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Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series
Sponsor: LG Chem
Summary
The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine 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 and thereby to select the optimal dose of candidate vaccine(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)
Official title: A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active-controlled, Parallel-group, Operationally Seamless Phase 2/3 Clinical Study to Evaluate the Immunogenicity and Safety of LBVD, a Fully Liquid Hexavalent Diphtheria-Tetanus-Whole Cell Pertussis-Hepatitis B-poliomyelitis (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Given to Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series
Key Details
Gender
All
Age Range
6 Weeks - 8 Weeks
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2018-07-18
Completion Date
2019-02-21
Last Updated
2026-09-03
Healthy Volunteers
Yes
Interventions
LBVD (Hexavalent vaccine)
Injection within the muscle into the front area of the thigh
Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)
Injection within the muscle into the front area of the thigh
Locations (1)
Seoul National University Hospital
Seoul, South Korea