NCT00186836 - 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)

Abraham B, Baine Y, De-Clercq N, Tordeur E, Gerard PP, Manouvriez PL, Parenti DL
Magnitude and quality of antibody response to a combination hepatitis A and hepatitis B vaccine. Antiviral Res. 2002 Jan;53(1):63-73.
Ambrosch F, André FE, Delem A, D'Hondt E, Jonas S, Kunz C, Safary A, Wiedermann G
Simultaneous vaccination against hepatitis A and B: results of a controlled study. Vaccine. 1992;10 Suppl 1:S142-5.
Czeschinski PA, Binding N, Witting U
Hepatitis A and hepatitis B vaccinations: immunogenicity of combined vaccine and of simultaneously or separately applied single vaccines. Vaccine. 2000 Jan 6;18(11-12):1074-80.
Kallinowski B, Knöll A, Lindner E, Sänger R, Stremmel W, Vollmar J, Zieger B, Jilg W
Can monovalent hepatitis A and B vaccines be replaced by a combined hepatitis A/B vaccine during the primary immunization course? Vaccine. 2000 Aug 15;19(1):16-22.
Knöll A, Hottenträger B, Kainz J, Bretschneider B, Jilg W
Immunogenicity of a combined hepatitis A and B vaccine in healthy young adults. Vaccine. 2000 Apr 3;18(19):2029-32.
Lee MB, Middleton D
Enteric illness in Ontario, Canada, from 1997 to 2001. J Food Prot. 2003 Jun;66(6):953-61.
Leroux-Roels G, Moreau W, Desombere I, Safary A
Safety and immunogenicity of a combined hepatitis A and hepatitis B vaccine in young healthy adults. Scand J Gastroenterol. 1996 Oct;31(10):1027-31.
Murdoch DL, Goa K, Figgitt DP
Combined hepatitis A and B vaccines: a review of their immunogenicity and tolerability. Drugs. 2003;63(23):2625-49. Review.
Recommendations for preventing transmission of infections among chronic hemodialysis patients
MMWR Recomm Rep. 2001 Apr 27;50(RR-5):1-43.

Efficacy of Combined Hepatitis A and Hepatitis B (Twinrix) Vaccine Compared With Hepatitis B Vaccine Alone in Providing Seroprotection Against Hepatitis B in Hemodialysis Patients

Details for clinical trial NCT00186836

Clinical trial NCT00186836 - References