Non-specific Response to H1N1 Vaccine

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

This is a prospective observational study with recruitment of healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1 vaccines.

NCT number	NCT01178918
Study type	Observational
Source	The University Clinic of Pulmonary and Allergic Diseases Golnik
Contact
Status	Completed
Phase
Start date	November 2009
Completion date	July 1, 2012

Non-specific Response to H1N1 Vaccine

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms