Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47
An Open-Label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC47, a New Vaccine Against Streptococcus Pneumoniae, in Healthy Subjects.
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 31, 2009
CompletedFirst Posted
Study publicly available on registry
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedOctober 19, 2012
October 1, 2012
11 months
March 31, 2009
October 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (1)
Determination of vaccine-specific IgG levels
Day 0 - Day 264
Study Arms (4)
IC47 30 mcg
EXPERIMENTAL30 mcg with Alum
IC47 30 mcg w/o
EXPERIMENTAL30 mcg without Alum
IC47 150 mcg
EXPERIMENTAL150 mcg with Alum
IC47 150 mcg w/o
EXPERIMENTAL150 mcg without Alum
Interventions
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
Eligibility Criteria
You may qualify if:
- Written informed consent
- Healthy adults ≥ 18 to \</= 65
- female subjects: post-menopausal or practicing reliable methods of contraception during the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Valneva Austria GmbHlead
- PATHcollaborator
Study Sites (1)
Parexel International GmbH, Institute for Clinical Pharmacology
Berlin, State of Berlin, 14050, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Evelyn Hatzenbichler, PhD
Valneva Austria GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2009
First Posted
April 1, 2009
Study Start
March 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
October 19, 2012
Record last verified: 2012-10