A Phase 4 interventional study of Live attenuated chimeric Japanese Encephalitis vaccine and Inactivated Hepatitis A vaccine in Encephalitis, sponsored by Siriraj Hospital. Completed. Open to participants aged 1 Year to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-07.
Sponsored by Siriraj Hospital · Phase 4, Interventional, and Prevention
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.
283 studies on the registry are indexed under Encephalitis; 55 are open to participants now.
This study's enrollment of 50 is below the median of 118 across 174 interventional studies indexed under Encephalitis.
Browse Encephalitis studies →Siriraj Hospital is the lead sponsor of 95 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Biological: Live attenuated chimeric Japanese Encephalitis vaccine · Biological: Inactivated Hepatitis A vaccine
0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
Also known as: Imojev
0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Also known as: Havrix
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).
Time frame: Day 0 (Baseline) and Day 28 (post-vaccination)
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.
Time frame: Day 0 (Baseline) and Day 28 (post-vaccination)
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.
Time frame: Up to 28 days post booster vaccination
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.
| Milestone | Imojev |
|---|---|
| Started | 50 |
| Completed | 49 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).
| titers | Imojev |
|---|---|
| Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination | 9144 (7365 to 11353) |
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.
| percentage of participants | Imojev |
|---|---|
| Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination | 100 |
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.
| percentage of participants | Imojev |
|---|---|
| Immediate reactions | 0 |
| Injection site pain | 10.2 |
| Injection site redness | 6.1 |
| Injection site swelling | 6.1 |
| Fever | 10.3 |
| Crying/Irritability | 8.3 |
| Drowsiness | 10.4 |
| Low Appetite | 8.2 |
| Skin Rash | 12.2 |
| Unsolicited adverse events | 49.0 |
| Serious adverse events | 0 |
Collected over 28 days following vaccination. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Imojev | — | 0/49 (0%) | 31/49 (63.3%) |
| Event | Imojev |
|---|---|
| Unsolicited adverse eventsGeneral disorders | 24/49 |
| Solicited systemic reactionsGeneral disorders | 12/49 |
| Solicited local reactionsSkin and subcutaneous tissue disorders | 6/49 |
| Immediate reactionsGeneral disorders | 0/49 |
| Age, Continuous(months) | Imojev |
|---|---|
| Mean | 20.5 ± 0.8 |
| Sex: Female, Male(Participants) | Imojev |
|---|---|
| Female | 27 |
| Male | 23 |
| Region of Enrollment(participants) | Imojev |
|---|---|
| Thailand | 50 |
No study locations are listed for this record.
Plan to share: No — The submission of study review and results to a peer-review journal is ongoing.
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Siriraj Hospital