ATN 064 Vaccination Follow-up Type of Reaction Dataset in Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women
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下载链接:
https://dash.nichd.nih.gov/dataset/16077
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资源简介:
Data from Vaccination Follow-Up Summary Form: Type of Reaction [CRF 16, type of reaction table]
Study Description
A Phase II, open-label, multi-center study that evaluated the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women. The vaccine was administered at the recommended dose and schedule (Day 0, Week 8, and Week 24) with safety assessments after each vaccination and reactive antibody measurements pre- and post-vaccination. Attitudes and behaviors were measured using self-administered questionnaires.
HIV-infected young women between 16 and 23 years of age
疫苗接种随访总结表数据:反应类型 [病例报告表16(CRF 16),反应类型表格]
研究概况
本研究为一项II期开放标签多中心临床试验,旨在评估HPV-6、11、16、18型疫苗在人类免疫缺陷病毒(HIV,Human Immunodeficiency Virus)感染青年女性中的免疫原性、安全性、耐受性及行为学影响。该疫苗按照推荐剂量与接种程序进行接种(第0天、第8周及第24周),每次接种后均开展安全性评估,并在疫苗接种前后检测反应性抗体水平。研究对象的态度与行为通过自填式问卷进行采集与评估。
研究对象为16至23岁的HIV感染青年女性。
创建时间:
2017-04-14



