NCT00996853 - 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)

Nazareth I, Tavares F, Rosillon D, Haguinet F, Bauchau V
Safety of AS03-adjuvanted split-virion H1N1 (2009) pandemic influenza vaccine: a prospective cohort study. BMJ Open. 2013 Feb 5;3(2). pii: e001912. doi: 10.1136/bmjopen-2012-001912. Print 2013.
Tavares F, Nazareth I, Monegal JS, Kolte I, Verstraeten T, Bauchau V
Pregnancy and safety outcomes in women vaccinated with an AS03-adjuvanted split virion H1N1 (2009) pandemic influenza vaccine during pregnancy: a prospective cohort study. Vaccine. 2011 Aug 26;29(37):6358-65. doi: 10.1016/j.vaccine.2011.04.114. Epub 2011 May 17.

Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK2340272A) in the United Kingdom (UK)

Clinical trial NCT00996853 - References