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Following vaccination, a risk window of 2\u2009years was defined for AIT and IBD and 42\u2009days for GBS. Odds ratios (ORs) were estimated using three methods: meta\u2010analysis inverse\u2010variance with continuity correction (primary analysis), pooled estimate, and beta\u2010binomial regression.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In all studies apart from the case\u2010control study, 154\u2009398 exposed and 1 504\u2009322 non\u2010exposed subjects were included, among whom there were 141 and 1972 cases of (autoimmune) thyroiditis; 2 and 2 cases of GBS; and 43 and 401 cases of IBD, respectively. In the case\u2010control study, there were 97 cases of AIT and 13 of GBS; matched with 802 and 130 controls, respectively. The primary analysis OR estimates were 1.46 (95% confidence interval [CI] 1.22\u20101.76), 11.14 (2.00\u201061.92), and 1.11 (0.75\u20101.66) for (autoimmune) thyroiditis, GBS, and IBD, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This meta\u2010analysis did not show an increased risk of IBD following vaccination with AS04\u2010HPV\u201016\/18. The 1.5\u2010fold increased risk of (autoimmune) thyroiditis does not allow us to conclude about a causal association. For GBS, the very low number of cases and wide 95% CIs negate any firm conclusion.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5063","type":"journal-article","created":{"date-parts":[[2020,6,25]],"date-time":"2020-06-25T03:49:52Z","timestamp":1593056992000},"page":"1159-1167","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Meta\u2010analysis of the risk of autoimmune thyroiditis, <scp>Guillain\u2010Barr\u00e9<\/scp> syndrome, and inflammatory bowel disease following vaccination with <scp>AS04<\/scp>\u2010adjuvanted human papillomavirus 16\/18 vaccine"],"prefix":"10.1002","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7230-1978","authenticated-orcid":false,"given":"Dominique","family":"Rosillon","sequence":"first","affiliation":[{"name":"Research and Development GSK  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6310-6019","authenticated-orcid":false,"given":"Corinne","family":"Willame","sequence":"additional","affiliation":[{"name":"Research and Development GSK  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fernanda","family":"Tavares Da Silva","sequence":"additional","affiliation":[{"name":"Research and Development GSK  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrienne","family":"Guignard","sequence":"additional","affiliation":[{"name":"Research and Development GSK  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sophie","family":"Caterina","sequence":"additional","affiliation":[{"name":"Research and Development GSK  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Welby","sequence":"additional","affiliation":[{"name":"Research and Development GSK  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Struyf","sequence":"additional","affiliation":[{"name":"Research and Development GSK  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,6,24]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"European Medicines Agency. 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