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【资讯翻译】Safety Profile of the 9-Valent HPV Vaccine: A Combined Anal...

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发表于 2016-8-11 14:22:18 | 显示全部楼层 |阅读模式
Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials

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.


信源地址:http://pediatrics.aappublications.org/content/138/2/e20154387?download=true

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发表于 2016-8-11 14:45:07 | 显示全部楼层
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发表于 2016-8-11 15:22:40 | 显示全部楼层
9价HPV疫苗的安全性:7个III期临床试验联合分析
目的:7个III期临床研究评估了9价人乳头瘤病毒疫苗(9vhpv)的总体安全性,这些研究中包括年龄在9至26岁的男性和女性(在入组时未怀孕)。
方法:疫苗进行3次接种方案,分别在第1天,第2个月和第6个月。超过15 000受试者接受超过1剂9vhpv疫苗。在2项研究中,超过 7000个对照组患者接受超过1剂四价HPV疫苗。严重和不严重的不良事件(AE)和新的医疗条件被记录在整个研究中。受试者在第1天的妊娠检测为阳性,不接种疫苗,那些在第一天接种疫苗后怀孕,则停止进一步的疫苗接种,直到怀孕终止。根据结果,研究开始后检测是否怀孕(n = 2950)。
结果:9vhpv疫苗接种者发生的最常见的不良事件(≥5%)是被注射部位的不良反应(疼痛、肿胀、红斑)和疫苗相关的全身性不良事件(头痛、发热)。9vhpv疫苗比qhpv疫苗接种者发生注射部位的不良反应更多见;大多数为轻度至中度。停药和疫苗相关的严重不良事件非常罕见(分别为0.1%和<0.1%)。报告了七例死亡,无一例被认为是与疫苗有关的。怀孕受试者中发生不良结局的比例在总人群报告的范围内。
结论:该9vhpv疫苗在年龄为9岁至26岁的受试者中一般耐受性良好,不良反应与四价HPV疫苗相似;9vhpv疫苗接种后发生注射部位不良反应较为常见。其额外的覆盖范围和安全性支持9vhpv疫苗的广泛接种。

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 楼主| 发表于 2016-8-12 14:59:29 | 显示全部楼层
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