Evidence map›Paper›PMID 26575983›Full record

Trial reportHuman vaccines & immunotherapeutics2016

Antibody persistence up to 5 years after vaccination of toddlers and children between 12 months and 10 years of age with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine.

Timo Vesikari, Aino Forsten, Veronique Bianco, Marie Van der Wielen, Jacqueline M Miller

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
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 NCT00427908 (Evaluate Non-Inferiority and Persistence of the Immune Response of GSK Biologicals' Meningococcal Vaccine 134612 Versus Meningitec™ or Mencevax™ ACWY in Healthy Subjects), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.5field-weighted citation impact, top 11% 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.

NCT00427908 phase2completednot on this map

Evaluate Non-Inferiority and Persistence of the Immune Response of GSK Biologicals' Meningococcal Vaccine 134612 Versus Meningitec™ or Mencevax™ ACWY in Healthy Subjects (1-10 Years of Age)

TypeinterventionalSponsorGlaxoSmithKlineRan2007 to 2007Enrolled613ConditionsInfections, MeningococcalArmsGSK Biolgicals' meningococcal vaccine 134612 (Nimenrix), Mencevax™ ACWY, Meningitec™
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Real-world impact and effectiveness of MenACWY-TT.Human vaccines & immunotherapeutics · 2023
    Review
  5. Article
  6. Article
  7. Article
  8. [Journal of preventive medicine and hygiene · 2021
    Article
  9. The epidemiology of invasive meningococcal disease and the utility of vaccination in Malta.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2020
    Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
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

5 authors at 2 institutions in 1 country.

Timo Vesikaria Vaccine Research Center; University of Tampere; Medical School ; Tampere , Finland.
Aino Forstena Vaccine Research Center; University of Tampere; Medical School ; Tampere , Finland.
Veronique Biancob GSK Vaccines ; Wavre , Belgium.
Marie Van der Wielenb GSK Vaccines ; Wavre , Belgium.
Jacqueline M Millerc GSK Vaccines ; King of Prussia , PA USA.
Tampere University · FITampere University · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We studied the persistence of serum bactericidal antibody using rabbit and human complement (rSBA/hSBA, cut-offs 1:8) 5 y after a single dose of meningococcal serogroups A, C, W, Y tetanus toxoid conjugate vaccine (MenACWY-TT) compared with age-appropriate control vaccines in toddlers and children (NCT00427908). Children were previously randomized (3:1) to receive either MenACWY-TT or control vaccine (MenC-CRM197 in 1-<2 y olds; MenACWY-polysaccharide vaccine [Men-PS] in 2-<11 y olds). Subjects with rSBA-MenC titers <1:8 at any time point were revaccinated with MenC conjugate vaccine and discontinued from the study. A repeated measurement statistical model assessed potential selection effects due to drop-outs. At year 5 in MenACWY-TT-vaccinated-toddlers for serogroups A, C, W, and Y respectively, percentages with rSBA titers ≥1:8 were 73.5%, 77.6%, 34.7%, and 42.9%, hSBA ≥1:8 were 35.6%, 91.7%, 82.6% and 80.0%. For MenC-CRM197 recipients, 63.6% had persisting rSBA-MenC titers ≥1:8 and 90.9% had hSBA-MenC ≥1:8 (not significantly different versus MenACWY-TT for either assay: exploratory analyses). In 2-<11 y olds rSBA titers ≥1:8 in MenACWY-TT-vaccinees were 90.8%, 90.8%, 78.6%, and 78.6% and 15.4%, 100%, 0.0%, 7.7% in Men-PS-vaccinees (significantly different for serogroups A, W and Y, exploratory analyses). Serogroups A, W and Y rSBA GMTs were ≥ 26-fold higher in MenACWY-TT-vaccinees. As expected, GMTs modeled at year 5 to assess the impact of subject drop out (mainly for revaccination), appeared lower for serogroup C. No vaccine-related SAEs were reported. Antibody persistence was observed for all serogroups up to 5 y after MenACWY-TT vaccination.

Indexed as

Blood Bactericidal ActivityAdjuvants, ImmunologicAntibodies, BacterialChildChild, PreschoolComplement System ProteinsHumansInfantMeningococcal VaccinesTetanus ToxoidTime FactorsVaccines, ConjugateAdjuvants, ImmunologicAntibodies, BacterialComplement System ProteinsMenACWYMeningococcal VaccinesTetanus ToxoidVaccines, Conjugatebactericidal activitychildrenconjugate vaccinepersistencequadrivalent meningococcal vaccinetoddler

Identifiers

PMID26575983
PMCPMC4962747
OpenAlexW2301673964

What OpenQuestion holds

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LicenceCC BY-NC
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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.