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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
204
Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study
Percentage of Seroresponders Before and After the Challenge Vaccination
A seroresponder was a participant with an anti-hepatitis B surface antibody titer \>=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.
Time frame: Predose (Day 1) and 1 month after challenge dose (Month 1)
Percentage of Participants With One or More Adverse Experiences
An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse experience. The percentage of participants with one or more adverse experiences was assessed.
Time frame: Up to Day 15 after challenge dose
Percentage of Participants Who Discontinued the Study Due to an Adverse Experience
The percentage of participants who discontinued the study due to an adverse experience was assessed.
Time frame: Up to Month 7
Percentage of Participants With One or More Injection-site Adverse Experiences
The percentage of participants with one or more injection-site adverse experiences was assessed.
Time frame: Up to Day 15 after challenge dose
Percentage of Participants With One or More Systemic Adverse Experiences
The percentage of participants with one or more systemic adverse experiences was assessed.
Time frame: Up to Day 15 after challenge dose
Percentage of Participants With One or More Serious Adverse Experiences
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A serious adverse experience is an adverse experience that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse experiences was assessed.
Time frame: Up to Month 1 after challenge dose