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

NCT03208101 | Completed Phase 1

• 1 other identifier: LG-VDCL001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B; Haemophilus Influenzae Type b Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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.

  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)

  Day 29 (+7 days window period)

Study Arms (2)

Test group

EXPERIMENTAL

DTP-HepB-IPV-Hib vaccine

Biological: DTP-HepB-IPV-Hib vaccine

Control group

ACTIVE COMPARATOR

DTP-HepB-Hib vaccine \& IPV

Biological: DTP-HepB-Hib vaccine & IPV

Interventions

DTP-HepB-IPV-Hib vaccine BIOLOGICAL

Hexavalent vaccine (DTP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Inactivated Poliovirus-Haemophilus influenzae type b vaccine)

Test group

DTP-HepB-Hib vaccine & IPV BIOLOGICAL

Pentavalent vaccine (DTP-HepB-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b vaccine)+ IPV(Inactivated poliovirus vaccine)

Control group

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Poliomyelitis; Hepatitis B; Haemophilus Infections

Interventions

Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• WJ Kim

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 5, 2017
• Study Start: July 3, 2017
• Primary Completion: September 6, 2017
• Study Completion: December 21, 2017
• Last Updated: August 29, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)