Evidence map›Paper›PMID 32716500›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

Safety, Tolerability, and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Adults 60 to 64 Years of Age.

Donald Hurley, Carl Griffin, Mariano Young, Daniel A Scott, Michael W Pride, Ingrid L Scully, John Ginis, Joseph Severs, Kathrin U Jansen, William C Gruber and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03313037 (A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 60 THROUGH 64 YEARS OF AGE), which is not on this map. Cited by 77 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 3 pooled it
15.9field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT03313037 phase2completednot on this map

A phase 2, randomized, double-blind trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in adults 60 through 64 years of age

TypeinterventionalSponsorPfizerRan2017 to 2018Enrolled444ConditionsPneumococcal InfectionsArmsMultivalent, Prevnar 13, PPSV23, Saline
3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 3 syntheses or guidelines pooled it, 157 citations in OpenAlex.

  1. Pooled it
  2. 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 · 2023
    Guideline
  3. Pooled it
  4. Trial
  5. Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
  6. Trial
  7. Trial
  8. Review
  9. Review
  10. Review
  11. Recommendations on PCV20 vaccine in adults and at-risk populations.European respiratory review : an official journal of the European Respiratory Society · 2025
    Review
  12. Article
  13. Article
  14. Article
  15. Comparison of 13-, 15- and 20-valent pneumococcal conjugate vaccines in the paediatric Canadian population: A cost-utility analysis.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2025
    Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review

17 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Donald HurleyMedical Research South, LLC, Charleston, South Carolina, USA.
Carl GriffinLynn Health Science Institute, Oklahoma City, Oklahoma, USA.
Mariano YoungVaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.
Daniel A ScottVaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.
Michael W PrideVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Ingrid L ScullyVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
John GinisVaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.
Joseph SeversVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Kathrin U JansenVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
William C GruberVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Wendy WatsonVaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.
Pfizer (United States) · USLynn Health Science Institute · USMedical University of South Carolina · US

Funding

Pfizer Inc. SAF2016-80033-R
6 · The paper itself

Abstract

backgroundPneumococcal conjugate vaccines (PCVs) have significantly decreased pneumococcal disease worldwide; however, expanding serotype coverage may further reduce disease burden. A 20-valent PCV (PCV20) containing capsular polysaccharide conjugates of serotypes present in the 13-valent PCV (PCV13) and 7 new serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) is currently in development. This phase 2 study evaluated safety, tolerability, and immunogenicity of PCV20 in adults without prior pneumococcal vaccination.

methodsIn this randomized, active-controlled, double-blinded trial, 444 adults 60 through 64 years of age were randomized to receive either a single dose of PCV20 followed 1 month later by saline placebo or a single dose of PCV13 followed 1 month later by 23-valent polysaccharide vaccine. Local injection site reactions, select systemic symptoms, and adverse events (AEs) were recorded. Immunogenicity was assessed by measuring serotype-specific opsonophagocytic activity (OPA) titers before and approximately 1 month after each vaccination.

resultsLocal reaction and systemic event rates were similar after vaccination with PCV20 or PCV13; no serious vaccine-related AEs were reported. In the PCV20 group, functional immune responses as measured by OPA were robust for all 20 serotypes included in the vaccine, with geometric mean fold rises from baseline ranging from 6.0 to 113.4.

conclusionsPCV20 was well tolerated in adults 60 to 64 years of age, with a safety profile consistent with historical experience of PCVs in this age group. Substantial OPA responses were elicited against all serotypes. Results demonstrate the potential for PCV20 to expand pneumococcal disease protection. CLINICAL TRIALS REGISTRATION: NCT03313037.

Indexed as

Antibodies, BacterialPneumococcal InfectionsDouble-Blind MethodHumansImmunogenicity, VaccineMiddle AgedPneumococcal VaccinesSerogroupVaccines, ConjugateAntibodies, BacterialPneumococcal VaccinesVaccines, Conjugate20-valent pneumococcal conjugate vaccineadultclinical trialimmunogenicity and safetyStreptococcus pneumoniae

Identifiers

PMID32716500
PMCPMC8492133
OpenAlexW3045505453

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.