Evidence map›Paper›PMID 30648919›Full record

Trial reportHuman vaccines & immunotherapeutics2019

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults.

Helen L Stacey, Jeffrey Rosen, James T Peterson, Angela Williams-Diaz, Vanita Gakhar, Tina M Sterling, Camilo J Acosta, Katrina M Nolan, Jianing Li, Alison Pedley and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02547649 (A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Pneumococcal Vaccine-Naïve Adults 50 Years of Age or Older), which is not on this map. Cited by 41 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 2 pooled it
10.1field-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.

NCT02547649 phase2completednot on this map

A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Pneumococcal Vaccine-Naïve Adults 50 Years of Age or Older

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2016Enrolled690ConditionsPneumococcal InfectionsArmsV114-A, V114-B, Prevnar 13®
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 2 syntheses or guidelines pooled it, 109 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Vaccination in systemic lupus erythematosus.Human vaccines & immunotherapeutics · 2026
    Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. IAPSM's Position Paper on Pneumococcal Vaccine (PCV) for Adult Immunization in India.Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine · 2024
    Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Distribution of Serotypes Causing Invasive Pneumococcal Disease in Children From High-Income Countries and the Impact of Pediatric Pneumococcal Vaccination.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
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

16 authors at 4 institutions in 1 country.

Helen L Staceya Diablo Clinical Research, Inc , Walnut Creek , CA , USA.ORCID 0000-0003-1919-0302
Jeffrey Rosenb Clinical Research of South Florida , Coral Gables , FL , USA.
James T Petersonc J. Lewis Research, Inc./Foothill Family Clinic , Salt Lake City , USA.
Angela Williams-Diazd Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Vanita Gakhard Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Tina M Sterlingd Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Camilo J Acostad Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Katrina M Noland Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.ORCID 0000-0001-5030-7930
Jianing Lid Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Alison Pedleyd Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Patrice Bennerd Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Chitrananda Abeygunawardanad Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Michael Kosinskid Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
William J Smithd Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Hari Pujard Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Luwy K Museyd Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USClinical Research of South Florida · USDiablo Clinical Research · USFoothill Family Clinic · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPneumococcal disease remains a public health priority in adults. Safety and immunogenicity of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) containing 13 serotypes included in 13-valent pneumococcal conjugate vaccine (PCV13) plus 2 additional serotypes (22F and 33F) were evaluated in adults ≥ 50 years (V114-006; NCT02547649).

methodsA total of 690 subjects (230/arm) received a single dose of either PCV15 Formulation A, PCV15 Formulation B, or PCV13 and were followed for safety for 14 days postvaccination. Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) and Immunoglobulin G (IgG) geometric mean concentrations (GMCs) were measured immediately prior and 30 days postvaccination.

resultsBoth PCV15 formulations had generally comparable safety profiles to PCV13. Baseline IgG GMCs and OPA GMTs were comparable across vaccination groups. At 30 days postvaccination, both PCV15 formulations induced serotype specific antibodies to all 15 serotypes in the vaccine. IgG GMCs and OPA GMTs in recipients of either PCV15 formulation were non-inferior (≤ 2-fold margin) to those measured in recipients of PCV13 for shared serotypes and superior (> 1.0-fold difference) for serotypes unique to PCV15. Formulation B generally induced higher immune responses than Formulation A.

conclusionIn healthy adults ≥ 50 years of age, both new formulations of PCV15 displayed acceptable safety profiles and induced serotype-specific immune responses comparable to PCV13.

Indexed as

Immunogenicity, VaccineAgedAntibodies, BacterialFemaleHealthy VolunteersHumansImmunoglobulin GMaleMiddle AgedPneumococcal InfectionsPneumococcal VaccinesSerogroupStreptococcus pneumoniaeVaccines, Conjugate13-valent pneumococcal vaccineAntibodies, BacterialImmunoglobulin GPneumococcal VaccinesVaccines, Conjugateimmunogenicitypneumococcal conjugate vaccinesafety

Identifiers

PMID30648919
PMCPMC6605726
OpenAlexW2909509146

What OpenQuestion holds

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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.