Evidence map›Paper›PMID 27149114›Full record

Trial reportHuman vaccines & immunotherapeutics2016

Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects.

Karen Ciprero, Kirill A Zykov, Nikolay I Briko, Tulin Shekar, Tina M Sterling, Elizaveta Bitieva, Jon E Stek, Luwy Musey

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01734239 (A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal Disease, From the Russian Population), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 20% 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.

NCT01734239 phase3completednot on this map

A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal Disease, From the Russian Population

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2013 to 2013Enrolled102ConditionsPneumococcal DiseaseArmsPneumovax™ 23
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. 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

8 authors at 3 institutions in 2 countries.

Karen Cipreroa Merck & Co., Inc. , Kenilworth , NJ , USA.
Kirill A Zykovb Moscow State University of Medicine and Dentistry , Moscow , Russian Federation.
Nikolay I Brikoc I.M. Sechenov First Moscow State Medical University , Moscow , Russian Federation.
Tulin Shekara Merck & Co., Inc. , Kenilworth , NJ , USA.
Tina M Sterlinga Merck & Co., Inc. , Kenilworth , NJ , USA.
Elizaveta Bitievad Merck Sharp & Dohme (MSD) Pharmaceuticals LLC , Moscow , Russian Federation.
Jon E Steka Merck & Co., Inc. , Kenilworth , NJ , USA.
Luwy Museya Merck & Co., Inc. , Kenilworth , NJ , USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USMoscow State University of Medicine and Dentistry · RUSechenov University · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pneumococcal infection is a major cause of pneumonia, bacteremia, and meningitis. Incidence of pneumococcal disease (PD) varies worldwide. The 23-valent pneumococcal polysaccharide vaccine (PPV23) displays an acceptable safety profile and has been demonstrated cost-effective in reducing burden of PD.

methodsApproximately 100 subjects from the Russian Federation who were either 2 to 49 y of age with increased risk for PD or ≥50 years of age were enrolled into the study (NCT01734239) to receive a single dose of PPV23 administered intramuscularly. Each subject was followed for local and systemic adverse events (AEs) for 5 and 14 days, respectively. Serious AEs were collected for 28 d postvaccination. Blood samples were collected immediately prior to vaccination and 28 d postvaccination for the measurement of IgG to serotypes 1, 6B, 14, 19F, and 23F.

resultsHigh proportion of subjects had ≥2 -fold increase in IgG following receipt of PPV23. Rates were 92.0%, 83.0%, 89.0%, 81%, 84% for serotypes 1, 6B, 14, 19F, and 23F, respectively. Similar rates of responders and increases in the magnitude of immune responses were observed in both age groups (2-49, ≥50 ). PPV23 was generally safe and well tolerated. Injection site and systemic AEs were reported by 14.7% and 18.6% of study subjects, respectively.

conclusionsPPV23 is generally safe, well tolerated, and highly immunogenic when given as a single dose to Russian individuals 50 y of age and older, as well as Russian individuals 2 to 49 y of age who are at high risk for PD.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, BacterialChildChild, PreschoolDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunoglobulin GInjections, IntramuscularMaleMiddle AgedPneumococcal VaccinesRussia23-valent pneumococcal capsular polysaccharide vaccineAntibodies, BacterialImmunoglobulin GPneumococcal Vaccinesimmunogenicitypneumococcal polysaccharide vaccinepneumococcal vaccineRussian populationsafety

Identifiers

PMID27149114
PMCPMC4994758
OpenAlexW2346385011

What OpenQuestion holds

Textmetadata
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.