) and 19-year-olds (risk-based through age 64 years and age-based at age 65 years). A spreadsheet-based Monte Carlo simulation software was used to estimate immunization costs, medical costs, non-medical costs, and overall disease burden under different vaccine strategies. The model tracked inpatient invasive pneumococcal disease (IPD) and non-bacteremic pneumonia (NBP) in inpatient and outpatient settings. One-way sensitivity analyses incorporated indirect effects of prospective pediatric vaccination with PCV15 and PCV20 on adult IPD and NBP incidence. Costs were reported in 2021 US dollars. All future costs and outcomes were discounted at 3 % per year.

RESULTS:

Age-based use of either PCV20 alone or PCV15 in series with PPSV23 at age 65 years were both shown to be cost-saving (improved health outcomes and saved costs). Combined cost-effectiveness of risk-based (19-64 years) plus age-based (65 years) (risk-and-age-based) use of PCV20 alone was cost-saving, whereas use of PCV15 in series with PPSV23 increased quality-adjusted life years (QALYs) but cost $412,111 (95 % CI: 270,295, 694,869) per QALY gained.

CONCLUSION:

In U.S. adults, replacing the previous recommendations with PCV20 alone or PCV15 in series with PPSV23 improved health outcomes. Except for risk-and-age-based use of PCV15 in series with PPSV23 that resulted in increased cost per QALY gained, the interventions also reduced costs.

01 Jan 2025·PEDIATRIC INFECTIOUS DISEASE JOURNAL

Severe Invasive Pneumococcal Disease Caused by Serotype 19A in Children Under Five Years in Tāmaki Makaurau Auckland, Aotearoa New Zealand

Article

Author: Burton, Cameron ; Humphrey, Alexander ; Best, Emma ; Anglemyer, Andrew ; Tuato’o, Amelie ; Webb, Rachel

Background::

Increases in childhood invasive pneumococcal disease (IPD) have been reported in several countries following the easing of COVID-19 pandemic mitigations. In Aotearoa New Zealand (AoNZ), a surge in IPD is occurring in young children concurrent with changes in pneumococcal vaccines and declining immunization coverage. We sought to examine epidemiologic and clinical features of IPD among children under 5 years in a large urban region of AoNZ in the 3 years post-COVID-19.

Methods::

Demographic, clinical and laboratory data were collated from children under 5 years with Streptococcus pneumoniae identified from normally sterile sites between January 1, 2021, and December 31, 2023, in Tāmaki Makaurau Auckland, AoNZ.

Results::

We identified 93 episodes of IPD (annual incidence of 18–40 cases per 100,000 population per year). Serotype was identified in 68 episodes and 46 (68%) were serotype 19A. Incidence was higher in Pacific children compared with non-Māori, non-Pacific children (incidence rate ratio: 2.3; 95% confidence interval: 1.4–3.7). Bacteremia occurred in 65 (70%) episodes, empyema in 47 (51%), meningitis in 11 (12%) and hemolytic uremic syndrome in 7 (7.5%). All cases of hemolytic uremic syndrome and empyema were only among children with serotype 19A. Two children died, both had serotype 19A, and 13/91 survivors (14%) experienced serious sequelae.

Conclusions::

The use of the pneumococcal conjugate vaccine with lower valency and easing of COVID-19 containment measures each may have contributed to an increase in IPD in AoNZ. Serotype 19A is associated with empyema and causes severe disease in young children. Urgent efforts are required to improve PCV13 coverage in AoNZ.

31 Dec 2024·Expert Review of Vaccines

Cost-effectiveness analysis of 20-valent pneumococcal conjugate vaccine for routine pediatric vaccination programs in Japan

Article

Author: Togo, Kanae ; Kamei, Kazumasa ; Yonemoto, Naohiro ; Perdrizet, Johnna ; Hayamizu, Tomoyuki ; Morii, Junko ; Shinjoh, Masayoshi

BACKGROUND:

The Japanese National Immunization Program currently includes the pediatric 13 valent pneumococcal conjugate vaccine (PCV13) to prevent pneumococcal infections. We aimed to evaluate the cost-effectiveness of 20-valent PCV (PCV20) as a pediatric vaccine versus PCV13.

METHODS:

A decision-analytic Markov model was used to estimate expected costs, quality-adjusted life-years (QALYs), and prevented cases and deaths caused by invasive pneumococcal disease, pneumonia, and acute otitis media over a ten-year time horizon from the societal and healthcare payer perspectives.

RESULTS:

PCV20 was dominant, i.e. less costly and more effective, over PCV13 (gained 294,599 QALYs and reduced Japanese yen [JPY] 352.6 billion [2.6 billion United States dollars, USD] from the societal perspective and JPY 178.9 billion [USD 1.4 billion] from the payer perspective). Sensitivity and scenario analyses validated the robustness of the base scenario results. When comparing PCV20 with PCV13, the threshold analysis revealed an incremental cost-effectiveness ratio that was within the threshold value (JPY 5 million/QALY) at a maximum acquisition cost of JPY 74,033 [USD 563] (societal perspective) and JPY 67,758 [USD 515] (payer perspective).

CONCLUSIONS:

As a pediatric vaccine, PCV20 was dominant over PCV13 regardless of the study perspective.

113

News (Medical) associated with 20-valent Pneumococcal Conjugate Vaccine(Pfizer)

23 Dec 2024

·www.globenewswire.com

Press Release: Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines

Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines Pneumococcal disease remains a major global health challenge despite the availability of current vaccines This 21-valent pneumococcal conjugate vaccine (PCV21) is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter phase 3 in infants & toddlers Paris, December 23, 2024. Sanofi and SK bioscience have entered into a new chapter of their collaboration in pneumococcal vaccines with an expanded agreement to develop, license and commercialize next-generation PCVs for both pediatric and adult populations, reaffirming their commitment to fighting pneumococcal disease. Despite decades of public health vaccination programs, invasive pneumococcal disease (IPD) continues to inflict a substantial burden of disease, primarily due to Streptococcus pneumoniae serotypes that are not included in currently available conjugate vaccines. Next-generation PCVs have the potential to extend vaccine coverage of disease-causing serotypes. This expansion builds on the companies’ existing collaboration to develop and commercialize a PCV21 pediatric vaccine, for which the phase 3 clinical program commenced last week. This vaccine candidate is the first-ever PCV containing more than 20 serotypes to enter a phase 3 clinical study in infants and toddlers. Thomas Triomphe Executive Vice President, Vaccines, Sanofi“Given the vast unmet public health needs in IPD, we’re delighted to expand this collaboration and continue our pursuit of innovative work in PCV. Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease.” Jaeyong AhnCEO and President of SK bioscience “We’re thrilled about the expansion of our collaboration with Sanofi, which serves as the core of our strategy to develop new solutions to combat pneumococcal disease. The ongoing expansion of our state-of-the-art manufacturing base, cofinanced by Sanofi, will support launch of PCV21 and future next generation vaccines.” The PCV21 phase 3 program is based on positive phase 2 results communicated last year and will include more than 7,700 infants, toddlers, young children and adolescents across multiple geographies, including the US, Europe, Australia, Asia, and Latin America. Under the terms of their expanded agreement, both companies will co-fund research and development costs. Sanofi will pay EUR 50M upfront to SK bioscience, followed by development and commercial milestone payments. Once registered, Sanofi will commercialize the vaccines worldwide except for South Korea, where SK bioscience will have commercial exclusivity. SK bioscience will receive royalty payments on product sales outside South Korea. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com Léo Le Bourhis | + 33 6 75 06 43 81 | leo.lebourhis@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.comTimothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com Investor RelationsThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Press Release

