Related Experiment Video
Updated: May 6, 2026
A Suction Blister Protocol to Study Human T-cell Recall Responses In Vivo
Published on: August 11, 2018
A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in
Hitt Sharma1, Sameer Parekh2, Pramod Pujari2
1Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., Pune, India. drhjs@seruminstitute.com.
Insights
A new fully liquid hexavalent vaccine (DTwP-HepB-IPV-Hib) demonstrated lot-to-lot consistency and non-inferiority to licensed vaccines in infants. The DTwP-HepB-IPV-Hib vaccine was well-tolerated with no safety concerns.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Infectious Diseases
Background:
- Development of comprehensive vaccines like hexavalents is crucial for infant immunization programs.
- Ensuring lot-to-lot consistency and demonstrating non-inferiority are essential for vaccine licensure and public trust.
Purpose of the Study:
- To evaluate the lot-to-lot consistency of a fully liquid hexavalent vaccine (DTwP-HepB-IPV-Hib).
- To assess the non-inferiority of the DTwP-HepB-IPV-Hib vaccine compared to a licensed combination vaccine (DTwP-HepB-Hib + IPV).
- To evaluate the safety and immunogenicity of the DTwP-HepB-IPV-Hib vaccine in infants.
Main Methods:
- An open-label, randomized Phase II/III clinical study was conducted.
- Healthy infants received either the DTwP-HepB-IPV-Hib vaccine or a licensed DTwP-HepB-Hib + IPV vaccine at 6, 10, and 14 weeks of age.
- Seroprotection/seroconversion rates and geometric mean concentrations were measured post-vaccination.
Main Results:
- The DTwP-HepB-IPV-Hib vaccine demonstrated non-inferiority to the licensed comparator vaccine regarding seroprotection/seroconversion rates.
- Lot-to-lot consistency was confirmed, with geometric mean concentration ratios falling within equivalence limits (0.5-2).
- The vaccine was well-tolerated, and no safety concerns were identified during the study.
Conclusions:
- The fully liquid hexavalent DTwP-HepB-IPV-Hib vaccine is consistent, non-inferior, and safe for infant immunization.
- This vaccine offers a promising alternative for simplifying infant vaccination schedules.
- Further studies may support its widespread adoption in public health programs.
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.
