A Phase 1 interventional study of IC47 in Pneumococcal Infections, sponsored by Valneva Austria GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-19.
Sponsored by Valneva Austria GmbH · Phase 1 and Interventional
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.
281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.
This study's enrollment of 32 is below the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →Valneva Austria GmbH is the lead sponsor of 44 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
30 mcg with Alum
Biological: IC47
30 mcg without Alum
Biological: IC47
150 mcg with Alum
Biological: IC47
150 mcg without Alum
Biological: IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
Occurrence of any SAEs (possibly)related to the study vaccine
Time frame: Day 0 - Day 264
Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine
Time frame: Day 0 - Day 264
Occurrence of solicited local and systemic AEs within 1 week after vaccination
Time frame: Day 0 - Day 264
Determination of vaccine-specific IgG levels
Time frame: Day 0 - Day 264
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Valneva Austria GmbH