A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults
NCT ID: NCT05952596
Last Updated: 2023-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
42 participants
INTERVENTIONAL
2023-07-17
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Test group
DTaP-HepB-IPV-Hib vaccine
DTaP-HepB-IPV-Hib vaccine
Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acelluar Pertussis-Hepatitis B-Sabin Inactivated Poliovirus-Haemophilus influenzae type b vaccine)
Control group
DTaP-HepB-IPV-Hib vaccine
DTaP-HepB-IPV-Hib vaccine
Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-poliomyelitis(inactived)-Haemophilus influenzae type b vaccine)
Interventions
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DTaP-HepB-IPV-Hib vaccine
Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acelluar Pertussis-Hepatitis B-Sabin Inactivated Poliovirus-Haemophilus influenzae type b vaccine)
DTaP-HepB-IPV-Hib vaccine
Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-poliomyelitis(inactived)-Haemophilus influenzae type b vaccine)
Eligibility Criteria
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Inclusion Criteria
* Those without clinically significant abnormalities on the screening test on Visit 1
* Those with a confirmed BMI of 18.5 kg/m2 to less than 30 kg/m2 on Visit 1
* Those who have heard a detailed explanation of the study and whose written consent to participate in the study was given voluntarily by themselves or their legal representatives
Exclusion Criteria
* Those who took tetanus toxoid (TT), tetanus-diphtheria (Td), tetanus-reduced diphtheria-acellular pertussis (Tdap) vaccine for adults, or other vaccines containing tetanus-diphtheria for adults within 5 years from Visit 1
* Those who were vaccinated within 4 weeks from Visit 1 or who plan to receive vaccines other than the investigational vaccine from the participation in this study to Visit 5
* Have had diphtheria, tetanus, pertussis, hepatitis B, polio, or invasive diseases caused by Haemophilus influenzae type b
19 Years
55 Years
ALL
Yes
Sponsors
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LG Chem
INDUSTRY
Responsible Party
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Principal Investigators
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Nam Joong Kim
Role: PRINCIPAL_INVESTIGATOR
Seoul National University College of Medicine
Central Contacts
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Other Identifiers
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LG-VGCL001
Identifier Type: -
Identifier Source: org_study_id
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