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The study was terminated during the EC submission process prior to the enrolment
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This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) in children 2-<6 years of age.
This Phase 1 randomized, placebo-controlled, observer-blind study will evaluate the safety, reactogenicity and immunogenicity of different formulations of SCB-1019T vaccine in children 2-<6 years of age. A placebo is used as a control in the study because there is no licensed RSV comparator vaccine available for young children globally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (low dose SCB-1019T ) | Experimental | 24 children (2-<6 years of age) will receive low-dose unadjuvanted SCB-1019T at Day 1 |
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| Group 2 (adjuvanted low dose SCB-1019T) | Experimental | 24 children (2-<6 years of age) will receive low-dose adjuvanted SCB-1019T at Day 1 |
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| Group 3 (Placebo) | Placebo Comparator | 8 children (2-<6 years of age) will receive placebo at Day 1 |
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| Group 4 (high dose SCB-1019T) | Experimental | 24 children (2-<6 years of age) will receive high-dose unadjuvanted SCB-1019T at Day 1 |
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| Group 5 ( adjuvanted high dose SCB-1019T) | Experimental | 24 children (2-<6 years of age) will receive high-dose adjuvanted SCB-1019T at Day 1 |
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| Group 6 (Placebo) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dose SCB-1019T | Biological | Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine | Porportion of participants with local and systemic solicied AEs | Within 7 days after vaccination |
| Evaluate porportions of participants with unsolicited AEs of SCB-1019T vaccine | Porportions of participants with unsolicited AEs | Within 28 days after vaccination |
| Evaluate porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019T vaccine | Porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study | Throughout the study period, from enrollment to 6 months follow up |
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Inclusion Criteria:
• Male and female participants 2 to <6 years of age at Visit 1. • Parents/guardians of participants willing and able to provide written informed consent and comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. • Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator.
For full inclusion criteria, please refer to full protocol.
Exclusion Criteria:
For full Exclusion criteria, please refer to full protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kids Research Institute | Perth | Western Australia | 6009 | Australia |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| Placebo Comparator |
8 children (2-<6 years of age) will receive placebo at Day 1 |
|
| adjuvanted low dose SCB-1019T | Biological | Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) |
|
| high dose SCB-1019T | Biological | Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) |
|
| adjuvanted high dose SCB-1019T | Biological | Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) |
|
| Placebo | Other | 0.9% NaCl saline placebo |
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| D014777 | Virus Diseases |
| D007239 | Infections |