Evidence map›Paper›PMID 32233961›Full record

Trial reportHuman vaccines & immunotherapeutics2020

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study.

Judith Kirstein, Miriam Pina, Judy Pan, Emilia Jordanov, Mandeep S Dhingra

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized 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 NCT01732627 (Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% 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.

NCT01732627 phase2completednot on this map

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2012 to 2013Enrolled301ConditionsMeningitis, Meningococcal Meningitis, Meningococcal Infections, Invasive Meningococcal DiseaseArmsMeningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine, Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020
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  18. [Journal of preventive medicine and hygiene · 2021
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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

5 authors at 2 institutions in 1 country.

Judith KirsteinAdvanced Clinical Research , West Jordan, UT, USA.ORCID 0000-0001-9665-8525
Miriam PinaClinical Development, Sanofi Pasteur , Swiftwater, PA, USA.
Judy PanClinical Development, Sanofi Pasteur , Swiftwater, PA, USA.
Emilia JordanovClinical Development, Sanofi Pasteur , Swiftwater, PA, USA.
Mandeep S DhingraClinical Development, Sanofi Pasteur , Swiftwater, PA, USA.ORCID 0000-0002-2507-7165
Sanofi (United States) · USAdvanced Pharma · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

MenACYW-TT is an investigational quadrivalent meningococcal conjugate vaccine intended for the prevention of invasive meningococcal disease (IMD) caused by serogroups A, C, W, and Y in individuals aged 6 weeks and above. This Phase II, randomized, open-label, multicenter, exploratory study assessed the safety and immunogenicity of MenACYW-TT compared with a quadrivalent meningococcal polysaccharide vaccine (MPSV4) in 301 healthy adults aged ≥56 y in the US (NCT01732627). Participants were randomized 2:1 to receive MenACYW-TT or MPSV4. Serum bactericidal assays using human (hSBA) or baby rabbit (rSBA) complement were used to measure functional antibodies against meningococcal serogroups A, C, W, and Y at baseline and 30 d post-vaccination. Safety data were collected up to 30 d post-vaccination. Proportions of study participants with hSBA titers ≥1:8 against serogroups A, C, W, and Y were increased at Day 30 compared with baseline in both vaccine groups. The proportions of participants with hSBA titers ≥1:8 after MenACYW-TT vaccination were comparable to those after MPSV4 vaccination for serogroups A and C (A: 93.8% vs. 85.1%; C: 74.9% vs. 62.8%) and distinctly higher than after MPSV4 for serogroups W and Y (W: 79.5% vs. 60.6%; Y: 80.5% vs. 59.6%). Proportions of participants with rSBA titers ≥1:8 were comparable between vaccine groups for all four serogroups. The reactogenicity profiles of both vaccines were similar. Most unsolicited adverse events (AEs) were of Grade 1 or Grade 2 intensity, and no serious AEs were reported. The MenACYW-TT conjugate vaccine was well tolerated and immunogenic in adults aged ≥56 y.

Indexed as

Meningococcal InfectionsMeningococcal VaccinesAntibodies, BacterialFemaleHumansMaleMiddle AgedTetanus ToxoidVaccines, ConjugateAntibodies, BacterialMeningococcal VaccinesTetanus ToxoidVaccines, Conjugateinvasive meningococcal diseaseMenACYW-TTMPSV4older adultsvaccine

Identifiers

PMID32233961
PMCPMC7482642
OpenAlexW3014373788

What OpenQuestion holds

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LicenceCC BY
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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.