Evidence map›Paper›PMID 30427749›Full record

Trial reportHuman vaccines & immunotherapeutics2019

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.

James T Peterson, Helen L Stacey, John E MacNair, Jianing Li, Jonathan S Hartzel, Tina M Sterling, Patrice Benner, Gretchen M Tamms, Luwy K Musey

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
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 NCT02573181 (A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 7% 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.

NCT02573181 phase2completednot on this map

A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2016Enrolled253ConditionsPneumococcal InfectionsArmsV114, Prevnar 13™
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 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
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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

9 authors at 3 institutions in 1 country.

James T Petersona Foothill Family Clinic , Salt Lake City , USA.
Helen L Staceyb Diablo Clinical Research , Walnut Creek , USA.ORCID 0000-0003-1919-0302
John E MacNairc Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Jianing Lic Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Jonathan S Hartzelc Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Tina M Sterlingc Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Patrice Bennerc Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Gretchen M Tammsc Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Luwy K Museyc Merck & Co., Inc., Merck Research Laboratories , Kenilworth , NJ , USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · 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. Previous studies have suggested that administration of pneumococcal polysaccharide vaccine or pneumococcal conjugate vaccine within three years following receipt of PPV23 was associated with increased reactogenicity and reduced antibody titers in comparison to longer intervals. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) was evaluated in adults ≥ 65 years of age with prior history of PPV23 vaccination (V114-007; NCT02573181).

methodsA total of 250 adults who received PPV23 at least 1 year prior to study entry received a single dose of either PCV15 or PCV13 (125/arm) and were followed for safety for 14 days postvaccination. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 30 days postvaccination.

resultsSafety profiles were comparable between PCV15 and PCV13 recipients. Following vaccination, serotype-specific antibody responses for the 13 shared serotypes were generally comparable between recipients of PCV15 and PCV13 for IgG GMCs, OPA GMTs, and geometric mean fold rises (GMFRs) and percentages of subjects with ≥ 4-fold-rise from baseline for both IgG and OPA. Recipients of PCV15 had numerically higher antibody responses than PCV13 for two serotypes unique to PCV15 (22F, 33F).

conclusionPCV15 was generally well tolerated and induced high levels of IgG and OPA antibodies to all 15 serotypes included in the vaccine when given as a single dose to adults ≥ 65 years of age previously vaccinated with PPV23.

Indexed as

Immunization, SecondaryAgedAntibodies, BacterialDouble-Blind MethodFemaleHumansImmunoglobulin GMalePneumococcal InfectionsPneumococcal VaccinesSerogroupStreptococcus pneumoniaeVaccines, Conjugate13-valent pneumococcal vaccine23-valent pneumococcal capsular polysaccharide vaccineAntibodies, BacterialImmunoglobulin GPneumococcal VaccinesVaccines, Conjugateimmunogenicitypneumococcal conjugate vaccinesafety

Identifiers

PMID30427749
PMCPMC6605723
OpenAlexW2900942222

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.