Pneumococcal Infections Clinical Trial
Official title:
An Open-Label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC47, a New Vaccine Against Streptococcus Pneumoniae, in Healthy Subjects.
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. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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Phase 2 | |
| Completed |
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|
Phase 2 |