Delving into the Latest Updates on Pneumococcal polysaccharide vaccine 23-valent(Merck Sharp & Dohme) with Synapse

Overview

Basic Info

Drug Type

Polysaccharide vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

Pneumococcal 23-valent Polysaccharide Vaccine, Pneumococcal Polysaccharide Vaccine, Pneumococcal Polyvalent Vaccine

+ [9]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Pneumococcal Infections

Inactive Indication

Severe Acute Respiratory Syndrome

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

Merck Sharp & Dohme Corp.

Merck & Co., Inc.Merck Canada, Inc.

Inactive Organization

Merck Sharp & Dohme LLC

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (21 Nov 1977),

Pneumococcal Infections

Regulation-

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This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD).
The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis [Tdap]) and Pneumovax 23 (PPSV) vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus placebo. The study will evaluate the percentage of participants achieving a positive anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response at Week 16 (key secondary endpoint).
Study details include:
The study duration will be up to 36 weeks (for participants not entering the LTS17367 [RIVER-AD]).
The screening period will be 9 days to 4 weeks. The treatment duration will be up to 16 weeks. The post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7 (or 6 for those entering LTS17367 [RIVER-AD]).

Start Date06 Oct 2023

Sponsor / Collaborator

Sanofi

NCT05827874

/ CompletedPhase 1

A Randomized, Open-Label Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

The purpose of this study is to assess the effect of nipocalimab treatment on the antibody (a protein made in the body to response to a foreign substance) response following tetanus, diphtheria, pertussis (Tdap) vaccination in healthy participants at Week 4.

Start Date12 Apr 2023

Sponsor / Collaborator

Janssen Research & Development LLC

NCT05170399

/ RecruitingPhase 4IIT

Vaccine Responses in Patients With B Cell Malignancies

Background:
People with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers.
Objective:
To learn how well vaccines work in people who have certain types of blood cancers.
Eligibility:
Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.
Design:
Participants will get one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine.
Participants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose.
Participants will have pregnancy tests, if needed.
Participants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks.
Participants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional.
Participation will last for up to 5 years after each vaccine series is received.

Start Date14 Sep 2022

Sponsor / Collaborator

National Heart, Lung & Blood Institute

100 Clinical Results associated with Pneumococcal polysaccharide vaccine 23-valent(Merck Sharp & Dohme)

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100 Translational Medicine associated with Pneumococcal polysaccharide vaccine 23-valent(Merck Sharp & Dohme)

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100 Patents (Medical) associated with Pneumococcal polysaccharide vaccine 23-valent(Merck Sharp & Dohme)

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840

Literatures (Medical) associated with Pneumococcal polysaccharide vaccine 23-valent(Merck Sharp & Dohme)

31 Dec 2025·Human Vaccines & Immunotherapeutics

Effectiveness of pneumococcal vaccination in reducing hospitalization and mortality among the elderly: A systematic review and meta-analysis

Review

Author: Khan, Anas A. ; Alim, Hussam M. ; Turkistani, Yosra A. ; Alamri, Fahad A. ; Zaini, Rania ; Khadawardi, Hadeel A. ; Alkhotani, Amar Mohammad A. ; Alhazmi, Aous Sami Hayat ; Dairi, Mohammad S. ; Alqashqri, Hamsah Saleh ; Bulkhi, Adeeb ; Hariri, Nahla H. ; Saleh, Saleh A. K. ; Garout, Mohammed A. ; Alwafi, Hassan ; Almoallim, Hani M. ; Abdulkhaliq, Altaf A. ; Alghamdi, Ismail Ahmad ; Adly, Heba M. ; Obaid, Majed Sameer

This meta-analysis assesses pneumococcal vaccine effectiveness in reducing hospitalization and mortality among the elderly. The studies retrieved from PubMed, Scopus, Embase, and Cochrane through March 2025. Of 3,002 identified studies, 35 met inclusion criteria (30 cohort, 3 RCTs, 2 case-control), encompassing 1.65 million vaccinated and 2.62 million unvaccinated individuals. Pneumonia-related hospitalization significantly declined in subgroups receiving mixed pneumococcal polysaccharide vaccine (PPV) and conjugate vaccine (PCV-13), notably among individuals aged >75 and those with chronic conditions. All-cause hospitalization dropped (OR: 0.94; 95% CI: 0.91-0.97), especially in PPV-23 recipients, Asian populations, and those with comorbidities. Pneumonia mortality decreased across age groups >60, and all-cause mortality declined among those aged 60-75. No significant impact was observed on emergency visit rates. Although findings favor vaccine effectiveness, high heterogeneity warrants further comparative trials to confirm outcomes.

