PMID- 27422279 OWN - NLM STAT- MEDLINE DCOM- 20170615 LR - 20240210 IS - 1098-4275 (Electronic) IS - 0031-4005 (Linking) VI - 138 IP - 2 DP - 2016 Aug TI - Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. LID - e20154387 [pii] LID - 10.1542/peds.2015-4387 [doi] AB - OBJECTIVES: The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age. METHODS: Vaccination was administered as a 3-dose regimen at day 1, and months 2 and 6. More than 15 000 subjects received >/=1 dose of 9vHPV vaccine. In 2 of the studies, >7000 control subjects received >/=1 dose of quadrivalent HPV (qHPV) vaccine. Serious and nonserious adverse events (AEs) and new medical conditions were recorded throughout the study. Subjects testing positive for pregnancy at day 1 were not vaccinated; those who became pregnant after day 1 were discontinued from further vaccination until resolution of the pregnancy. Pregnancies detected after study start (n = 2950) were followed to outcome. RESULTS: The most common AEs (>/=5%) experienced by 9vHPV vaccine recipients were injection-site AEs (pain, swelling, erythema) and vaccine-related systemic AEs (headache, pyrexia). Injection-site AEs were more common in 9vHPV vaccine than qHPV vaccine recipients; most were mild-to-moderate in intensity. Discontinuations and vaccine-related serious AEs were rare (0.1% and <0.1%, respectively). Seven deaths were reported; none were considered vaccine related. The proportions of pregnancies with adverse outcome were within ranges reported in the general population. CONCLUSIONS: The 9vHPV vaccine was generally well tolerated in subjects aged 9 to 26 years with an AE profile similar to that of the qHPV vaccine; injection-site AEs were more common with 9vHPV vaccine. Its additional coverage and safety profile support widespread 9vHPV vaccination. CI - Copyright (c) 2016 by the American Academy of Pediatrics. FAU - Moreira, Edson D Jr AU - Moreira ED Jr AD - Associacao Obras Sociais Irma Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; edson@bahia.fiocruz.br. FAU - Block, Stan L AU - Block SL AD - Kentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky; FAU - Ferris, Daron AU - Ferris D AD - Department of Medicine, Medical College of Georgia, Augusta University, Augusta, Georgia; FAU - Giuliano, Anna R AU - Giuliano AR AD - Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, Florida; FAU - Iversen, Ole-Erik AU - Iversen OE AD - Department of Gynaecology, University of Bergen, Bergen, Norway; FAU - Joura, Elmar A AU - Joura EA AD - Department of Obstetrics, Medical University of Vienna, Vienna, Austria; FAU - Kosalaraksa, Pope AU - Kosalaraksa P AD - Department of Medicine, Khon Kaen University, Khon Kaen, Thailand; FAU - Schilling, Andrea AU - Schilling A AD - Departamento de Ginecologia y Obstetricia Clinica Alemana, Facultad de Medicina Clinica Alemana-Universidad Del Desarrollo, Santiago, Chile; FAU - Van Damme, Pierre AU - Van Damme P AD - Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; FAU - Bornstein, Jacob AU - Bornstein J AD - Department of Obstetrics and Gynecology, Galilee Medical Center and Bar Ilan University Faculty of Medicine, Nahariya, Israel; FAU - Bosch, F Xavier AU - Bosch FX AD - Catalan Institute of Oncology/IDIBELL, Barcelona, Spain; FAU - Pils, Sophie AU - Pils S AD - Department of Obstetrics, Medical University of Vienna, Vienna, Austria; FAU - Cuzick, Jack AU - Cuzick J AD - Wolfson Institute of Preventive Medicine, London, United Kingdom; FAU - Garland, Suzanne M AU - Garland SM AD - Royal Women's Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, Australia; FAU - Huh, Warner AU - Huh W AD - Division of Gynecologic Oncology, University of Alabama Birmingham, Birmingham, Alabama; FAU - Kjaer, Susanne K AU - Kjaer SK AD - Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; FAU - Qi, Hong AU - Qi H AD - Merck & Co., Inc., Kenilworth, New Jersey; and. FAU - Hyatt, Donna AU - Hyatt D AD - Merck & Co., Inc., Kenilworth, New Jersey; and. FAU - Martin, Jason AU - Martin J AD - Merck & Co., Inc., Kenilworth, New Jersey; and. FAU - Moeller, Erin AU - Moeller E AD - Merck & Co., Inc., Kenilworth, New Jersey; and. FAU - Ritter, Michael AU - Ritter M AD - Merck & Co., Inc., Kenilworth, New Jersey; and. FAU - Baudin, Martine AU - Baudin M AD - Sanofi Pasteur MSD, Lyon, France. FAU - Luxembourg, Alain AU - Luxembourg A AD - Merck & Co., Inc., Kenilworth, New Jersey; and. LA - eng SI - ClinicalTrials.gov/NCT00543543 SI - ClinicalTrials.gov/NCT00943722 SI - ClinicalTrials.gov/NCT01651949 SI - ClinicalTrials.gov/NCT00988884 SI - ClinicalTrials.gov/NCT01047345 SI - ClinicalTrials.gov/NCT01073293 SI - ClinicalTrials.gov/NCT01304498 GR - 16891/CRUK_/Cancer Research UK/United Kingdom PT - Journal Article PT - Meta-Analysis DEP - 20160715 PL - United States TA - Pediatrics JT - Pediatrics JID - 0376422 RN - 0 (Papillomavirus Vaccines) SB - IM MH - Adolescent MH - Adult MH - Child MH - Clinical Trials, Phase III as Topic MH - Edema/etiology MH - Erythema/etiology MH - Female MH - Fever/etiology MH - Follow-Up Studies MH - Headache/etiology MH - Humans MH - Immunization Schedule MH - Male MH - Outcome Assessment, Health Care MH - Pain/etiology MH - Papillomavirus Vaccines/administration & dosage/*adverse effects MH - Pregnancy MH - Pregnancy Complications/etiology MH - Pregnancy Outcome MH - Young Adult EDAT- 2016/07/17 06:00 MHDA- 2017/06/16 06:00 CRDT- 2016/07/17 06:00 PHST- 2016/05/12 00:00 [accepted] PHST- 2016/07/17 06:00 [entrez] PHST- 2016/07/17 06:00 [pubmed] PHST- 2017/06/16 06:00 [medline] AID - peds.2015-4387 [pii] AID - 10.1542/peds.2015-4387 [doi] PST - ppublish SO - Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.