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The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L dose of Hexavalent | Experimental | Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib) |
|
| M dose of Hexavalent | Experimental | Middle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib) |
|
| H dose of Hexavalent | Experimental | High dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib). |
|
| Pentavalent+IPV | Active Comparator | Co-administration of EupentaTM Inj and Imovax Polio |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTwP-HepB-Sabin IPV-Hib | Biological | Intramuscular injection into the anterolateral area of the thigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| seroprotection/seroconversion/vaccine-response rate | Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components | 4 weeks after three-dose primary series |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean concentration (GMC) or Geometric mean titer (GMT) | GMC or GMT and their ratio of all types of antibodies | 4 weeks after three-dose primary series |
| Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunjeong Yang | Contact | +82-2-6987-4158 | yangyj@lgchem.com |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D006509 | Hepatitis B |
| D011051 | Poliomyelitis |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Pentavalent vaccine and Salk IPV | Biological | Intramuscular injection into anterolateral area of the thigh |
|
Proportion of subjects achieving anti-diphtheria toxoid antibody level with cut-off ≥ 1.0 IU/mL
| 4 weeks after three-dose primary series |
| Seroprotection rate against tetanus with cut-off ≥ 1.0 IU/mL | Proportion of subjects achieving anti-tetanus toxoid antibody level with cut-off ≥ 1.0 IU/mL | 4 weeks after three-dose primary series |
| Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL | Proportion of subjects achieving anti-PRP antibody level with cut-off ≥ 1 µg/mL | 4 weeks after three-dose primary series |
| Seroconversion rate against Salk serotypes | Proportion of subjects achieving seroconversion of each Salk wild poliovirus serotype | 4 weeks after three-dose primary series |
| Seroprotection rate against Sabin and Salk serotypes | Proportion of subjects achieving seroprotection of each Sabin and Salk poliovirus serotype | 4 weeks after three-dose primary series |
| 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 |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D016871 | Pasteurellaceae Infections |