Safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in adolescents aged 12-15 years : Interim analysis of a large community-randomized controlled trial

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Lehtinen , M , Eriksson , T , Apter , D , Hokkanen , M , Natunen , K , Paavonen , J , Pukkala , E , Angelo , M-G , Zima , J , David , M-P , Datta , S , Bi , D , Struyf , F & Dubin , G 2016 , ' Safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in adolescents aged 12-15 years : Interim analysis of a large community-randomized controlled trial ' , Human Vaccines & Immunotherapeutics , vol. 12 , no. 12 , pp. 3177-3185 . https://doi.org/10.1080/21645515.2016.1183847

Title: Safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in adolescents aged 12-15 years : Interim analysis of a large community-randomized controlled trial
Author: Lehtinen, Matti; Eriksson, Tiina; Apter, Dan; Hokkanen, Mari; Natunen, Kari; Paavonen, Jorma; Pukkala, Eero; Angelo, Maria-Genalin; Zima, Julia; David, Marie-Pierre; Datta, Sanjoy; Bi, Dan; Struyf, Frank; Dubin, Gary
Contributor: University of Helsinki, Clinicum
Date: 2016
Language: eng
Number of pages: 9
Belongs to series: Human Vaccines & Immunotherapeutics
ISSN: 2164-5515
URI: http://hdl.handle.net/10138/176241
Abstract: This community-randomized controlled trial was initiated to assess the overall and herd effects of 2 different human papillomavirus (HPV) immunization strategies in over 80,000 girls and boys aged 1215 y in 33 communities in Finland (ClinicalTrials.gov NCT00534638). Overall, 14,838 adolescents received HPV-16/18 vaccine (2,440 boys and 12,398 girls) and 17,338 received hepatitis-B virus (HBV) vaccine {9,221 boys and 8,117 girls). In an interim analysis, vaccine safety was assessed by active monitoring and surveillancece via health registry linkage. Active monitoring showed that the HPV-16/18 vaccine has acceptable safety and reactogenicity in boys. In all study participants, the observed incidences (per 100,000 person-years) of serious adverse events (SAEs) possibly, related to vaccination were 54.3 (95% Confidence Interval [CI]: 34.0-82.1) in the HPV-16/18 group and 64.0 (95% CI: 43.2-91.3) in the HBV group. During the follow-up period for this interim analysis, the most common new-onset autoimmune diseases (NOADs; with incidence rate >= 15 per 100,000) in any group based on hospital discharge registry (HILMO) download were ulcerative colitis, juvenile arthritis, celiac disease insulin-dependent diabetes mellitus (IDDM) and Crohn's disease. No increased NOAD incidences were observed in HPV-16/18 vaccine recipients compared to HBV vaccine recipients. In both the SAE possibly related- and HILMO-analyses, a lower incidence of IDDM was observed in HPV-16/18 vaccinees compared to HBV vaccinees (relative risks, 0.26 [95% CI: 0.03-1.24] and 0.16 [95% CI: 0.03-0.55], respectively).
Subject: Human papillomavirus (HPV)
HPV-16/18 AS04-adjuvanted vaccine
adolescents
safety
autoimmune disease
insulin-dependent diabetes mellitus
CROSS-PROTECTIVE EFFICACY
HPV VACCINATION
POOLED ANALYSIS
IMMUNIZATION PRACTICES
ADVISORY-COMMITTEE
CLINICAL-TRIALS
ADVERSE EVENTS
DOUBLE-BLIND
FOLLOW-UP
GIRLS
3123 Gynaecology and paediatrics
1183 Plant biology, microbiology, virology
318 Medical biotechnology
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