Title
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Safety profile of the 9-valent HPV vaccine : a combined analysis of 7 phase III clinical trials
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Author
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Abstract
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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. |
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Language
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English
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Source (journal)
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Pediatrics / American Academy of Pediatrics [Elk Grove Village, Ill.] - Evanston, Ill., 1948, currens
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Publication
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Evanston, Ill.
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2016
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ISSN
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0031-4005
[print]
1098-4275
[online]
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DOI
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10.1542/PEDS.2015-4387
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Volume/pages
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138
:2
(2016)
, 13 p.
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Article Reference
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e20154387
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ISI
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000381002500020
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Medium
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E-only publicatie
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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