Clinical Trial: Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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.
Brief Summary:
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.
Detailed Summary: 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.
Sponsor: Valneva Austria GmbH
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Determination of vaccine‐specific IgG levels [ Time Frame: Day 0 - Day 264 ]
Original Secondary Outcome: Same as current
Information By: Valneva Austria GmbH
Dates:
Date Received: March 31, 2009
Date Started: March 2009
Date Completion:
Last Updated: October 18, 2012
Last Verified: October 2012
