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| Name | Class |
|---|---|
| Novotech (Australia) Pty Limited | INDUSTRY |
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This is a randomized, observer-blind, positive-controlled study. There will be 3 treatment groups, in each treatment group, participants will be randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio that are defined as Dose A, Dose M, and Dose H, respectively) or control vaccine in a ratio of 3:1 in each group. Distribution of participant's gender should be balanced in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental vaccine group A, Low dose, Intramuscular injection (IM) | Experimental | 1 dose of Low-adjuvant dose VLP-Polio vaccine on Visit 1 |
|
| Control vaccine group A, IM | Active Comparator | 1 dose of IPOL vaccine on Visit 1 |
|
| Experimental vaccine group B, Medium dose, Intramuscular injection (IM) | Experimental | 1 dose of Medium dose VLP-Polio vaccine on Visit 1 |
|
| Control vaccine group B, IM | Active Comparator | 1 dose of IPOL vaccine on Visit 1 |
|
| Experimental vaccine group C, High dose, Intramuscular injection (IM) | Experimental | 1 dose of High dose VLP-Polio vaccine on Visit 1 |
|
| Control vaccine group C, IM |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) | Biological | 1 dose of VLP-Polio vaccine (0.5ml) on Visit 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited adverse reactions (AEs) within 7 days post vaccination. | Within 7 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of unsolicited AEs within 28 days post-vaccination. | Within 28 days post-vaccination | |
| Occurrence of solicited AEs within 30 mins post-vaccination. | Within 30 mins post-vaccination | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Chang, Dr | Nucleus Network Pty Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd | Geelong | Victoria | Australia | |||
| Nucleus Network Pty Ltd |
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1 dose of IPOL vaccine on Visit 1 |
|
| Inactivated poliomyelitis vaccine (IPOL) | Biological | 1 dose of IPOL vaccine (0.5ml) on Visit 1 |
|
| VLP-Polio | Biological | 1 dose of VLP-Polio vaccine (0.5ml) on Visit 1 |
|
| IPOL | Biological | 1 dose of IPOL vaccine (0.5ml) on Visit 1 |
|
| VLP-Polio | Biological | 1 dose of VLP-Polio vaccine (0.5ml) on Visit 1 |
|
| IPOL | Biological | 1 dose of IPOL vaccine (0.5ml) on Visit 1 |
|
| Occurrence of abnormal safety laboratory parameters on Day 3, Day 8. |
| Day 3, Day 8 post-vaccination |
| Occurrence of serious adverse events (SAEs) during the study period. | Through study completion, an average of 6 months |
| Geometric mean titer (GMT) of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination. | Day 1 before vaccination and Day 29 and Day 180 after the vaccination |
| Geometric mean fold increase (GMI) of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination. | Day 1 before vaccination and Day 29 and Day 180 after the vaccination |
| Seroconversion rate of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination. | Day 1 before vaccination and Day 29 and Day 180 after the vaccination |
| Melbourne |
| Victoria |
| Australia |
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | 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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| ID | Term |
|---|---|
| D011054 | Poliovirus Vaccine, Inactivated |
| ID | Term |
|---|---|
| D015164 | Vaccines, Inactivated |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
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