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A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II/III Clinical Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series
The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants
Stage 1 (Phase 2) 1\. To compare the immunogenicity and safety of LBVD to the licensed Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age Stage 2 (Phase 3) 1. To demonstrate the non-inferior immunogenicity of LBVD to the licensed Control Vaccine at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age 2. To demonstrate lot-to-lot consistency in the immunogenicity of three separate lots of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
Care CT Group
Dasmariñas, Cavite, Philippines
Start Date
May 30, 2025
Primary Completion Date
November 1, 2026
Completion Date
April 1, 2027
Last Updated
July 3, 2025
1,186
ESTIMATED participants
LBVD
BIOLOGICAL
Pentavalent vaccine and Inactivated Polio vaccine
BIOLOGICAL
Lead Sponsor
LG Chem
NCT07203755
NCT07112144
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