Phase 3VaccineLicense out/inPhase 2

23 Dec 2024

·www.pharmaceutical-technology.com

SK bioscience and Sanofi expand agreement for pneumococcal conjugate vaccines

SK bioscience retains exclusive rights in Korea, with Sanofi handling other markets and paying royalties on international sales. Credit: SK bioscience. SK bioscience and Sanofi have expanded their agreement to jointly develop pneumococcal conjugate vaccines (PCVs) targeting both paediatric and adult populations. This partnership extension leverages their ongoing efforts with GBP410, a paediatric vaccine candidate entering Phase III trials. Under the new agreement, Sanofi will make an upfront payment of €50m ($52.1m) to SK bioscience, with additional potential milestones. Research and development expenses will be shared equally, whereas Sanofi will cover all commercialisation expenses. SK bioscience retains exclusive rights in Korea, with Sanofi handling other markets and paying royalties on international sales. Sanofi Vaccines executive vice-president Thomas Triomphe said: “Given the vast unmet public health needs in IPD, we’re delighted to extend this collaboration and continue our pursuit of innovative work in PCV. Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease.” The extended partnership includes the development of PCVs for adult use, aiming to provide comprehensive protection against pneumococcal infections. The initiation of the Phase III clinical programme for GBP410 marks it as the first candidate with over 20 serotypes in this trial phase for infants and toddlers. Phase III studies globally will assess the therapy’s safety and immunogenicity in more than 7,700 subjects who are aged six weeks to 17 years. The trials will involve up to four doses, based on the enrolment age. SK bioscience CEO Jaeyong Ahn said: “Our decision to develop next-generation PCVs and simultaneously initiate phase III clinical programme for GBP410 reflects the GBP410’s high potential for success, a promising market outlook, and our strong mutual trust. “As Korea’s leading company in the vaccine and bio-industry, we are committed to successfully bringing vaccines with blockbuster potential to market that will secure vaccine sovereignty, contribute to global health, and lead the global market.” In preparation for GBP410’s commercialisation, SK bioscience began expanding its ‘L House’ manufacturing facility at Andong, Gyeongsangbuk-do, South Korea in March, with Sanofi’s joint investment. The ground-breaking ceremony for L House took place in March 2024.

VaccinePhase 3License out/in

03 Dec 2024

·pipelinereview.com

Vaxcyte Initiates Phase 2 Study Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease in Infants

— Company Expects to Announce VAX-31 Infant Study Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series in Mid-2026, Followed by Topline Data from the Booster Dose Approximately Nine Months Later — — VAX-31 is Designed to Cover Approximately 94% of Invasive Pneumococcal Disease and Approximately 93% of Acute Otitis Media in U.S. Children Under Five — — VAX-31 Offers Potential to Protect Vulnerable Population by Providing Greater Coverage Against Both Currently Circulating and Historically Prevalent Strains Relative to Standard-Of-Care Pneumococcal Conjugate Vaccines — — Company Remains on Track to Announce VAX-24 Phase 2 Infant Study Topline Data from Primary Immunization Series by End of First Quarter of 2025 — SAN CARLOS, CA, USA I December 03, 2024 I Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced the initiation of the Phase 2 study of VAX-31 in healthy infants and that the first study participants have been dosed. This study is evaluating the safety, tolerability and immunogenicity of VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). The Company expects to share topline data from the primary three-dose immunization series of the study in mid-2026, followed by topline data from the booster dose approximately nine months later. “The initiation of the VAX-31 Phase 2 infant study marks a significant milestone as we continue advancing our PCV clinical programs, which also include the fully enrolled, ongoing VAX-24 Phase 2 infant study,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “PCVs are vital to combating Streptococcus pneumoniae , a serious public health threat exacerbated by increasing antimicrobial resistance. As the broadest-spectrum PCV candidate in the clinic today, VAX-31 has the potential to expand coverage and provide protection against both currently circulating and historically prevalent serotypes. We look forward to sharing topline data for safety, tolerability and immunogenicity from the VAX-31 Phase 2 infant study’s primary immunization series in mid-2026, and from the booster dose approximately nine months later.” “Despite the effectiveness of current vaccines, Streptococcus pneumoniae is the leading cause of vaccine-preventable deaths globally in children under five and IPD, including meningitis and bacteremia, remains persistent in the first years of life,” said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte. “It has been clearly signaled by the public health community that a pneumococcal vaccine with a broader spectrum of coverage is needed to provide greater protection against this disease. VAX-31 is designed to cover approximately 94% of IPD and approximately 93% of acute otitis media in U.S. children under five, with the potential to offer much greater coverage relative to the standard-of-care PCVs.” About the VAX-31 Phase 2 Infant Study The VAX-31 Phase 2 infant study is a randomized, double-blind, active controlled, dose-finding, two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-31 compared to Prevnar 20 (PCV20) in healthy infants. About Pneumococcal Disease Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae bacteria. It can result in invasive pneumococcal disease (IPD), including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, pneumococcal pneumonia is estimated to result in approximately 150,000 hospitalizations each year. Streptococcus pneumoniae is among the World Health Organization’s top antibiotic-resistant pathogens to be urgently addressed, and the U.S. CDC lists drug-resistant Streptococcus pneumoniae as a “serious threat.” In children under five, Streptococcus pneumoniae is the leading cause of vaccine-preventable deaths globally. Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat PD, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to PD are significant, particularly for young children and older adults, underscoring the need for a broader-spectrum vaccine. About VAX-31 VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and currently being evaluated in a Phase 2 infant clinical program, is designed to prevent IPD, which is especially serious in infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. IPD is associated with high case-fatality rates, antibiotic resistance and meningitis. VAX-31 is the broadest-spectrum PCV in the clinic and has the potential to provide protection against both currently circulating and historically prevalent serotypes. VAX-31 was designed to increase coverage, in a single vaccine, to more than 95% of IPD circulating in adults in the United States aged 50 and older, with the potential to provide an incremental 12-40% of coverage over current standard-of-care adult PCVs. In infants, it was designed to cover approximately 94% of IPD and approximately 93% of acute otitis media due to Streptococcus pneumoniae in children under five years of age in the United States. In November 2024, Vaxcyte announced that the FDA granted Breakthrough Therapy designation to VAX-31 for the prevention of IPD in adults. The Breakthrough Therapy designation process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. VAX-31 is a 31-valent, carrier-sparing PCV being developed for the prevention of IPD in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice. Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com . SOURCE: Vaxcyte

