Evidence map›Paper›PMID 32209015›Full record

Trial reportHuman vaccines & immunotherapeutics2020

Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study.

Germán Áñez, James Hedrick, Michael W Simon, Shane Christensen, Robert Jeanfreau, Eddy Yau, Judy Pan, Emilia Jordanov, Mandeep S Dhingra

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
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 NCT02752906 (Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults), 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
3.2field-weighted citation impact, top 8% 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.

NCT02752906 phase3completednot on this map

Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2016 to 2016Enrolled810ConditionsMeningitis, Meningococcal Meningitis, Meningococcal InfectionsArmsMeningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 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
    Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Meningococcal Disease in Pediatric Age: A Focus on Epidemiology and Prevention.International journal of environmental research and public health · 2022
    Article
  17. Meningococcal disease and vaccination in college students.Human vaccines & immunotherapeutics · 2021
    Review
  18. [Journal of preventive medicine and hygiene · 2021
    Article
  19. Review
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

9 authors at 5 institutions in 2 countries.

Germán ÁñezGlobal Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.ORCID 0000-0001-5361-3001
James HedrickKentucky Pediatric/Adult Research , Bardstown, KY, USA.
Michael W SimonPrivate Practice , Nicholasville, KY, USA.
Shane ChristensenJ. Lewis Research , Salt Lake City, UT, USA.
Robert JeanfreauMedPharmics , Metairie, LA, USA.
Eddy YauGlobal Biostatistical Sciences, Sanofi Pasteur , Toronto, ON, Canada.
Judy PanGlobal Biostatistical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.
Emilia JordanovGlobal Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.
Mandeep S DhingraGlobal Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.ORCID 0000-0002-2507-7165
Sanofi (United States) · USJean Brown Research · USJessamine County Schools · USOhio Pediatric Research Association · USSanofi (Canada) · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) was assessed as a booster in this Phase III trial (NCT02752906). Quadrivalent meningococcal conjugate vaccine (MCV4)-primed individuals aged ≥15 y (n = 810) were randomized 1:1 to receive a single booster dose of MenACYW-TT (n = 403) or a licensed MCV4 (Menactra®; MCV4-DT [n = 407]). Serum bactericidal antibody assay with human complement (hSBA) was used to measure functional antibodies against serogroups A, C, W, and Y at baseline and Day 30 post-vaccination. Proportions of participants achieving seroresponse (post-vaccination titer ≥1:16 for those with baseline titer <1:8 or ≥4-fold increase in post-vaccination titer for those with baseline titer ≥1:8) were determined. Safety data were collected for 180 d post-vaccination. Non-inferiority of the immune response was demonstrated for MenACYW-TT compared with MCV4-DT based on the proportion of participants achieving hSBA vaccine seroresponse for each of the meningococcal serogroups at Day 30. Moreover, ≥99% of participants in both study groups had hSBA titers ≥1:8 for the four meningococcal serogroups at Day 30. Reactogenicity profiles were comparable between groups. These Phase III data in adolescents and adults show that MenACYW-TT boosts the immune response in those primed with MCV4 vaccines 4-10 y previously, irrespective of whether MCV4-DT or MCV4-CRM was used for priming.

Indexed as

Meningococcal InfectionsMeningococcal VaccinesAdolescentAdultAntibodies, BacterialHumansTetanus ToxoidVaccines, ConjugateAntibodies, BacterialMeningococcal VaccinesTetanus ToxoidVaccines, Conjugateadolescentsadultsbooster doseimmunizationinvasive meningococcal diseasemeningococcal quadrivalent conjugate vaccinemeningococcusNeisseria meningitidisvaccination

Identifiers

PMID32209015
PMCPMC7482862
OpenAlexW3013033584

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.