Evidence map›Paper›PMID 32233959›Full record

Trial reportHuman vaccines & immunotherapeutics2020

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in healthy toddlers: a Phase II randomized study.

Timo Vesikari, Ray Borrow, Aino Forsten, Helen Findlow, Mandeep S Dhingra, Emilia Jordanov

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03205358 (A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
2.8field-weighted citation impact, top 9% 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.

NCT03205358 phase2completednot on this map

A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2015 to 2015Enrolled188ConditionsMeningitis, 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

24 citing papers in PubMed, 37 citations in OpenAlex.

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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

6 authors at 3 institutions in 3 countries.

Timo VesikariVaccine Research Center, University of Tampere , Tampere, Finland.
Ray BorrowVaccine Evaluation Unit, Public Health England , Manchester, UK.
Aino ForstenVaccine Research Center, University of Tampere , Tampere, Finland.
Helen FindlowVaccine Evaluation Unit, Public Health England , Manchester, UK.
Mandeep S DhingraGlobal Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.ORCID 0000-0002-2507-7165
Emilia JordanovGlobal Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.
Public Health England · GBSanofi (United States) · USTampere University · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

neisseria meningitidiscan lead to invasive meningococcal disease to which young children are particularly vulnerable. We assessed the immunogenicity and safety of Sanofi Pasteur's investigational quadrivalent (serogroups A, C, Y, and W) meningococcal tetanus-toxoid conjugate vaccine, MenACYW-TT, as a single dose, in healthy meningococcal vaccine-naïve toddlers versus a licensed conjugate vaccine MCV4-TT (NCT03205358). In this Phase II study conducted in Finland, 188 toddlers aged 12-24 months were randomized 1:1 to MenACYW-TT or MCV4-TT. Serum bactericidal antibody assays using human complement (hSBA) and baby rabbit complement (rSBA) measured antibodies against each serogroup before and 30 days after vaccination. Participants were monitored for immediate adverse events (AEs) and post-vaccination AEs for 30 days. All analyses were descriptive. All 188 participants completed the study. The Day 30 hSBA seroresponses (hSBA titer <8 at baseline and post-vaccination titer ≥8, or ≥8 at baseline and ≥4-fold increase post-vaccination) were comparable between participants receiving MenACYW-TT (96.7-100%), and MCV4-TT (86.0-100.0%) for each serogroup. Most unsolicited AEs were of Grade 1 or Grade 2 intensity. There were no immediate hypersensitivity reactions, and no AEs or serious AEs leading to discontinuation from the study. In this exploratory study, MenACYW-TT vaccine was well tolerated and immunogenic. If confirmed in Phase III, a single dose of the MenACYW-TT vaccine may show promise as an alternative vaccine option for toddlers receiving meningococcal vaccination for the first time.

Indexed as

Meningococcal InfectionsMeningococcal VaccinesAntibodies, BacterialFemaleFinlandHumansInfantMaleTetanus ToxoidVaccines, ConjugateAntibodies, BacterialMeningococcal VaccinesTetanus ToxoidVaccines, ConjugatemenACYW-TTMeningococcalquadrivalent meningococcal conjugate vaccinetoddlers

Identifiers

PMID32233959
PMCPMC7538019
OpenAlexW3014482175

What OpenQuestion holds

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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.