6-8 周龄健康婴儿中由 Human Biologicals Institute 生产的五联（DTwP-Hb-Hib）液体组合疫苗的免疫原性和安全性：一项 III 期、随机、单盲、非劣效性研究。
Immunogenicity and safety of a liquid Pentavalent (DTwP-Hb-Hib) combination vaccine manufactured by Human Biologicals Institute in 6-8 weeks old healthy infants: A phase III, randomized, single blind, non-inferiority study.
机构信息
Human Biologicals Institute, Hyderabad, India.
Department of Community Medicine, School of Public Health, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
出版信息
Vaccine. 2019 Aug 23;37(36):5452-5459. doi: 10.1016/j.vaccine.2019.06.067. Epub 2019 Jul 19.
BACKGROUND
A liquid Pentavalent (DTwP-Hb-Hib) combination vaccine, developed by Human Biologicals Institute, underwent a Phase III clinical study in India. In this randomized, single blind, non-inferiority study, the immunogenicity and safety of this Investigational vaccine was compared with Pentavac SD® vaccine in 6-8 weeks old healthy infants.
METHODS
A total of 405 healthy infants aged 6-8 weeks old were randomized in 2:1 ratio to receive three doses of either the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine or Pentavac SD® vaccine at four to six weeks interval. Immunogenicity was compared by estimation of antibody titers before the first dose and 4-6 weeks after the third dose of vaccination. Safety of each vaccine was assessed and compared by collection of data on solicited and unsolicited adverse events throughout the study period.
RESULTS
Out of a total of 405 enrolled subjects, 387 subjects completed the study. The seroconversion rates, seroprotection rates and geometric mean titres of the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine group were found to be comparable and non-inferior to the Pentavac SD® vaccine group at 4-6 weeks after the third dose of vaccination. Pain, erythema and swelling at the site of injection were found to be the most common local adverse events whereas fever, irritability and unusual crying were found to be the most common systemic adverse events in both the vaccine groups. No vaccine related serious adverse event was reported. In this study, both the Investigational vaccine as well as the Comparator vaccine were found to be immunogenic and well tolerated.
CONCLUSION
After assessment of the results of the study it was concluded that the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine developed by Human Biologicals Institute was immunogenic and safe when administered to infants aged 6-8 weeks and was non-inferior in immunogenicity and safety to Pentavac SD® vaccine. Clinical Trial Registry of India Identifier: CTRI/2016/01/006541.
背景
由 Human Biologicals Institute 研发的一种五价（DTwP-Hb-Hib）结合疫苗在印度进行了 III 期临床研究。在这项随机、单盲、非劣效性研究中，该研究性疫苗的免疫原性和安全性与 Pentavac SD®疫苗在 6-8 周龄健康婴儿中进行了比较。
方法
共有 405 名 6-8 周龄的健康婴儿以 2:1 的比例随机分为两组，分别接受三剂研究性液体五价（DTwP-Hb-Hib）结合疫苗或 Pentavac SD®疫苗，间隔 4-6 周。通过在第一剂前和第三剂后 4-6 周评估抗体滴度来比较免疫原性。通过收集整个研究期间的不良事件（包括局部和全身）数据，评估并比较每种疫苗的安全性。
结果
在总共 405 名入组的受试者中，有 387 名受试者完成了研究。在第三剂后 4-6 周，研究性液体五价（DTwP-Hb-Hib）结合疫苗组的血清转化率、血清保护率和几何平均滴度被发现与 Pentavac SD®疫苗组相当且非劣效。在两组中，注射部位疼痛、红斑和肿胀是最常见的局部不良事件，而发热、烦躁和异常哭泣是最常见的全身不良事件。在这项研究中，未报告与疫苗相关的严重不良事件。研究结果表明，该研究性液体五价（DTwP-Hb-Hib）结合疫苗在 6-8 周龄婴儿中具有免疫原性和安全性，并且在免疫原性和安全性方面与 Pentavac SD®疫苗相当。印度临床试验注册中心标识符：CTRI/2016/01/006541。
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