NCT01012557 - 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)

Bischoff AL, Følsgaard NV, Carson CG, Stokholm J, Pedersen L, Holmberg M, Bisgaard A, Birch S, Tsai TF, Bisgaard H
Altered response to A(H1N1)pnd09 vaccination in pregnant women: a single blinded randomized controlled trial. PLoS One. 2013 Apr 18;8(4):e5
Bischoff AL, Følsgaard NV, Vissing NH, Birch S, Brix S, Bisgaard H
Airway mucosal immune-suppression in neonates of mothers receiving A(H1N1)pnd09 vaccination during pregnancy. Pediatr Infect Dis J. 2015 Jan;34(1):84-90. doi: 10.1097/INF.0000000000000529.

H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza AH1N1v Vaccination in Pregnant Women

Clinical trial NCT01012557 - References