A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults

LG Chem

Status and phase

Completed

Phase 1

Conditions

Haemophilus Influenzae Type b Infection

Poliomyelitis

Diphtheria

Hepatitis B

Pertussis

Tetanus

Treatments

Biological: DTP-HepB-IPV-Hib vaccine

Biological: DTP-HepB-Hib vaccine & IPV

Study type

Interventional

Funder types

Industry

Identifiers

NCT03208101

LG-VDCL001

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adults between 19 and 55 years of age at the time of Visit 1 (Screening)
Persons who or whose legal representatives have voluntarily signed an informed consent after receiving explanation about the objectives, methods, effects, etc. of the clinical study
Persons who are surgically sterile, postmenopausal women, or agree to use contraceptive measures

Exclusion criteria

Persons who have an experience of participation in another interventional clinical study within 3 months prior to Visit 1 (Screening)
Persons who have a record of vaccination with the tetanus toxoid (TT)/tetanus diphtheria (Td)/tetanus diphtheria pertussis (Tdap) vaccine or other vaccines containing tetanus-diphtheria for adults or who are suspected to have been vaccinated with either of them within 5 years prior to Visit 1 (Screening)
Persons who were vaccinated within 4 weeks prior to Visit 1 (Screening) or who are scheduled to be vaccinated with the vaccines other than the study vaccine during the study period
Persons with a history of diphtheria, tetanus, pertussis, hepatitis B virus, polio virus, or the invasive diseases caused by Haemophilus influenzae type b