A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants-Reference-Cited by-同舟云学术

A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants

Published:2024-02-22 Issue:1 Volume:9 Page:
ISSN:2059-0105
Container-title:npj Vaccines
language:en
Short-container-title:npj Vaccines

Author:

Sharma Hitt^ORCID,Parekh Sameer^ORCID,Pujari Pramod,Shewale Sunil^ORCID,Desai Shivani,Kawade Anand,Lalwani Sanjay,Ravi M. D.,Kamath Veena,Mahopatra Jagannath,Kulkarni Ganesh,Tayade Deepak^ORCID,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^ORCID,Dogar Vikas,Gautam Manish,Jaganathan K. S.,Kumar Rakesh,Sharma Inderjit,Gairola Sunil

Abstract

AbstractA 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

Publisher

Springer Science and Business Media LLC

Link

https://www.nature.com/articles/s41541-024-00828-w.pdf

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