Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD), Ligand - LARVOL DELTA

A dynamic transmission model for assessing the impact of pneumococcal vaccination in the United States. (PubMed, PLoS One) - "The calibrated model was then used to project the epidemiological impact of PCV15, a 15-valent pneumococcal vaccine, compared with the status quo vaccination with PCV13 and demonstrated the value of added serotypes in PCV15. Projections revealed that PCV15 would reduce IPD incidence by 6.04% (range: 6.01% to 6.06%) over 10 years when compared to PCV13."

Journal • Infectious Disease • Pediatrics • Pneumococcal Infections • Pneumonia

PCV13-Serotype Breakthrough Pneumococcal Disease in Infants Receiving High-Valency Conjugate Vaccines: Population-Level Modeling in France. (PubMed, Infect Dis Ther) - "Implementation of PCV15 in a 2 + 1 regimen could reduce bIPD incidence due to all PCV13 serotypes in infants, whereas PCV20 in a 2 + 1 regimen may lead to substantial increases in bIPD cases from PCV13 serotypes in infants. PCV20 in a 3 + 1 regimen could potentially lead to a resurgence of bIPD from PCV7 serotypes in infants."

Journal • Infectious Disease • Pneumococcal Infections

RATIONALE-15: Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15 (clinicaltrials.gov) - P4 | N=106 | Recruiting | Sponsor: University of Oxford | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections • Pneumonia

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age (clinicaltrials.gov) - P3 | N=900 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Infectious Disease • Measles • Mumps • Rubella • Varicella Zoster

Safety, Tolerability, and Immunogenicity of the Pneumococcal Vaccines PPSV23 or PCV15 Co-Administered with a Booster Dose of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adults ≥50 Years of Age. (PubMed, Vaccines (Basel)) - P3 | "Co-administration of mRNA-1273 with PPSV23 or PCV15 in healthy adults ≥50 years of age was immunogenic and well tolerated."

Journal • Infectious Disease • Novel Coronavirus Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age (clinicaltrials.gov) - P3 | N=1840 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Varicella Zoster

A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Infectious Disease • Varicella Zoster

A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age (clinicaltrials.gov) - P3 | N=750 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Varicella Zoster

Corrigendum to "A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1)" [Vaccine 41 (2023) 3387-3398]. (PubMed, Vaccine) - No abstract available

Clinical • P3 data

Expanded Recommendations for Use of Pneumococcal Conjugate Vaccines Among Adults Aged ≥50 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024. (PubMed, MMWR Morb Mortal Wkly Rep) - "Options included either 20-valent PCV (PCV20; Prevnar20; Wyeth Pharmaceuticals) or 21-valent PCV (PCV21; CAPVAXIVE; Merck Sharp & Dohme) alone or 15-valent PCV (PCV15; VAXNEUVANCE; Merck Sharp & Dohme) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23; Merck Sharp & Dohme)...Recommendations for PCVs among adults aged 19-49 years with risk conditions and PCV13-vaccinated adults have not changed from previous recommendations. This report summarizes evidence considered for these recommendations and provides updated clinical guidance for use of PCV."

Journal • Infectious Disease • Pneumococcal Infections

MISP 60528 Pneumococcal Vaccination (clinicaltrials.gov) - P=N/A | N=45 | Recruiting | Sponsor: Montefiore Medical Center | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Jul 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections • Transplantation

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age (clinicaltrials.gov) - P3 | N=1840 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Infectious Disease • Varicella Zoster

RATIONALE-15: Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15 (clinicaltrials.gov) - P4 | N=106 | Not yet recruiting | Sponsor: University of Oxford

New P4 trial • Pneumococcal vaccines • Infectious Disease • Pneumococcal Infections • Pneumonia

A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age (clinicaltrials.gov) - P3 | N=750 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Infectious Disease • Varicella Zoster

A phase III randomized study to evaluate the safety, tolerability and immunogenicity of V116, an adult-specific pneumococcal conjugate vaccine (PCV), followed by PCV15, in adults living with HIV (STRIDE-7) (HIV-Glasgow 2024) - P3 | "In adults living with HIV, V116 was well tolerated and induced comparable immune responses to PCV15 + PPSV23 for common serotypes and higher responses for V116-unique serotypes."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease • Pediatrics • Pneumococcal Infections • CD4

Cost-Effectiveness Analysis of the Use of V116, a 21-Valent Pneumococcal Conjugate Vaccine, in Vaccine-Naïve Adults Aged ≥ 65 Years in the United States. (PubMed, Infect Dis Ther) - "These results demonstrated that using V116 in adults aged ≥ 65 years in the US can prevent a substantial number of PD cases and deaths while remaining highly favorable economically over a wide range of inputs and scenarios."

