NCT00971100 - 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)

Knuf M, Leroux-Roels G, Rümke H, Rivera L, Pedotti P, Arora AK, Lattanzi M, Kieninger D, Cioppa GD
Immunogenicity and safety of cell-derived MF59®-adjuvanted A/H1N1 influenza vaccine for children. Hum Vaccin Immunother. 2015;11(2):358-76. doi: 10.4161/21

A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Cell-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects From 6 Months to 17 Years of Age

Details for clinical trial NCT00971100

Clinical trial NCT00971100 - References