A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults
NCT03208101 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2019-08-29
Summary
This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta co-administered with Imovax Polio in healthy adults.
Conditions
- Diphtheria
- Tetanus
- Pertussis
- Poliomyelitis
- Hepatitis B
- Haemophilus Influenzae Type b Infection
Interventions
- BIOLOGICAL
-
DTP-HepB-IPV-Hib vaccine
Hexavalent vaccine (DTP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Inactivated Poliovirus-Haemophilus influenzae type b vaccine)
- BIOLOGICAL
-
DTP-HepB-Hib vaccine & IPV
Pentavalent vaccine (DTP-HepB-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b vaccine)+ IPV(Inactivated poliovirus vaccine)
Sponsors & Collaborators
-
LG Chem
lead INDUSTRY
Principal Investigators
-
WJ Kim · Korea University Guro Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-07-03
- Primary Completion
- 2017-09-06
- Completion
- 2017-12-21
Countries
- South Korea
Study Locations
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