NCT04073459

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

A Multi-center, Randomized, Active-controlled, Parallel-group, Open-label and Phase II Study to Evaluate Immunogenicity and Safety of LBVD (Fully Liquid Hexavalent Vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B- Inactivated Poliomyelitis (Sabin) and Haemophilus Influenzae Type b Conjugate Vaccine) Compared to Co-administration of EupentaTM Inj. and Imovax® Polio (Poliomyelitis Vaccine (Inactivated)) in Separate Injections in Healthy Infants at 6-10-14 Weeks of Age as Primary Series

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 6 Weeks – 8 Weeks
• Healthy volunteers: Accepted

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

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Poliomyelitis
• Haemophilus Influenzae Type b Infection

Interventions

Type	Name	Description
BIOLOGICAL	DTwP-HepB-Sabin IPV-Hib	Intramuscular injection into the anterolateral area of the thigh
BIOLOGICAL	Pentavalent vaccine and Salk IPV	Intramuscular injection into anterolateral area of the thigh

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-04-01
• Completion: 2020-08-01
• First posted: 2019-08-29
• Last updated: 2019-09-06