Status:
COMPLETED
Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age
Lead Sponsor:
Novartis Vaccines
Conditions:
Pandemic Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin i...
Eligibility Criteria
Inclusion
- Males and females 18 years of age and above on the day of enrollment;
- Individuals in good health
- Individuals are able to comply with all study procedures
- Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Exclusion
- Individual not able to comprehend and to follow all required study procedures;
- History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- Any serious chronic or progressive disease according to judgment of the investigator
- History of any anaphylaxis, serious vaccine reactions, to any excipients.
- Adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1;
- Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study;
- Any other vaccines within 4 weeks prior to enrollment or who are planning to receive any vaccine within 4 weeks from the study vaccines; only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations.
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
- Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;
- Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;
- History of progressive or severe neurological disorders;
- Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
- Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;
- Female pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
- Members of the research staff or their relatives.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
812 Patients enrolled
Trial Details
Trial ID
NCT00970177
Start Date
August 1 2009
End Date
March 1 2011
Last Update
December 1 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Gent, Antwerpen, Belgium
2
Wurzburg, Fulda, Neumunster, Balve, Leipzig, Magdeburg
München, Germany
3
Zurich, Switzerland