Hexasiil (DTwP–HepB-IPV-Hib) / Serum Institute of India - LARVOL DELTA

Infant Malaria Vaccine Schedule Optimization (clinicaltrials.gov) - P2 | N=1200 | Recruiting | Sponsor: PATH | Trial completion date: Nov 2027 ➔ Mar 2028 | Trial primary completion date: Nov 2027 ➔ Mar 2028

Trial completion date • Trial primary completion date • Infectious Disease • Malaria

Infant Malaria Vaccine Schedule Optimization (clinicaltrials.gov) - P2 | N=1200 | Recruiting | Sponsor: PATH | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Malaria

Infant Malaria Vaccine Schedule Optimization (clinicaltrials.gov) - P2 | N=1200 | Not yet recruiting | Sponsor: PATH

New P2 trial • Infectious Disease • Malaria

A randomized, active-controlled, multi-centric, phase-II clinical study to assess safety and immunogenicity of a fully liquid DTwP-HepB-IPV-Hib hexavalent vaccine (HEXASIIL®) in Indian toddlers. (PubMed, Vaccine) - "HEXASIIL® vaccine was found to be safe and immunogenic in toddlers and supported its further clinical development in infants. Clinical Trial Registration - CTRI/2019/11/022052."

Journal • P2 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Respiratory Diseases • Tetanus

Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV (clinicaltrials.gov) - P3 | N=1557 | Recruiting | Sponsor: Serum Institute of India Pvt. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV (clinicaltrials.gov) - P3 | N=1557 | Not yet recruiting | Sponsor: Serum Institute of India Pvt. Ltd.

New P3 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants. (PubMed, NPJ Vaccines) - "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."

Journal • P3 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16-24 months. (PubMed, Hum Vaccin Immunother) - "was found to be safe, well tolerated and showed a robust immune response in toddlers. It was concluded that this vaccine should be assessed in the next phases of clinical development in the target population.Clinical Trial Registration - CTRI/2018/10/015875."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus