None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : 1. Test Vaccine: BVN008 (adsorbed diphtheria, tetanus, and purified pertussis combination vaccine for adults) in two doses (each for Test group 1 and Test group 2
Sponsors
Boryungbiopharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects aged 10 to under 65 years
Exclusion criteria
Exclusion criteria: 1) Presence of wounds, tattoos, scars, skin conditions, or infections at the injection site that may affect safety evaluation 2) History of infection with any of diphtheria, tetanus, or pertussis (clinically, serologically, or microbiologically confirmed) 3) Receipt of any other vaccine within 4 weeks before or scheduled within 4 weeks after administration of the investigational product 4) If a vaccine containing any of the antiphtheria, antifungal toxoid or anti-pertussive ingredients has been vaccinated within 10 years prior to the inoculation of clinical trial drugs (however, children aged 10 to under 19 have been inoculated or vaccinated within the last 5 years) 5) If you have experienced hypersensitivity reactions, neurological complications, temporary thrombocytopenia, etc. after vaccination with diphtheria, tetanus or pertussis, or hypersensitivity reactions to the components of this vaccine 6) If you have experienced encephalopathy of unknown etiology within 7 days of vaccination containing pertussis ingredients in the past 7) Acute fever (38.0 º C or higher) disease or fever within 72 hours prior to clinical trial drug inoculation 8) If treatment is required for serious/severe acute/chronic or progressive disease within two weeks prior to clinical trial drug inoculation, or if, as determined by the tester, serious/severe acute/chronic or progressive disease that may interfere with the progression and completion of this clinical trial 9) A malignant tumor, including solid cancer, or a blood disease, or has a history of it (however, malignant tumors are allowed if they do not recur within 5 years after the diagnosis of cure) 10) A patient with progressive neurological disease, uncontrolled epilepsy or progressive encephalopathy, or a history of Guillain-Barré Syndrome 11) A person with thrombocytopenia or other blood clotting disorders during screening or receiving anticoagulant therapy at risk of hematoma 12) Showing symptoms of chronic cough prior to clinical trial drug inoculation or having a history of related diseases having such symptoms 13) If you have an immunodeficiency disease or a family history (such as congenital immunodeficiency, cellular immunodeficiency, hypogammaglobulinemia, dysgamaglobulinemia, etc.) 14) If there is a history of organ transplantation or bone marrow transplantation 15) HBsAg, quantification of anti-HCV Antibody or HCV RNA during screening, and if any of the HIV Antibody test results are positive 16) In clinical laboratory tests conducted by screening, the examiner's judgment indicates hypernatremia, hyponatremia, hypokalemia, hyponatremia, hyponatremia, hypoproteinemia, or other clinically significant abnormal findings 17) If a person has received a blood preparation or a blood-derived preparation or immunoglobulin within 12 weeks prior to inoculation of a clinical trial drug 18) Where immunomodulatory therapy, immunosuppressive therapy, systemic steroids, etc. have been performed within 24 weeks prior to inoculation of clinical trial drugs - Irradiation, Antimetabolites, Alkylating agents, Cytotoxic drugs (Azathioprine, Cyclosporine, Interferon, G-CSF [Granulocyte-Colony Stimulating Factor], Tacrolimus, Everolimus, Sirolimus ) - Use of high-dose or chronic systemic corticosteroids (however, for less than 14 consecutive days (or equivalent doses) of <20 mg/day in adults over 19 years of age or <0.5 mg/kg/day in children over 10 years of age (but no more than 20 mg/day) based on Prednisolone is p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean concentration (GMC) of pertussis (Anti-PT, Anti-FHA) antibodies before and 4 weeks (28 days) after administration of the investigational product;Booster response rate for pertussis (Anti-PT, Anti-FHA) antigens 4 weeks (28 days) after administration of the investigational product;Booster response rate for diphtheria toxoid and tetanus toxoid 4 weeks (28 days) after administration of the investigational product | — |
Secondary
| Measure | Time frame |
|---|---|
| GMC of diphtheria and tetanus antibodies before and 4 weeks (28 days) after administration of the investigational product;Geometric mean ratio (GMR) of diphtheria, tetanus, and pertussis antibodies before and 4 weeks (28 days) after administration of the investigational product;Proportion of subjects with diphtheria and tetanus antibody titers =0.1 IU/mL 4 weeks (28 days) after administration of the investigational product | — |
Countries
Korea, Republic of
Contacts
Public ContactJunghyun Choi
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Outcome results
None listed