Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)

Summary

Hepatitis B Vaccine \[Recombinant\] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: \[1\] induce protection against the morbidity and mortality of acute hepatitis B virus infection, \[2\] reduce the incidence of chronic infection in vaccinated populations, and \[3\] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine \[Recombinant\] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine \[Recombinant\] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current vaccine.

Timeline

Start

2006-05

Primary completion

2007-07

Completion

2007-07

Outcome

Met primary endpoint

paper The GMT ratio (mpHBV/control) was 1.26 (95% confidence interval [CI]: 0.94, 1.69), meeting the prespecified non-inferiority criteria. PMID 22227229 ↗

Publications

• Minervini G, McCarson BJ, Reisinger KS, Martin JC, Stek JE, Atkins BM, Nadig KB, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates. Vaccine. 2012 Feb 14;30(8):1476-80. doi: 10.1016/j.vaccine.2011.12.095. Epub 2012 Jan 5.

Drugs

Indications