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The purpose of this study is to assess whether ChimeriVaxâ„¢ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | All subjects received a single injection of placebo on Day 0. |
|
| ChimeriVaxâ„¢ JE 4 log10 PFU Vaccine | Experimental | All participants received a single injection of ChimeriVaxâ„¢ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChimeriVax-JE, Japanese Encephalitis vaccine | Biological | 0.5 mL, Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVaxâ„¢-JE or a Placebo | Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30. | Day 0 up to 30 days post-vaccination |
| Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVaxâ„¢-JE or a Placebo | Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported. | Day 0 up to 30 days post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven G Hull, MD | Vince and Associates Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burbank | California | 92505 | 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 2004 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants were enrolled and vaccinated from 10 October 2005 to 30 March 2006 at 6 clinical centers in Australia and 16 clinical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single injection of placebo on Day 0. |
| FG001 | ChimeriVaxâ„¢-JE 4 log10 PFU Vaccine | Participants received a single injection of ChimeriVaxâ„¢-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 0.9% Saline | Biological | 0.5 mL, Subcutaneous |
|
| Costa Mesa |
| California |
| 92708 |
| United States |
| Davis | California | 95616 | United States |
| San Francisco | California | 94102 | United States |
| Vallejo | California | 94589 | United States |
| Miami | Florida | 33173 | United States |
| Orlando | Florida | 32809 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| Iowa City | Iowa | 52242 | United States |
| Overland Park | Kansas | 66212 | United States |
| Bardstown | Kentucky | 40004 | United States |
| Livonia | Michigan | 48152 | United States |
| Sprnigfield | Missouri | 65802 | United States |
| Omaha | Nebraska | 68134 | United States |
| Winston-Salem | North Carolina | 27109 | United States |
| Fort Worth | Texas | 76135 | United States |
| Darlinghurst | NSW 2010 | Australia |
| Enoggera | QLD 4051 | Australia |
| Heidelbeg West | VIC 3081 | Australia |
| Kippa-Ring | QLD 4021 | Australia |
| Mill Park | VIC 3082 | Australia |
| Toorak Gardens | SA 5056 | Australia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single injection of placebo on Day 0. |
| BG001 | ChimeriVaxâ„¢-JE 4 log10 PFU Vaccine | Participants received a single injection of ChimeriVaxâ„¢-JE 4 log10 PFU Vaccine on Day 0. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVaxâ„¢-JE or a Placebo | Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30. | Treatment related adverse events were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population). | Posted | Number | Participants | Day 0 up to 30 days post-vaccination |
|
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| Primary | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVaxâ„¢-JE or a Placebo | Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported. | Treatment emergent local adverse reactions and systemic reactions were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population). | Posted | Number | Participants | Day 0 up to 30 days post-vaccination |
|
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Adverse events data were collected from Day 0 to Month 6 post 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 | Placebo | Participants received a single injection of placebo on Day 0. | 2 | 403 | 124 | 403 | ||
| EG001 | ChimeriVaxâ„¢-JE 4 log10 PFU Vaccine | Participants received a single injection of ChimeriVaxâ„¢-JE 4 log10 PFU Vaccine on Day 0. | 5 | 1,601 | 597 | 1,601 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Streptococcal Sepsis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Fallopian Tube Cyst | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Feeling Hot | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Injection Site Pain | 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 |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Fatigue | General 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D004660 | Encephalitis |
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| 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 |
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| ID | Term |
|---|---|
| D022321 | Japanese Encephalitis Vaccines |
| C445780 | ChimeriVax |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
|
| Male |
|
| Australia |
|
| Injection Site Pain |
|
| Feeling Hot |
|
| Chills |
|
| Injection Site Erythema |
|
| Injection Site Pruritus |
|
| Headache |
|
| Myalgia |
|
| Arthralgia |
|
| Diarrhea |
|
| Nausea |
|
| Abdominal Pain |
|
| Pharyngolaryngeal Pain |
|
| Dyspnea |
|
| Nasal Congestion |
|
| Nasopharyngitis |
|
|