Evidence map›Paper›PMID 35445641›Full record

Trial reportHuman vaccines & immunotherapeutics2022

Comparing the meningococcal serogroup C immune response elicited by a tetanus toxoid conjugate quadrivalent meningococcal vaccine (MenACYW-TT) versus a quadrivalent or monovalent C tetanus toxoid conjugate meningococcal vaccine in healthy meningococcal vaccine-naïve toddlers: A randomised, controlled trial.

Markus Knuf, Mika Rämet, Nina Breinholt Stærke, Isabelle Bertrand-Gerentes, Yaël Thollot, Siham B'Chir, Habiba Arroum, Philipp Oster

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03890367 (Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix® or NeisVac-C® in Healthy Toddlers 12 to 23 Months of Age), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 27% 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.

NCT03890367 phase3completednot on this map

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix® or NeisVac-C® in Healthy Toddlers 12 to 23 Months of Age

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2019 to 2020Enrolled707ConditionsMeningococcal Immunisation (Healthy Volunteers)ArmsMeningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine, Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine, Meningococcal group C polysaccharide Conjugate vaccine adsorbed
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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  3. Review
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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

8 authors at 4 institutions in 4 countries.

Markus KnufHelios Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden, Germany.
Mika RämetVaccine Research Center, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Nina Breinholt StærkeDepartment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
Isabelle Bertrand-GerentesGlobal Medical Operations, Sanofi, Lyon, France.
Yaël ThollotGlobal Medical Operations, Sanofi, Lyon, France.
Siham B'ChirGlobal Biostatistical Sciences, Sanofi, Marcy-l'Étoile, France.
Habiba ArroumGlobal Pharmacovigilance, Sanofi, Chilly-Mazarin, France.
Philipp OsterGlobal Medical Operations, Sanofi, Lyon, France.
Sanofi (France) · FRAarhus University Hospital · DKHelios Dr. Horst Schmidt Kliniken Wiesbaden · DETampere University · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

MenACYW-TT (MenQuadfi®) is a quadrivalent meningococcal tetanus toxoid conjugate vaccine licensed in Europe for use in individuals ≥12 months. This study assessed whether serogroup C immune responses with MenACYW-TT were at least non-inferior, or superior, to those of quadrivalent meningococcal ACWY (MCV4-TT; Nimenrix®) and monovalent meningococcal C (MenC-TT; NeisVac-C®) vaccines in toddlers (12-23 months). In this modified, double-blind Phase III study (NCT03890367), 701 toddlers received one dose of MenACYW-TT (n = 230), MCV4-TT (n = 232) or MenC-TT (n = 239). Serum bactericidal assays with human (hSBA) and baby rabbit (rSBA) complement were used to measure anti-meningococcal serogroup C antibodies at baseline and 30 days post-vaccination. A sequential statistical approach was used for primary and secondary objectives. For the primary objectives, superiority of serogroup C was assessed in terms of hSBA seroprotection rates (defined as titers ≥1:8) and GMTs for MenACYW-TT compared to MCV4-TT, and rSBA GMTs compared to MenC-TT. The safety of all vaccines within 30 days post-vaccination was described. When administered as a single dose to meningococcal vaccine-naïve healthy toddlers the superiority of the MenACYW-TT serogroup C immune response versus MCV4-TT was demonstrated for hSBA GMTs (ratio 16.3 [12.7-21.0]) and seroprotection (difference 10.43% [5.68-16.20]); and versus MenC-TT in terms of rSBA GMTs (ratio 1.32 [1.06-1.64]). The safety profiles of a single dose of MenACYW-TT, MCV4-TT and MenC-TT were similar. In meningococcal vaccine-naïve toddlers, MenACYW-TT induced superior immune responses to serogroup C versus MCV4-TT in terms of hSBA seroprotection and GMTs and versus MenC-TT in terms of rSBA GMTs.

Indexed as

Meningococcal InfectionsMeningococcal VaccinesNeisseria meningitidisNeisseria meningitidis, Serogroup CAnimalsAntibodies, BacterialChild, PreschoolHumansImmunityRabbitsSerogroupTetanus ToxoidVaccines, CombinedVaccines, ConjugateAntibodies, BacterialMeningococcal VaccinesTetanus ToxoidVaccines, CombinedVaccines, Conjugateimmunogenicityinvasive meningococcal diseaseMCV4-TTMenACYW-TTMenC-TTmeningococcal serogroup Cnon-inferiorityseroprotectionsuperioritytoddlers

Identifiers

PMID35445641
PMCPMC9225511
OpenAlexW4224251029

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.