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

doi:10.1038/s41541-024-00828-w

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

NPJ Vaccines. 2024 Feb 22;9(1):41. doi: 10.1038/s41541-024-00828-w.

Authors

Hitt Sharma¹, Sameer Parekh², Pramod Pujari², Sunil Shewale², Shivani Desai², Anand Kawade³, Sanjay Lalwani⁴, M D Ravi⁵, Veena Kamath⁶, Jagannath Mahopatra⁷, Ganesh Kulkarni⁸, Deepak Tayade⁹, Padmasani Venkat Ramanan¹⁰, Kheya Ghosh Uttam¹¹, Lalit Rawal¹², Avinash Gawande¹³, N Ravi Kumar¹⁴, Nishikant Tiple¹⁵, Jayant Vagha¹⁶, Pareshkumar Thakkar¹⁷, Prashant Khandgave¹⁸, Bhaskar Jedhe Deshmukh¹⁹, Anurag Agarwal²⁰, Vikas Dogar²¹, Manish Gautam²¹, K S Jaganathan²², Rakesh Kumar²², Inderjit Sharma²², Sunil Gairola²¹

Affiliations

¹ Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., Pune, India. drhjs@seruminstitute.com.
² Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., Pune, India.
³ Department of Pediatrics, KEM Hospital Research Centre, Vadu, Pune, India.
⁴ Department of Pediatrics, Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital, Pune, India.
⁵ Department of Pediatrics, JSS Hospital, Mysuru, India.
⁶ Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education (MAHE), Manipal, India.
⁷ Department of Pediatrics, Hamdard Institute of Medical Science and Research, New Delhi, India.
⁸ Department of Pediatrics, Sanjeevani Children's Hospital, Aurangabad, India.
⁹ Department of Pediatrics, Mahatma Gandhi Mission's Medical College and Hospital, Aurangabad, India.
¹⁰ Department of Pediatrics, Sri Ramachandra Hospital, Chennai, India.
¹¹ Department of Pediatrics, Institute of Child Health, Kolkata, India.
¹² Department of Pediatrics, Grant Medical Foundation Ruby Hall Clinic, Pune, India.
¹³ Department of Pediatrics, Government Medical College and Hospital, Nagpur, India.
¹⁴ Department of Pediatrics, Niloufer Hospital, Hyderabad, India.
¹⁵ Department of Pediatrics, Government Medical College, Chandrapur, India.
¹⁶ Department of Pediatrics, Acharya Vinoba Bhave Rural Hospital, Wardha, India.
¹⁷ Department of Pediatrics, Sir Sayajirao General Hospital, Baroda, India.
¹⁸ Department of Pediatrics, Pulse Multispeciality Hospital, Pune, India.
¹⁹ Department of Pediatrics, Baramati Hospital, Pune, India.
²⁰ Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India.
²¹ Department of Quality Control, Serum Institute of India Pvt. Ltd, Pune, India.
²² Production Department, Serum Institute of India Pvt. Ltd, Pune, India.

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.