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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
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This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.
The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imojev | Experimental | Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live attenuated chimeric Japanese Encephalitis vaccine | Biological | 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination | Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). | Day 0 (Baseline) and Day 28 (post-vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination | Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination. | Day 0 (Baseline) and Day 28 (post-vaccination) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kulkanya Chokephaibulkit, Professor | Siriraj Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27846060 | Derived | Sricharoenchai S, Lapphra K, Chuenkitmongkol S, Phongsamart W, Bouckenooghe A, Wittawatmongkol O, Rungmaitree S, Chokephaibulkit K. Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine as a Booster Dose After Primary Vaccination With Live Attenuated SA14-14-2 Vaccine: A Phase IV Study in Thai Children. Pediatr Infect Dis J. 2017 Feb;36(2):e45-e47. doi: 10.1097/INF.0000000000001395. |
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The submission of study review and results to a peer-review journal is ongoing.
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This phase IV study was conducted between 01 June 2014 and 04 July 2014 in accordance with ICH GCP. The study was approved by the Siriraj IRB. Written Informed Consent was obtained from all participants' parents or legal guardians before study entry.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imojev | Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Imojev | Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh |
| 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 | Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination | Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). | Per-protocol analysis | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 0 (Baseline) and Day 28 (post-vaccination) |
|
28 days following vaccination
Patients' parents/guardians were provided with rulers, digital thermometers, and diary cards to record daily temperature and any solicited local injection site reactions (pain, redness, and swelling) and general symptoms (fever, abnormal crying/irritability, drowsiness, loss of appetite and skin rash) during the 28-day period following each study vaccination. The occurrence of unsolicited (i.e. spontaneously reported) adverse events were recorded for up to 28 days following 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 | Imojev | Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immediate reactions | General disorders | MedDRA (10.0) | Systematic Assessment | Any reactions occurring within 30 minutes following vaccination |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof.Kulkanya Chokephaibulkit | Siriraj Hospital | 662 4195695 | kulkanya.cho@mahidol.ac.th |
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| ID | Term |
|---|---|
| D004660 | Encephalitis |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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|
| Inactivated Hepatitis A vaccine | Biological | 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh |
|
|
| Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ | Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment. | Up to 28 days post booster vaccination |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination | Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination. | Posted | Number | percentage of participants | Day 0 (Baseline) and Day 28 (post-vaccination) |
|
|
|
| Secondary | Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ | Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment. | Posted | Number | percentage of participants | Up to 28 days post booster vaccination |
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| 0 |
| 49 |
| 31 |
| 49 |
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| Solicited local reactions | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Solicited injection site reactions including pain, redness, swelling |
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| Solicited systemic reactions | General disorders | MedDRA (10.0) | Systematic Assessment | Solicited systemic reactions including fever, crying/irritability, drowsiness, low appetite, skin rash |
|
| Unsolicited adverse events | General disorders | MedDRA (10.0) | Systematic Assessment | Unsolicited adverse events are the spontaneously reported adverse events by patients or patients' parents/guardians |
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| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |
| Title | Measurements |
|---|---|
|
| Injection site swelling |
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| Fever |
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| Crying/Irritability |
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| Drowsiness |
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| Low Appetite |
|
| Skin Rash |
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| Unsolicited adverse events |
|
| Serious adverse events |
|