31 Dec 2025·Human Vaccines & Immunotherapeutics

The microbiological characteristics and diagnosis of Streptococcus pneumoniae infection in the conjugate vaccine era

Review

Author: Chen, Chih-Jung ; Tsai, Ming-Han ; Chen, Chih-Ho ; Chen, Chyi-Liang ; Su, Lin-Hui ; Chiu, Cheng-Hsun

Two pneumococcal conjugate vaccines, PCV15 and PCV20, were licensed in June 2021. PCV15 includes two additional serotypes (22F, 33F) beyond those in PCV13, while PCV20 adds seven more (8, 10A, 11A, 12F, 15B, 22F, 33F), covering approximately 30% of invasive pneumococcal disease (IPD) cases in adults. In June 2023, the US CDC's Advisory Committee on Immunization Practices (ACIP) recommended either PCV15 or PCV20 for all children aged < 5 years and children aged 2‒18 years with risk conditions. In June 2024, the FDA approved PCV21 for adults ≥ 18 years. In October 2024, ACIP recommended either PCV20 or PCV21 alone or PCV15 with PPSV23 for adults ≥ 50 years or 19-49 years with risk conditions. These advancements highlight the evolving landscape of pneumococcal vaccination. This review examines the molecular epidemiology of pneumococcal infections, advancements in diagnostic methods, and the anticipated public health impact of these vaccines in reducing pneumococcal disease burden.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

The incremental net monetary benefit of higher-valent pneumococcal conjugate vaccines for adults: a systematic review and meta-analysis of economic evaluations

Review

Author: Cho, Jeong-Yeon ; Chaiyakunapruk, Nathorn ; Lee, Haeseon ; Vietri, Jeffrey ; Dawson, Euan

AIMS:

This study aimed to evaluate the cost-effectiveness of newly developed higher-valent pneumococcal conjugate vaccines (PCVs) - including PCV15, PCV20, and PCV21 - for adult populations through a systematic review and meta-analysis of economic evaluations (MAEE), providing pooled incremental net benefits (INBs) as a quantitative summary across studies.

METHODS:

Economic evaluation studies of PCV15, PCV20, or PCV21 were identified through database searches (PubMed, EMBASE, EconLit, Tufts CEA registry, HTA database, and NITAG resource center) through November 2024. INBs were calculated and pooled using a random-effects model, with positive INB indicating cost-effectiveness. Outcomes were stratified by population age (≥ 18, ≥ 50 and ≥ 60 years), perspective (healthcare and societal), and country income level. Sensitivity analyses assessed the impact of funding sources, imputed variance, and incomplete sensitivity analysis.

RESULTS:

Twenty-seven studies were included, with 14 comparisons eligible for meta-analysis. PCV20 was the most frequently studied vaccine. From a healthcare perspective, PCV20 was significantly cost-effective compared to PCV15 followed by PPSV23 (PCV15 + PPSV23) in ≥ 18 population (INB = 19.3; 95% CI = 14.2-24.4) and ≥ 60 population (44.3; 21.1-67.4). A similar trend was observed when compared against PPSV23 alone (269.3; 96.4-442.1 and 161.2; 3.5-318.9). Among ≥ 18 population, PCV20 showed favorable INBs compared to PCV13 + PPSV23 (241.7; -5.6-488.9; healthcare perspective, and 171.4; -44.2-386.9; societal perspective), and no vaccine (65.6; -35.7-167.0; healthcare perspective). Among ≥ 60 population, PCV20 was significantly cost-effective compared to PCV15 alone (37.5; 28.0-47.0), but not compared to no vaccine (-13.3; -122.0-95.5). PCV15 and PCV21 had few meta-analyzable comparisons.

