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The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine 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 and thereby to select the optimal dose of candidate vaccine(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)
Stage 1 (Dose-level Finding;Phase 2)
1. To compare the immunogenicity and safety of three LBVD vaccine candidates, varying at different dose levels, to the Control vaccines at 4 weeks after a three-dose primary series of vaccination and thereby, select an optimal vaccine dose level for Stage 2
Stage 2 (Evaluation of Safety, Immunogenicity, and Lot-to-lot Consistency;Phase 3)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group 1 | Experimental | Low dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot A for Stage 2 |
|
| Test group 2 | Experimental | Middle dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot B for Stage 2 |
|
| Test group 3 | Experimental | High dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib)for Stage 1/ selected dose of hexavalent vaccine Lot C for Stage 2 |
|
| Control group | Active Comparator | Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBVD (Hexavalent vaccine) | Biological | Injection within the muscle into the front area of the thigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection/seroconservison/ 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 |
| Immediate reactions after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Lead | Contact | +82-2-3777-1114 | lgclinical@lgchem.com |
| Name | Affiliation | Role |
|---|---|---|
| Edison Alberto, MD | Health Index Multispecialty Clinic | Principal Investigator |
| Josefina Carlos, MD | UERM Memorial Medical Center | Principal Investigator |
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| Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains) | Biological | Injection within the muscle into the front area of the thigh |
|
Immediate reactions after vaccination including all the signs and symptoms that occur within 30 minutes after the vaccination will be monitored at site. It is collected as an adverse event, but is classified as an immediate reaction only if the AE occurs within 30 minutes after vaccination.
| 30 minutes after each vaccination |
| Solicited adverse event | Expected local or systemic side effects after vaccination | 7 days after each vaccination |
| Unsolicited adverse event | All unwanted or bad events after vaccination other than solicited adverse event | 28 days after each vaccinations |
| 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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