NCT00995527 - Clinical Trial References

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.

Citation(s)

Neumann G, Noda T, Kawaoka Y
Emergence and pandemic potential of swine-origin H1N1 influenza virus. Nature. 2009 Jun 18;459(7249):931-9. doi: 10.1038/nature08157. Review.
Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K
Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86.
Zimmer SM, Burke DS
Historical perspective--Emergence of influenza A (H1N1) viruses. N Engl J Med. 2009 Jul 16;361(3):279-85. doi: 10.1056/NEJMra0904322. Epub 2009 Jun 29.

Characterization of the Innate Immune Response in Healthy NIH Employees at Baseline and After Immunization With the H1N1 Vaccine

Clinical trial NCT00995527 - References