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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1127-6896 | Other Identifier | WHO |
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The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative.
Primary Objective
Secondary Objectives:
Study participants who received a first dose of recombinant Hep B vaccine at birth will receive either DTaP-IPV-Hep B-PRP~T combined vaccine at 2, 4, and 6 months of age + 3 doses of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants will receive 3 injections of the study vaccine (DTaP-IPV-Hep B-PRP~T combined vaccine) at 2, 4, and 6 months of age |
|
| Group B | Active Comparator | Participants will receive 2 injections of monovalent Hep B vaccine (Euvax B®) at age 1 and 6 months and 3 injections of DTaP IPV//PRP~T vaccine (Pentaxim™) at age 2, 4, and 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T combined vaccine | Biological | 0.5 mL, Intramuscular |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL | Anti-Diphtheria antibodies will be measured by a toxin neutralization test | 1 month post third vaccination |
| Number of participants with anti-Tetanus antibody concentrations ≥ 0.1 International unit (IU)/mL | Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA). | 1 month post third vaccination |
| Number of participants with ≥ 4 fold increase in anti-PT and anti-FHA antibody concentrations (EU/mL) from 1 month pre-dose 1 to 1 month post-dose 3 | Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA). | I month post dose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL International Units (IU)/mL | Anti-Diphtheria antibodies will be measured by a toxin neutralization test | Day 0 Pre-vaccination |
| Number of participants with anti-Hepatitis B antibody concentrations ≥ 10 mIU/mL international unit (IU)/mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daejeon | 301 724 | South Korea | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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| DTaP-IPV//PRP~T and Hepatitis B vaccine |
| Biological |
0.5 mL, Intramuscular |
|
|
Anti-Hepatitis B antibodies will be measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology |
| Day 0 Pre-vaccination |
| Number of participants with anti Diphtheria antibody concentrations ≥ 0.1 IU/mL International Units (IU)/mL | Anti-Diphtheria antibodies will be measured by a toxin neutralization test | 1 month post third vaccination |
| Number of participants reporting solicited injection site and solicited systemic reactions, unsolicited adverse events, and serious adverse events following vaccination with either DTaP-IPV-Hep B-PRP~T combined vaccine or Pentaxim™ and Euvax B® vaccine | Solicited injection site reactions Tenderness, Erythema, and Swelling. Solicited systemic reactions Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability. | Day 0 and up to Day 180 post-vaccination |
| Number of participants with response to vaccine Pertussis toxoid (PT) and Filamentous Haemagglutinin (FHA) antigens | Vaccine response defined as: Post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantitation (LLOQ) if pre-vaccination concentration is < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ | 1 month post third vaccination |
| Gyeonggi-do |
| 425 707 |
| South Korea |
| Gyeonggi-do | South Korea |
| Gyeongsangnam Do | 641 560 | South Korea |
| Gyeongsangnam Do | South Korea |
| Jeollabuk Do | 570 711 | South Korea |
| Jeonbuk | 561 712 | South Korea |
| Kangwon Do | 220 701 | South Korea |
| Kyunggi Do | 420 717 | South Korea |
| Seoul | 120 752 | South Korea |
| Seoul | 130 87 | South Korea |
| Seoul | 137 701 | South Korea |
| Seoul | 139 709 | South Korea |
| Seoul | 158 710 | South Korea |
| Seoul | South Korea |
| Suwon Gyeonggi Do | 442 723 | South Korea |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D006192 | Haemophilus Infections |
| D011051 | Poliomyelitis |
| D006509 | Hepatitis B |
| 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 |
| D016871 | Pasteurellaceae Infections |
| 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 |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| C426945 | Pentavac |
| C484909 | Euvax-B |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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