{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T15:57:00Z","timestamp":1772639820422,"version":"3.50.1"},"reference-count":14,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2020,5,20]],"date-time":"2020-05-20T00:00:00Z","timestamp":1589932800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Protein Sciences"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Recombinant trivalent influenza vaccine (RIV3) was initially licensed in 2013 and approved for all adults\u2005\u226518 in 2014. This study evaluated the safety of RIV3 compared with trivalent standard-dose, inactivated influenza vaccine (IIV3) in Kaiser Permanente Northern California (KPNC).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This Phase 4 observational, postmarketing safety study included persons\u2005\u226518 years vaccinated with RIV3 or IIV3 in KPNC during the 2015\u20132016 influenza season. We compared (1) the rates of prespecified diagnoses of interest (Guillain-Barr\u00e9 Syndrome, pericarditis, pleural effusion, narcolepsy\/cataplexy, asthma, acute hypersensitivity reactions, and fever) during various postvaccination risk intervals as well as (2) all-cause hospitalization and mortality 0\u2013180 days after vaccination. We estimated odds ratios (ORs) and 95% confidence intervals (CIs) using logistic regression analyses adjusted for age, sex, race\/ethnicity, month of vaccination, and concomitant receipt of other vaccinations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Comparing the 21\u2005976 persons who received RIV3 with the 283\u2005683 who received IIV3, there were statistically significant differences in the prespecified diagnoses of interest between the 2 groups. Specifically, RIV3 vaccination was associated with fewer fever diagnoses during the 0\u201341 days postvaccination (OR, 0.38; 95% CI, 0.14\u20130.86). Also, RIV3 was associated with fewer all-cause hospitalizations during the 0\u2013180 days postvaccination (OR, 0.66; 95% CI, 0.61\u20130.73), which was mostly related to pregnancy-related hospitalizations in IIV3 recipients. There were no serious adverse events or deaths related to RIV3.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This study did not identify any safety concerns regarding the use of RIV3 in adults.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ofid\/ofaa179","type":"journal-article","created":{"date-parts":[[2020,5,20]],"date-time":"2020-05-20T19:58:15Z","timestamp":1590004695000},"source":"Crossref","is-referenced-by-count":6,"title":["Safety of Recombinant Influenza Vaccine Compared to Inactivated Influenza Vaccine in Adults: An Observational Study"],"prefix":"10.1093","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7891-2673","authenticated-orcid":false,"given":"John","family":"Hansen","sequence":"first","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center, Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristin","family":"Goddard","sequence":"first","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center, Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julius","family":"Timbol","sequence":"first","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center, Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lea","family":"Zhang","sequence":"first","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center, Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ned","family":"Lewis","sequence":"first","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center, Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2973-0245","authenticated-orcid":false,"given":"Lisa","family":"Dunkle","sequence":"first","affiliation":[{"name":"Sanofi Pasteur, Swiftwater, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruvim","family":"Izikson","sequence":"first","affiliation":[{"name":"Sanofi Pasteur, Swiftwater, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1777-4814","authenticated-orcid":false,"given":"Nicola P","family":"Klein","sequence":"first","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center, Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2020,5,20]]},"reference":[{"key":"2020062514034023200_CIT0001","article-title":"Centers for Disease Control and Prevention, National Center for Immunization and Respiratory 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