Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024
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).
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05420961 (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), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Use of 21-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024.MMWR. Morbidity and mortality weekly report · 2024Guideline
- A phase 3, randomized study to evaluate the safety, tolerability, and immunogenicity of V116 in children and adolescents with increased risk of pneumococcal disease (STRIDE-13).Human vaccines & immunotherapeutics · 2026Trial
- Prevalence, Serotype Distribution, and Risk Factors Associated WithOpen forum infectious diseases · 2026Article
- Serotype distribution and coverage by pneumococcal vaccines in hospitalised adults with pneumococcal pneumonia in Germany.ERJ open research · 2026Article
- Pneumococcal vaccination and aspiration pneumonia in super-aged societies: A scoping review of the evidence landscape.Global health & medicine · 2026Review
- What is driving the resurgence and persistence of vaccine-targeted pneumococcal serotypes?-Serotype 19F as the paradigm.PLoS pathogens · 2026Review
- Advancing Vaccination Strategies for Older Adults: Insights of the Adult Immunization Board Meeting.Drugs & aging · 2026Review
- A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naïve Adults 18-64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE-8.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Article
- Long-term Immunogenicity and Boostability of the 13-valent Pneumococcal Conjugate Vaccine Followed by the 23-valent Pneumococcal Polysaccharide Vaccine in Adults Receiving Immunosuppressive Therapy and Adults With HIV-3-year Follow-up of a Prospective Cohort Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Erratum: Pneumococcal Vaccination of Adults in Italy: What Strategies?Journal of preventive medicine and hygiene · 2025Article
- Recent developments of vaccines for older adults: Adjuvants and beyond.Human vaccines & immunotherapeutics · 2025Review
- Rationale and design of the Pneumococcal Pneumonia Epidemiology, Urine Serotyping and Mental Outcomes (PNEUMO) study Europe.ERJ open research · 2025Article
- Cross reactivity within pneumococcal serogroups 6 and 15 following adult vaccination with pneumococcal conjugate vaccine V116.Communications medicine · 2025Article
- Recommendations on PCV20 vaccine in adults and at-risk populations.European respiratory review : an official journal of the European Respiratory Society · 2025Review
- Article
- Pneumococcal Vaccination of Adults in Italy: What Strategies?Journal of preventive medicine and hygiene · 2025Article
- Cost-effectiveness and budget impact analyses of the 24-valent pneumococcal conjugate vaccine in adults aged 50 and older.Vaccine · 2025Article
- All-Cause and Pneumococcal Community-Acquired Pneumonia Hospitalizations Among Adults in Tennessee and Georgia.JAMA network open · 2025Article
- Review
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
backgroundPneumococcal diseases cause considerable morbidity and mortality in adults. V116 is an investigational 21-valent pneumococcal conjugate vaccine (PCV) specifically designed to protect adults from pneumococcal serotypes responsible for the majority of residual pneumococcal diseases. This phase 3 study evaluated safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-experienced adults aged ≥50 years.
methodsA total of 717 adults were enrolled to receive a single dose of pneumococcal vaccine as follows: cohort 1 (n = 350) previously received 23-valent pneumococcal polysaccharide vaccine (PPSV23) and were randomized 2:1 to receive V116 or PCV15, respectively; cohort 2 (n = 261) previously received PCV13 and were randomized 2:1 to receive V116 or PPSV23, respectively; cohort 3 (n = 106) previously received PPSV23 + PCV13, PCV13 + PPSV23, PCV15 + PPSV23, or PCV15 and all received open-label V116. Immunogenicity was evaluated 30 days postvaccination using opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) for all V116 serotypes. Safety was evaluated as the proportion of participants with adverse events (AEs).
resultsV116 was immunogenic across all 3 cohorts as assessed by serotype-specific OPA GMTs and IgG GMCs postvaccination for all 21 serotypes. V116 elicited comparable immune responses to serotypes shared with PCV15 (cohort 1) or PPSV23 (cohort 2), and higher immune responses to serotypes unique to V116. The proportions of participants with solicited AEs were generally comparable across cohorts.
conclusionsV116 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. CLINICAL TRIALS REGISTRATION: NCT05420961; EudraCT 2021-006679-41.
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