Japanese Encephalitis
Conditions
Keywords
Japanese encephalitis, IMOJEV®, Japanese encephalitis chimeric virus vaccine
Brief summary
The aim of this study is to further characterize the safety profile of IMOJEV®. Primary Objective: * To describe serious adverse events (SAEs, including adverse events of special interest \[AESIs\]) up to 60 days after administration of one dose of IMOJEV®. Secondary Objective: * To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.
Detailed description
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.
Interventions
BIOLOGICALIMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous.
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 4 Years
Healthy volunteers
Yes
Inclusion criteria
* Children requiring vaccination against Japanese encephalitis * Children aged 9 months to less than 5 years on the day of inclusion * In good general health at the time of inclusion * Informed consent form has been signed and dated by the parent(s)/legal guardian(s) * Subject and parent(s)/legal guardian(s) are able to attend the scheduled visit and any additional visits that may need to be done in case of an SAE (including AESI), and are able to comply with all trial procedures * The subject's parent(s)/legal guardian(s) have a telephone number at which they can be contacted throughout the study
Exclusion criteria
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the vaccination * Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination * Planned participation in another clinical trial during the present trial period * Children previously vaccinated with the live attenuated Japanese encephalitis vaccine CD-JEVAX® (SA14-14-2 LAV) * Contraindications to vaccination according to the IMOJEV® Summary of Product Characteristics (SmPC) * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study * Children who received IMOJEV® as primary vaccination in this study.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Day O up to Day 60 post-vaccination | Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure. |
Countries
Thailand
Participant flow
Recruitment details
The study participants were enrolled from 03 November 2013 to 08 February 2015 in 10 trial centers in Thailand.
Pre-assignment details
A total of 10,000 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Primary Vaccination Group Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination. | 6,851 |
| Booster Vaccination Group Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster. | 3,149 |
| Total | 10,000 |
Baseline characteristics
| Characteristic | Booster Vaccination Group | Primary Vaccination Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3149 Participants | 6851 Participants | 10000 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.60 Years STANDARD_DEVIATION 0.892 | 1.22 Years STANDARD_DEVIATION 0.486 | 1.97 Years STANDARD_DEVIATION 1.28 |
| Region of Enrollment Thailand | 3149 Participants | 6851 Participants | 10000 Participants |
| Sex: Female, Male Female | 1550 Participants | 3321 Participants | 4871 Participants |
| Sex: Female, Male Male | 1599 Participants | 3530 Participants | 5129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6,851 | 0 / 3,149 |
| serious Total, serious adverse events | 204 / 6,851 | 59 / 3,149 |
Outcome results
Primary
Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®
Time frame: 30 minutes post-vaccination up to Day 60 post-vaccination
Population: Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Vaccination Group | Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® | Grade 3 immediate systemic adverse event | 0 Participants |
| Primary Vaccination Group | Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® | Seriuos adverse events | 204 Participants |
| Primary Vaccination Group | Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® | Death | 0 Participants |
| Booster Vaccination Group | Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® | Seriuos adverse events | 59 Participants |
| Booster Vaccination Group | Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® | Grade 3 immediate systemic adverse event | 0 Participants |
| Booster Vaccination Group | Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® | Death | 1 Participants |
Primary
Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®
Time frame: Day O up to Day 60 post-vaccination
Population: Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Vaccination Group | Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® | SAEs in Subjects 9 to <12 Months | 43 Participants |
| Primary Vaccination Group | Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® | SAEs in Subjects 1 to 2 Years | 155 Participants |
| Primary Vaccination Group | Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® | SAEs in Subjects 2 to <5 Years | 6 Participants |
| Booster Vaccination Group | Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® | SAEs in Subjects 1 to 2 Years | 0 Participants |
| Booster Vaccination Group | Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® | SAEs in Subjects 9 to <12 Months | 0 Participants |
| Booster Vaccination Group | Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® | SAEs in Subjects 2 to <5 Years | 59 Participants |
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.
Time frame: Day O up to Day 60 post-vaccination
Population: Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Vaccination Group | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Convulsion | 1 Participants |
| Primary Vaccination Group | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Frontal lobe epilepsy | 1 Participants |
| Primary Vaccination Group | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Epilepsy | 1 Participants |
| Primary Vaccination Group | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Urticaria | 0 Participants |
| Primary Vaccination Group | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Febrile convulsion | 25 Participants |
| Booster Vaccination Group | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Urticaria | 2 Participants |
| Booster Vaccination Group | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Febrile convulsion | 2 Participants |
| Booster Vaccination Group | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Convulsion | 0 Participants |
| Booster Vaccination Group | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Epilepsy | 0 Participants |
| Booster Vaccination Group | Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Frontal lobe epilepsy | 0 Participants |