CONCLUSIONS:

Higher-valent PCVs appear cost-effective in most adult populations and settings, especially in high-income countries and from the healthcare perspective. This meta-analysis provides a rigorous quantitative synthesis to support vaccine policy decisions.

47

News (Medical) associated with Pneumococcal polysaccharide vaccine 23-valent(Merck Sharp & Dohme)

11 Sep 2025

·www.fiercepharma.com

Despite being designed for seniors, Merck's pneumococcal shot shows potential in children

Merck's Capvaxive was designed to protect seniors from pneumococcal disease, but it has also shown a potential to provide protection for children. Approved 15 months ago as a pneumococcal disease vaccine for adults—and billed as the first shot designed for seniors—Merck’s Capvaxive now has data supporting its potential in children and adolescents.In a phase 3 study of 882 participants aged 2 through 17 who have completed a primary pediatric pneumococcal vaccination regimen and have one or more chronic medical conditions that put them at an increased risk of the respiratory disorder, Capvaxive made the grade in three key measures.First, in the primary immunogenicity endpoint, in 12 shared serotypes with Merck’s Pneumovax, Capvaxive’s immune response 30 days after vaccination measured up to the 23-valent polysaccharide pneumococcal shot that has been on the market since 1983. In its nine unique serotypes, Capvaxive showed a superior immune response to Pneumovax.In a secondary immunogenicity endpoint, Capvaxive generated immune responses to all 21 strains it covers. This was determined by measuring serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at 30 days after vaccination.Thirdly, in the primary safety endpoint, the proportion of participants with adverse events, including events that were systemic and were serious and vaccine-related, were generally comparable between the two groups.“Children and adolescents living with chronic medical conditions are at increased risk of pneumococcal disease and offering them additional protection is essential,” Rotem Lapidot, M.D., the chief of pediatric infectious diseases at Rambam Health Care Campus in Israel, and an investigator in the Stride-13 trial, said in a release. Lapidot added that children and adolescents may benefit from the additional coverage provided by Capvaxive, which defends against serotypes not included in other pneumococcal disease shots for infants. Results were presented Thursday at the 6th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Conference on Vaccines in Lisbon, Portugal.Merck said it will share the data with global regulatory authorities.“While Capvaxive was designed to specifically cover the serotypes that cause the majority of invasive pneumococcal disease cases in adults, findings from Stride-13 underscore its added potential to help protect children and adolescents who are at an increased risk,” Paula Annunziato, who heads up Merck’s infectious diseases and vaccines development, added in a statement. The value of Capvaxive for patients 50 and older is that its 21 serotypes account for 84% of the pneumococcal disease of people in the age group, compared to a 52% figure in the same population for the 20 serotypes covered by the world’s dominant pneumococcal shot, Pfizer’s Prevnar 20, which is allowed in children and adults.Sales of Capvaxive have scaled up from $50 million in the fourth quarter of 2024 to $107 million in the first quarter of this year, followed by a $129 million showing in the second quarter.

Clinical ResultPhase 3VaccineDrug ApprovalImmunotherapy

11 Sep 2025

·pharma.economictimes.indiatimes.com

Merck's pneumococcal shot shows promise in at-risk children and teens

Bengaluru: Merck's pneumococcal vaccine triggered immune responses in children and teens who are at higher risk of serious illness in a late-stage study, the drugmaker said on Thursday. The company was testing the shot, Capvaxive , against its older vaccine Pneumovax 23 , in children aged two years and above and teens aged below 18 years, who have completed a primary pediatric pneumococcal vaccination regimen, and have one or more chronic medical conditions that put them at increased risk. Capvaxive is already approved for adults in the U.S., European Union and Japan among other places. The shot generated immune responses against 21 strains of the bacteria responsible for pneumococcal infections, which can cause severe illnesses including pneumonia, meningitis and sepsis. In the study that had 882 participants, Capvaxive was shown to be noninferior to Pneumovax 23 against the 12 bacterial strains common to both vaccines and superior against the nine unique to Capvaxive, at 30 days after vaccination, Merck said. Proportion of patients with treatment-related side effects were comparable for the two vaccines, the drugmaker said. Merck also offers two other pneumococcal vaccines: Vaxneuvance for individuals aged six weeks and older and Pneumovax 23 for adults over 50 and children above two. Pfizer's shot Prevnar 20, which protects against 20 strains of the bacteria, is approved for individuals above six weeks of age. Pneumococcal disease spreads through direct contact with respiratory secretions such as saliva or mucus. Children younger than five and adults older than 65 are at an increased risk of contracting the disease. (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Sahal Muhammed)

