ArticleJournal of the Pediatric Infectious Diseases Society2014
Comparison of the Safety and Immunogenicity of a Novel Quadrivalent Meningococcal ACWY-Tetanus Toxoid Conjugate Vaccine and a Marketed Quadrivalent Meningococcal ACWY-Diphtheria Toxoid Conjugate Vaccine in Healthy Individuals 10-25 Years of Age.
Article in Journal of the Pediatric Infectious Diseases Society, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01165242 (Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Menactra® in Healthy Subjects Aged 10-25 Years
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- 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 · 2020Guideline
- Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Naïve Children 2-9 Years of Age: A Phase III, Randomized Study.The Pediatric infectious disease journal · 2020Trial
- Comparison of Immune Responses to Two Quadrivalent Meningococcal Conjugate Vaccines (CRM197 and Diphtheria Toxoid) in Healthy Adults.Journal of Korean medical science · 2019Trial
- Efficacy and Safety of Quadrivalent Conjugate Meningococcal Vaccines: A Systematic Review and Meta-Analysis.Vaccines · 2023Review
- Tolerability of MenACWY-TT vaccination in adolescents in the Netherlands; a cross-sectional study.BMC public health · 2021Article
- Epidemiologic Trends, Global Shifts in Meningococcal Vaccination Guidelines, and Data Supporting the Use of MenACWY-TT Vaccine: A Review.Infectious diseases and therapy · 2019Review
- A review of complement sources used in serum bactericidal assays for evaluating immune responses to meningococcal ACWY conjugate vaccines.Human vaccines & immunotherapeutics · 2019Review
- Meningococcal quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT, Nimenrix™): A review of its immunogenicity, safety, co-administration, and antibody persistence.Human vaccines & immunotherapeutics · 2016Review
- Routinely vaccinating adolescents against meningococcus: targeting transmission & disease.Expert review of vaccines · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUniversal immunization of adolescents against meningococcal disease with a quadrivalent meningococcal ACWY (MenACWY) conjugate vaccine is recommended in a number of countries.
methodsIn a randomized, controlled, observer-blinded, multicenter trial, 1016 participants, 10-25 years of age, were randomly allocated 1:1:1 to receive a single dose of 1 of 2 lots of an investigational tetanus toxoid-conjugated MenACWY vaccine (MenACWY-TT) or a marketed diphtheria toxoid-conjugated MenACWY vaccine (MenACWY-DT). The primary outcome was the noninferiority of the vaccine response after MenACWY-TT (lot A) compared with MenACWY-DT for all 4 serogroups. Vaccine response was defined as a postvaccination human serum bactericidal antibody (hSBA) titer against each of the serogroups of at least 1:8 in persons initially seronegative (<1:4) or as a 4-fold increase in titer pre- to postvaccination in persons initially seropositive (≥1:4). Adverse events (AEs) after immunization were measured 4 and 31 days postvaccination.
resultsThe mean age of participants was 16.3 years; 977 (96.6%) completed the study. The noninferiority of MenACWY-TT (lot A) to the control vaccine in terms of the percentage of participants with hSBA vaccine response was demonstrated for each serogroup. Vaccine response rates ranged from 51.0% to 82.5% for the 4 serogroups after MenACWY-TT (both lots) compared with 39.0%-76.3% for the 4 serogroups after MenACWY-DT. Pain was the most common injection-site reaction reported by 50.8%-55.4% across the 3 groups. Fatigue and headache were the most common systemic solicited AEs, reported by 27.3%-29.2% and 25.5%-26.4%, respectively.
conclusionsTetanus toxoid-conjugated MenACWY vaccine was well tolerated and elicited an immune response that was noninferior to that of a marketed MenACWY-DT (www.clinicaltrials.gov NCT01165242).
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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.