Primary Physicians Research, Pittsburgh, PA, USA.
Pediatrics. 2010 Jun;125(6):1142-51. doi: 10.1542/peds.2009-2336. Epub 2010 May 3.
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.
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.
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.
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.
人乳头瘤病毒疫苗加德西（Gardasil）的多国 III 期临床试验表明，该疫苗通常具有良好的耐受性、疗效和免疫原性。我们评估了加德西与美奈喜康（Menactra）和安立泽（Adacel）联合接种的免疫原性和安全性。
在这项开放性标签研究中，10 至 17 岁的男孩（n=394）和女孩（n=648）以 1:1 的比例随机分组，具体分组如下：A 组（同时接种组）在第 1、2 和 6 天接受 0.5 毫升剂量的加德西，在第 1 天接受 0.5 毫升剂量的美奈喜康和安立泽；B 组（非同时接种组）在第 1、2 和 6 天接受加德西，在第 1 个月接受美奈喜康和安立泽。测量所有疫苗成分的抗体水平。监测全身、注射部位和严重不良事件（AE）。
同时接种 3 种疫苗后的免疫反应不劣于非同时接种。两组 A 和 B 的加德西血清转化率均≥99%。对于美奈喜康和安立泽，疫苗同时接种被证明不劣于非同时接种。同时接种通常具有良好的耐受性。没有参与者因 AE 而退出。B 组有 1 例接种第 3 剂加德西后出现短暂性肌无力（持续时间<24 小时）的严重 AE，研究者认为该事件可能与疫苗有关。
总体而言，同时接种通常具有良好的耐受性，且不会干扰各疫苗的免疫反应。同时接种应尽量减少单独接种每种疫苗所需的就诊次数，从而提高依从性并更有效地预防疾病。
