drugset / Trial / NCT01311674

Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)

NCT01311674 ↗

Phase 3 Terminated 141 enrolled Emergent BioSolutions
RandomizedParallel-groupOpen-labelOther

Summary

Hepatitis B Virus Antibody Booster Program

Timeline

Start
2009-09
Primary completion
2011-03-11
Completion
2011-03-11

Outcome

Missed primary endpoint

Stopped: “Prematurely terminated due to failure to meet study objectives.”

registry Schedule 1- Standard Dose Primary Vaccination Series vs Schedule 2 - High Dose Primary Vaccination Series; p = 0.96; t-test, 2 sided NCT01311674 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Hepatitis B vaccine Vaccine 20 ug —
Subject Hepatitis B vaccine Vaccine 40 ug —

Indications

No indication recorded.