Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 64
Updated:10/3/2013
Start Date:August 2013
End Date:October 2014
Contact:Novartis Drug Information Services
Phone:+1 800 244 7668

Use our guide to learn which trials are right for you!

Phase I Multi-center, Observer-Blind, Randomized Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated A/H7N9 Monovalent Subunit Influenza Virus Vaccine (H7N9c) in Adults 18 to <65 Years


Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults
between the ages of 18 years and 65 years.


Inclusion Criteria:

1. Healthy adult subject ages 18-64 years.

2. Individuals willing to provide written informed consent

3. Individuals in good health.

4. Individuals who can comply with study procedures and follow-up.

Exclusion Criteria:

1. Individuals with history of cognitive or behavioral impairment or psychiatric
disease,

2. Individuals unable to understand and follow study procedures,

3. History of significant illness,

4. History of chronic medical condition or progressive disease,

5. Allergy to any vaccine component or adverse event related to a vaccine component,

6. Impairment/alteration of the immune system,

7. Presence of progressive or severe neurological disorder,

8. Pregnant or breast-feeding,

9. Female of Child-bearing potential unwilling to use acceptable method of birth
control,

10. Presence of medically significant cancer,

11. Receipt of investigational product within 30 day prior to entry into the study,

12. History of previous or suspected illness from avian flu caused by H7N9 virus,

13. History of H7 vaccination,

14. Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness
within 3 days of intended study vaccination,

15. Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study
vaccination,

16. Receipt of any vaccination 2 weeks before study entry or 4 weeks after study
vaccination,

17. History of drug or alcohol abuse within the past 2 years,

18. Body Mass Index (BMI) greater than or equal to 35kg/m2,

19. Individuals conducting the study or their immediate family members.
We found this trial at
6
sites
Melbourne, Florida 32935
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
Peoria, Illinois 61602
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
Salt Lake City, Utah 84109
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Salt Lake City, Utah 84121
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92108
?
mi
from
San Diego, CA
Click here to add this to my saved trials