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This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period.
Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JE-CV Group | Experimental | Participants will receive Japanese encephalitis chimeric virus vaccine (JE-CV) |
|
| MBDV Group | Active Comparator | Participants will receive the mouse brain-derived vaccine (MBDV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChimeriVax™-JE | Biological | One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged > 3 years and 0.5 ml to children and infants aged < 3 years administered subcutaneously |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Day 14 up to Day 42 Post-vaccination | |
| Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Day 14 up to Day 42 Post-vaccination | |
| Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil). | Day 42 Post-vaccination |
| Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). | Day 42 Post Dose 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anand Dubey, M.D | Maulana Azad Medical College, New Delhi, India | Principal Investigator |
| Bakul B. Javadekar, M.D. | Government Medical College, Baroda, India | Principal Investigator |
| Atul Shanker, Dr. | Dr Atul's Child Hospital, Jaipur, Rajasthan, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Atul's Child Hospital | Jaipur | Rajasthan | 302016 | India | ||
| Government Medical College |
A total of 96 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled and vaccinated from 03 January 2007 to 13 January 2009 at 3 clinical centers in India.
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| ID | Title | Description |
|---|---|---|
| FG000 | ChimeriVax™-JE | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. |
| FG001 | Mouse Brain Derived Vaccine | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ChimeriVax™-JE | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. |
| BG001 | Mouse Brain Derived Vaccine |
| 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 Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Adverse events were assessed in all enrolled participants, intent-to-treat (safety) population. | Posted | Number | Participants | Day 14 up to Day 42 Post-vaccination |
|
Adverse events were assessed from Day 14 to Day 42 (up to 28 days after completion of the course of 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 | ChimeriVax™-JE | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 9.0 | 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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| Japanese Encephalitis Inactivated Mouse Brain Vaccine | Biological | Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged > 3 years and 0.5 ml is given to children and infants aged < 3 years administered subcutaneously |
|
| Day 42 Post Dose 1 |
| Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). | Day 42 Post-vaccination |
| Baroda |
| 390001 |
| India |
| Maulana Azad Medical College | New Delhi | 110002 | India |
Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
| 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 |
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Adverse events were assessed all enrolled and vaccinated participants, intent-to-treat (safety) population. | Posted | Number | Participants | Day 14 up to Day 42 Post-vaccination |
|
|
|
| Primary | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil). | Seroconversion was assessed all participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination samples (Day 42) for antibody analysis, per-protocol population. | Posted | Number | Participants | Day 42 Post-vaccination |
|
|
|
