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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208101
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
LG Chem

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.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Poliomyelitis Hepatitis B Haemophilus Influenzae Type b Infection Biological: DTP-HepB-IPV-Hib vaccine Biological: DTP-HepB-Hib vaccine & IPV Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : July 3, 2017
Actual Primary Completion Date : September 6, 2017
Actual Study Completion Date : December 21, 2017


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)




Primary Outcome Measures :
  1. Number of subjects with immediate reactions [ Time Frame: For 30 minutes after the vaccination ]
    Immediate reactions after vaccination with the study vaccine mean all the signs and symptoms occurring within 30 minutes after the vaccination.

  2. Number of subjects with solicited adverse events [ Time Frame: For 14 days after the vaccination [Day 1-15] ]
    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.

  3. Number of subjects with any unsolicited adverse events [ Time Frame: For 28 days (+7 days of window period) after the vaccination [Day 1-29] ]
    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 :
  1. 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. [ Time Frame: Day 29 (+7 days window period) ]
    Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b

  2. GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29) [ Time Frame: Day 29 (+7 days window period) ]
    Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208101


Locations
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Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Chem
Investigators
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Principal Investigator: WJ Kim Korea University Guro Hospital
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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT03208101    
Other Study ID Numbers: LG-VDCL001
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diphtheria
Haemophilus Infections
Hepatitis B
Poliomyelitis
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Gram-Negative Bacterial Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Pasteurellaceae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs