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The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) 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
Stage 1 (Phase 2)
1. To compare the immunogenicity and safety of LBVD to the licensed Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age
Stage 2 (Phase 3)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group 1 for Stage 1 | Experimental | LBVD |
|
| Test group 1 for Stage 2 | Experimental | LBVD Lot A |
|
| Test group 2 for Stage 2 | Experimental | LBVD Lot B |
|
| Test group 3 for Stage 2 | Experimental | LBVD Lot C |
|
| Control group for Stage 1 and Stage 2 | Active Comparator | Co-administration of Pentavalent vaccine and Inactivated Polio vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBVD | Biological | Intramuscular injection into the anterolateral area of the thigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection/seroconversion rate | proportion of participants achieving pre-defined immune response to each antigen | 4 weeks after a three-dose primary series |
| Geometric mean concentration (GMC) for pertussis | GMC for pertussis antigen | 4 weeks after a three-dose primary series |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) or GMC | GMT or GMC for all antigens | 4 weeks after the three-dose primary series |
| Seroprotection/seroconversion rate | Proportion of participant achieving pre-defined immune response to each antigen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Lead | Contact | +82-2-6987-4156 | lgclinical@lgchem.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care CT Group | Recruiting | Dasmariñas | Cavite | Philippines |
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| Pentavalent vaccine and Inactivated Polio vaccine | Biological | Intramuscular injection into the anterolateral area of the thigh |
|
| 4 weeks after the three-dose primary series |
| Immediate reactions after vaccination | any signs and symptoms which occur within the first 30 minutes after each vaccination will be monitored | 30 minutes after each vaccination |
| Solicited adverse event | local or systemic signs and symptoms | within 7 days after each vaccination |
| Unsolicited adverse event | All adverse events other than solicited adverse event | 4 weeks after the three-dose primary series |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D011054 | Poliovirus Vaccine, Inactivated |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D015164 | Vaccines, Inactivated |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
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