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| Name | Class |
|---|---|
| New Jeddah Clinic Hospital | INDUSTRY |
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The aim of this study is to examine the result of seroprotection using the accelerated vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis A and B vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatitis B recombinant DNA vaccine | Active Comparator | Each Hepatitis B recombinant DNA vaccine vial contained 20 microgram of vaccine dose. Two vials will be intramuscularly injected one vial in each deltoid muscle on months zero, one, two and six. |
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| Combined hepatitis A and B vaccine | Active Comparator | Each one-milliliter dose of vaccine contains 720 ELISA units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum. Two vials will be intramuscularly injected one vial in each deltoid muscle on on days zero, seven, and 21. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis B recombinant DNA vaccine | Drug | Hepatitis B recombinant DNA vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis B virus Seroprotection after one month | Hepatitis B virus surface antibodies titer after one month | one month after third dose of the vaccine |
| Hepatitis B virus Seroprotection after three months | Hepatitis B virus surface antibodies titer after three month | three months after third dose of the vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Fever | The proportion of fever among patients in both arms | 4 Days after each vaccination dose |
| Pain scale | Visual pain scale for pain from injection |
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Inclusion Criteria:
Exclusion Criteria:
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Patient seuentially randomized to either vaccine
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| Combined hepatitis A and B vaccine | Drug | Combined hepatitis A and B vaccine given to the patients |
|
| 1 Hour after each vaccination dose |
| 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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