npj Vaccines (Feb 2024)
A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants
- Hitt Sharma,
- Sameer Parekh,
- Pramod Pujari,
- Sunil Shewale,
- Shivani Desai,
- Anand Kawade,
- Sanjay Lalwani,
- M. D. Ravi,
- Veena Kamath,
- Jagannath Mahopatra,
- Ganesh Kulkarni,
- Deepak Tayade,
- Padmasani Venkat Ramanan,
- Kheya Ghosh Uttam,
- Lalit Rawal,
- Avinash Gawande,
- N. Ravi Kumar,
- Nishikant Tiple,
- Jayant Vagha,
- Pareshkumar Thakkar,
- Prashant Khandgave,
- Bhaskar Jedhe Deshmukh,
- Anurag Agarwal,
- Vikas Dogar,
- Manish Gautam,
- K. S. Jaganathan,
- Rakesh Kumar,
- Inderjit Sharma,
- Sunil Gairola
Affiliations
- Hitt Sharma
- Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd.
- Sameer Parekh
- Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd.
- Pramod Pujari
- Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd.
- Sunil Shewale
- Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd.
- Shivani Desai
- Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd.
- Anand Kawade
- Department of Pediatrics, KEM Hospital Research Centre
- Sanjay Lalwani
- Department of Pediatrics, Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital
- M. D. Ravi
- Department of Pediatrics, JSS Hospital
- Veena Kamath
- Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education (MAHE)
- Jagannath Mahopatra
- Department of Pediatrics, Hamdard Institute of Medical Science and Research
- Ganesh Kulkarni
- Department of Pediatrics, Sanjeevani Children’s Hospital
- Deepak Tayade
- Department of Pediatrics, Mahatma Gandhi Mission’s Medical College and Hospital
- Padmasani Venkat Ramanan
- Department of Pediatrics, Sri Ramachandra Hospital
- Kheya Ghosh Uttam
- Department of Pediatrics, Institute of Child Health
- Lalit Rawal
- Department of Pediatrics, Grant Medical Foundation Ruby Hall Clinic
- Avinash Gawande
- Department of Pediatrics, Government Medical College and Hospital
- N. Ravi Kumar
- Department of Pediatrics, Niloufer Hospital
- Nishikant Tiple
- Department of Pediatrics, Government Medical College
- Jayant Vagha
- Department of Pediatrics, Acharya Vinoba Bhave Rural Hospital
- Pareshkumar Thakkar
- Department of Pediatrics, Sir Sayajirao General Hospital
- Prashant Khandgave
- Department of Pediatrics, Pulse Multispeciality Hospital
- Bhaskar Jedhe Deshmukh
- Department of Pediatrics, Baramati Hospital
- Anurag Agarwal
- Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital
- Vikas Dogar
- Department of Quality Control, Serum Institute of India Pvt. Ltd
- Manish Gautam
- Department of Quality Control, Serum Institute of India Pvt. Ltd
- K. S. Jaganathan
- Production Department, Serum Institute of India Pvt. Ltd
- Rakesh Kumar
- Production Department, Serum Institute of India Pvt. Ltd
- Inderjit Sharma
- Production Department, Serum Institute of India Pvt. Ltd
- Sunil Gairola
- Department of Quality Control, Serum Institute of India Pvt. Ltd
- DOI
- https://doi.org/10.1038/s41541-024-00828-w
- Journal volume & issue
-
Vol. 9,
no. 1
pp. 1 – 9
Abstract
Abstract 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