Drug ApprovalClinical ResultVaccine

11 Sep 2025

·firstwordpharma.com

Merck & Co. says pneumococcal shot meant for adults could protect kids as well

Merck & Co. presented data on its 21-valent pneumococcal conjugate vaccine Capvaxive at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) conference on Thursday suggesting that the shot — designed to prevent invasive pneumococcal disease and pneumonia in adults — could also be beneficial for at-risk children.The new data follows shortly after the vaccine's approval in the EU for people 18 and older. Capvaxive was similarly approved last year in the US, where it is currently recommended for adults over 50."While Capvaxive was designed to specifically cover the serotypes that cause the majority of invasive pneumococcal disease cases in adults, findings from STRIDE-13 underscore its added potential to help protect children and adolescents who are at an increased risk," said Paula Annunziato, SVP of infectious diseases and vaccines at Merck.The Phase III STRIDE-13 trial evaluated the safety and immunogenicity of Capvaxive against Merck's older 23-valent polysaccharide vaccine, PPSV23, in 882 children and adolescents at least 2 years old, but younger than 18, who have completed a primary paediatric pneumococcal vaccination regimen and have a chronic medical condition, such as diabetes, liver disease, lung disease, heart disease or kidney disease.At the 30-day post-vaccination mark, Capvaxive demonstrated noninferior immunogenicity — the primary endpoint — versus PPSV23 for each of the 12 serotypes shared between the vaccines. The 21-valent vaccine was superior for each of the nine serotypes unique to it.On the secondary immunogenicity endpoint, Capvaxive elicited immune responses to all 21 serotypes as measured by serotype-specific opsonophagocytic activity geometric mean titers at 30 days post-vaccination.According to Merck, the rate of systemic and serious vaccine-related adverse events was "generally comparable" between the Capvaxive and PPSV23, meeting the main safety endpoint."Results from STRIDE-13 demonstrate the potential of Capvaxive to deliver protection for these vulnerable populations, who may benefit from additional pneumococcal disease coverage by including serotypes not contained in other approved pneumococcal infant regimens," said Rotem Lapidot, an investigator on the STRIDE-13 trial. Merck said the STRIDE-13 results — the final readout from its Phase III STRIDE programme — will be shared with global regulatory authorities.

Phase 3Clinical ResultVaccineDrug Approval

100 Deals associated with Pneumococcal polysaccharide vaccine 23-valent(Merck Sharp & Dohme)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pneumococcal Infections	United States	Merck & Co., Inc.	21 Nov 1977

