Evidence map›Paper›PMID 33439463›Full record

ArticleInfectious diseases and therapy2021

Post-Marketing Surveillance Observational Study of Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine (MenACWY-DT, MCV4/Menactra

Hee Soo Kim, Solene Engel, David Neveu, Yael Thollot, Philipp Oster, Kuhyun Yang

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02864927 (Postmarketing Surveillance Study for Use of Meningococcal), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 33% 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.

NCT02864927 phase4completednot on this map

Postmarketing Surveillance Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in the Republic of Korea

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2016 to 2019Enrolled1,311ConditionsMeningitis, Meningococcal Meningitis, Meningococcal InfectionsArmsMeningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Observational
  3. Review
  4. Infectious Respiratory Diseases Decreased during the COVID-19 Pandemic in South Korea.International journal of environmental research and public health · 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

6 authors at 3 institutions in 3 countries.

Hee Soo KimSanofi Pasteur, Seoul, South Korea.
Solene EngelSanofi Pasteur, Montpellier, France.
David NeveuSanofi Pasteur, Swiftwater, PA, USA.
Yael ThollotSanofi Pasteur, Lyon, France.
Philipp OsterSanofi Pasteur, Lyon, France.
Kuhyun YangSanofi Pasteur, Seoul, South Korea. slhygh04@hotmail.com.
Sanofi (France) · FRSanofi (South Korea) · KRSanofi (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInvasive meningococcal disease is a notifiable disease in the Republic of Korea. The meningococcal (groups A, C, Y, and W) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-DT, Menactra

methodsThe PMS observational study (NCT02864927) included participants aged 9 months to 55 years and who were given MenACWY-DT during routine healthcare visits. The study participants were followed-up for up to 30 days following vaccination (additional time was allowed for the visit or phone call to be conducted). Study outcomes included solicited and unsolicited adverse reactions, unexpected adverse events, and serious adverse events (SAEs).

resultsA total of 640 participants 9-23 months of age and 671 participants 2-55 years of age were eligible for safety analysis. Overall, AEs were reported by 35.3% of participants aged < 2 years and 45% of participants aged 2-55 years. Solicited adverse reactions were reported by 21.4% and 17.4% of participants aged < 2 years and 2-55 years, respectively. Unsolicited adverse reactions were reported by 26.1% and 37.9%, respectively. No vaccine-related SAEs occurred during the study. The AEs reported in Korean population were consistent with the known safety profile of MenACWY-DT, and most were of grade 1-2 in severity.

conclusionsThis study did not detect any unanticipated or new safety findings of concern with MenACWY-DT in either of the study age groups, and provides reassurance that MenACWY-DT can be used as part of routine immunization care for the prevention of invasive meningococcal disease.

trial registrationClinicalTrials.gov Identifier, NCT02864927.

Indexed as

Adverse reactions or eventsMCV4Menactra®MenACWY-DTMeningococcal infectionsMeningococcal vaccineSafetyVaccines

Identifiers

PMID33439463
PMCPMC7954957
OpenAlexW3118700710

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.