Status:
COMPLETED
Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47
Lead Sponsor:
Valneva Austria GmbH
Collaborating Sponsors:
PATH
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Detailed Description
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. Th...
Eligibility Criteria
Inclusion
- Written informed consent
- Healthy adults ≥ 18 to \</= 65
- female subjects: post-menopausal or practicing reliable methods of contraception during the study
Exclusion
- History of autoimmune diseases and malignancies.
- History of severe hypersensitivity reactions and anaphylaxis.
- Immunodeficiency due to immunosuppressive therapy.
- Infection with HIV, Hepatitis B or Hepatitis C.
- Pregnancy, lactation
- Vulnerable subjects
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00873431
Start Date
March 1 2009
End Date
February 1 2010
Last Update
October 19 2012
Active Locations (1)
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1
Parexel International GmbH, Institute for Clinical Pharmacology
Berlin, State of Berlin, Germany, 14050