Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials

dc.creatorMoreira Júnior, Edson Duarte
dc.creatorBlock, Stan L
dc.creatorFerris, Daron
dc.creatorGiuliano, Anna R
dc.creatorIversen, Ole-Erik
dc.creatorJoura, Elmar A
dc.creatorKosalaraksa, Pope
dc.creatorSchilling, Andrea
dc.creatorVan Damme, Pierre
dc.creatorBornstein, Jacob
dc.creatorBosch, F Xavier
dc.creatorPils, Sophie
dc.creatorCuzick, Jack
dc.creatorGarland, Suzanne M
dc.creatorHuh, Warner
dc.creatorKjaer, Susanne K
dc.creatorQi, Hong
dc.creatorHyatt, Donna
dc.creatorMartin, Jason
dc.creatorMoeller, Erin
dc.creatorRitter, Michael
dc.creatorBaudin, Martine
dc.creatorLuxembourg, Alain
dc.date2017-03-29T17:54:30Z
dc.date2017-03-29T17:54:30Z
dc.date2016
dc.date.accessioned2023-09-26T22:51:17Z
dc.date.available2023-09-26T22:51:17Z
dc.identifierMOREIRA JUNIOR, E. D. et al. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics, v. 138, n. 2, e2 0154387, 2016.
dc.identifier1098-4275
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/18198
dc.identifier10.1542/peds.2015-4387
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8883986
dc.descriptionMerck & Co., Inc., Kenilworth, New Jersey
dc.descriptionThe 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. OBJECTIVES: The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine abstract 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.
dc.formatapplication/pdf
dc.languageeng
dc.publisherAmerican Academy of Pediatrics
dc.rightsopen access
dc.subjectVacinas contra HPV
dc.subjectVacinas contra papilomavírus humano
dc.subjectHumanos
dc.subjectInfecção
dc.subjectVacina quadrivalente
dc.subjectHPV vaccines
dc.subjectHuman Papillomavirus Vaccines
dc.subjectHuman
dc.subjectInfection
dc.subjectQuadrivalent vaccine
dc.titleSafety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
dc.typeArticle


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