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

Puneet Vir Singh, Paola Tiberi, Gabriele Filippo Di Domenico, Valerio Romolini, Thembile Mzolo, Marco Costantini, Tauseefullah Akhund, Venere Basile, Maria Lattanzi and Michele Pellegrini ()
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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

Drug Safety, 2023, vol. 46, issue 1, No 8, 99-108

Abstract: 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

Date: 2023
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DOI: 10.1007/s40264-022-01242-8

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