Evidence map›Paper›PMID 32598244›Full record

Trial reportHuman vaccines & immunotherapeutics2020

Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age.

Timo Vesikari, Paula Peyrani, Chris Webber, Marie Van Der Wielen, Brigitte Cheuvart, Nathalie De Schrevel, Emmanuel Aris, Mark Cutler, Ping Li, John L Perez

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase III
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 NCT01962207 (A PHASE IIIB, OPEN, MULTI-CENTER STUDY TO EVALUATE THE LONG-TERM ANTIBODY PERSISTENCE AT 6, 7, 8, 9 AND 10 YEARS AFTER THE ADMINISTRATION OF ONE DOSE OF THE MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT VERSUS ONE DOSE OF MENINGITEC), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.0field-weighted citation impact, top 27% 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.

NCT01962207 phase3completednot on this map

A phase iiib, open, multi-center study to evaluate the long-term antibody persistence at 6, 7, 8, 9 and 10 years after the administration of one dose of the meningococcal conjugate vaccine menacwy-tt versus one dose of meningitec(registered) vaccine or one dose of the meningococcal polysaccharide vaccine mencevax(registered) acwy, and to evaluate the safety and immunogenicity of a booster dose of menacwy-tt vaccine administered 10 years after primary vaccination of 1-10 year old subjects with menacwy-tt, meningitec(registered) or mencevax(registered) acwy.

TypeinterventionalSponsorPfizerRan2013 to 2018Enrolled243ConditionsInfections, MeningococcalArmsMeningococcal vaccine GSK134612
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
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  10. [Journal of preventive medicine and hygiene · 2021
    Article
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

10 authors at 3 institutions in 3 countries.

Timo VesikariNordic Research Network Ltd , Tampere, Finland.
Paula PeyraniPfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, USA.
Chris WebberPfizer Vaccine Clinical Research and Development, Pfizer Ltd , Hurley, Berkshire, UK.
Marie Van Der WielenGlobal Vaccines Research and Development, GlaxoSmithKline , Wavre, Belgium.
Brigitte CheuvartGlobal Vaccines Research and Development, GlaxoSmithKline , Wavre, Belgium.
Nathalie De SchrevelGlobal Vaccines Research and Development, GlaxoSmithKline , Rixensart, Belgium.
Emmanuel ArisGlobal Vaccines Research and Development, GlaxoSmithKline , Wavre, Belgium.
Mark CutlerPfizer Vaccine Research and Development, Pfizer Inc , Pearl River, NY, USA.
Ping LiPfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, USA.
John L PerezPfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, USA.
GlaxoSmithKline (Belgium) · BEPfizer (United States) · USPfizer (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase 3B, open-label, extension study (NCT01962207) evaluated long-term persistence of antibodies induced by the quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) compared with the meningococcal serogroup C vaccine conjugated to CRM (MenC-CRM) and the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS) 6 to 10 y after primary vaccination in toddlers (aged 1-<2 y; MenACWY-TT and MenC-CRM) and children (aged 2-<11 y; MenACWY-TT and MenACWY-PS). Antibody responses against meningococcal serogroups A, C, W, and Y were assessed by serum bactericidal antibody assays using rabbit (rSBA) or human (hSBA) complement. A MenACWY-TT booster dose at Year 10 was given to all eligible subjects regardless of the primary vaccine received. At Year 10, the percentages of subjects with rSBA titers ≥1:8 for serogroups A, C, W, and Y were as follows: MenACWY-TT (toddlers), 65.6%, 82.8%, 31.3%, 43.8%, respectively; MenC-CRM, 88.2% for serogroup C; MenACWY-TT (children), 88.9%, 84.1%, 67.1%, 65.9%; and MenACWY-PS, 28.6%, 81.0%, 23.8%, and 23.8%. Corresponding percentages for hSBA titers ≥1:4 were as follows: MenACWY-TT (toddlers), 31.1%, 91.9%, 44.4%, 41.4%; MenC-CRM, 93.8% for serogroup C; MenACWY-TT (children), 34.8%, 91.1%, 61.2%, 72.6%; and MenACWY-PS, 33.3%, 100.0%, 26.3%, and 44.4%. One month after the MenACWY-TT booster, the percentage of subjects with vaccine response ranged from 75.7% to 100.0% across serogroups in all study groups. Postbooster vaccine responses were generally comparable between groups across serogroups. No new safety signals were identified. Antibody responses persisted 10 y after MenACWY-TT vaccination. The MenACWY-TT booster dose was well tolerated and elicited robust immune responses.

Indexed as

Meningococcal InfectionsMeningococcal VaccinesAntibodies, BacterialChildChild, PreschoolHumansInfantTime FactorsVaccinationVaccines, ConjugateAntibodies, BacterialMeningococcal Vaccinestetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccineVaccines, Conjugatebactericidal activityboosterchildrenconjugate vaccinepersistencequadrivalent meningococcal vaccinetoddler

Identifiers

PMID32598244
PMCPMC7482884
OpenAlexW3040402247

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.