DTwP-HepB-IPV-Hib疫苗（HEXASIIL）在婴儿中安全性和免疫原性的III期随机对照研究。
A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL) in infants.
作者信息
Sharma Hitt, Parekh Sameer, Pujari Pramod, Shewale Sunil, Desai Shivani, Kawade Anand, Lalwani Sanjay, Ravi M D, Kamath Veena, Mahopatra Jagannath, Kulkarni Ganesh, Tayade Deepak, Ramanan Padmasani Venkat, Uttam Kheya Ghosh, Rawal Lalit, Gawande Avinash, Kumar N Ravi, Tiple Nishikant, Vagha Jayant, Thakkar Pareshkumar, Khandgave Prashant, Deshmukh Bhaskar Jedhe, Agarwal Anurag, Dogar Vikas, Gautam Manish, Jaganathan K S, Kumar Rakesh, Sharma Inderjit, Gairola Sunil
机构信息
Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., Pune, India.
Department of Pediatrics, KEM Hospital Research Centre, Vadu, Pune, India.
出版信息
NPJ Vaccines. 2024 Feb 22;9(1):41. doi: 10.1038/s41541-024-00828-w.
A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed.Clinical Trial Registration - CTRI/2019/11/022052.
一种全液体六价疫苗，包含白喉（D）、破伤风（T）类毒素、全细胞百日咳（wP）、乙型肝炎（Hep B）、1型、2型、3型灭活脊髓灰质炎病毒（IPV）和b型流感嗜血杆菌（Hib）结合疫苗（DTwP-HepB-IPV-Hib疫苗，HEXASIIL），在一项开放标签、随机的II/III期研究中，对其批次间一致性和相对于已获许可的DTwP-HepB-Hib + IPV的非劣效性进行了测试。在III期部分，健康婴儿在6、10和14周龄时接种DTwP-HepB-IPV-Hib或DTwP-HepB-Hib + IPV疫苗。在首次接种前和第3剂接种后28天采集血样。对于血清保护/血清转化率的治疗差异，以95%置信区间证明了相对于DTwP-HepB-Hib + IPV的非劣效性。对于DTwP-HepB-IPV-Hib批次，接种后几何平均浓度比的95%置信区间界限在等效界限（0.5和2）内。疫苗耐受性良好，未观察到安全问题。临床试验注册 - CTRI/2019/11/022052。
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