Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007_565 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V232 Modified Process Hepatitis B Vaccine: Lot A | Experimental | Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. |
|
| V232 Modified Process Hepatitis B Vaccine: Lot B | Experimental | Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. |
|
| V232 Modified Process Hepatitis B Vaccine: Lot C | Experimental | Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. |
|
| V232 Current Process Hepatitis B Vaccine | Active Comparator | Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V232 Modified Process Hepatitis B Vaccine: Lot A | Biological |
| ||
| V232 Modified Process Hepatitis B Vaccine: Lot B |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Seroprotection to Hepatitis B Surface Antigen | 1 month after the third vaccination (Month 7) | |
| Geometric Mean Titers to Hepatitis B Surface Antigen | 1 month after the third vaccination (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with an Adverse Experience | Up to 15 days after any vaccination | |
| Percentage of Participants with an Injection-site Adverse Experience | Up to 15 days after any vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18690015 | Background | Van Damme P, Minervini G, Liss CL, McCarson B, Vesikari T, Boslego JW, Bhuyan PK. Safety, tolerability and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young adults. Hum Vaccin. 2009 Feb;5(2):92-7. doi: 10.4161/hv.5.2.6587. Epub 2009 Feb 14. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
|
| V232 Modified Process Hepatitis B Vaccine: Lot C | Biological |
|
| V232 Current Process Hepatitis B Vaccine | Biological |
|
| Percentage of Participants with a Systemic Adverse Experience | Up to 15 days after any vaccination |
| Percentage of Participants with Fever (>=37.8°C, 100.0°F) | Up to 5 days after any vaccination |
| 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 |
Not provided
Not provided