NCT00233064 - 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)

Makari D, Jensen KM, Harris B, Jafri HS
Randomized, Double-Blind Study of the Safety of the Liquid Versus Lyophilized Formulation of Palivizumab in Premature Infants and Children with Chronic Lung Disease of Prematurity. Infect Dis Ther. 2014 Dec;3(2):339-47. doi: 10.1007/s40121-014-0033-y. Epub 2014 Aug 26.

A Phase IV, Randomized, Double-Blind Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis) in Children at High Risk for the Development of Serious RSV Disease

Details for clinical trial NCT00233064

Clinical trial NCT00233064 - References