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Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis

Author

Listed:
  • Puneet Vir Singh

    (GSK, Safety Evaluation and Risk Management)

  • Paola Tiberi

    (GSK, Safety Evaluation and Risk Management)

  • Gabriele Filippo Di Domenico

    (GSK, Biostatistics and Statistical Programming)

  • Valerio Romolini

    (GSK, Biostatistics and Statistical Programming)

  • Thembile Mzolo

    (GSK, Biostatistics)

  • Marco Costantini

    (GSK, Biostatistics and Statistical Programming)

  • Tauseefullah Akhund

    (GSK, Clinical Research and Development Centre)

  • Venere Basile

    (GSK, Global Clinical Operations)

  • Maria Lattanzi

    (GSK, Clinical Research and Development Centre)

  • Michele Pellegrini

    (GSK, Clinical Research and Development Centre)

Abstract

Introduction The currently licensed quadrivalent MenACWY-CRM conjugate vaccine presentation consists of two vials (lyophilized MenA and liquid MenCWY) to be reconstituted before injection. A new fully liquid, single-vial formulation has been developed to simplify administration and prevent reconstitution errors. We present pooled safety data from two randomized, controlled, observer-blind phase 2b clinical trials, in which the fully liquid presentation was compared with the licensed presentation. Methods This is a post hoc analysis of two studies, in which safety data from participants aged 10–40 years who received one dose of either liquid MenACWY-CRM (1337 participants; MenACWY liquid group) or licensed MenACWY-CRM (1332 participants; MenACWY licensed group) were pooled. Frequencies were calculated for solicited adverse events (AEs) during 7 days post-vaccination and unsolicited AEs, including medically attended AEs and serious AEs (SAEs), during the 6-month safety follow-up period. Analysis results are presented by vaccine group, overall and by age category (10–17 and 18–40 years). Results Overall, AEs solicited for collection during the first 7 days after vaccination were reported by similar percentages of participants (69.2%, MenACWY liquid; 68.2%, MenACWY licensed), and were generally mild/moderate in intensity. Solicited local AEs were reported by 46.0% of the MenACWY liquid group and 43.5% of the MenACWY licensed group and solicited systemic AEs by 55.2 and 54.1%, respectively. During the 6-month post-vaccination period, unsolicited AEs were reported by 32.2 and 31.2% of the MenACWY liquid group and MenACWY licensed group, respectively, and medically attended AEs by 18.6 and 17.3%, respectively. Overall, 14 participants in each group (1.0 and 1.1%, respectively) reported SAEs, none of which was considered vaccine-related by the investigator. The safety profiles of both MenACWY-CRM presentations were similar for each age group and overall. Conclusions This pooled analysis shows the safety profile of fully liquid MenACWY-CRM is comparable with that of the currently licensed vaccine presentation. Clinical Trial Registration ClinicalTrials.gov Identifiers: NCT03652610 (August 29, 2018), NCT03433482 (14 February 2018). Graphical abstract

Suggested Citation

  • Puneet Vir Singh & Paola Tiberi & Gabriele Filippo Di Domenico & Valerio Romolini & Thembile Mzolo & Marco Costantini & Tauseefullah Akhund & Venere Basile & Maria Lattanzi & Michele Pellegrini, 2023. "Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis," Drug Safety, Springer, vol. 46(1), pages 99-108, January.
    • Handle: RePEc:spr:drugsa:v:46:y:2023:i:1:d:10.1007_s40264-022-01242-8
    DOI: 10.1007/s40264-022-01242-8
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