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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel.
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Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel.

机译：与Menactra和Adacel一起给予的gardasil的安全性，耐受性和免疫原性。

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OBJECTIVES: Multinational phase III trials of a human papillomavirus vaccine, Gardasil, have shown the vaccine to be generally well-tolerated, efficacious, and immunogenic. We evaluated the immunogenicity and safety of Gardasil administered concomitantly with Menactra and Adacel. METHODS: In this open-label study, boys (n = 394) and girls (n = 648) aged 10 to 17 were randomly assigned in a 1:1 ratio as follows: group A (concomitant administration) received a 0.5-mL dose of Gardasil at day 1, month 2, and month 6 and a 0.5-mL dose of Menactra and Adacel on day 1; group B (nonconcomitant administration) received Gardasil at day 1, month 2, and month 6 and Menactra and Adacel at month 1. Antibody levels for all vaccine components were measured. Systemic, injection-site, and serious adverse experiences (AEs) were monitored. RESULTS: Immune responses after concomitant administration of the 3 vaccines were noninferior to nonconcomitant administration. Seroconversion for Gardasil was > or = 99% in both groups A and B. For Menactra and Adacel, concomitant administration of the vaccines was demonstrated to be noninferior to nonconcomitant administration. Concomitant administration was generally well-tolerated. No participants withdrew because of an AE. One serious AE of transient muscular weakness of <24 hours' duration after the third Gardasil injection was reported in group B and was deemed possibly vaccine-related by the investigator. CONCLUSIONS: Overall, concomitant administration was generally well-tolerated and did not interfere with the immune response to the respective vaccines. Concomitant administration should minimize the number of visits required to deliver each vaccine individually, leading to increased compliance and more effective disease prevention.
机译：目的：人类乳头瘤病毒疫苗Gardasil的多国III期试验显示，该疫苗通常具有良好的耐受性，有效性和免疫原性。我们评估了与Menactra和Adacel并用的Gardasil的免疫原性和安全性。方法：在这项开放性研究中，年龄为10至17岁的男孩（n = 394）和女孩（n = 648）以1：1的比例随机分配，如下所示：A组（伴随给药）接受0.5 mL剂量在第1、2、6个月服用Gardasil，并在第1天服用0.5mL的Menactra和Adacel; B组（非伴随给药）在第1天，第2个月和第6个月接受Gardasil，在第1个月接受Menactra和Adacel的检测。监测全身，注射部位和严重不良反应（AE）。结果：3种疫苗同时给药后的免疫反应不次于非同时给药。在A组和B组中，Gardasil的血清转化率均≥99％。对于Menactra和Adacel，疫苗的同时给药被证明不劣于非同时给药。伴随给药通常耐受良好。没有参与者因不良事件而退出。在B组中报告了第三次Gardasil注射后<24小时持续时间出现的一种严重的短暂性肌无力严重不良事件，研究者认为这可能与疫苗有关。结论：总体而言，伴随给药通常耐受性良好，并且不会干扰对相应疫苗的免疫反应。伴随给药应尽量减少单独接种每种疫苗所需的访问次数，从而提高依从性和更有效的疾病预防。

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