Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022
Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03760146 (A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 YEARS OF AGE AND OLDER), which is not on this map. Cited by 80 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 18 years of age and older
Who cites it
80 citing papers in PubMed, 2 syntheses or guidelines pooled it, 158 citations in OpenAlex.
- The relative immunogenicity of 20-valent and 15-valent pneumococcal conjugate vaccines: A systematic review and network meta-analysis.Human vaccines & immunotherapeutics · 2026Pooled it
- Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2023Guideline
- The mutual effects on safety and immunogenicity of combined vaccination with 15-valent pneumococcal conjugate vaccine and adsorbed acellular DPT in 3-month healthy infants: A randomized, open-label, controlled, phase III clinical trial.Human vaccines & immunotherapeutics · 2026Trial
- Immunogenicity and safety of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults ≥18 years of age in India: A phase 3 single-arm trial.Human vaccines & immunotherapeutics · 2026Trial
- Immunogenicity and Safety of Co-administration of Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine With 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years: A Randomized, Non-inferiority Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- 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).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study.Human vaccines & immunotherapeutics · 2023Trial
- Immunogenicity of a 20-valent pneumococcal conjugate vaccine in adults 18 to 64 years old with medical conditions and other factors that increase risk of pneumococcal disease.Human vaccines & immunotherapeutics · 2022Trial
- Vaccination in systemic lupus erythematosus.Human vaccines & immunotherapeutics · 2026Review
- Immunofitness in the elderly: The role of vaccination in promoting healthy aging.Human vaccines & immunotherapeutics · 2026Review
- An overview of the clinical development of the 20-valent pneumococcal conjugate vaccine in adults.Human vaccines & immunotherapeutics · 2026Review
- Pulmonary mRNA-LNP vaccines for rapid and durable protection against bacterial infection.Nature communications · 2026Article
- Cost effectiveness and public health impact of PCV20 among adults in France.BMC public health · 2026Article
- Lack of harmonisation in immunological data: challenges in synthesising data during the COVID-19 pandemic.EBioMedicine · 2026Review
- Anticipating impact of implementing PCV20 or PCV21 vaccines for older adults in the immunisation programme for invasive pneumococcal disease, using nationwide surveillance data, Israel, 2009 to 2024.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2026Article
- Advancing Vaccination Strategies for Older Adults: Insights of the Adult Immunization Board Meeting.Drugs & aging · 2026Review
- Development and Validation of a Functional Antibody Assay for Evaluating Protein-Based Pneumococcal Vaccines.Vaccines · 2026Article
- Article
- Association of frailty and malnutrition with pneumonia severity in PCV-13 vaccinated older adults: a single-centre experience.BMC geriatrics · 2025Article
- Global distribution and characteristics of pneumococcal serotypes in adults.Human vaccines & immunotherapeutics · 2025Review
20 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
15 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPneumococcal conjugate vaccines (PCVs) have significantly reduced pneumococcal disease, but disease from non-PCV serotypes remains. The safety, tolerability, and immunogenicity of a 20-valent PCV (PCV20) were evaluated.
methodsThis pivotal phase 3, randomized, double-blind study enrolled adults into 3 age groups (≥60, 50-59, and 18-49 years) at US and Swedish sites. Participants were randomized to receive 1 PCV20 or 13-valent PCV (PCV13) dose. After 1 month, participants aged ≥60 years also received 1 dose of saline or 23-valent polysaccharide vaccine (PPSV23). Safety assessments included local reactions, systemic events, adverse events, serious adverse events, and newly diagnosed chronic medical conditions. Opsonophagocytic activity geometric mean titers 1 month after PCV20 were compared with 13 matched serotypes after PCV13 and 7 additional serotypes after PPSV23 in participants aged ≥60 years; noninferiority was declared if the lower bound of the 2-sided 95% confidence interval for the opsonophagocytic activity geometric mean titer ratio (ratio of PCV20/saline to PCV13/PPSV23 group) was >0.5. PCV20-elicited immune responses in younger participants were also bridged to those in 60-64-year-olds.
resultsThe severity and frequency of prompted local reactions and systemic events were similar after PCV20 or PCV13; no safety concerns were identified. Primary immunogenicity objectives were met, with immune responses after PCV20 noninferior to 13 matched serotypes after PCV13 and to 6 additional PPSV23 serotypes in participants aged ≥60 years; serotype 8 missed the statistical noninferiority criterion. PCV20 induced robust responses to all 20 vaccine serotypes across age groups.
conclusionsPCV20 was safe and well tolerated, with immunogenicity comparable to that of PCV13 or PPSV23. PCV20 is anticipated to expand protection against pneumococcal disease in adults. CLINICAL TRIALS REGISTRATION: NCT03760146.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.