drugset / Trial / NCT04073459

Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants

NCT04073459

Phase 2 Unknown 336 enrolled LG Chem
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio 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

Timeline

Start
2019-11
Primary completion
2020-04
Completion
2020-08

Drugs

EvaluationDrugModalityDoseRoute
Subject DTwP-HepB-Sabin IPV-Hib Vaccine Intramuscular
Comparator Inactivated Poliomyelitis Vaccine (Salk strains) Vaccine Intramuscular
Comparator Pentavalent vaccine Vaccine Intramuscular