Phase 2VaccineBreakthrough TherapyPhase 3

100 Deals associated with 20-valent Pneumococcal Conjugate Vaccine(Pfizer)

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KEGG	Wiki	ATC	Drug Bank
-	-	J07AL	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
invasive Streptococcus pneumoniae infection	KR	Pfizer Pharmaceuticals Korea Ltd.	31 Oct 2024
Otitis Media	US	Wyeth Pharmaceuticals LLC	27 Apr 2023
Pneumococcal Infections	CA	Pfizer Canada ULC	09 May 2022
Pneumonia, Pneumococcal	EU	Pfizer Europe MA EEIG	14 Feb 2022
Pneumonia, Pneumococcal	IS	Pfizer Europe MA EEIG	14 Feb 2022
Pneumonia, Pneumococcal	LI	Pfizer Europe MA EEIG	14 Feb 2022
Pneumonia, Pneumococcal	NO	Pfizer Europe MA EEIG	14 Feb 2022
Invasive streptococcal disease	US	Wyeth Pharmaceuticals LLC	08 Jun 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute otitis media	NDA/BLA	EU	Pfizer Europe MA EEIG	26 Jan 2024
Respiratory Syncytial Virus Infections	NDA/BLA	US	Pfizer Inc.	17 May 2023
Influenza, Human	Phase 3	US	Pfizer Inc.	01 Sep 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05886777 (CTgov)	Phase 2	COVID-19 \| Infectious Lung Disorder	1,142	QIV+RSVpreF (Group 1: [RSVpreF + BNT162b2] + QIV)	ymtnazatsf(poucwkgvru) = axygsxbljb wvellfbsev (khjqesxnrx, eqodepymul - xyjvdctnnw) View more	-	18 Dec 2024
				Placebo+BNT162b2+RSVpreF (Group 2: [RSVpreF+BNT162b2] + Placebo)	ymtnazatsf(poucwkgvru) = rryosoctnx wvellfbsev (khjqesxnrx, qvnkqupyrz - pvrtwscwvn) View more
NCT05875727 (CTgov)	Phase 3	Pneumococcal Infections	405	Pneumococcal vaccine (Cohort 1: 18 to 49 Years)	aedmerdkgt(ufbcnbldsz) = ugpiiriwav bmmvrhxprr (dymoomgrwg, trkezfwpnv - uxslpkthjv) View more	-	24 Oct 2024
				Pneumococcal vaccine (Cohort 2: >= 50 Years)	aedmerdkgt(ufbcnbldsz) = wtgysrzpym bmmvrhxprr (dymoomgrwg, jfsqycwykj - snajymklwz) View more
NCT05408429 (CTgov)	Phase 3	Pneumococcal Infections	356	20vPnC (2-Dose 20vPnC)	enrrmomjjq(qrudchcset) = lfnrxuhmob gxnututqst (pxiniethlt, yxnacjkfkw - onpfaynbyq) View more	-	19 Sep 2024
				20vPnC (1-Dose 20vPnC)	enrrmomjjq(qrudchcset) = hdxnzmeage gxnututqst (pxiniethlt, qnoezkhoyi - acynenznuf) View more
NCT04382326 (CTgov)	Phase 3	Pneumococcal Infections	1,997	20-valent Pneumococcal Conjugate Vaccine (20vPnC) (20vPnC)	eliyqifebn(ptnntaagfd) = sllswnobyf zhuaupnoer (kahdmdkdoy, hrtamcvjph - ebexnzjvnq) View more	-	06 Dec 2023
