6: Additional pharmacovigilance activities (planned or ongoing) Additional activity Assigned safety Actions/outcome concern proposed planned of final data Pregnancy Registry Exposure to To monitor 9 months (category 3). vaccine during pregnancy after final pregnancy. outcomes in data Planned study. women exposed to available No protocol 9vHPV vaccine available; concept during pregnancy. sheet available. V503-021 Nordic Viral type To monitor the Q4, 2027 Long-term replacement long term safety of (first Study (10-Year 9vHPVvaccine. Long-term interim extension in subjects Effectiveness/ report: from V503-001) Immunogenicity Q4, 2017) (category 3). Unanticipated Planned study safety signals (extension of Registry – study. Protocol available. V503-002-20 Post Long-term To evaluate Dose 3 Follow-Up Effectiveness/ Study (10-Year Post Immunogenicity immunogenicity Dose 3 Extension) and safety of V503 Unanticipated (category 3). in subjects who safety signals were enrolled in Planned study Protocol V503-002 (second extension of when they were V503-002) Clinical – between 9 and 15 trial. of age. Protocol available. Post Authorization Unanticipated To assess the Safety Study (PASS) safety signals general safety of (category 3). V503 in the course of routine clinical Planned study. practice. No protocol available; concept available.
6: Additional pharmacovigilance activities (planned or ongoing) Additional activity Assigned safety concern Actions/outcome proposed planned of final data Pregnancy Registry (category 3). Planned study. No protocol available; concept sheet available. Exposure to vaccine during pregnancy. To monitor pregnancy outcomes in women exposed to 9vHPV vaccine during pregnancy. 9 months after final data available V503-021 Nordic Long-term Study (10-Year extension in subjects from V503-001) (category 3). Planned study (extension of – Registry study. Protocol available. Viral type replacement Long-term Effectiveness/ Immunogenicity Unanticipated safety signals To monitor the long term safety of 9vHPVvaccine. Q4, 2027 (first interim report: Q4, 2017) V503-002-20 Post Dose 3 Follow-Up Study (10-Year Post Dose 3 Extension) (category 3). Planned study (second extension of V503-002) – Clinical trial. Protocol available. Long-term Effectiveness/ Immunogenicity Unanticipated safety signals To evaluate immunogenicity and safety of V503 in subjects who were enrolled in Protocol V503-002 when they were between 9 and 15 of age. Post Authorization Safety Study (PASS) (category 3). Planned study. No protocol available; concept available. Unanticipated safety signals To assess the general safety of V503 in the course of routine clinical practice.
auspar-human-papillomavirus-9-valent-vaccine-170103.docx