{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T13:07:46Z","timestamp":1789736866774,"version":"4.0.1"},"reference-count":44,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2014,2,20]],"date-time":"2014-02-20T00:00:00Z","timestamp":1392854400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2014,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>The purpose of this study is to further evaluate the safety of the human papillomavirus (HPV)\u201016\/18\u2010AS04\u2010adjuvanted vaccine (HPV\u201016\/18\u2010vaccine <jats:italic>Cervarix<\/jats:italic>\u00ae, GlaxoSmithKline, Belgium) through a pooled analysis of data from 42 completed\/ongoing clinical studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Unsolicited adverse events (AEs) were reported for 30\u2009days after each dose. Medically significant conditions, serious AEs (SAEs), potential immune\u2010mediated diseases (pIMDs) and pregnancy outcomes were captured until study completion. Events leading to subject withdrawal were reviewed. Relative risks compared incidences of spontaneous abortion and pIMDs in controlled studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirty one thousand one hundred seventy\u2010three adolescent girls\/women received HPV\u201016\/18\u2010vaccine alone (HPV group), 2166 received HPV\u201016\/18\u2010vaccine coadministered with another vaccine and 24\u2009241 were controls. Mean follow\u2010up was 39\u2009months (range 0\u2013113.3). Incidences of unsolicited AEs reported within 30\u2009days after any dose were similar between HPV and Control groups (30.8%\/29.7%). During the entire study period, reports of medically significant conditions (25.0%\/28.3%) and SAEs (7.9%\/9.3%) were also similarly distributed between groups. Deaths were rare: HPV (alone\/coadministered) <jats:italic>n<\/jats:italic>\u2009=\u200925, controls <jats:italic>n<\/jats:italic>\u2009=\u200920 (<jats:italic>n<\/jats:italic>\u2009=\u200918 in blinded groups). pIMDs within 1\u2009year were reported by 0.2% of HPV\u201016\/18 vaccinees and controls. For each pIMD event category, no increased relative risks were reported for HPV\u201016\/18 vaccinees versus controls. Coadministration did not change the overall safety profile. Pregnancy outcomes and withdrawal rates were similar between groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Analysis of safety data arising from 57\u2009580 subjects and 96\u2009704 HPV\u201016\/18\u2010vaccine doses shows that the incidences and distribution of AEs were similar among HPV\u201016\/18\u2010vaccine recipients and controls. No new safety signals were identified. The data confirm previous findings that HPV\u201016\/18\u2010vaccine has an acceptable benefit\u2010risk profile in adolescent girls and adult women. \u00a9 2014 GlaxoSmithKline. <jats:italic>Pharmacoepidemiology and Drug Safety<\/jats:italic> published by John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3554","type":"journal-article","created":{"date-parts":[[2014,2,20]],"date-time":"2014-02-20T17:42:33Z","timestamp":1392918153000},"page":"466-479","source":"Crossref","is-referenced-by-count":85,"title":["Pooled analysis of large and long\u2010term safety data from the human papillomavirus\u201016\/18\u2010AS04\u2010adjuvanted vaccine clinical trial programme"],"prefix":"10.1002","volume":"23","author":[{"given":"Maria\u2010Genalin","family":"Angelo","sequence":"first","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie\u2010Pierre","family":"David","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Zima","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurence","family":"Baril","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Dubin","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines  King of Prussia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felix","family":"Arellano","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Struyf","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,2,20]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(10)70230-8"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2011.04.046"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)61248-4"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)68439-0"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)17398-4"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(11)70287-X"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.4161\/hv.18865"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/IGC.0b013e3181da2128"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2010.07.007"},{"key":"e_1_2_9_11_1","unstructured":"AngeloM ZimaJ TavaresF BarilL ArellanoF.Post\u2010licensure safety surveillance for AS04\u2010adjuvanted Human Papillomavirus vaccine: more than 4 years of experience.Pharmacoepidemiol Drug Safsubmitted for publication."},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.4161\/hv.5.5.7211"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2013.01.042"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.3109\/08830181003746304"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinids\/12.2.204"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/08916930500050277"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2008.09.049"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102796.2011.02467.x"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.aje.a009747"},{"key":"e_1_2_9_20_1","doi-asserted-by":"crossref","first-page":"282","DOI":"10.1177\/014107680109400607","article-title":"Design or accident? 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