| Primary | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). | Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 42 Post Dose 1 |
|
|
|
| Secondary | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil). | Seroprotection was assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population. | Posted | Number | Participants | Day 42 Post Dose 1 |
|
|
|
| Secondary | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). | Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 42 Post-vaccination |
|
|
|
| 0 |
| 48 |
| 6 |
| 48 |
| EG001 | Mouse Brain Derived Vaccine | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. | 0 | 48 | 5 | 48 |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | 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 |
| Impetigo (All; N = 48, 48) |
|
| Pharyngitis (All; N = 48, 48) |
|
| Diarrhea (All; N = 48, 48) |
|
| Vomiting (All; N = 48, 48) |
|
| Hematochezia (All; N = 48, 48) |
|
| Mucous Stools (All; N = 48, 48) |
|
| Rhinorrhea (All; N = 48, 48) |
|
| Cough (All; N = 48, 48) |
|
| Wheezing (All; N = 48, 48) |
|
| Pyrexia (All; N = 48, 48) |
|
| Injection Site Pain (All; N = 48, 48) |
|
| Injection Site Swelling (All; N = 48, 48) |
|
| Malaise (All; N = 48, 48) |
|
| Pain (All; N = 48, 48) |
|
| Irritability (All; N = 48, 48) |
|
| Anorexia (All; N = 48, 48) |
|
| Anemia (All; N = 48, 48) |
|
| Lacrimation Increased (All; N = 48, 48) |
|
| Rash (All; N = 48, 48) |
|
| Pyrexia (≥5 to <10 yr; N = 16, 16) |
|
| Injection Site Pain (≥5 to <10 yr; N = 16, 16) |
|
| Pain (≥5 to <10 yr; N = 16, 16) |
|
| Upper Respiratory Tract Infection (≥5 to <10 yr) |
|
| Injection Site Pain (≥2 to <5 yr; N = 16, 16) |
|
| Injection Site Swelling (≥2 to <5 yr; N = 16, 16) |
|
| Diarrhea (≥9 mo to <2 yr; N = 16, 16) |
|
| Vomiting (≥9 mo to <2 yr; N = 16, 16) |
|
| Hematochezia (≥9 mo to <2 yr; N = 16, 16) |
|
| Mucous Stools (≥9 mo to <2 yr; N = 16, 16) |
|
| Cough (≥9 mo to <2 yr; N = 16, 16) |
|
| Rhinorrhea(≥9 mo to <2 yr; N = 16, 16) |
|
| Wheezing (≥9 mo to <2 yr; N = 16, 16) |
|
| Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16) |
|
| Impetigo (≥9 mo to <2 yr; N = 16, 16) |
|
| Pharyngitis (≥9 mo to <2 yr; N = 16, 16) |
|
| Anorexia (≥9 mo to <2 yr; N = 16, 16) |
|
| Anemia (≥9 mo to <2 yr; N = 16, 16) |
|
| Irritability (≥9 mo to <2 yr; N = 16, 16) |
|
| Malaise (≥9 mo to <2 yr; N = 16, 16) |
|
| Injection Site Pain (≥9 mo to <2 yr; N = 16, 16) |
|
| Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16) |
|
| Rash (≥9 mo to <2 yr; N = 16, 16) |
|
| JE-CV PRNT (N = 33, 35) |
|
| Nakayama PRNT (N = 32, 35) |
|
| Indian WT virus PRNT (N = 33, 35) |
|
| JE-CV PRNT (N = 34, 35) |
|
| Nakayama PRNT (N = 33, 35) |
|
| Indian WT virus PRNT (N = 34, 35) |
|
| JE-CV Virus (All; N = 33, 35) |
|
| Nakayama Strain (All; N = 32, 35) |
|
| Wild Type Virus (All; N = 33, 35) |
|
| JE-CV Virus (≥5 to <10 yr; N = 12, 13) |
|
| JE Virus Nakayama strain (≥5 to <10 yr; N =12, 13) |
|
| Wild Type Virus (≥5 to <10 yr; N = 12, 13) |
|
| JE-CV Virus (≥2 to <5 yr; N = 8, 9) |
|
| JE Virus Nakayama strain (≥2 to <5 yr; N = 9, 9) |
|
| Wild Type Virus (≥2 to <5 yr; N = 8, 9) |
|
| JE-CV Virus (≥9 mo to <2 yr; N = 13, 13) |
|
| JE Virus Nakayama (≥9 mo to <2 yr; N = 11, 13) |
|
| Wild Type Virus (≥9 mo to <2 yr; N=13, 13) |
|
| Wild Type Virus (All; N = 34, 35) |
|
| JE-CV Virus (≥5 to <10 yr; N = 12, 13) |
|
| JE Virus Nakayama Strain (≥5 to <10 yr; N =12, 13) |
|
| Wild Type virus (≥5 to <10 yr; N = 12, 13) |
|
| JE-CV Virus (≥2 to <5 yr; N = 9, 9) |
|
| JE Virus Nakayama Strain (≥2 to <5 yr; N = 9, 9) |
|
| Wild Type Virus (≥2 to <5 yr; N = 9, 9) |
|
| JE-CV Virus (≥9 mo to <2 yr; N = 13, 13) |
|
| JE Virus Nakayama (≥9 mo to <2 yr; N = 12, 13) |
|
| Wild Type Virus (≥9 mo to <2 yr; N = 13, 13) |
|