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| ID | Type | Description | Link |
|---|---|---|---|
| rHB01C | Other Identifier | MCMVaccBV (SPMSD) Protocol Number | |
| 2006-003649-18 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Process Hepatitis B Vaccine in Base Study | Experimental | 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 |
|
| ENGERIX-B™ Vaccine in Base Study | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Process Hepatitis B Vaccine | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Predose (Day 1) and 1 month after challenge dose (Month 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25996838 | Result | Sharma R, Ahlm C, Ostergaard L, Dowell A, Tran C, Thomas S, Eymin C. Persistence of immunity in healthy adults aged >/= 50 years primed with a hepatitis B vaccine 3 years previously. Hum Vaccin Immunother. 2015;11(7):1709-16. doi: 10.1080/21645515.2015.1019187. |
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Study participants received 3 doses of Modified Process Hepatitis B Vaccine or ENGERIX-B™ vaccine in the Base Study (V232-059, NCT00440531). Two years after completion of the Base Study vaccinations, participants were eligible to receive one challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study.
A total of 296 participants were eligible for the challenge-dose study and 204 were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Process Hepatitis B Vaccine in Base Study | Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
| FG001 | ENGERIX-B™ Vaccine in Base Study | Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled and vaccinated participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Process Hepatitis B Vaccine in Base Study | Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
| BG001 | ENGERIX-B™ Vaccine in Base Study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of challenge dose |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Vaccinated participants with immunogenicity results, excluding those with protocol violations that might interfere with the immunogenicity evaluation | Posted | Number | 95% Confidence Interval | Percentage of participants | Predose (Day 1) and 1 month after challenge dose (Month 1) |
|
All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose
The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified Process Hepatitis B Vaccine in Base Study | Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bipolar disorder | Psychiatric disorders | MedDRA version 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection-site erythema | General disorders | MedDRA version 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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|
| 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. | 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. | 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. | 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. | Up to Month 1 after challenge dose |
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| ENGERIX-B™ Vaccine in Base Study |
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
|
|
| Secondary | 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. | Participants who received a challenge dose and had safety follow-up | Posted | Number | Percentage of participants | Up to Day 15 after challenge dose |
|
|
|
| Secondary | 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. | Participants who received a challenge dose and had safety follow-up | Posted | Number | Percentage of participants | Up to Month 7 |
|
|
|
| Secondary | 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. | Participants who received a challenge dose and had safety follow-up | Posted | Number | Percentage of participants | Up to Day 15 after challenge dose |
|
|
|
| Secondary | Percentage of Participants With One or More Systemic Adverse Experiences | The percentage of participants with one or more systemic adverse experiences was assessed. | Participants who received a challenge dose and had safety follow-up | Posted | Number | Percentage of participants | Up to Day 15 after challenge dose |
|
|
|
| Secondary | 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. | Participants who received a challenge dose and had safety follow-up | Posted | Number | Percentage of participants | Up to Month 1 after challenge dose |
|
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|
| 0 |
| 96 |
| 34 |
| 96 |
| EG001 | ENGERIX-B™ Vaccine in Base Study | Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study | 1 | 107 | 30 | 107 |
| Injection-site pain | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Injection-site swelling | General disorders | MedDRA version 14.0 | Systematic Assessment |
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The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study sixty (60) days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |