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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_516 |
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The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | RECOMBIVAX HB™ |
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| 2 | Experimental | Modified Process Hepatitis B Vaccine |
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| 3 | Active Comparator | ENGERIX-B™ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) | Biological | RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine) | The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination). | 7 months (1 month after third vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine) | The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22185811 | Derived | Gilbert CL, Klopfer SO, Martin JC, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy adults >/=50 years. Hum Vaccin. 2011 Dec;7(12):1336-42. doi: 10.4161/hv.7.12.18333. Epub 2011 Dec 1. |
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In the Modified Process group, 2 participants were randomized but not vaccinated: 1 participant withdrew consent, and 1 participant had an SAE (Serious Adverse Experience) of hypertension prior to vaccination.
27-Nov-2006 (First Participant Enrolled in Study) to 26-Nov-2007 (Last Participant had their Last Visit). This study was conducted at 22 sites: 10 in Canada, 2 in Denmark, 5 in Sweden, and 5 in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Process Hepatitis B Vaccine | Modified Process Hepatitis B Vaccine, 10 µg (micrograms) |
| FG001 | RECOMBIVAX-HB™ | RECOMBIVAX-HB™, 10 µg (micrograms) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: Modified Process Hepatitis B Vaccine (Experimental) | Biological | Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months. |
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| Comparator: ENGERIX-B™ (currently licensed product) | Biological | ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months. |
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| 7 months (1 month after third vaccination) |
| The Total Number of Participants With One or More Injection-site Adverse Experiences | Days 1-5 After Any Vaccination |
| The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C | Day 1-5 After Vaccination |
| The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences | During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months) |
| FG002 | ENGERIX-B™ | ENGERIX-B™, 20 µg (micrograms) |
| Vaccination 1 |
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| Vaccination 2 |
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| Vaccination 3 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Process Hepatitis B Vaccine | Modified Process Hepatitis B Vaccine, 10 µg (micrograms) |
| BG001 | RECOMBIVAX-HB™ | RECOMBIVAX-HB™, 10 µg (micrograms) |
| BG002 | ENGERIX-B™ | ENGERIX-B™, 20 µg (micrograms) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine) | The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination). | Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol. | Posted | Number | Participants | 7 months (1 month after third vaccination) |
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| Secondary | The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine) | The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination). | Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol. | Posted | Number | Participants | 7 months (1 month after third vaccination) |
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| Secondary | The Total Number of Participants With One or More Injection-site Adverse Experiences | Safety Analysis Set - defined as all participants who received at least one injection of vaccine and who had a safety follow-up. | Posted | Number | Participants | Days 1-5 After Any Vaccination |
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| Secondary | The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C | Safety Analysis Set - defined as all participants who received at least one injection of vaccine and who had a safety follow-up. | Posted | Number | Participants | Day 1-5 After Vaccination |
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| Secondary | The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences | Safety Analysis Set - defined as all participants who received at least one injection of vaccine and who had a safety follow-up. | Posted | Number | Participants | During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months) |
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Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Male |
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No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs >=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.
| single-group percentage |
| 68 |
| 95 |
| 59.80 |
| 75.50 |
| Superiority or Other |
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