Trial reportHuman vaccines & immunotherapeutics2014
Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults: a randomized open-label trial.
Trial report in Human vaccines & immunotherapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04056117 (Safety and Immunogenicity of a Shigella-Tetravalent Bioconjugate Vaccine), which is not on this map. Cited by 23 papers, 4 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.
Safety and Immunogenicity of a Shigella-Tetravalent Bioconjugate Vaccine: A Phase 1/2 Randomized Controlled and Age Descending Study Including Dose Finding in 9 Month Old Infants
Who cites it
23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Serotype distribution of invasive and non-invasive pneumococcal disease in adults ≥65 years of age following the introduction of 10- and 13-valent pneumococcal conjugate vaccines in infant national immunization programs: a systematic literature review.Frontiers in public health · 2025Pooled 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
- Pooled it
- Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Updated Recommendations of the Advisory Committee on Immunization Practices.MMWR. Morbidity and mortality weekly report · 2019Guideline
- Safety, Tolerability, and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Adults 60 to 64 Years of Age.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine compared to the 23-valent pneumococcal polysaccharide vaccine in elderly Japanese adults.Human vaccines & immunotherapeutics · 2015Trial
- An overview of the clinical development of the 20-valent pneumococcal conjugate vaccine in adults.Human vaccines & immunotherapeutics · 2026Review
- What is driving the resurgence and persistence of vaccine-targeted pneumococcal serotypes?-Serotype 19F as the paradigm.PLoS pathogens · 2026Review
- B cell-expressed CD1d promotes MPL/TDCM lipid emulsion adjuvant effects in polysaccharide vaccines.Journal of immunology (Baltimore, Md. : 1950) · 2025Article
- Potential impact of combined influenza and pneumococcal vaccines on the severity of respiratory illness in COVID-19 infection among type 2 diabetic patients.Clinical and experimental medicine · 2023Article
- Precision Vaccine Adjuvants for Older Adults: A Scoping Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Article
- Polysaccharide and conjugate vaccines toScience translational medicine · 2022Article
- COVID-19 Vaccines in Older Adults: Challenges in Vaccine Development and Policy Making.Clinics in geriatric medicine · 2022Review
- Development and Immunogenicity of a Prototype Multivalent Group BACS infectious diseases · 2021Article
- Sequential administration of Prevnar 13™ and PNEUMOVAX™ 23 in healthy participants 50 years of age and older.Human vaccines & immunotherapeutics · 2021Article
- Article
- Efficacy and Safety of the Pneumococcal Conjugate-13 Valent Vaccine in Adults.Aging and disease · 2019Review
- An Adjuvant That Increases Protective Antibody Responses to Polysaccharide Antigens and Enables Recall Responses.The Journal of infectious diseases · 2019Article
- Anti-infective vaccination strategies in patients with hematologic malignancies or solid tumors-Guideline of the Infectious Diseases Working Party (AGIHO) of the German Society for Hematology and Medical Oncology (DGHO).Annals of oncology : official journal of the European Society for Medical Oncology · 2018Review
- Economic evaluation of pneumococcal vaccines for adults aged over 50 years in Belgium.Human vaccines & immunotherapeutics · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This randomized open-label trial was designed to provide preliminary immunogenicity and safety data to support development of the pediatric 13-valent pneumococcal conjugate vaccine (PCV13) for adults. The aims were to: identify an age-appropriate PCV13 formulation, i.e., with (n = 309) or without (n = 304) aluminum phosphate (AlPO 4); compare the selected PCV13 formulation (n = 309) with 23-valent pneumococcal polysaccharide vaccine (PPSV23; n = 301); and, together with an extension study, assess sequential use of pneumococcal vaccines at 1-year intervals in adults aged ≥65 years (n = 105) not pre-vaccinated with PPSV23. Immune responses were measured by ELISA and opsonophagocytic activity assays 1 month postvaccination. Immunoglobulin G responses elicited by PCV13 with AlPO 4 and PCV13 without AlPO 4 were similar for the majority, and noninferior for all PCV13 serotypes. PCV13 with AlPO 4 was generally more reactogenic, with reactions mainly mild or moderate. Thus, PCV13 with AlPO 4 (hereafter PCV13) became the selected formulation. Immune responses to PCV13 were noninferior for all but one serotype and for most PCV13 serotypes superior to PPSV23. Vaccine sequence assessments showed that for PCV13/PPSV23, the initial PCV13 dose generally enhanced responses to a subsequent PPSV23 dose, compared with PPSV23 alone. For PCV13/PCV13, a second dose did not enhance the first dose response when given after 1 year. For PCV13/PPSV23/PCV13, priming with PCV13 (vaccination 1) did not protect against lower responses induced by PPSV23 to subsequent PCV13 (vaccination 3). In conclusion, the pediatric PCV13 formulation with AlPO 4 is well tolerated and immunogenic in adults, is generally more immunogenic than PPSV23, and subsequent vaccination with PPSV23 is possible if required.
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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.