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Henogen Adjuvanted Hepatitis B Vaccine Lot Consistency Study

NCT00480116Phase 3

Key facts

Status: Completed
Start: Jan 2008
Primary completion: Apr 2008
Countries: 1
Sponsor: Henogen
Modality: Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics

Drugs: adjuvanted hepatitis B vaccine HB-AS02V
Conditions: hepatitis B (HBV)

Overview

Phase 3, randomised, double-blind trial of adjuvanted hepatitis B vaccine HB-AS02V in hepatitis B (HBV) (3 arms), sponsored by Henogen. Primary endpoint: Anti-HBs seroprotection rates at Month 2. Started Jan 2008; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Lot 1
HB-AS02V Lot 1 administered at Month 0 and 1
Lot 2
HB-AS02V Lot 2 administered at Month 0 and 1
Lot 3
HB-AS02V Lot 3 administered at Month 0 and 1

Who it enrols

Healthy adults aged 18-40 years without history of Hepatitis B infection or vaccination, and not taking immunosuppressants.

Endpoints

Primary

Anti-HBs seroprotection ratesMonth 2

Secondary

Anti-HBs geometric mean concentrationMonth 2
Occurrence and intensity of solicited local and general signs and symptomsDay 0 to 3
Occurrence, intensity and relationship to vaccination of unsolicited symptomsDay 0 to 30
Occurrence, intensity and relationship to vaccination of all serious adverse eventsMonth 0 to 2

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