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Clinical Trial 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)


Clinical Trial Description

Stage 1 (Dose-level Finding;Phase 2) 1. To compare the immunogenicity and safety of three LBVD vaccine candidates, varying at different dose levels, to the Control vaccines at 4 weeks after a three-dose primary series of vaccination and thereby, select an optimal vaccine dose level for Stage 2 Stage 2 (Evaluation of Safety, Immunogenicity, and Lot-to-lot Consistency;Phase 3) 1. To demonstrate the non-inferiority and lot-to-lot consistency in the immunogenicity of three separate lots of LBVD to the Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age 2. To demonstrate the safety and immunogenicity of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05457946
Study type Interventional
Source LG Chem
Contact Study Lead
Phone +82-2-3777-1114
Email lgclinical@lgchem.com
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date April 1, 2023
Completion date September 30, 2025

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