NCT01499914 - 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)

d'Alessandro E, Hubert D, Launay O, Bassinet L, Lortholary O, Jaffre Y, Sermet-Gaudelus I
Determinants of refusal of A/H1N1 pandemic vaccination in a high risk population: a qualitative approach. PLoS One. 2012;7(4):e34054. doi: 10.1371/journal.pone.0034
Launay O, Boelle PY, Krivine A, Grenet D, Boussaud V, Rémus N, Corvol H, Chedevergne F, Hubert D, Sermet-Gaudelus I; Inserm MUCOFLU group
Factors associated with humoral immune response to pandemic A/H1N1(v) 2009 influenza vaccine in cystic fibrosis. Vac

Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination in Patients With Cystic Fibrosis and, Where Applicable, the Clinical Expression of Influenza A (H1N1)

Details for clinical trial NCT01499914

Clinical trial NCT01499914 - References