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| Name | Class |
|---|---|
| PATH | OTHER |
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The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination.
A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.
This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. The following table shows the design of the different study groups. The amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC47 30 mcg | Experimental | 30 mcg with Alum |
|
| IC47 30 mcg w/o | Experimental | 30 mcg without Alum |
|
| IC47 150 mcg | Experimental | 150 mcg with Alum |
|
| IC47 150 mcg w/o | Experimental | 150 mcg without Alum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IC47 | Biological | solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any SAEs (possibly)related to the study vaccine | Day 0 - Day 264 | |
| Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine | Day 0 - Day 264 | |
| Occurrence of solicited local and systemic AEs within 1 week after vaccination | Day 0 - Day 264 |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of vaccine-specific IgG levels | Day 0 - Day 264 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evelyn Hatzenbichler, PhD | Valneva Austria GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH, Institute for Clinical Pharmacology | Berlin | State of Berlin | 14050 | Germany |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| D007239 | Infections |