{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T11:54:34Z","timestamp":1791806074562,"version":"4.3.4"},"reference-count":39,"publisher":"Public Library of Science (PLoS)","issue":"6","license":[{"start":{"date-parts":[[2022,6,3]],"date-time":"2022-06-03T00:00:00Z","timestamp":1654214400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Victorian Government\u2019s Operational Infrastructure Support Program"},{"name":"Australian Government Research Training Program Scholarship"},{"name":"MCRI PhD Top Up Scholarship"},{"DOI":"10.13039\/501100001711","name":"Schweizerischer Nationalfonds zur F\u00f6rderung der Wissenschaftlichen Forschung","doi-asserted-by":"publisher","award":["Early Postdoc Mobility Grant, P2GEP3_178155"],"award-info":[{"award-number":["Early Postdoc Mobility Grant, P2GEP3_178155"]}],"id":[{"id":"10.13039\/501100001711","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Health and Medical Research Council Investigator Grant","award":["GNT1197117"],"award-info":[{"award-number":["GNT1197117"]}]},{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["INV-017302"],"award-info":[{"award-number":["INV-017302"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100016056","name":"Minderoo Foundation","doi-asserted-by":"crossref","award":["COV-001"],"award-info":[{"award-number":["COV-001"]}],"id":[{"id":"10.13039\/501100016056","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Sarah and Lachlan Murdoch"},{"DOI":"10.13039\/100014607","name":"Royal Children's Hospital Foundation","doi-asserted-by":"publisher","award":["2020-1263 BRACE Trial"],"award-info":[{"award-number":["2020-1263 BRACE Trial"]}],"id":[{"id":"10.13039\/100014607","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Health Services Union NSW"},{"DOI":"10.13039\/501100014093","name":"Peter Sowerby Foundation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100014093","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Ministry of Health Government of South Australia"},{"name":"the NAB Foundation"},{"name":"Calvert-Jones Foundation"},{"name":"Modara Pines Charitable Foundation"},{"name":"UHG Foundation Pty Ltd"},{"name":"Epworth Healthcare"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>With the emergence of novel vaccines and new applications for older vaccines, co-administration is increasingly likely. The immunomodulatory effects of BCG could theoretically alter the reactogenicity of co-administered vaccines. Using active surveillance in a randomised controlled trial, we aimed to determine whether co-administration of BCG vaccination changes the safety profile of influenza vaccination.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>Participants who received influenza vaccine alone (Influenza group) were compared with those who also received BCG-Denmark vaccine in the contralateral arm (Influenza+BCG group). Data on the influenza vaccination site were collected using serial questionnaires and active follow-up for 3 months post vaccination.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>Of 1351 participants in the Influenza+BCG group and 1418 participants in the Influenza group, 2615 (94%) provided influenza vaccine safety data. There was no significant difference in the proportion of participants with any local adverse reaction between the Influenza+BCG group and the Influenza group (918\/1293 [71.0%] versus (906\/1322 [68.5%], p = 0.17). The proportion of participants reporting any pain, erythema and tenderness at the influenza vaccination site were similar in both groups. Swelling was less frequent (81\/1293 [6.3%] versus 119\/1322 (9.0%), p = 0.01) and the maximal diameter of erythema was smaller (mean 1.8 cm [SD 2.0] versus 3.0 cm [SD 2.5], p&lt;0.001) in the Influenza+BCG group. Sixteen participants reported serious adverse events: 9 participants in the Influenza+BCG group and 7 in the Influenza group.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>Adverse events following influenza vaccination are not increased when BCG is co-administered.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0268042","type":"journal-article","created":{"date-parts":[[2022,6,3]],"date-time":"2022-06-03T17:38:04Z","timestamp":1654277884000},"page":"e0268042","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":4,"title":["The safety of co-administration of Bacille Calmette-Gu\u00e9rin (BCG) and influenza vaccines"],"prefix":"10.1371","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6504-2979","authenticated-orcid":true,"given":"Paola","family":"Villanueva","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ushma","family":"Wadia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nigel W.","family":"Crawford","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole L.","family":"Messina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2403-9762","authenticated-orcid":true,"given":"Tobias R.","family":"Kollmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michaela","family":"Lucas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4334-5351","authenticated-orcid":true,"given":"Laurens","family":"Manning","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Richmond","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laure F.","family":"Pittet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nigel","family":"Curtis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2022,6,3]]},"reference":[{"key":"pone.0268042.ref001","article-title":"Accelerated COVID-19 vaccine development: milestones, lessons, and prospects","author":"K Bok","year":"2021","journal-title":"Immunity"},{"key":"pone.0268042.ref002","unstructured":"Immunization Action Coalition. 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