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
| Autor: | Tiina Eriksson, Dan Bi, Eero Pukkala, Frank Struyf, Kari Natunen, Julia Zima, Mari Hokkanen, Jorma Paavonen, Marie-Pierre David, Matti Lehtinen, Dan Apter, Maria-Genalin Angelo, Gary Dubin, Sanjoy K Datta |
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| Přispěvatelé: | Clinicum, Department of Obstetrics and Gynecology, University of Helsinki, HUS Gynecology and Obstetrics |
| Rok vydání: | 2016 |
| Předmět: |
Male
Pediatrics insulin-dependent diabetes mellitus ADVISORY-COMMITTEE HPV-16/18 AS04-adjuvanted vaccine Aluminum Hydroxide law.invention HPV VACCINATION DOUBLE-BLIND 0302 clinical medicine Randomized controlled trial law 3123 Gynaecology and paediatrics Immunology and Allergy Medicine 030212 general & internal medicine adolescents Child 1183 Plant biology microbiology virology Finland CROSS-PROTECTIVE EFFICACY 318 Medical biotechnology 3. Good health Vaccination Lipid A 030220 oncology & carcinogenesis GIRLS Female CLINICAL-TRIALS Research Paper safety medicine.medical_specialty Adolescent Drug-Related Side Effects and Adverse Reactions Immunology autoimmune disease Autoimmune Diseases POOLED ANALYSIS 03 medical and health sciences IMMUNIZATION PRACTICES Humans Hepatitis B Vaccines Papillomavirus Vaccines Adverse effect Pharmacology Hepatitis Human papillomavirus (HPV) Reactogenicity business.industry Papillomavirus Infections Interim analysis medicine.disease Confidence interval Clinical trial ADVERSE EVENTS business FOLLOW-UP |
| Zdroj: | Human Vaccines & Immunotherapeutics |
| ISSN: | 2164-554X |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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