NCT01019083 - 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)

Ahmed T, Svennerholm AM, Al Tarique A, Sultana GN, Qadri F
Enhanced immunogenicity of an oral inactivated cholera vaccine in infants in Bangladesh obtained by zinc supplementation and by temporary withholding breast-feeding. Vaccine. 2009 Feb 25;27(9):1433-9. doi: 10.1016/j.vaccine.2008.12.036. Epub 2009 Jan 13.
Qadri F, Ahmed T, Wahed MA, Ahmed F, Bhuiyan NA, Rahman AS, Clemens JD, Black RE, Albert MJ
Suppressive effect of zinc on antibody response to cholera toxin in children given the killed, B subunit-whole cell, oral cholera vaccine. Vaccine. 2004 Jan 2;22(3-4):416-21.

Studies of Acute and Memory Immune Responses to Orally Administered Vaccines in Developing Country Children and Factors That May Augment Such Responses

Details for clinical trial NCT01019083

Clinical trial NCT01019083 - References