Evidence map›Paper›PMID 37755671›Full record

ArticleInfectious diseases and therapy2023

Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older.

David Neveu, Tamala Mallett Moore, Betzana Zambrano, Aiying Chen, Marie-Laure Kürzinger, Lydie Marcelon, Mandeep Singh Dhingra

Open access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 39% 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

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. 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

7 authors at 2 institutions in 2 countries.

David NeveuGlobal Pharmacovigilance, Sanofi, Swiftwater, PA, USA. David.Neveu@sanofi.com.
Tamala Mallett MooreGlobal Pharmacovigilance, Sanofi, Swiftwater, PA, USA.
Betzana ZambranoGlobal Clinical Development Strategy, Sanofi, Montevideo, Uruguay.
Aiying ChenGlobal Biostatistical Sciences, Sanofi, 1 Discovery Dr, Swiftwater, PA, 18370, USA.
Marie-Laure KürzingerGlobal Epidemiology and Benefit-Risk Evaluation, Sanofi, Chilly-Mazarin, France.
Lydie MarcelonGlobal Epidemiology and Benefit-Risk Evaluation, Sanofi, Lyon, France.
Mandeep Singh DhingraGlobal Clinical Development Strategy, Sanofi, Swiftwater, PA, USA.
Sanofi (United States) · USSanofi (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA favorable benefit-risk balance is required to support licensure of biologics, in keeping with regulatory agencies' evolving recommendations, including the United States Food and Drugs Administration. We present a structured semi-quantitative benefit-risk analysis of MenACYW-TT, a quadrivalent meningococcal conjugate vaccine against Neisseria meningitidis serogroups, A, C, W and Y versus licensed comparators in individuals aged ≥ 12 months.

methodsWe used data from six MenACYW-TT clinical trials, stratified by age group, versus licensed vaccines: toddlers (12-23 months; Nimenrix

resultsMenACYW-TT showed favorable seroresponse and seroprotection among vaccine-naïve participants aged ≥ 2 years, against all serogroups, compared with MCV4-CRM, MCV4-DT and MPSV4. In vaccine-naïve toddlers, there was a favorable effect for serogroup C, but no difference between MenACYW-TT and MCV4-TT for serogroups A, Y and W. A favorable effect for MenACYW-TT against serogroup C was observed in all vaccine-naïve and combined vaccine-naïve and MenC conjugate vaccine-primed groups. For all risk criteria, there were no differences between MenACYW-TT and MCV4s in toddlers, children, adolescents and adults. Results for solicited injection site and systemic reactions favored MPSV4 in older adults.

conclusionsThe benefit-risk profile for MenACYW-TT showed favorable seroresponse and seroprotection in individuals aged ≥ 2 years and no difference in risk criteria between MenACYW-TT and MCV4s. MenACYW-TT may provide an alternative to the standard-of-care for meningococcal disease prevention in those aged ≥ 12 months.

Indexed as

Benefit-risk analysisImmunogenicityMenACYW-TTQuadrivalent meningococcal conjugate vaccineSafety

Identifiers

PMID37755671
PMCPMC10600069
OpenAlexW4387077402

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LicenceCC BY-NC
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Registered trials

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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.