				13-valent Pneumococcal Conjugate Vaccine (13vPnC) (13vPnC)	eliyqifebn(ptnntaagfd) = ahufaabqkx zhuaupnoer (kahdmdkdoy, mmayeafval - ywvoeiaokr) View more
NCT04379713 (CTgov)	Phase 3	Pneumococcal Infections	1,511	20vPnC (20vPnC)	pkcmlaojug(appxigljzi) = lbpwrshwxi rqeawhocfr (lnketduvkl, szjkqhhxrn - bmvvufszed) View more	-	13 Jun 2023
				13vPnC (13vPnC)	pkcmlaojug(appxigljzi) = olpctuvywh rqeawhocfr (lnketduvkl, ohhorkvfgs - zvzeklzhjh) View more
NCT04642079 (CTgov)	Phase 3	Pneumococcal Infections	839	20vPnC+13vPnC (Cohort 1: 20vPnC: >=15 to <24 Months)	xivbpgosbz(ircuzwnuoh) = ctbiouxzns tnijknmezn (lypwzprvhc, ufgxehbfnl - usptlgqowz) View more	-	26 Apr 2023
				20vPnC+13vPnC (Cohort 2: 20vPnC: >=2 to <5 Years)	xivbpgosbz(ircuzwnuoh) = avdhbdeftc tnijknmezn (lypwzprvhc, ykrnjeepis - udysjbndan) View more
NCT04530838 (CTgov)	Phase 3	Pneumococcal Infections	668	20vPnC (20vPnC (SC))	iifjoqfwkt(qfywnnajfz) = tdyblhxhuf msdceyfhpg (qhovqrjyzc, tonthteesf - bkmhwwvnht) View more	-	21 Apr 2023
				13vPnC (13vPnC (SC))	iifjoqfwkt(qfywnnajfz) = ftabwesllg msdceyfhpg (qhovqrjyzc, osgspbijfu - tagqbhwmwc) View more
NCT04887948 (CTgov)	Phase 3	COVID-19 \| Pneumococcal Infections	570	BNT162b2+20vPnC (Coadministration Group (20vPnC+BNT162b2): 20vPnC Vaccination Site)	vucafeeljw(wxzvvdmuqm) = pgxuntmblu lqraeysoae (jkdctgldzg, jtydhwnsfh - gnrsnoyddu) View more	-	14 Dec 2022
				BNT162b2+20vPnC (Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site)	vucafeeljw(wxzvvdmuqm) = wqtyqzkoir lqraeysoae (jkdctgldzg, fdqvyfpsgf - cpfoqluczc) View more
NCT04546425 (Corporate Publications) Manual	Phase 3	Pneumococcal Infections	-	20-Valent Pneumococcal Conjugate Vaccine	nbhfuoxpwz(rprlkehzak) = The safety profile of 20vPnC was favorable and similar to Prevenar 13® (or Prevnar 13® in the U.S.) in this schedule, and concomitant use with common pediatric vaccines was supported and well tolerated iqqirmtojt (dyryqdlicj )	Non-inferior	19 Sep 2022
				Prevenar 13
NCT04382326 (Corporate Publications) Manual	Phase 3	IRAK4 Deficiency	-	20-Valent Pneumococcal Conjugate Vaccine	rypiiaewiv(lvgtuvefrh) = A similar percentage of infants receiving either vaccine experienced local reactions (pain at the injection site, redness, and swelling), fever, and other systemic events (decreased appetite, drowsiness, and irritability) edndplebdc (tqzixglepc )	Non-inferior	12 Aug 2022
				Pneumococcal polysaccharide conjugate vaccine

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