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Severe Acute Respiratory Syndrome	Phase 3	United States	Merck Sharp & Dohme Corp.	12 Jan 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05158140 (V110-911, CTgov)	Phase 3	Pneumococcal Infections \| Severe Acute Respiratory Syndrome	850	Placebo for V110+mRNA-1273+V110 (V110 Concomitant With mRNA-1273 (V110 Concomitant))	zcogjeuzvz = taovujuzyg bqcogviaoo (galzdeidwb, pvnwjqfzbj - lccvoxywsg) View more	-	13 Feb 2024
				Placebo for V110+mRNA-1273+V110 (V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant))	zcogjeuzvz = fzvrkdqdoj bqcogviaoo (galzdeidwb, bgdmktkipg - edqaygkwot) View more
NCT02707692 (CTgov)	Not Applicable	Acquired Immunodeficiency Syndrome	54	placebo+Pneumovax-23 (Pneumococcal Vaccine)	nhhipyshrs(faighkcuhk) = cndetmtjxr eewvmkjkwr (oovvngtmub, 2998.0)	-	24 Aug 2022
				Fluarix+placebo (Influenza Vaccine)	nhhipyshrs(faighkcuhk) = sbasmanaxo eewvmkjkwr (oovvngtmub, 243.2) View more
NCT03104075 (CTgov)	Phase 4	Pneumonia	40	Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein (Prevnar 13)	pdwopkufut(grkbhrwbik) = duzwsgakvk vwbvqajaqi (udoyxeckax, 19.4) View more	-	07 Dec 2021
				Pneumococcal Vaccine Polyvalent (Pneumovax 23)	pdwopkufut(grkbhrwbik) = wxgpwaroxs vwbvqajaqi (udoyxeckax, 18.6) View more
NCT03260790 (CTgov)	Phase 4	Asthma	17	PCV13+PPSV23 (PCV13 and PPSV23)	mnczpglmgh(wlycsyfrfm) = rvpznebirz zbavxpjumt (liptcxannb, nkgbfkllbb - gemydyxggj) View more	-	05 Nov 2021
				PPSV23 (PPSV23)	mnczpglmgh(wlycsyfrfm) = vdjdnoxzao zbavxpjumt (liptcxannb, bpubtzwwvr - xdiqsiwqta) View more
NCT03802994 (CTgov)	Early Phase 1	-	57	Peripheral blood sample (1.Aging RT)	fcpibmncsy(qkvyoxdzwu) = vozpfacrjd sgbnjzbxig (stdxtfqzse, 10.52) View more	-	30 Apr 2021
				Peripheral blood sample (2.Young RT)	fcpibmncsy(qkvyoxdzwu) = hscxbeqpph sgbnjzbxig (stdxtfqzse, 8.52) View more
NCT02225587 (V110-029, CTgov)	Phase 3	Pneumococcal Infections	400	Placebo+Pneumovax™ 23+Prevnar 13™ (Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo)	kpeylbnzuw = scyebxayke mcszmtqsoc (egmatqhjrf, xzpqsjfbnp - tniljmlaic) View more	-	05 Feb 2020
				Placebo+Pneumovax™ 23+Prevnar 13™ (Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23)	kpeylbnzuw = gcmllvkorw mcszmtqsoc (egmatqhjrf, jeueiwdcez - coiuaegivc) View more
NCT01307449 (CTgov)	Not Applicable	Pneumococcal Infections	88	PNEUMOVAX (Older Group (60-89) on PNEUMOVAX)	flobofoetx = pmuhpztpmb bapcbaeend (ehsbcvwhzx, fvrtqpfuxf - uevsbkxtrq) View more	-	02 Oct 2018
				PREVNAR (Older Group (60-89) on PREVNAR)	flobofoetx = xahwjrsgha bapcbaeend (ehsbcvwhzx, ohfargdkfb - rpapwkbehu) View more
NCT02260882 (V110-902, CTgov)	Phase 4	Pneumococcal Infections	243	PNEUMOVAX™ 23 (Revaccination Group)	hvserqghbp(cygkrnmeaa) = ckxdazpoow jhngcborcc (zmitdlmwnc, bcahnnnnps - ikhyencvpb) View more	-	17 Feb 2016
				PNEUMOVAX™ 23 (Primary Vaccination Group)	ucidbzsggn(wbqowpvywt) = mjgkpjuqix jkbbimoppl (didmyuvlsx, lqeyhddgzw - pblbxzchmr) View more
NCT00714064 (PneuMum, Pubmed \| Vaccine)	Phase 3	Ear Diseases	313	23-valent pneumococcal polysaccharide vaccination (23vPPV at 30-36 weeks gestation)	etxyhqdefo(lrqcjclnpi) = xhhflitluk ulgqoxrtiv (aufywsktic, -12% - 31%) View more	-	27 Nov 2015
				23-valent pneumococcal polysaccharide vaccination (23vPPV at birth)	fidjbkouva(hdzrowtwtr) = kyhpaeygpp rlknuizxcw (qwlxdluwiq )
NCT00457977 (PNEUMO, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	181	Pneumovax (Pneumovax (PPSV23))	wngnrdqipn(skzvtmtflb) = hzurxmshvs ytbbxklxke (ugjsuwndab, rjbxkhhisy - xlwdgrgccv) View more	-	12 May 2015
				PCV7 (Prevnar (PCV7))	wngnrdqipn(skzvtmtflb) = sumedziwaf ytbbxklxke (ugjsuwndab, udkfdxuxxm - ecqrfwwied) View more