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

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dc.contributor.authorEdson, Moreira
dc.contributor.authorBlock, Stan
dc.contributor.authorFerris, Daron
dc.contributor.authorGiuliano, Anna
dc.contributor.authorIversen, Ole-Erik
dc.contributor.authorJoura, Elmar
dc.contributor.authorKosalaraksa, Pope
dc.contributor.authorSchilling, Andrea
dc.contributor.authorVan Damme, Pierre
dc.contributor.authorBornstein, Jacob
dc.contributor.authorBosch, Xavier
dc.contributor.authorPils, Sophie
dc.contributor.authorCuzick, Jack
dc.contributor.authorGarland, Suzanne
dc.contributor.authorHuh, Warner
dc.contributor.authorKjaer, Susanne
dc.contributor.authorQi, Hong
dc.contributor.authorHyatt, Donna
dc.contributor.authorMartin, Jason
dc.contributor.authorMoeller, Erin
dc.contributor.authorRitter, Michael
dc.contributor.authorBaudin, Martine
dc.contributor.authorLuxembourg, Alain
dc.date.accessioned2017-12-28T19:31:43Z
dc.date.available2017-12-28T19:31:43Z
dc.date.issued2016
dc.description.abstractOBJECTIVES: 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.
dc.format.extent15
dc.identifier.citationPediatrics. 2016 Aug;138(2). pii: e20154387
dc.identifier.urihttp://hdl.handle.net/11447/1810
dc.identifier.urihttp://dx.doi.org/10.1542/peds.2015-4387
dc.language.isoen_US
dc.publisherAmerican Academy of Pediatrics
dc.subjectPapillomavirus Vaccines
dc.subjectPregnancy
dc.subjectClinical Trials, Phase III as Topic
dc.titleSafety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
dc.typeArtículo

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