Abstract
ABSTRACT This manuscript discloses end-of-study safety data of a community-randomized controlled trial in Finland (NCT00534638), assessing the effectiveness of two vaccination strategies (gender-neutral versus females only) using the AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18) vaccine. The total vaccination cohort included 32,175 adolescents aged 12–15 y at vaccination of whom 14,837 received the AS04-HPV-16/18 vaccine and 17,338 received the hepatitis-B virus vaccine (control). Spontaneous reporting of serious adverse events (SAEs) combined with surveillance using nation-wide health registries showed an acceptable safety profile of the AS04-HPV-16/18 vaccine. During the study period (up to 6.5 y), the incidences (per 100,000 person-years) of reported SAEs considered as possibly related to vaccination were 39.1 (95% confidence interval [CI]: 25.3–57.7) and 39.8 (95%CI: 26.8–56.8) in the HPV and control groups, respectively. The most frequently reported new-onset autoimmune diseases (NOADs) were ulcerative colitis (incidence rates of 28.2 and 33.1 per 100,000 person-years in the HPV and control groups, respectively), insulin-dependent diabetes mellitus (21.9 and 37.1), Crohn’s disease (15.6 and 22.5), celiac disease (15.6 and 21.2), and juvenile idiopathic arthritis (14.1 and 15.9). Of 1,344 pregnancies reported (777 and 567 in the HPV and control groups, respectively), most resulted in elective termination (58.4% and 58.6%), birth of a live infant (32.7% and 32.3%), or in spontaneous abortion (8.0% and 7.9%). No major, registered congenital anomalies were identified. The incidence rates of NOADs and pregnancy outcomes were generally balanced between groups. No specific safety signals were identified in the population-based health registry surveillance.
Highlights
Since the first licensure in 2007, more than 71 million doses of the prophylactic AS04-adjuvanted human papillomavirus (HPV)-16 and −18 (AS04-HPV-16/18) vaccine have been distributed worldwide.[1]
This study provides further unique, population-based safety data from vaccinated Finnish adolescents monitored via health registries up to 6.5 y of follow-up
The incidence rates of subjects experiencing at least one serious adverse events (SAEs) judged possibly related to vaccination according to the investigator and classified by the Medical Dictionary for Regulatory Activities (MedDRA) during the entire follow-up period were calculated by vaccine group for all participants and by gender with exact 95% confidence interval (CI), together with relative risk (RR) adjusted by gender
Summary
Since the first licensure in 2007, more than 71 million doses of the prophylactic AS04-adjuvanted human papillomavirus (HPV)-16 and −18 (AS04-HPV-16/18) vaccine have been distributed worldwide.[1] The vaccine was adjuvanted with an adjuvant system (AS04) containing 3-O-desacyl-4ʹ-. Monophosphoryl lipid A (50 μg MPL; produced by GSK) adsorbed on aluminum salt (500 μg Al3+) and has. This article has been republished with minor changes. These changes do not impact the academic content of the article.
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