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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Pertussis; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Influenzae Type b Infection
• Intervention / Treatment: Biological: DTP-HepB-IPV-Hib vaccine; Biological: DTP-HepB-Hib vaccine & IPV

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults between 19 and 55 years of age at the time of Visit 1 (Screening)
2. 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
3. Persons who are surgically sterile, postmenopausal women, or agree to use contraceptive measures

Exclusion Criteria:

1. Persons who have an experience of participation in another interventional clinical study within 3 months prior to Visit 1 (Screening)
2. 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)
3. 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
4. Persons with a history of diphtheria, tetanus, pertussis, hepatitis B virus, polio virus, or the invasive diseases caused by Haemophilus influenzae type b

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; DTP-HepB-IPV-Hib vaccine	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)
Active Comparator: Control group; DTP-HepB-Hib vaccine & IPV	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with immediate reactions	Immediate reactions after vaccination with the study vaccine mean all the signs and symptoms occurring within 30 minutes after the vaccination.	For 30 minutes after the vaccination
Number of subjects with solicited adverse events	Solicited adverse events are classified into the local(pain, tenderness, erythema/redness, induration/swelling) and systemic(fever, fatigue, chills/shivering, myalgia, headache, arthralgia, decreased appetitie, diarrhea, nausea/vomiting, rash) signs and symptoms.	For 14 days after the vaccination [Day 1-15]
Number of subjects with any unsolicited adverse events	Unsolicited adverse events mean all the adverse events excluding the immediate reactions after vaccination with the study vaccine and the solicited adverse events.	For 28 days (+7 days of window period) after the vaccination [Day 1-29]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportions of the subjects who have shown seroprotection/vaccine-response to each antigen and the subjects who have shown seroconversion 28 days post-vaccination with the study vaccine (Day 29) compared to pre-vaccination.	Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b	Day 29 (+7 days window period)
GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29)	Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b	Day 29 (+7 days window period)

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: WJ Kim, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2017
• Primary Completion (Actual): September 6, 2017
• Study Completion (Actual): December 21, 2017

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Neuromuscular Diseases; Central Nervous System Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Corynebacterium Infections; Hepatitis; Myelitis; Pasteurellaceae Infections; Hepatitis B; Diphtheria; Poliomyelitis; Haemophilus Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: LG-VDCL001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No