PMID- 35164991 OWN - NLM STAT- MEDLINE DCOM- 20220310 LR - 20220531 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 40 IP - 12 DP - 2022 Mar 15 TI - Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. PG - 1872-1878 LID - S0264-410X(22)00092-5 [pii] LID - 10.1016/j.vaccine.2022.01.046 [doi] AB - BACKGROUND: The MenB-FHbp vaccine (Trumenba(R)) is licensed in various countries for the prevention of meningococcal serogroup B disease in individuals >/= 10 years of age. The clinical development program included 11 completed trials where, in each trial, MenB-FHbp had an acceptable safety profile after a primary vaccination series was administered to individuals 10-65 years of age. However, the detection of potential rare events was limited because of individual clinical trial size. The current safety analysis evaluates pooled reactogenicity and other adverse events (AEs) reported in these trials to identify new safety signals not detectable in individual trials. METHODS: Eleven trials contributed safety data, of which 10 recorded local and systemic reactogenicity events; 8 of the trials were controlled, and reactogenicity data were pooled for 7 of these 8 trials. Additional AE evaluations included immediate AEs (IAEs), medically attended AEs (MAEs), serious AEs (SAEs), newly diagnosed chronic medical conditions (NDCMCs), and autoimmune or neuroinflammatory conditions. RESULTS: Local and systemic reactions were more frequent in the MenB-FHbp group (n = 15,294) compared with controls (n = 5509), although most reactions were transient and mild to moderate in severity. Frequencies of IAEs, SAEs, MAEs, NDCMCs, and autoimmune or neuroinflammatory conditions were similar between the MenB-FHbp and control groups. CONCLUSIONS: MenB-FHbp demonstrated a favorable safety and tolerability profile in the clinical development program of > 15,000 vaccine recipients >/= 10 years of age. No new safety signals were identified in the pooled analysis compared with data from the individual trials. Continued postmarketing safety surveillance is important for the identification of rare events. Clinicaltrials.gov: NCT01299480; NCT000808028; NCT00879814; NCT00780806; NCT01352845; NCT01352793; NCT01461993; NCT01323270; NCT01830855; NCT01461980; NCT01768117. CI - Copyright (c) 2022 Elsevier Ltd. All rights reserved. FAU - Beeslaar, Johannes AU - Beeslaar J AD - Pfizer Vaccine Clinical Research and Development, Horizon Building, Honey Lane, Hurley, SL6 6RJ, UK. Electronic address: johannes.beeslaar@pfizer.com. FAU - Mather, Susan AU - Mather S AD - Pfizer Worldwide Research and Development, 500 Arcola Rd, Collegeville, PA, USA. Electronic address: susan.mather@pfizer.com. FAU - Absalon, Judith AU - Absalon J AD - Pfizer Vaccine Clinical Research and Development, 401 North Middletown Rd, Pearl River, NY, USA. Electronic address: judith.absalon@pfizer.com. FAU - Eiden, Joseph J AU - Eiden JJ AD - Pfizer Vaccine Clinical Research and Development, 401 North Middletown Rd, Pearl River, NY, USA. Electronic address: eidenj@icloud.com. FAU - York, Laura J AU - York LJ AD - Pfizer Vaccine Medical Development, Scientific & Clinical Affairs, 500 Arcola Rd, Collegeville, PA, USA. Electronic address: laurayork@outlook.com. FAU - Crowther, Graham AU - Crowther G AD - Pfizer Vaccine Clinical Research and Development, Horizon Building, Honey Lane, Hurley, SL6 6RJ, UK. Electronic address: graham.crowther@pfizer.com. FAU - Maansson, Roger AU - Maansson R AD - Pfizer Vaccine Clinical Research and Development, 500 Arcola Rd, Collegeville, PA, USA. Electronic address: roger.maansson@pfizer.com. FAU - Maguire, Jason D AU - Maguire JD AD - Pfizer Vaccine Clinical Research and Development, 401 North Middletown Rd, Pearl River, NY, USA. Electronic address: jason.maguire@pfizer.com. FAU - Peyrani, Paula AU - Peyrani P AD - Pfizer Vaccine Clinical Research and Development, 500 Arcola Rd, Collegeville, PA, USA. Electronic address: paula.peyrani@pfizer.com. FAU - Perez, John L AU - Perez JL AD - Pfizer Vaccine Clinical Research and Development, 500 Arcola Rd, Collegeville, PA, USA. Electronic address: john.perez@pfizer.com. LA - eng SI - ClinicalTrials.gov/NCT00780806 SI - ClinicalTrials.gov/NCT01830855 SI - ClinicalTrials.gov/NCT01323270 SI - ClinicalTrials.gov/NCT01352793 SI - ClinicalTrials.gov/NCT01768117 SI - ClinicalTrials.gov/NCT01461993 SI - ClinicalTrials.gov/NCT01299480 SI - ClinicalTrials.gov/NCT00879814 SI - ClinicalTrials.gov/NCT01461980 SI - ClinicalTrials.gov/NCT01352845 SI - ClinicalTrials.gov/NCT00808028 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220211 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antigens, Bacterial) RN - 0 (Meningococcal Vaccines) SB - IM MH - Antigens, Bacterial MH - Child MH - Clinical Trials as Topic MH - Humans MH - Immunotherapy MH - *Meningococcal Infections/prevention & control MH - *Meningococcal Vaccines/adverse effects MH - *Neisseria meningitidis, Serogroup B MH - Records OTO - NOTNLM OT - Clinical trial OT - Invasive meningococcal disease OT - Safety OT - Serogroup B OT - Vaccines 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 or former employees of Pfizer Inc and may hold stock or stock options. EDAT- 2022/02/16 06:00 MHDA- 2022/03/11 06:00 CRDT- 2022/02/15 05:33 PHST- 2020/11/16 00:00 [received] PHST- 2022/01/20 00:00 [revised] PHST- 2022/01/24 00:00 [accepted] PHST- 2022/02/16 06:00 [pubmed] PHST- 2022/03/11 06:00 [medline] PHST- 2022/02/15 05:33 [entrez] AID - S0264-410X(22)00092-5 [pii] AID - 10.1016/j.vaccine.2022.01.046 [doi] PST - ppublish SO - Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.