Evidence map›Paper›PMID 25424958›Full record

Trial reportHuman vaccines & immunotherapeutics2014

Safety and immunogenicity of meningococcal ACWY CRM197-conjugate vaccine in children, adolescents and adults in Russia.

Natalia Ilyina, Susanna Kharit, Leila Namazova-Baranova, Asmik Asatryan, Mayya Benashvili, Elmira Tkhostova, Chiranjiwi Bhusal, Ashwani Kumar Arora

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

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. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 31% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020
    Guideline
  2. Review
  3. Article
  4. Review
  5. [Journal of preventive medicine and hygiene · 2021
    Article
  6. Article
  7. Article
  8. 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 5 institutions in 2 countries.

Natalia Ilyinaa Federal State Budgetary Institution "State Scientific Center "Institution of Immunology" of the Russian Federal Biomedical Agency"; Moscow, Russia.
Susanna Kharit
Leila Namazova-Baranova
Asmik Asatryan
Mayya Benashvili
Elmira Tkhostova
Chiranjiwi Bhusal
Ashwani Kumar Arora
Nova Medical (United States) · USCenter for Children · USChildren's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency · RUFederal Medical-Biological Agency · RUSaint Petersburg Pasteur Institute · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Neisseria meningitidis is the leading cause of bacterial invasive infections in people aged <15 years in the Russian Federation. The aim of this phase III, multicenter, open-label study was to assess the immunogenicity and safety of the quadrivalent meningococcal CRM197-conjugate vaccine MenACWY when administered to healthy Russian subjects aged 2 years and above. A total of 197 subjects were immunized with a single dose of the vaccine, and serogroup-specific serum bactericidal activity was measured pre and 1-month post-vaccination with human complement (hSBA) serum titers. Regardless of baseline serostatus, 1 month after a single dose of MenACWY-CRM197 85% (95%CI, 79-90%) of subjects showed serologic response against serogroup A, 74% (67-80%) against serogroup C, 60% (53-67%) against serogroup W, and 83% (77-88%) against serogroup Y. The percentage of subjects with hSBA titers ≥ 1:8 1 month after vaccination was 89% (83-93%) against serogroup A, 84% (78-89%) against serogroup C, 97% (93-99%) against serogroup W, and 88% (82-92%) against serogroup Y. Comparable results were obtained across all subjects: children (2 to 10 years), adolescents (11 to 17 years), and adults (≥18 years). The MenACWY-CRM197 vaccine showed an acceptable safety profile and was well tolerated across all age groups, with no serious adverse events or deaths reported during the study. In conclusion, a single dose of meningococcal MenACWY-CRM197 vaccine is immunogenic and has an acceptable safety profile, provides a broad protection against the most frequent epidemic serogroups, and is a suitable alternative to currently available unconjugated monovalent or bivalent polysaccharide vaccines in Russia.

Indexed as

AdolescentAdultAgedBlood Bactericidal ActivityChildChild, PreschoolDrug-Related Side Effects and Adverse ReactionsHealthy VolunteersHumansMeningococcal InfectionsMeningococcal VaccinesMiddle AgedNeisseria meningitidis, Serogroup ANeisseria meningitidis, Serogroup CNeisseria meningitidis, Serogroup W-135Neisseria meningitidis, Serogroup YMenACWY-CRM vaccineMeningococcal VaccinesVaccines, ConjugateadolescentadultchildrenCRM197-conjugateimmunogenicitymeningococcalquadrivalent vaccineRussiasafety

Identifiers

PMID25424958
PMCPMC4896799
OpenAlexW1999659815

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.