A Phase 3 interventional study of Modified Process Hepatitis B Vaccine in Hepatitis B, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 204 is above the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Biological: Modified Process Hepatitis B Vaccine
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
Biological: Modified Process Hepatitis B Vaccine
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
Also known as: HBVaxPro
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
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
A total of 296 participants were eligible for the challenge-dose study and 204 were enrolled
| Milestone | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
|---|---|---|
| Started | 96 | 108 |
| Vaccinated | 96 | 108 |
| Completed | 95 | 107 |
| Not completed | 1 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| Percentage of participants | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
|---|---|---|
| Predose (Day 1); n=88, 102 | 45.5 (34.8 to 56.4) | 58.8 (48.6 to 68.5) |
| Postdose (Month 1); n=88, 103 | 85.2 (76.1 to 91.9) | 88.3 (80.5 to 93.8) |
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.
| Percentage of participants | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
|---|---|---|
| Percentage of Participants With One or More Adverse Experiences | 39.6 | 45.8 |
The percentage of participants who discontinued the study due to an adverse experience was assessed.
| Percentage of participants | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
|---|---|---|
| Percentage of Participants Who Discontinued the Study Due to an Adverse Experience | 0 | 0 |
The percentage of participants with one or more injection-site adverse experiences was assessed.
| Percentage of participants | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
|---|---|---|
| Percentage of Participants With One or More Injection-site Adverse Experiences | 35.4 | 29.9 |
The percentage of participants with one or more systemic adverse experiences was assessed.
| Percentage of participants | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
|---|---|---|
| Percentage of Participants With One or More Systemic Adverse Experiences | 16.7 | 28.0 |
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.
| Percentage of participants | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
|---|---|---|
| Percentage of Participants With One or More Serious Adverse Experiences | 0 | 0.9 |
Collected over All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Modified Process Hepatitis B Vaccine in Base Study | — | 0/96 (0%) | 34/96 (35.4%) |
| ENGERIX-B™ Vaccine in Base Study | — | 1/107 (0.9%) | 30/107 (28%) |
| Event | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
|---|---|---|
| Bipolar disorderPsychiatric disorders | 0/96 | 1/107 |
| Event | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
|---|---|---|
| Injection-site painGeneral disorders | 31/96 | 27/107 |
| Injection-site erythemaGeneral disorders | 7/96 | 5/107 |
| Injection-site swellingGeneral disorders | 7/96 | 4/107 |
All enrolled and vaccinated participants
| Age, Continuous(Years) | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study | Total |
|---|---|---|---|
| Mean | 63.8 ± 7.3 | 63.6 ± 6.7 | 63.7 ± 7.0 |
| Sex: Female, Male(Participants) | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study | Total |
|---|---|---|---|
| Female | 48 | 63 | 111 |
| Male | 48 | 45 | 93 |
No study locations are listed for this record.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC