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The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against diphtheria, tetanus, pertussis, and polio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTaP-IPV combination vaccine | Experimental | DTaP-IPV 0.5ml IM boosting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV combination vaccine | Biological | Dosage and administration: A single intramuscular injection of 0.5 mL will be given to healthy children aged 4 to 6 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate after boosting vaccination | Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA). | boosting vaccination after Day 28 [+14 days] |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rate for anti-DT, anti-TT, and anti-poliovirus or seropositive (>30 IU/mL) rate for anti-PT and anti-FHA before boosting vaccination | Seroprotection rate | Day 1 Pre-vaccination |
| Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunhye IM | Contact | +82-2-780-8454 | Imsunhye@boryungbio.co.kr | |
| Seohee Byeon | Contact | +82-2-740-4154 | seohee@boryungbio.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Byeonguk Eun | Eulji University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Recruiting | Ansan | South Korea |
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DTaP-IPV combined vaccine, 0.5mL, imtramuscular
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Seroprotection rate (≥ 0.01 IU/mL) |
| Day 1 Pre-vaccination |
| Pre-booster antibody level | Day 1 Pre-vaccination |
| Post-booster antibody level | boosting vaccination after Day 28 [+14 days] |
| Geometric mean ratio (GMR) between the pre- and post-booster antibody level | Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days] |
| GMR between the pre- and post-booster antibody level in each subgroup depending on the pre-booster antibody level (≥ seroprotective/seropositive level or < seroprotective/seropositive level) | Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days] |
| Reverse cumulative distribution curves for pre- and post-booster antibody level | Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days] |
| Seroprotection rate for anti-DT, anti-TT, and anti-poliovirus or seropositive (>30 IU/mL) rate for anti-PT and anti-FHA after boosting vaccination | boosting vaccination after Day 28 [+14 days] |
| Proportion of subjects with post-booster antibody levels for anti-DT and anti-TT ≥1.0 IU/mL | boosting vaccination after Day 28 [+14 days] |
| Hallym University Medical Center | Recruiting | Anyang | South Korea |
|
| Changwon Fatima Hospital | Recruiting | Changwon | South Korea |
|
| KeiMyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
|
| Hallym University Medical Center | Recruiting | Gyeonggi-do | South Korea |
|
| Myongji Hospital | Recruiting | Gyeonggi-do | South Korea |
|
| Wonkwang University Hospital | Recruiting | Iksan | South Korea |
|
| Inha University Hospital | Recruiting | Incheon | South Korea |
|
| The Catholic University of Korea Incheon St. Mary's Hospital | Recruiting | Incheon | South Korea |
|
| Jeonbuk National University Hospital | Recruiting | Jeonju | South Korea |
|
| Mediplex Sejong Hospital | Recruiting | Sejong | South Korea |
|
| Bundang Cha Hospital | Recruiting | Seongnam | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | South Korea |
|
| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
|
| Eulji University Hospital | Recruiting | Seoul | South Korea |
|
| Gangnam Sevrance Christian Hospital | Recruiting | Seoul | South Korea |
|
| Hanil General Hospital | Recruiting | Seoul | South Korea |
|
| Kangdong Sacred Heart Hospital | Recruiting | Seoul | South Korea |
|
| Korea Cancer Center Hospital | Recruiting | Seoul | South Korea |
|
| KyungHee University Hospital at Gangdong | Recruiting | Seoul | South Korea |
|
| KyungHee University Hospital | Recruiting | Seoul | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| Severance Hospital | Recruiting | Seoul | South Korea |
|
| Ajou University Hospital | Recruiting | Suwon | South Korea |
|
| The Catholic University of Korea St. Vincent's Hospital | Recruiting | Suwon | South Korea |
|
| Wonju Sevrance Christian Hospital | Recruiting | Wŏnju | South Korea |
|
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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