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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208101
• Other study ID #: LG-VDCL001
• Status: Completed
• Phase: Phase 1
• Start date: July 3, 2017
• Est. completion date: December 21, 2017

Study information

• Verified date: April 2018
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 21, 2017
• Est. primary completion date: September 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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]
Primary	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	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)
Secondary	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)