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Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children (JE0153)

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ClinicalTrials.gov Identifier: NCT01408537
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Pornthep Chanthavanich, Mahidol University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Encephalitis, Japanese B
Intervention Biological: JEVAC
Enrollment 152
Recruitment Details The enrollment took place in 2 sites (Department of Tropical Pediatrics, Faculty of Tropical Medicine and Nopparat Rajathanee Hospital) from 3rd May 2010 to 10th August 2010. One hundred and fifty two subjects who illegible for the inclusion and exclusion criteria were enrolled in the study.
Pre-assignment Details There was no subject who did not get the study vaccine after informed consent was signed.
Arm/Group Title JEVAC
Hide Arm/Group Description JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Period Title: Overall Study
Started 152
Completed 144
Not Completed 8
Reason Not Completed
Withdrawal by Subject             2
Protocol Violation             3
Lost to Follow-up             3
Arm/Group Title JEVAC
Hide Arm/Group Description JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Overall Number of Baseline Participants 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
<=18 years
152
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants
1.2  (0.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
Female
73
  48.0%
Male
79
  52.0%
1.Primary Outcome
Title Seroconversion Rate After Primary Vaccination
Hide Description To determine the seroconversion rate by using neutralizing antibody (NT) against JE virus (Beijing P3 strain) JE virus from <10 on before first vaccination To >= 10 at 28 days after second vaccination (primary vaccination). Those who have NT titer >=10 before first vaccination, will not be included in immunogenicity evaluation.
Time Frame 28 days after second dose of JEVAC
Hide Outcome Measure Data
Hide Analysis Population Description
There were 152 enrolled subjects in the study. However, 5 subjects had NT titer >= 10 before first vaccination and one subject whom blood on 28days after second vaccination was not drawn due to withdrawn consent. Therefore, the number of subjects for the outcome measurement should be 146.
Arm/Group Title JEVAC
Hide Arm/Group Description:
JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of seroconversion
100
2.Secondary Outcome
Title Geometric Mean Titer of NT After Primary and Booster Vaccination
Hide Description To determine the geometric mean titers (GMT) of neutralizing antibody of JEVAC 1 month after primary and then before and after booster vaccinations.
Time Frame 28 days after second vaccination, before and 28 days after booster vaccination with JEVAC
Hide Outcome Measure Data
Hide Analysis Population Description
152 were enrolled, 1 withdrawn consent before second vaccine, 5 had NT >= 10 before first vaccine, 146 included in D28 after second vaccine. At 1 year, 3 received JE vaccine outside the study, 3 lost follow up, 140 included in before booster, At D28 after booster, 1 could not draw blood, 139 included in D28 after booster.
Arm/Group Title GMT of NT on 28days After Vaccination GMT of NT Before Booster Vaccine GMT of NT Titer After Booster Vaccine
Hide Arm/Group Description:
GMT of NT titer of subjects on 28 days after vaccination (excluded the subject who had NT titer > =10 before first vaccination).
GMT of NT of subject at 1 year before booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
GMT of NT of subject at 28 days after booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
Overall Number of Participants Analyzed 146 140 139
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
150.01
(126.4 to 175.7)
49.33
(39.0 to 62.4)
621.66
(510.4 to 757.2)
3.Secondary Outcome
Title Adverse Events of Vaccine
Hide Description To determine the adverse events of JEVAC
Time Frame 7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively
Hide Outcome Measure Data
Hide Analysis Population Description
Determined AEs by number of injections 152 injection for the first dose 151 injection for the second dose 145 injection for the third dose
Arm/Group Title Fever After Vaccination Local AE JEVAC After Vaccination Chills After Vaccination Poor Appetite After Vaccination Vomiting After Vaccination Urticaria After Vaccination Unsolicited AEs After Each Vaccination SAEs Entire the Study
Hide Arm/Group Description:
Fever (Temp > =37.5 Axillary )after each vaccinations (3 doses). Episode of fever was collected up to 28 days after each vaccination.

Local Adverse event (tenderness, redness, ecchymosis, hematoma and swelling) after each vaccinations the first vaccination was on day of enrollment, the second dose was Day7 (+21day))

, Booster vaccine was on 1 year(+30days). Local AEs were collected up to 28 days after each vaccination.

Chills after each vaccinations (3 doses). Episode of chills was collected up to 28 days after each vaccination.
Poor appetite after each vaccinations (3 doses). Episode of poor appetite was collected up to 28 days after each vaccination.
Vomiting after each vaccinations (3 doses). Episode of vomiting was collected up to 28 days after each vaccination.
Urticaria after each vaccinations (3 doses). Episode of Urticaria was collected up to 28 days after each vaccination.
unsolicited AEs after each vaccinations (3 doses). Episode of unsolicited AEs (excluded SAEs) were collected up to 28 days after each vaccination
SAEs which occured entire the study period were recorded.
Overall Number of Participants Analyzed 152 152 152 152 152 152 152 152
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
448 448 448 448 448 448 448 448
Measure Type: Number
Unit of Measure: events
79 5 3 24 36 3 63 21
4.Secondary Outcome
Title Neutralizing Antibody Persistence One Year After the Primary Vaccination
Hide Description To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.
Time Frame 1 year after primary vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was excluded 5 subjects who had NT titer >10 on D0
Arm/Group Title JEVAC
Hide Arm/Group Description:
JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Overall Number of Participants Analyzed 140
Measure Type: Number
Unit of Measure: participants
125
Time Frame In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title JEVAC
Hide Arm/Group Description JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
All-Cause Mortality
JEVAC
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
JEVAC
Affected / at Risk (%) # Events
Total   21/152 (13.82%)    
Gastrointestinal disorders   
diarrhea  1  4/152 (2.63%)  4
Infections and infestations   
infection (other)  1  2/152 (1.32%)  2
Nervous system disorders   
seizure  1  5/152 (3.29%)  5
Respiratory, thoracic and mediastinal disorders   
pneumonia  1  6/152 (3.95%)  6
bronchitis  1  2/152 (1.32%)  2
pharyngitis  1  1/152 (0.66%)  1
Skin and subcutaneous tissue disorders   
skin infection * 1  1/152 (0.66%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
JEVAC
Affected / at Risk (%) # Events
Total   89/152 (58.55%)    
Gastrointestinal disorders   
diarrhea  1  9/152 (5.92%)  9
vomiting  2  1/152 (0.66%)  1
poor appetite  2  22/152 (14.47%)  24
vomiting  2  32/152 (21.05%)  36
Infections and infestations   
infection  1  7/152 (4.61%)  7
Fever  2 [1]  64/152 (42.11%)  79
chills  2  3/152 (1.97%)  3
Respiratory, thoracic and mediastinal disorders   
upper respiratory tract infection  1  27/152 (17.76%)  27
bronchitis  1  3/152 (1.97%)  3
Skin and subcutaneous tissue disorders   
skin infection  1  1/152 (0.66%)  1
pruritus  1  1/152 (0.66%)  1
urticaria  1  1/152 (0.66%)  1
contact dermatitis  1  13/152 (8.55%)  13
urticaria  2  3/152 (1.97%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA (10.0)
[1]
Axillary temperature greater than or equal 37.5 celsius
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Pornthep Chanthavanich
Organization: Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Thailand
Phone: 6623549161
Responsible Party: Pornthep Chanthavanich, Mahidol University
ClinicalTrials.gov Identifier: NCT01408537     History of Changes
Other Study ID Numbers: JE0153
First Submitted: August 2, 2011
First Posted: August 3, 2011
Results First Submitted: April 23, 2013
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014