PMID- 36369456
OWN - NLM
STAT- MEDLINE
DCOM- 20230111
LR  - 20230123
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Print)
IS  - 0114-5916 (Linking)
VI  - 46
IP  - 1
DP  - 2023 Jan
TI  - Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis.
PG  - 99-108
LID - 10.1007/s40264-022-01242-8 [doi]
AB  - 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).
CI  - (c) 2022. GSK.
FAU - Vir Singh, Puneet
AU  - Vir Singh P
AUID- ORCID: 0000-0002-1363-7815
AD  - GSK, Safety Evaluation and Risk Management, Siena, Italy.
FAU - Tiberi, Paola
AU  - Tiberi P
AUID- ORCID: 0000-0001-7970-4980
AD  - GSK, Safety Evaluation and Risk Management, Siena, Italy.
FAU - Di Domenico, Gabriele Filippo
AU  - Di Domenico GF
AUID- ORCID: 0000-0001-9848-7360
AD  - GSK, Biostatistics and Statistical Programming, Siena, Italy.
FAU - Romolini, Valerio
AU  - Romolini V
AD  - GSK, Biostatistics and Statistical Programming, Siena, Italy.
FAU - Mzolo, Thembile
AU  - Mzolo T
AUID- ORCID: 0000-0002-9453-6302
AD  - GSK, Biostatistics, Amsterdam, The Netherlands.
FAU - Costantini, Marco
AU  - Costantini M
AUID- ORCID: 0000-0003-4709-2590
AD  - GSK, Biostatistics and Statistical Programming, Siena, Italy.
FAU - Akhund, Tauseefullah
AU  - Akhund T
AD  - GSK, Clinical Research and Development Centre, Siena, Italy.
FAU - Basile, Venere
AU  - Basile V
AUID- ORCID: 0000-0002-7475-7749
AD  - GSK, Global Clinical Operations, Siena, Italy.
FAU - Lattanzi, Maria
AU  - Lattanzi M
AUID- ORCID: 0000-0002-3457-426X
AD  - GSK, Clinical Research and Development Centre, Siena, Italy.
FAU - Pellegrini, Michele
AU  - Pellegrini M
AUID- ORCID: 0000-0001-8505-9260
AD  - GSK, Clinical Research and Development Centre, Siena, Italy. 
      michele.x.pellegrini@gsk.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT03652610
SI  - ClinicalTrials.gov/NCT03433482
SI  - ClinicalTrials.gov/NCT03652610
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221111
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (MenACWY-CRM vaccine)
SB  - IM
MH  - Humans
MH  - *Vaccination/methods
PMC - PMC9829640
COIS- PVS, PT, GFDD, VR, TM, MC, VB, ML, and MP are employed by GSK. TA was employed by 
      GSK when the analyses were conducted. PVS, TA, VB, ML, and MP hold shares in GSK. 
      PVS, PT, GFDD, VR, TM, MC, TA, VB, ML, and MP declare no other financial and 
      non-financial relationships and activities.
EDAT- 2022/11/13 06:00
MHDA- 2023/01/12 06:00
PMCR- 2022/11/11
CRDT- 2022/11/12 00:36
PHST- 2022/09/19 00:00 [accepted]
PHST- 2022/11/13 06:00 [pubmed]
PHST- 2023/01/12 06:00 [medline]
PHST- 2022/11/12 00:36 [entrez]
PHST- 2022/11/11 00:00 [pmc-release]
AID - 10.1007/s40264-022-01242-8 [pii]
AID - 1242 [pii]
AID - 10.1007/s40264-022-01242-8 [doi]
PST - ppublish
SO  - Drug Saf. 2023 Jan;46(1):99-108. doi: 10.1007/s40264-022-01242-8. Epub 2022 Nov 
      11.