Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origi… (NCT00971906) | Clinical Trial Compass
CompletedPhase 3
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
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 influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults