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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1117-7378 | Other Identifier | WHO |
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The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine [CD.JEVAX™]) after a single dose vaccination to support product registration.
Primary Objective:
Secondary Objectives:
All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMOJEV™ Vaccine Group | Experimental | Participants will receive a single dose of the Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV™) on Day 0. |
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| CD.JEVAX ™ Vaccine Group | Active Comparator | Participants will receive a single dose of the Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine), CD.JEVAX™ on Day 0 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live attenuated Japanese encephalitis chimeric virus vaccine | Biological | 0.5 mL, Subcutaneous |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline. | Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). JE-CV PRNT50 antibody titer >10 (1/dil, Day 0) | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goyang | South Korea | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25483480 | Derived | Kim DS, Houillon G, Jang GC, Cha SH, Choi SH, Lee J, Kim HM, Kim JH, Kang JH, Kim JH, Kim KH, Kim HS, Bang J, Naimi Z, Bosch-Castells V, Boaz M, Bouckenooghe A. A randomized study of the immunogenicity and safety of Japanese encephalitis chimeric virus vaccine (JE-CV) in comparison with SA14-14-2 vaccine in children in the Republic of Korea. Hum Vaccin Immunother. 2014;10(9):2656-63. doi: 10.4161/hv.29743. Epub 2014 Nov 6. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 274 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
The study participants were enrolled from 12 July 2011 to 28 September 2012 at 10 clinic centers in South Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | IMOJEV™ Vaccine Group | Participants age 12 to 24 months received one dose of IMOJEV™ |
| FG001 | CD.JEVAX™ Vaccine Group | Participants age 12 to 24 months received one dose of CD.JEVAX™ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine) | Biological | 0.5 mL, Subcutaneous |
|
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| Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | 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 (pre-vaccination) and Day 28 post-vaccination |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever >39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable. | Day 0 up to Day 14 post-vaccination |
| Incheon |
| South Korea |
| Seongnam | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| Wŏnju | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IMOJEV™ Vaccine Group | Participants age 12 to 24 months received one dose of IMOJEV™ |
| BG001 | CD.JEVAX™ Vaccine Group | Participants age 12 to 24 months received one dose of CD.JEVAX™ |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| 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 | Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline. | Seroconversion to JE-CV was assessed in the Per-Protocol Analysis Set. | Posted | Number | Percentage of Participants | Day 28 post-vaccination |
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| Secondary | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). JE-CV PRNT50 antibody titer >10 (1/dil, Day 0) | Geometric mean titers against the JE-CV was assessed in the Per-Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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| Secondary | Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | 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. | Seroprotection against JE-CV was assessed in the Per-Protocol Analysis Set. | Posted | Number | Participants | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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| Secondary | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever >39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable. | Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day 14 post-vaccination |
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Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 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 | IMOJEV™ Vaccine Group | Participants age 12 to 24 months received one dose of IMOJEV™ | 17 | 137 | 74 | 137 | ||
| EG001 | CD.JEVAX™ Vaccine Group | Participants age 12 to 24 months received one dose of CD.JEVAX™ | 18 | 137 | 69 | 137 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Intussusception | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Croup infectious | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Hand foot and mouth disease | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Herpangina | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Lymph node abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Meningitis aseptic | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Pharyngotonsillitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Febrile convulsion | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Kawasaki's disease | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Injection site Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Injection site Erythema | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Injection site Swelling | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Fever | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Crying Abnormal | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Drowsiness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Appetite Loss | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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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 |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| 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 |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| C000607270 | SA-14-14-2 vaccine |
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| >=65 years |
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| Male |
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| Participants |
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