Hepatitis B Challenge Dose in Adults (V232-059-10)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: Modified Process Hepatitis B Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01251276

2006-003649-18 (EudraCT Number)

V232-059-10

rHB01C (Other Identifier)

Details and patient eligibility

About

The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.

Enrollment: 204 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In general good health based on a medical history.
• Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.

Exclusion criteria

• Known history of previous Hepatitis B infection.
• History of vaccination with any Hepatitis B vaccine within the last 2 years.
• History of febrile illness.
• Known or suspected hypersensitivity to any component of HBVaxPro.
• Receipt of medication / vaccine that may interfere with study assessments.
• Known or suspected immune impairment.
• Pregnant women and nursing mothers.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

204 participants in 2 patient groups

Modified Process Hepatitis B Vaccine in Base Study

Experimental group

Description:

Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study

Treatment:

Biological: Modified Process Hepatitis B Vaccine

ENGERIX-B™ Vaccine in Base Study

Experimental group

Description:

Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study

Treatment:

Biological: Modified Process Hepatitis B Vaccine