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Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

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ClinicalTrials.gov Identifier: NCT02526550
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Kulkanya Chokephaibulkit, Siriraj Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Encephalitis
Interventions Biological: Live attenuated chimeric Japanese Encephalitis vaccine
Biological: Inactivated Hepatitis A vaccine
Enrollment 50
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Imojev
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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

Period Title: Overall Study
Started 50
Completed 49
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Imojev
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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

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 50 participants
20.5  (0.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
27
  54.0%
Male
23
  46.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 50 participants
50
1.Primary Outcome
Title Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
Hide Description 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)
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Per-protocol analysis
Arm/Group Title Imojev
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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

Overall Number of Participants Analyzed 49
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
9144
(7365 to 11353)
2.Secondary Outcome
Title Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
Hide Description 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)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imojev
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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

Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
100
3.Secondary Outcome
Title 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™
Hide Description 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imojev
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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

Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
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
Time Frame 28 days following vaccination
Adverse Event Reporting Description 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.
 
Arm/Group Title Imojev
Hide Arm/Group Description

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

All-Cause Mortality
Imojev
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Imojev
Affected / at Risk (%) # Events
Total   0/49 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Imojev
Affected / at Risk (%) # Events
Total   31/49 (63.27%)    
General disorders   
Immediate reactions  1 [1]  0/49 (0.00%)  0
Solicited systemic reactions  1 [2]  12/49 (24.49%)  25
Unsolicited adverse events  1 [3]  24/49 (48.98%)  34
Skin and subcutaneous tissue disorders   
Solicited local reactions  1 [4]  6/49 (12.24%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Any reactions occurring within 30 minutes following vaccination
[2]
Solicited systemic reactions including fever, crying/irritability, drowsiness, low appetite, skin rash
[3]
Unsolicited adverse events are the spontaneously reported adverse events by patients or patients' parents/guardians
[4]
Solicited injection site reactions including pain, redness, swelling
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Prof.Kulkanya Chokephaibulkit
Organization: Siriraj Hospital
Phone: 662 4195695
Responsible Party: Kulkanya Chokephaibulkit, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT02526550     History of Changes
Other Study ID Numbers: JEC26-EXT
First Submitted: August 9, 2015
First Posted: August 18, 2015
Results First Submitted: January 12, 2016
Results First Posted: December 7, 2016
Last Update Posted: December 7, 2016