Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up

Chen Wen; Zhao Yun; Xie Xing; Liu Jihong; Li Jingran; Zhao Chao; Wang Shaoming; Liao Xueyan; Shou Qiong; Zheng Minghuan; Saah Alfred J.; Wei Lihui; Qiao Youlin

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Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up

机译：四级人乳头瘤病毒疫苗的安全性在3阶段，随机，双盲，安慰剂对照临床治疗临床试验，在90个月后的后续行动

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Background: A quadrivalent human papillomavirus (qHPV) vaccine (HPV6/11/16/18) has demonstrated efficacy and acceptable safety in international studies. However, these studies did not include participants from mainland China, which has a substantial burden of HPV-related disease. This is the first safety report with a follow-up period of up to 90 months from a randomized, double-blind, placebo-controlled trial of qHPV vaccine in Chinese women 20-45 years of age.

机译：背景：四肢乳头瘤病毒（QHPV）疫苗（HPV6 / 11/16/18）在国际研究中表现出疗效和可接受的安全性。然而，这些研究没有包括来自中国大陆的参与者，其具有与HPV相关疾病的重大负担。这是第一个安全报告，随机，双盲，安慰剂对照试验中中国女性20-45岁的QHPV疫苗的随机疫苗的后续期间。

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来源
《Vaccine》 |2019年第6期|共9页
作者
Chen Wen; Zhao Yun; Xie Xing; Liu Jihong; Li Jingran; Zhao Chao; Wang Shaoming; Liao Xueyan; Shou Qiong; Zheng Minghuan; Saah Alfred J.; Wei Lihui; Qiao Youlin;
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作者单位

Chinese Acad Med Sci Natl Clin Res Ctr Canc Dept Canc Epidemiol Natl Canc Ctr Canc Hosp 17 South Panjiayuan Lane Beijing 100021 Peoples R China;

Peking Univ Peoples Hosp Dept Obstet &

Gynecol 11 Xizhimen South St Beijing 100044 Peoples R China;

Zhejiang Univ Sch Med Womens Hosp Dept Gynecol Oncol 1 Xueshi Rd Hangzhou 310006 Zhejiang Peoples R China;

Sun Yat Sen Univ Dept Gynecol Oncol Canc Ctr 651 Dongfeng Rd East Guangzhou 510060 Guangdong Peoples R China;

Peking Univ Peoples Hosp Dept Obstet &

Gynecol 11 Xizhimen South St Beijing 100044 Peoples R China;

Peking Univ Peoples Hosp Dept Obstet &

Gynecol 11 Xizhimen South St Beijing 100044 Peoples R China;

Chinese Acad Med Sci Natl Clin Res Ctr Canc Dept Canc Epidemiol Natl Canc Ctr Canc Hosp 17 South Panjiayuan Lane Beijing 100021 Peoples R China;

MSD R&

D China 21 Rongda Rd Beijing 100012 Peoples R China;

MSD R&

D China 21 Rongda Rd Beijing 100012 Peoples R China;

MSD R&

D China 21 Rongda Rd Beijing 100012 Peoples R China;

Merck &

Co Inc 2000 Galloping Hill Rd Kenilworth NJ 07033 USA;

Peking Univ Peoples Hosp Dept Obstet &

Gynecol 11 Xizhimen South St Beijing 100044 Peoples R China;

Chinese Acad Med Sci Natl Clin Res Ctr Canc Dept Canc Epidemiol Natl Canc Ctr Canc Hosp 17 South Panjiayuan Lane Beijing 100021 Peoples R China;

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原文格式 PDF
正文语种 eng
中图分类医学免疫学;
关键词
Safety; Quadrivalent human papillomavirus vaccine; Randomised controlled trial;

机译：安全;四肢乳头瘤病毒疫苗;随机对照试验;

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1. Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up [J] . Chen Wen, Zhao Yun, Xie Xing, Vaccine . 2019,第6期

机译：四级人乳头瘤病毒疫苗的安全性在3阶段，随机，双盲，安慰剂对照临床治疗临床试验，在90个月后的后续行动
2. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. [J] . Villa LL, Costa RL, Petta CA, The lancet oncology . 2005,第5期

机译：预防性四价人类乳头瘤病毒（6、11、16和18型）L1病毒样颗粒疫苗在年轻女性中：一项随机的双盲安慰剂对照多中心II期疗效试验。
3. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: a randomized, double-blind, controlled phase III clinical trial in children aged 6-35 months in China [J] . Hu Yuemei, Shao Ming, Hu Yuansheng, Human vaccines & immunotherapeutics. . 2020,第7期

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机译：教师意见建议，在27岁或以上的人类免疫缺陷病毒感染的成年人中的四肢脂肪病疫苗的随机，安慰剂对照试验：艾滋病临床试验组议定书A5298。

Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up

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