Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)

Phase 3 Completed 1478 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupSingle-blindPrevention

Summary

To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.

Timeline

Start: 2006-09
Primary completion: 2008-06
Completion: 2008-06

Outcome

Missed primary endpoint

registry ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2); p = 0.19; Seroprotection rate (SPR) 91.6 (95.2% CI 88.0 to 94.4) NCT00393523 ↗

Publications

Results Diez-Domingo J, Flores SA, Martin JC, Klopfer SO, Schodel FP, Bhuyan PK. A randomized, multicenter, open-label clinical trial to assess the anamnestic immune response 4 to 8 years after a primary hepatitis B vaccination series. Pediatr Infect Dis J. 2010 Oct;29(10):972-4. doi: 10.1097/INF.0b013e3181f1b3b6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Engerix-B	Vaccine	10 ug	—
Subject	Modified Process Hepatitis B Vaccine	Vaccine	5 ug	—