Evidence map›Paper›PMID 40665158›Full record

ArticleInfectious diseases and therapy2025

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered with Routine Pediatric Vaccines: A European Randomized Controlled Trial.

Federico Martinon-Torres, Miia M Virta, Susanna Koski, Ignacio Salamanca de la Cueva, Henryk T Szymanski, Samantha Bosis, Anca C Drăgănescu, Sven-Arne Silfverdal, Betzana Zambrano, Mandeep S Dhingra and 6 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Infectious diseases and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03547271 (Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT03547271 phase3completednot on this map

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2018 to 2023Enrolled1,660ConditionsMeningococcal InfectionsArmsMenACYW conjugate vaccine, Meningococcal group A, C, W-135, and Y conjugate vaccine, DTaP-IPV-HB-Hib vaccine, Pneumococcal vaccine (13-valent), Pneumococcal vaccine (10-valent)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Trial
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

16 authors.

Federico Martinon-TorresTranslational Paediatrics and Infectious Diseases Section, Paediatrics Department, Hospital Clínico Universitario de Santiago de Compostela, 15701, Santiago de Compostela, Spain.
Miia M VirtaFinnish Vaccine Research, Järvenpää Clinic, Mannilantie, Järvenpää, Finland.
Susanna KoskiFinnish Vaccine Research, Helsinki South Clinic, Vuorikatu, Helsinki, Finland.
Ignacio Salamanca de la CuevaUnidad de Investigación, Grupo IHP (Instituto Hispalense de Pediatría), Seville, Spain.
Henryk T SzymanskiDepartment of Pediatrics, Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy, Prusicka 53-55, 55-100, Trzebnica, Poland.
Samantha BosisPneumology and Infectious Diseases Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Anca C DrăgănescuNational Institute for Infectious Diseases "Prof. Dr. Matei Bals", Bucharest, Romania.
Sven-Arne SilfverdalClinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
Betzana ZambranoGlobal Clinical Development Strategy, Sanofi, Montevideo, Uruguay.
Mandeep S DhingraGlobal Clinical Development Strategy, Sanofi, Swiftwater, PA, USA.
Siham B'ChirGlobal Biostatistical Sciences, Sanofi, Marcy L'Étoile, France.
Olga SyrkinaPatient Safety and Pharmacovigilance, Sanofi R&D, Cambridge, MA, USA.
Olga LyabisGlobal Clinical Development Strategy, Sanofi, Marcy L'Étoile, France.
Gustavo A VasquezGlobal Clinical Development Strategy, Sanofi, Swiftwater, PA, USA. gustavo.vasquez@sanofi.com.
Christine RehmGlobal Clinical Development Strategy, Sanofi, Swiftwater, PA, USA.
MET58 Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe immunogenicity and safety of MenACYW-TT (MenQuadfi

methodsOne set of healthy infants was randomized 1:1 to receive MenACYW-TT (group 1; n = 714) or MCV4-TT (group 2; n = 726) at age 2, 4, and 12-18 months (2 + 1 regimen) concomitantly with routine vaccines (including 10-valent pneumococcal conjugate vaccine). Another set was randomized 1:1 to receive MenACYW-TT in a 2 + 1 regimen (group 3; n = 112) or a 3 + 1 regimen at age 2, 4, 6, and 12-18 months (group 4; n = 108) concomitantly with routine vaccines (including 13-valent pneumococcal conjugate vaccine). Immune responses against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority of MenACYW-TT versus MCV4-TT was based on hSBA geometric mean titers (GMTs) 30 days post-booster (dose 3; primary endpoint) and rates of seroprotection 30 days post-dose 2 (secondary endpoint) against all vaccine meningococcal serogroups. Immune responses to co-administered vaccines and safety were also assessed. Post hoc, non-inferiority of MenACYW-TT was also assessed based on seroresponse rates 30 days post-booster.

resultsNon-inferiority of MenACYW-TT versus MCV4-TT, based on GMTs post-booster, was demonstrated for serogroups C, W, and Y but not for A. GMTs against serogroups C, W, and Y were 1.5- to 4.5-fold higher with MenACYW-TT than MCV4-TT; those against serogroup A were marginally lower. Antibody responses in groups 3 and 4 against all serogroups were similar to group 1. Non-inferiority of MenACYW-TT based on seroresponse rates post-booster against all serogroups was demonstrated post hoc. No interference with concomitant routine vaccines nor safety concerns were identified.

conclusionsConsideration of all immunogenicity and safety data generated in this study supports the incorporation of MenACYW-TT into the routine childhood vaccination schedule as a 2 + 1 regimen starting at age 6 weeks. CLINICALTRIALS: GOV IDENTIFIER: NCT03547271.

Indexed as

Concomitant vaccine administrationImmunogenicityInfantsInvasive meningococcal diseaseMCV4-TTMenACYW-TTMeningitisQuadrivalent meningococcal vaccinesSafetyToddlers

Identifiers

PMID40665158
PMCPMC12339823

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.