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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_515 | Other Identifier | Merck Registration Number |
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To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified process hepatitis B vaccine | Experimental | Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months. |
|
| ENGERIX-Bâ„¢2 | Active Comparator | ENGERIX-Bâ„¢ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: modified process hepatitis B vaccine | Biological | Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-Bâ„¢ (Currently Licensed Vaccine) at Month 7 | 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 dose) and at Month 7 (1 month after the third dose). | 7 months (1 month after the third dose) |
| The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-Bâ„¢ (Currently Licensed Vaccine) at Month 9 | 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 dose) and at Month 9 (1 month after the fourth dose). | 9 months (1 month after the fourth dose) |
| The Total Number of Participants With One or More Injection-Site Adverse Experiences | Days 1-15 After Any Vaccination | |
| The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C | Days 1-5 After Any Vaccination | |
| The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences | Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose). | 0-9 months (recorded from first dose until the participant completes or discontinues the study) |
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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 |
|---|---|---|---|
| 25252192 | Result | Gilbert CL, Stek JE, Villa G, Klopfer SO, Martin JC, Schodel FP, Bhuyan PK. Safety and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in renal pre-dialysis and dialysis patients. Vaccine. 2014 Nov 12;32(48):6521-6. doi: 10.1016/j.vaccine.2014.09.015. Epub 2014 Sep 22. |
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A screening serum sample was obtained prior to study entry and assayed for hepatitis B serologic markers. Only patients that were seronegative were considered for enrollment.
22-Dec-2006 (First Patient Enrolled in Study) to 05-May-2008 (Last Participant had their Last Visit). This study was conducted at 23 sites: 7 in Canada, 8 in the United Kingdom, 5 in Italy, and 3 in Spain. In the Modified Process group, one participant was randomized by mistake, and therefore was not vaccinated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Process Hepatitis B Vaccine | Modified Process Hepatitis B Vaccine, 40 µg(micrograms) |
| FG001 | ENGERIX-B™ | ENGERIX-B™, 2 x 20 µg(micrograms) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All vaccinated participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Process Hepatitis B Vaccine | Modified Process Hepatitis B Vaccine, 40 µg(micrograms) |
| BG001 | ENGERIX-B™ | ENGERIX-B™, 2 x 20 µg(micrograms) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-Bâ„¢ (Currently Licensed Vaccine) at Month 7 | 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 dose) and at Month 7 (1 month after the third dose). | 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 the third dose) |
|
All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
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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 | Modified Process Hepatitis B Vaccine, 40 µg(micrograms) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp | 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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| Comparator: ENGERIX-Bâ„¢ | Biological | ENGERIX-Bâ„¢ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months. |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Randomized by mistake |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| ENGERIX-Bâ„¢ |
ENGERIX-B™, 2 x 20 µg(micrograms) |
|
|
|
| Primary | The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-Bâ„¢ (Currently Licensed Vaccine) at Month 9 | 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 dose) and at Month 9 (1 month after the fourth dose). | 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 | 9 months (1 month after the fourth dose) |
|
|
|
|
| Primary | The Total Number of Participants With One or More Injection-Site Adverse Experiences | Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up | Posted | Number | Participants | Days 1-15 After Any Vaccination |
|
|
|
| Primary | The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C | Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up | Posted | Number | Participants | Days 1-5 After Any Vaccination |
|
|
|
| Primary | The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences | Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose). | Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up | Posted | Number | Participants | 0-9 months (recorded from first dose until the participant completes or discontinues the study) |
|
|
|
| 11 |
| 56 |
| EG001 | ENGERIX-B™ | ENGERIX-B™, 2 x 20 µg(micrograms) | 11 | 73 |
| Myocardial Infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Liver function test abnormal | General disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Renal haematoma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Athralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Injection site Erythema | General disorders | MedDRA | Systematic Assessment |
|
| Injection site Edema | General disorders | MedDRA | Systematic Assessment |
|
| Injection site Pain | General disorders | MedDRA | Systematic Assessment |
|
| Injection site Swelling | General disorders | MedDRA | Systematic Assessment |
|
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.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Percentage of Seroprotected Participants |
| 69.2 |
| 95 |
| 59.4 |
| 77.9 |
Exact binomial confidence interval |
| Superiority or Other |