NCT03460743 - 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)

Baxter R, Patriarca PA, Ensor K, Izikson R, Goldenthal KL, Cox MM
Evaluation of the safety, reactogenicity and immunogenicity of FluBlok® trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy adults 50-64 years of age. Vaccine. 2011 Mar 9;29(12):2272-8. doi: 10.1016/j.vaccine.2011.01.039. Epub 2011 Jan 28.
King JC Jr, Cox MM, Reisinger K, Hedrick J, Graham I, Patriarca P
Evaluation of the safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy children aged 6-59 months. Vaccine. 2009 Nov 5;27(47):6589-94. doi: 10.1016/j.vaccine.2009.08.032. Epub 2009 Aug 27.

Evaluation of the Immunogenicity, Relative Efficacy, Safety and Reactogenicity of Flublok Quadrivalent® (Quadrivalent Recombinant Influenza Vaccine, Seasonal Formulation) Compared With a Marketed Quadrivalent Vaccine in Healthy Children and Adolescents Aged 3 to 17 Years-old.

Details for clinical trial NCT03460743

Clinical trial NCT03460743 - References