NCT00287469 - 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)

Emerson SU, Purcell RH
Running like water--the omnipresence of hepatitis E. N Engl J Med. 2004 Dec 2;351(23):2367-8.
Purcell RH
Hepatitis viruses: changing patterns of human disease. Proc Natl Acad Sci U S A. 1994 Mar 29;91(7):2401-6. Review. Erratum in: Proc Natl Acad Sci U S A 1994 Sep 13;91(19):9195.
Worm HC, Schlauder GG, Brandstätter G
Hepatitis E and its emergence in non-endemic areas. Wien Klin Wochenschr. 2002 Aug 30;114(15-16):663-70. Review.
Worm HC, van der Poel WH, Brandstätter G
Hepatitis E: an overview. Microbes Infect. 2002 May;4(6):657-66. Review.
Worm HC, Wirnsberger G
Hepatitis E vaccines: progress and prospects. Drugs. 2004;64(14):1517-31. Review.

A Phase II, Prospective, Randomized, Double-blind, Placebo Controlled, Field Efficacy Trial of a Candidate Hepatitis E Vaccine in Nepal.

Clinical trial NCT00287469 - References