Cost effectiveness • HEOR • Journal • CNS Disorders • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Public Health Impact and Cost-Effectiveness of Replacing PCV13 With PCV15 in the National Immunization Program in Saudi Arabia (ISPOR-EU 2024) - "Including PCV15 in Saudi Arabian NIP can prevent a significant number of pneumococcal cases and deaths. PCV15 further offers value as a highly cost-effective immunization strategy compared to PCV13 both from payer and societal perspectives."

Cost effectiveness • HEOR • CNS Disorders • Infectious Disease • Otorhinolaryngology • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Cost-Effectiveness of PCV15 in the Pediatric Population for Preventing Pneumococcal Disease in France (ISPOR-EU 2024) - "Vaccinating the pediatric population with PCV15 is a cost-effective strategy compared to PCV13 due to its lower costs and better outcomes. The methodology and results of this economic evaluation have been validated by the French National Health Technology Agency (HAS)."

Clinical • Cost effectiveness • HEOR • CNS Disorders • Infectious Disease • Otorhinolaryngology • Pediatrics • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Descriptive analysis of safety and immunogenicity profiles of a 15-valent pneumococcal conjugate vaccine between subcutaneous and intramuscular administration in a phase 1 study of healthy Japanese infants (V114-028). (PubMed, J Infect Chemother) - "These results suggest the utility of IM administration as an option for V114 vaccination in Japanese infants."

Journal • P1 data • Dermatology • Immunology • Infectious Disease • Pain • Pediatrics • Pneumococcal Infections • Urticaria

Capvaxive - A 21-valent pneumococcal conjugate vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia

Cost-Effectiveness Analysis of Routine Childhood Immunization with 20-Valent versus 15-Valent Pneumococcal Conjugate Vaccines in Germany. (PubMed, Vaccines (Basel)) - "Most of the scenario and sensitivity analyses estimated that the ICER for PCV20 exceeded EUR 150,000/QALY. Routine childhood immunization with PCV20 instead of V114 may not be an economically efficient use of healthcare resources in Germany."

Cost effectiveness • HEOR • Journal • CNS Disorders • Infectious Disease • Pneumococcal Infections

Use of 21-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024. (PubMed, MMWR Morb Mortal Wkly Rep) - "Previously, options included either 20-valent PCV (PCV20; Prevnar20; Wyeth Pharmaceuticals, Inc.) alone or a 15-valent PCV (PCV15; VAXNEUVANCE; Merck Sharp & Dohme, LLC) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23; Merck Sharp & Dohme, LLC)...Indications for PCV have not changed from previous recommendations. This report summarizes evidence considered for these recommendations and provides clinical guidance for use of PCV21."

Clinical guideline • Journal • Infectious Disease • Pneumococcal Infections

A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (Stride-6). (PubMed, Clin Infect Dis) - "V116 is well tolerated with a safety profile comparable to currently licensed pneumococcal vaccines and generates IgG and functional immune responses to all V116 serotypes, regardless of prior pneumococcal vaccine received."

Journal • P3 data • Pneumococcal vaccines • Infectious Disease • Pneumococcal Infections

Prevalence, Clinical Severity, and Serotype Distribution of Pneumococcal Pneumonia Among Adults Hospitalized With Community-Acquired Pneumonia in Tennessee and Georgia, 2018-2022. (PubMed, Clin Infect Dis) - "Approximately 12% of adults hospitalized with CAP had S. pneumoniae detected, and approximately one-third of the detected pneumococcal serotypes were not contained in PCV15 or PCV20. Development of new pneumococcal vaccines with expanded serotype coverage has the potential to prevent a substantial burden of disease."

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF PCV15 IN HEALTHY INFANTS: A POOLED REGIONAL ANALYSIS OF FIVE PHASE 3 STUDIES (ESPID 2024) - "Small variations in serotype-specific immunogenicity and in the proportions of participants experiencing AEs were observed across regions. Consistent with the overall V114 phase 3 clinical program, these data support the use of V114 globally."

Clinical • P3 data • Infectious Disease • Otorhinolaryngology • Pneumococcal Infections • Pneumonia • Respiratory Diseases