Evidence map›Paper›PMID 33541457›Full record

Trial reportEpidemiology and infection2021

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT)

D van der Vliet, T Vesikari, B Sandner, F Martinón-Torres, G Muzsay, A Forsten, T Adelt, C Diaz Gonzalez, R Simko, S B'Chir and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Epidemiology and infection, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02955797 (Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age.), 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
1.8field-weighted citation impact, top 16% 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.

NCT02955797 phase3completednot on this map

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age.

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2017 to 2017Enrolled918ConditionsMeningitis, Meningococcal Meningitis, Meningococcal InfectionsArmsMeningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Meningococcal Disease in Pediatric Age: A Focus on Epidemiology and Prevention.International journal of environmental research and public health · 2022
    Article
  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

13 authors at 5 institutions in 4 countries.

D van der VlietSanofi Pasteur, Marcy l'Etoile, France.
T VesikariVaccine Research Center, University of Tampere, Tampere, Finland.
B SandnerNETSTAP (Network of children's physicians for clinical trials in the ambulant pediatrics), Aschaffenburg, Germany.
F Martinón-TorresTranslational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
G MuzsayGyor-Marcal Város II. sz. Gyermekorvosi Rendelő, Pediatrics, Győr, Hungary.
A ForstenVaccine Research Center, University of Tampere, Tampere, Finland.
T AdeltPediatric practice, Bramsche, in cooperation with NETSTAP (Network of Children's Physicians for clinical trials in the ambulant pediatrics), Germany.
C Diaz GonzalezHospital Universitario La Paz, Madrid, Spain.
R SimkoFuturenest Clinical Research, Miskolc, Hungary.
S B'ChirSanofi Pasteur, Marcy l'Etoile, France.
D NeveuSanofi Pasteur, Swiftwater, PA, USA.
E JordanovSanofi Pasteur, Swiftwater, PA, USA.
M S DhingraSanofi Pasteur, Swiftwater, PA, USA.ORCID 0000-0002-2507-7165
Sanofi (United States) · USSanofi (France) · FRTampere University · FIHospital Universitario La Paz · ESUniversidade de Santiago de Compostela · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Vaccination remains the best strategy to reduce invasive meningococcal disease. This study evaluated an investigational tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT) vs. a licensed tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MCV4-TT) (NCT02955797). Healthy toddlers aged 12-23 months were included if they were either meningococcal vaccine-naïve or MenC conjugate (MCC) vaccine-primed (≥1 dose of MCC prior to 12 months of age). Vaccine-naïve participants were randomised 1:1 to either MenACYW-TT (n = 306) or MCV4-TT (n = 306). MCC-primed participants were randomised 2:1 to MenACYW-TT (n = 203) or MCV4-TT (n = 103). Antibody titres against each of the four meningococcal serogroups were measured by serum bactericidal antibody assay using the human complement. The co-primary objectives of this study were to demonstrate the non-inferiority of MenACYW-TT to MCV4-TT in terms of seroprotection (titres ≥1:8) at Day 30 in both vaccine-naïve and all participants (vaccine-naïve and MCC-primed groups pooled). The immune response for all four serogroups to MenACYW-TT was non-inferior to MCV4-TT in vaccine-naïve participants (seroprotection: range 83.6-99.3% and 81.4-91.6%, respectively) and all participants (seroprotection: range 83.6-99.3% and 81.4-98.0%, respectively). The safety profiles of both vaccines were comparable. MenACYW-TT was well-tolerated and demonstrated non-inferior immunogenicity when administered to MCC vaccine-primed and vaccine-naïve toddlers.

Indexed as

EuropeFemaleFinlandHumansInfantMaleMeningococcal InfectionsMeningococcal VaccinesTetanusTetanus ToxoidVaccines, CombinedMeningococcal Vaccinesserogroup C meningococcal conjugate vaccineTetanus ToxoidVaccines, CombinedIMDMenACYW-TTquadrivalent meningococcal vaccinetoddlers

Identifiers

PMID33541457
PMCPMC8060839
OpenAlexW3128142637

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.