ArticleInfectious diseases and therapy2025
A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix
Article in Infectious diseases and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04819113 (A PHASE 3B, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX), which is not on this map. Cited by 1 paper.
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A PHASE 3B, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX(Registered) IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE
Who cites it
1 citing paper in PubMed.
- Meningococcal quadrivalent ACYW-TT conjugated vaccine at 6-23 months: phase III study (US/Puerto Rico).Pediatric research · 2026Article
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
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14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionInfants and young children typically have the highest age-related risk of invasive meningococcal disease. The immunogenicity and safety of a single primary dose and a booster of a meningococcal A/C/W/Y tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix
methodsIn this phase 3b, open-label, single-arm study, healthy 3-month-old infants received a single Nimenrix dose followed by a booster at age 12 months (1 + 1 series). Functional antibodies before and 1 month after each vaccination were evaluated with serum bactericidal antibody assays using rabbit (rSBA) or human (hSBA) complement for each A/C/W/Y serogroup. Primary endpoints were rSBA seroprotection (titers ≥ 1:8) rates and geometric mean titers (GMTs); supportive secondary endpoints included hSBA seroprotection (titers ≥ 1:4) rates and GMTs. Local reactions and systemic events occurring within 7 days, adverse events (AEs), serious AEs, and newly diagnosed chronic medical conditions following vaccination were assessed.
resultsOverall, 147 and 143 participants received the primary and booster Nimenrix doses, respectively. rSBA seroprotection rates across serogroups were 82.3-91.1% at 1 month after the primary dose and increased to 100% at 1 month after the booster. rSBA GMTs were considerably higher after the booster (1299.5‒2714.1) than after the primary dose (54.7‒202.4). In hSBA evaluations performed as supportive to rSBA evaluations, seroprotection rates increased from 38.8 to 95.5% after the primary dose to 100% after the booster, with corresponding GMT increases (8.8‒149.8 to 1208.4‒7299.6). Local reactions and most systemic events were mild to moderate in severity; no new safety concerns were identified.
conclusionNimenrix given at ages 3 and 12 months had a favorable safety profile and elicited protective immune responses and robust anamnestic booster responses across A/C/W/Y serogroups. These results provide important support for this alternative Nimenrix 1 + 1 immunization schedule for infants < 6 months, allowing flexibility in infant meningococcal immunization.
trial registrationClinicalTrials.gov, NCT04819113.
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