PMID- 36283896 OWN - NLM STAT- MEDLINE DCOM- 20221130 LR - 20230126 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 40 IP - 49 DP - 2022 Nov 22 TI - Clinical trial and postmarketing safety experience with MenACWY-TT, a meningococcal group A, C, W, and Y tetanus conjugate vaccine. PG - 7014-7021 LID - S0264-410X(22)01197-5 [pii] LID - 10.1016/j.vaccine.2022.09.077 [doi] AB - BACKGROUND: The meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix(R); Pfizer Ltd, Sandwich, Kent, UK) is licensed in more than 80 countries worldwide for the prevention of meningococcal disease caused by serogroups A, C, W, and Y in individuals throughout their lifespans. This report summarizes safety data from the MenACWY-TT clinical development program and postmarketing experience. METHODS: Within the clinical study program, reactogenicity data were based on 3 primary studies, including a large pooled analysis across multiple age groups, and long-term safety data were derived from 3 studies evaluating long-term antibody persistence. Postmarketing safety data through April 19, 2021, were collected and analyzed in connection with the MenACWY-TT Periodic Safety Update Report. RESULTS: Approximately 32 million doses of MenACWY-TT have been administered worldwide, with more than 21,530 additional individuals receiving MenACWY-TT as part of clinical trials. The safety profile of MenACWY-TT was consistent between the clinical study program and the postmarketing experience, as well as with other licensed meningococcal vaccines. The most commonly observed adverse events (AEs) were pyrexia/fever, headache, injection site pain/reactions, nausea/vomiting, and fatigue; serious AEs were rare relative to the number of doses administered. Several cases of serogroup replacement/lack of efficacy were observed in the 1-year postmarketing period but did not appear to be related to MenACWY-TT use. CONCLUSION: Extensive data derived from clinical trials and postmarketing experience indicate a consistently favorable safety profile for MenACWY-TT across a wide range of age groups. CI - Copyright (c) 2022 The Pfizer Inc, The Author(s). Published by Elsevier Ltd.. All rights reserved. FAU - Serra, Lidia AU - Serra L AD - Pfizer Vaccine Emerging Markets and China Medical and Scientific Affairs, Collegeville, PA, USA. FAU - Webber, Chris AU - Webber C AD - Pfizer Vaccine Clinical Research and Development, Hurley, UK. FAU - Burman, Cindy AU - Burman C AD - Pfizer Vaccine Medical Development and Scientific/Clinical Affairs, Collegeville, PA, USA. FAU - Bueti, Patrizia AU - Bueti P AD - Pfizer Worldwide Safety, Safety Surveillance and Risk Management, Collegeville, PA, USA. FAU - Gorruso, Maria AU - Gorruso M AD - Pfizer Worldwide Safety, Safety Surveillance and Risk Management, Collegeville, PA, USA. FAU - Mather, Susan AU - Mather S AD - Pfizer Worldwide Safety, Safety Surveillance and Risk Management, Collegeville, PA, USA. Electronic address: Susan.Mather@pfizer.com. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20221022 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Bacterial) RN - 0 (Meningococcal Vaccines) RN - 0 (Tetanus Toxoid) RN - 0 (tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine) RN - 0 (Vaccines, Combined) RN - 0 (Vaccines, Conjugate) SB - IM MH - Humans MH - Antibodies, Bacterial MH - Fever/chemically induced MH - Injection Site Reaction MH - *Meningococcal Infections/prevention & control MH - *Meningococcal Vaccines/adverse effects MH - Neisseria meningitidis MH - Tetanus MH - *Tetanus Toxoid/adverse effects MH - Vaccines, Combined MH - Vaccines, Conjugate/adverse effects MH - Clinical Trials as Topic OTO - NOTNLM OT - Clinical OT - MenACWY-TT OT - Meningococcal OT - Postmarketing OT - Safety COIS- Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors are employees of Pfizer Inc and may hold stock or stock options. EDAT- 2022/10/26 06:00 MHDA- 2022/11/22 06:00 CRDT- 2022/10/25 22:04 PHST- 2022/01/10 00:00 [received] PHST- 2022/09/23 00:00 [revised] PHST- 2022/09/26 00:00 [accepted] PHST- 2022/10/26 06:00 [pubmed] PHST- 2022/11/22 06:00 [medline] PHST- 2022/10/25 22:04 [entrez] AID - S0264-410X(22)01197-5 [pii] AID - 10.1016/j.vaccine.2022.09.077 [doi] PST - ppublish SO - Vaccine. 2022 Nov 22;40(49):7014-7021. doi: 10.1016/j.vaccine.2022.09.077. Epub 2022 Oct 22.