View Document Preview and Link Open Document File Size: 376,25 KB Share Result on Facebook Company Merck & Co. Inc. / Dohme Ltd. / AEs / Materials Reviewed Document Type Document Merck & Co. Inc / 9vHPVgroup / Merck / Appendicitis 9 16 Infectious / / Country United States / Brazil / Denmark / / Event FDA Phase / Product Recall / Product Issues / / IndustryTerm 9vHPV / recombinant systems / qHPV / prevention of cervical cancer / control / dose / adverse events injection-site non-injection-site / highdose 9vHPV vaccine groups / injection-site / dose 9vHPV / 9vHPV groups / dose 9vHPV vaccine groups / administration site / prevention of anal cancer / qHPV vaccine / prevention of vaginal and vulvar cancer / / MedicalCondition cervical cancers / common gynecologic cancer / anal cancer / Influenza-like illness / headache / polio virus / Hypervolemic shock / diphtheria / nausea / tetanus / anaphylaxis / Infectious / sarcoidosis / Syncope / genital warts / fatigue / Diarrhoea Nausea General disorders / CIN / hypersensitivity / diarrhea / pruritus / influenza / infectious etiology / asthma / abdominal pain / Fetal distress syndrome / hypovolemic and septic shock / necrosis / severe allergic reaction / volvulus / disease / nasopharyngitis / pertussis / HPV / cervical cancer / erythema / Multiple injuries / allergy / fever / Malignant melanoma / Cervical intraepithelial neoplasia / vaginal and vulvar cancer / acute lymphoblastic leukemia / pain / anal cancers / persistent infections / INTRODUCTION Cervical cancer / diseases / anogenital cancers / dizziness / Renal failure / spontaneous abortion / Fatigue Pyrexia Infections / rash / infectious disease / Bipolar disorder / Appendicitis / / MedicalTreatment vaccination / abdominal surgeries / vaccinations / / Organization office of Biostatistics / Department of Health and Human Services Food and Drug Administration Center / 9vHPV administration / FDA / / Person Women Dose-ranging / Virus-Like Particle (Vlp) / Adamma Mba‐Jonas / Haruhiko Murata / / Position investigator / Diarrhoea Nausea General / infectious disease specialist / BLA Chair / Acting Chief / Associate Director for Product Safety / Medical Officer / / Product sodium chloride / Dose-ranging Substudy Injection / Study medication / V503001 / V503-001 / V503-007 / V503-002 / US / V503-005 / HPV / V503-009 / V503-006 / / Technology 9 Protocol / / SocialTag