Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:65 - Any
Updated:2/1/2019
Start Date:January 2013
End Date:July 2014

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A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Elderly Subjects.

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived
influenza vaccine in elderly subjects


Inclusion Criteria:

1. Healthy elderly subjects ≥65 years,

2. Individuals willing to provide written informed consent,

3. Individuals in good health,

4. Individuals willing to allow for their serum samples to be stored beyond the study
period.

Exclusion Criteria:

1. Individuals not able to understand and follow study procedures,

2. History of any significant illness,

3. History of any serious chronic medical condition or progressive disease,

4. Presence of medically significant cancer,

5. Known or suspected impairment/alteration of immune function,

6. Presence of any progressive or severe neurologic disorder,

7. Presence of any bleeding disorders or conditions that prolongs bleeding time,

8. History of allergy to vaccine components,

9. Receipt of any other investigational product within 30 days prior to entry into the
study,

10. History of previous H5N1 vaccination,

11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into
the study,

12. Receipt of any other vaccine within 2 weeks prior to entry into the study

13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended
study vaccination,

14. Body mass index (BMI) ≥ 35 kg/m2,

15. History of drug or alcohol abuse,

16. Any planned surgery during study period,

17. Individuals conducting the study and their immediate family members,

18. Individuals with behavioral or cognitive impairment or psychiatric diseases.
We found this trial at
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Wichita, Kansas 67207
1186
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Austin, Texas 78705
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Endwell, New York 13760
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Georgetown, Texas 78745
1210
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Hollywood, Florida 33024
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Newcastle, New South Wales
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Newcastle,
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Phoenix, Arizona 85253
343
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Saint Louis, Missouri 63141
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Saint Louis, Missouri 63141
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Salt Lake City, Utah 84121
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South Cottonwood Heights, Utah 84121
565
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South Cottonwood Heights, UT
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South Jordan, Utah 84095
558
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South Jordan, UT
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Wichita, Kansas 67207
1186
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from 91732
Wichita, KS
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