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The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChimeriVaxâ„¢-JE | Experimental | Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVaxâ„¢-JE vaccine and saline placebo into different arms. |
|
| JE-VAX® | Active Comparator | Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChimeriVaxâ„¢-JE | Biological | 0.5 mL, Subcutaneous (ChimeriVaxâ„¢-JE); 1.0 mL, (Saline) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10. | Up to Day 60 post-first vaccination |
| Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported. Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash. | Day 0 (Pre-vaccination) up to 60 days post-first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). | Up to Day 60 post-first vaccination |
| Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Angles, M.D. | Heart of America Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago | Illinois | 60610 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20934459 | Derived | Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8. |
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A total of 820 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants were enrolled and treated from 07 November 2005 to 15 November 2006 at 5 clinical centers in Australia and 5 clinical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | JE-VAX® | All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30. |
| FG001 | ChimeriVaxâ„¢-JE | All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVaxâ„¢-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | JE-VAX® | All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30. |
| BG001 | ChimeriVaxâ„¢-JE |
| 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 With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10. | Seroconversion was assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population). | Posted | Number | Participants | Up to Day 60 post-first vaccination |
|
Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
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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 | JE-VAX® | All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non Cardiac Chest Pain | General disorders | MedDRA 7.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 7.1 | 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® |
| Biological |
0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline) |
|
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). |
| Day 60 post-first vaccination |
| Shawnee Mission |
| Kansas |
| 66216 |
| United States |
| Missoula | Montana | 59802 | United States |
| Dallas | Texas | 75231 | United States |
| Tacoma | Washington | 98403 | United States |
| Adelaide | Australia |
| Melbourne | Australia |
| New South Wales | Australia |
| Queensland | Australia |
| Victoria | Australia |
| Physician Decision |
|
| Adverse Event |
|
| Protocol Violation |
|
| Sponsor Decision |
|
All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVaxâ„¢-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
| 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 |
| ChimeriVaxâ„¢-JE |
All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVaxâ„¢-JE vaccine 4 log10 PFU and saline placebo into different arms. |
|
|
| Secondary | Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). | Geometric mean titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Up to Day 60 post-first vaccination |
|
|
|
| Secondary | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). | Antibody titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population). | Posted | Number | Participants | Day 60 post-first vaccination |
|
|
|
| Primary | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported. Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash. | Treatment emergent local adverse events and systemic reactions were assessed in all subjects who had at least one injection (ChimeriVax™-JE, JE-Vax®, or placebo), according to the treatment actually received (Safety Population). | Posted | Number | Participants | Day 0 (Pre-vaccination) up to 60 days post-first vaccination |
|
|
|
| 3 |
| 410 |
| 262 |
| 410 |
| EG001 | ChimeriVaxâ„¢-JE | All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVaxâ„¢-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms. | 2 | 410 | 193 | 410 |
| Cholecystitis | Hepatobiliary disorders | MedDRA 7.1 | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Multiple Sclerosis | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Parkinson's Disease | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Chronic Obstructive Airways Disease Exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 7.1 | 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 |
| Titer 20 to < 40 |
|
| Titer 40 to < 160 |
|
| Titer 160 to < 640 |
|
| Titer 640 to < 2560 |
|
| Titer ≥ 2560 |
|
| Injection Site Pruritus |
|
| Injection Site Swelling |
|
| Injection Site Hemorrhage |
|
| Injection Site Rash |
|
| Injection Site Edema |
|
| Injection Site Joint Pain |
|
| Injection Site Reaction |
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| Injection Site Discomfort |
|
| Injection Site Joint Movement Impairment |
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| Injection Site Warmth |
|
| Venipuncture Site Bruise |
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| Fatigue |
|
| Malaise |
|
| Chills |
|
| Pyrexia |
|
| Headache |
|
| Myalgia |
|
| Arthralgia |
|
| Diarrhea |
|
| Nausea |
|
| Vomiting |
|
| Rash |
|