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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1127-7052 | Other Identifier | WHO |
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The aim of this study is to further characterize the safety profile of IMOJEV®.
Primary Objective:
Secondary Objective:
Participants aged 1 year to less than 5 years will be randomized to receive one injection of IMOJEV® either as a primary vaccination or as a booster. Safety data will be collected for 60 days after IMOJEV® vaccination. The duration of each subject's participation in the trial will be 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Vaccination Group | Experimental | Participants who never received a JE vaccine, or who received a single dose of inactivated JE vaccine, or whose JE vaccination history is unknown or not documented. |
|
| Booster Vaccination Group | Active Comparator | Participants who received at least 2 doses of inactivated JE vaccine (at least 1 year earlier for the last dose), or received a single dose of IMOJEV®, THAIJEV®, or IMOJEV® MD as part of the routine vaccination schedule (i.e., outside of Study JEC17) at least 1 year earlier |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine | Biological | 0.5 mL, Subcutaneous. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® | 30 minutes post-vaccination up to Day 60 post-vaccination | |
| Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® | Day O up to Day 60 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure. | Day O up to Day 60 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 |
|---|---|---|---|---|---|---|
| Bangkok | 10330 | Thailand | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27903416 | Derived | Chotpitayasunondh T, Pruekprasert P, Puthanakit T, Pancharoen C, Tangsathapornpong A, Oberdorfer P, Kosalaraksa P, Prommalikit O, Tangkittithaworn S, Kerdpanich P, Techasaensiri C, Korejwo J, Chuenkitmongkol S, Houillon G. Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand. Vaccine. 2017 Jan 5;35(2):299-304. doi: 10.1016/j.vaccine.2016.11.062. Epub 2016 Nov 28. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 10,000 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
The study participants were enrolled from 03 November 2013 to 08 February 2015 in 10 trial centers in Thailand.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Vaccination Group | Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination. |
| FG001 | Booster Vaccination Group | Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine | Biological | 0.5 mL, Subcutaneous. |
|
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| Bangkok |
| 10400 |
| Thailand |
| Chiang Mai | 50200 | Thailand |
| Khon Kaen | 40002 | Thailand |
| Nakornnayok | 26120 | Thailand |
| Nonthaburi | 11120 | Thailand |
| Pathum Thani | 12120 | Thailand |
| Songkhla | 90110 | Thailand |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Vaccination Group | Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination. |
| BG001 | Booster Vaccination Group | Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster. |
| 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 | Years |
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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 | Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® | Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set | Posted | Number | Participants | 30 minutes post-vaccination up to Day 60 post-vaccination |
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| Primary | Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® | Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set | Posted | Number | Participants | Day O up to Day 60 post-vaccination |
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| Secondary | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure. | Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set | Posted | Number | Participants | Day O up to Day 60 post-vaccination |
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Adverse event data were collected from Day 0 (post-vaccination) up to 60 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 | Primary Vaccination Group | Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination. | 204 | 6,851 | 0 | 6,851 | ||
| EG001 | Booster Vaccination Group | Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster. | 59 | 3,149 | 0 | 3,149 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Allergy to arthropod sting | Immune system disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Acute tonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Bronchitis viral | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Burkholderia pseudomallei infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Croup infectious | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Dengue fever | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Exanthema subitum | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Gastritis bacterial | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Gastroenteritis rotavirus | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Hand-foot-mouth disease | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Herpangina | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Infectious mononucleosis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Otitis media acute | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Pharyngitis bacterial | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Pharyngotonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Scarlet fever | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Scrotal abcess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Urinary track infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Viral diarrhoea | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Viral rash | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Febrile convulsion | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Frontal lobe epilepsy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Kawasaki's disease | Vascular disorders | MedDRA 16.0 | Non-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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| >=65 years |
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| Male |
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| Death |
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