Trial reportBMC infectious diseases2013
Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study.
Trial report in BMC infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00356369 (Phase IIb Primary Vaccination Study to Evaluate Non-Inferiority & Persistence of the Immune Response of GSK Biologicals' MenACWY Conjugate Vaccine), which is not on this map. Cited by 14 papers.
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.
Phase IIb Primary Vaccination Study to Evaluate Non-Inferiority & Persistence of the Immune Response of GSK Biologicals' MenACWY Conjugate Vaccine (Intramuscularly) vs Mencevax ACWY (Subcutaneously) to Healthy Subjects (11-55 Years of Age)
Who cites it
14 citing papers in PubMed, 57 citations in OpenAlex.
- A phase 2b/3b MenACWY-TT study of long-term antibody persistence after primary vaccination and immunogenicity and safety of a booster dose in individuals aged 11 through 55 years.BMC infectious diseases · 2020Trial
- Antibody persistence up to 5 y after vaccination with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in adolescents.Human vaccines & immunotherapeutics · 2017Trial
- Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial.BMC infectious diseases · 2015Trial
- Real-world impact and effectiveness of MenACWY-TT.Human vaccines & immunotherapeutics · 2023Review
- Tolerability of MenACWY-TT vaccination in adolescents in the Netherlands; a cross-sectional study.BMC public health · 2021Article
- Different Long-Term Duration of Seroprotection againstVaccines · 2020Article
- Persistence of the immune response two years after vaccination with quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) in Asian adolescents.Human vaccines & immunotherapeutics · 2016Article
- Meningococcal quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT, Nimenrix™): A review of its immunogenicity, safety, co-administration, and antibody persistence.Human vaccines & immunotherapeutics · 2016Review
- Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants.Human vaccines & immunotherapeutics · 2016Review
- Routinely vaccinating adolescents against meningococcus: targeting transmission & disease.Expert review of vaccines · 2016Review
- Vaccines, adjuvants and autoimmunity.Pharmacological research · 2015Review
- Development and use of a serum bactericidal assay using pooled human complement to assess responses to a meningococcal group A conjugate vaccine in African toddlers.Clinical and vaccine immunology : CVI · 2014Article
- Review of meningococcal vaccines with updates on immunization in adults.Human vaccines & immunotherapeutics · 2014Review
- Meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine: a new conjugate vaccine against invasive meningococcal disease.Infection and drug resistance · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe best strategy to protect individuals against meningococcal disease is to immunize against multiple serogroups. Immunogenicity, antibody persistence, and safety of the EU-licensed meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) were evaluated in healthy participants aged 11-55 years from the Philippines and Saudi Arabia.
methodsIn this phase IIb, open, controlled study, 500 participants were randomised (3:1) to receive one dose of MenACWY-TT or a licensed meningococcal polysaccharide vaccine (Men-PS). Functional antibody responses against meningococcal serogroups A, C, W-135, and Y were assessed by a serum bactericidal antibody assay using rabbit complement (rSBA) at Month 0, Month 1, Year 1, Year 2, and Year 3. Vaccine response was defined as an rSBA titre ≥32 at Month 1 in participants who were seronegative (rSBA titre <8) pre-vaccination and as at least a four-fold increase in titre in participants who were seropositive pre-vaccination. Solicited symptoms were recorded up to Day 4, safety outcomes up to Month 6, and serious adverse events related to vaccination up to Year 3.
resultsPre-specified criteria for non-inferiority of MenACWY-TT versus Men-PS were met in terms of rSBA vaccine response and incidence of grade 3 general symptoms. At Month 1, 82.7%-96.3% of MenACWY-TT and 69.7%-91.7% in Men-PS recipients had a vaccine response for each serogroup. At Year 3, ≥99.1% and ≥92.9% of MenACWY-TT recipients retained rSBA titres ≥8 and ≥128, respectively, as compared to ≥86.7% and ≥80.0% in the Men-PS group. Both vaccines had a clinically acceptable safety profile, although injection site redness and swelling were more frequent in MenACWY-TT recipients.
conclusionsThese results suggest that MenACWY-TT could protect adolescents and adults against meningococcal disease up to three years post-vaccination.
trial registrationThis study is registered at http://www.clinicaltrials.gov/NCT00356369.
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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.