search
Back to results

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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DTP-HepB-IPV-Hib vaccine
DTP-HepB-Hib vaccine & IPV
Sponsored by
LG Chem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test group

Control group

Arm Description

DTP-HepB-IPV-Hib vaccine

DTP-HepB-Hib vaccine & IPV

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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
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

Full Information

First Posted
June 30, 2017
Last Updated
August 27, 2019
Sponsor
LG Chem
search

1. Study Identification

Unique Protocol Identification Number
NCT03208101
Brief Title
A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
September 6, 2017 (Actual)
Study Completion Date
December 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
DTP-HepB-IPV-Hib vaccine
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
DTP-HepB-Hib vaccine & IPV
Intervention Type
Biological
Intervention Name(s)
DTP-HepB-IPV-Hib vaccine
Intervention Description
Hexavalent vaccine (DTP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Inactivated Poliovirus-Haemophilus influenzae type b vaccine)
Intervention Type
Biological
Intervention Name(s)
DTP-HepB-Hib vaccine & IPV
Intervention Description
Pentavalent vaccine (DTP-HepB-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b vaccine)+ IPV(Inactivated poliovirus vaccine)
Primary Outcome Measure Information:
Title
Number of subjects with immediate reactions
Description
Immediate reactions after vaccination with the study vaccine mean all the signs and symptoms occurring within 30 minutes after the vaccination.
Time Frame
For 30 minutes after the vaccination
Title
Number of subjects with solicited adverse events
Description
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.
Time Frame
For 14 days after the vaccination [Day 1-15]
Title
Number of subjects with any unsolicited adverse events
Description
Unsolicited adverse events mean all the adverse events excluding the immediate reactions after vaccination with the study vaccine and the solicited adverse events.
Time Frame
For 28 days (+7 days of window period) after the vaccination [Day 1-29]
Secondary Outcome Measure Information:
Title
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.
Description
Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b
Time Frame
Day 29 (+7 days window period)
Title
GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29)
Description
Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b
Time Frame
Day 29 (+7 days window period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WJ Kim
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs