Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-Flagellin) Universal Influenza Vaccine in Healthy Adults - NCT00921947-84124 (Clinical Trial 298025)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy298025.aspx
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| City: |
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Salt Lake City |
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State:
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UT |
| Zip Code: |
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84124 |
| Conditions: |
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Influenza |
| Purpose: |
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1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the
VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level
delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.
2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102
vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered
i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked
immunosorbent assay (ELISA) in a healthy adult population.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Adult men or women aged 18 to 49 years inclusive.
- Able and willing to provide written informed consent to participate.
- Healthy, as determined by medical history, physical examination, and vital signs.
- Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c.
injection.
- Willing to provide multiple blood specimens collected by venipuncture.
- Females should avoid becoming pregnant during the course of the study
- Women of childbearing potential must have a negative urine pregnancy test within 24
hours preceding receipt of the first and preceding receipt of the second (booster)
vaccination.
- Must exhibit comprehension of the study requirements; expressed availability for the
required study period and expect to reside in the study area during the entire study
period, and ability to attend scheduled visits.
Exclusion Criteria:
- Persons under 18 years old or 50 years or older.
- Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease.
- Person currently pregnant, nursing mothers or planning a pregnancy within one month
of vaccination.
- Persons who have had a prior serious reaction to influenza vaccine.
- Persons with a history of anaphylactic-type reaction to injected vaccines.
- Persons with a history of drug or chemical abuse in the year preceding the study.
- Persons who received an influenza vaccine for the current influenza season or those
who plan to receive an influenza vaccine while participating in the study.
- Persons who received any other vaccine within one week prior to enrollment (may delay
enrollment).
- Persons who have had a respiratory illness or illness with fever within three days of
study enrollment (may delay enrollment).
- Persons currently participating in another research study involving any study
medications (medicines or vaccines). |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 2, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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