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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChimeriVaxâ„¢-JE | Experimental | Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVaxâ„¢-JE on Day 28. |
|
| JE-VAX® | Active Comparator | Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChimeriVaxâ„¢-JE vaccine | Biological | 0.5 mL, subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine | Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10. | Day 0 (pre-vaccination) and up to Day 56 post-vaccination |
| Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE | Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). | Day 0 up to Day 56 post-vaccination |
| Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine. | Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No'] | Day 0 (Pre-vaccination) and up to Month 12 After First Dose |
| Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX® | Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy L Abdou, MD | PRA Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharamacology Center | Lenexa | Kansas | 66219 | United States |
A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 18 May 2005 to 07 September 2005 at 1clinical center in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | ChimeriVaxâ„¢-JE After Placebo | Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVaxâ„¢-JE on Day 28. |
| FG001 | JE-VAX® | Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ChimeriVaxâ„¢-JE After Placebo | Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVaxâ„¢-JE on Day 28. |
| BG001 | JE-VAX® | Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine | Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10. | Seroconversion was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population). | Posted | Number | Participants | Day 0 (pre-vaccination) and up to Day 56 post-vaccination |
|
Adverse events data were collected from Day 0 after vaccination up to Month 12.
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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 | ChimeriVaxâ„¢-JE After Placebo | Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVaxâ„¢-JE on Day 28. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA 8.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
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| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| JE-VAX® vaccine | Biological | 1.0 mL, subcutaneously |
|
|
| Day 0 (pre-vaccination) up to month 12 post-vaccination |
| Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity. | Day 0 up to Day 6 post-vaccination |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG001 | JE-VAX® | Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. |
|
|
| Primary | Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE | Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). | Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per Protocol Population). | Posted | Mean | Standard Deviation | 1/dilutions | Day 0 up to Day 56 post-vaccination |
|
|
|
| Primary | Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine. | Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No'] | Seropositive status was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population). | Posted | Number | Participants | Day 0 (Pre-vaccination) and up to Month 12 After First Dose |
|
|
|
| Primary | Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX® | Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). | Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population). | Posted | Mean | Standard Deviation | 1/dilutions | Day 0 (pre-vaccination) up to month 12 post-vaccination |
|
|
|
| Primary | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity. | Adverse events were assessed in all participants who received at least one dose of study vaccine pr saline (Intent to Treat Population). | Posted | Number | Participants | Day 0 up to Day 6 post-vaccination |
|
|
|
| 0 |
| 30 |
| 25 |
| 30 |
| EG001 | JE-VAX® | Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. | 0 | 30 | 29 | 30 |
| Photophobia | Eye disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Feeling Hot | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Injection Site Haemorrhage | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Injection Site Pruritus | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 8.0 | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 8.0 | Non-systematic Assessment |
|
| White Blood Cell Count Increased | Investigations | MedDRA 8.0 | Non-systematic Assessment |
|
| White Blood Cells Urine Positive | Investigations | MedDRA 8.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| Day 28 |
|
| Day 42 |
|
| Day 56 |
|
| Month 6 (N = 26, 24) |
|
| Month 12 (N = 26, 22) |
|
| Month 6 (N = 26, 24) |
|
| Month 12 (N = 26, 22) |
|
| Photophobia |
|
| Grade 3 Photophobia |
|
| Abdominal Pain |
|
| Grade 3 Abdominal Pain |
|
| Diarrhoea |
|
| Grade 3 Diarrhoea |
|
| Nausea |
|
| Grade 3 Nausea |
|
| Vomiting |
|
| Grade 3 Vomiting |
|
| Chills |
|
| Grade 3 Chills |
|
| Fatigue |
|
| Grade 3 Fatigue |
|
| Feeling Hot |
|
| Grade 3 Feeling Hot |
|
| Injection Site Erythema |
|
| Grade 3 Injection Site Erythema |
|
| Injection Site Haemorrhage |
|
| Grade 3 Injection Site Haemorrhage |
|
| Injection Site Pain |
|
| Grade 3 Injection Site Pain |
|
| Malaise |
|
| Grade 3 Malaise |
|
| Contusion |
|
| Grade 3 Contusion |
|
| Excoriation |
|
| Grade 3 Excoriation |
|
| Limb Injury |
|
| Grade 3 Limb Injury |
|
| Body Temperature Increased |
|
| Grade 3 Body Temperature Increased |
|
| Arthralgia |
|
| Grade 3 Arthralgia |
|
| Myalgia |
|
| Grade 3 Myalgia |
|
| Disturbance in Attention |
|
| Grade 3 Disturbance in Attention |
|
| Dizziness |
|
| Grade 3 Dizziness |
|
| Headache |
|
| Grade 3 Headache |
|
| Lethargy |
|
| Grade 3 Lethargy |
|
| Somnolence |
|
| Grade 3 Somnolence |
|
| Pollakiuria |
|
| Grade 3 Pollakiuria |
|
| Dyspnoea |
|
| Grade 3 Dyspnoea |
|
| Pharyngolaryngeal Pain |
|
| Grade 3 Pharyngolaryngeal Pain |
|
| Sinus Congestion |
|
| Grade 3 Sinus Congestion |
|
| Erythema |
|
| Grade 3 Erythema |
|
| Pruritus |
|
| Grade 3 Pruritus |
|
| Rash |
|
| Grade 3 Rash |
|