Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01296360
Recruitment Status : Completed
First Posted : February 15, 2011
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Intervention Biological: IXIARO
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Booster Group Non-Booster Group
Hide Arm/Group Description IC51 booster vaccination ~12 months after primary immunization in study IC51-323 No treatment in study IC51-325
Period Title: Overall Study
Started 150 150
Visit 2 (Month 12) 148 [1] 149
Visit 2a (Month 13) 148 [2] 0
Completed 144 142
Not Completed 6 8
[1]
booster was administered
[2]
visit in Booster Group only: ~13 months after immunization in IC51-323 (i.e., 1 month post booster)
Arm/Group Title Booster Group Non-Booster Group Total
Hide Arm/Group Description IC51 booster vaccination ~12 months after primary immunization in study IC51-323 No treatment in study IC51-325 Total of all reporting groups
Overall Number of Baseline Participants 150 150 300
Hide Baseline Analysis Population Description
Safety Population: subjects who entered into the study and were randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 150 participants 300 participants
5.23  (5.084) 5.36  (5.135) 5.30  (5.101)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
Female
72
  48.0%
79
  52.7%
151
  50.3%
Male
78
  52.0%
71
  47.3%
149
  49.7%
1.Primary Outcome
Title SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose
Hide Description [Not Specified]
Time Frame 1 month post booster
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population: primary analysis population for the immunogenicity analyses; defined as all subjects randomized
Arm/Group Title >14 Months to <2 Years >3 Years - <18 Years
Hide Arm/Group Description:
booster vaccination: IXIARO 0.25 ml i.m. (milliliter, intramuscular)
booster vaccination: IXIARO 0.5 ml i.m (milliliter, intramuscular)
Overall Number of Participants Analyzed 81 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
100
(95.5 to 100)
100
(94.6 to 100)
2.Secondary Outcome
Title Rate of Subjects Achieving a >4-fold Increase in JEV (Japanese Encephalitis Virus) Neutralizing Antibody Titers at 1 Month After the Booster Dose
Hide Description [Not Specified]
Time Frame 1 month
Outcome Measure Data Not Reported
3.Secondary Outcome
Title GMTs (Geometric Mean Titre) for JEV Neutralizing Antibodies Measured Using a Validated PRNT (Plaque Reduction Neutralization Test) at 1 Month After the Booster Dose
Hide Description [Not Specified]
Time Frame 1 month
Outcome Measure Data Not Reported
4.Secondary Outcome
Title GMTs and Rate of Subjects With a PRNT Titer of >1:10 at Months 12, 24 and 36 After First IXIARO Vaccination in IC51-323 With and Without Booster Vaccination
Hide Description [Not Specified]
Time Frame 36 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Rate of Subjects With SAEs (Serious Adverse Events) Following Immunization and Medically Attended AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and
Hide Description [Not Specified]
Time Frame 36 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Rate of Subjects With Unsolicited AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and Relationship to Vaccinations.
Hide Description [Not Specified]
Time Frame 36 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Rate of Subjects With SAEs and Medically Attended AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.
Hide Description [Not Specified]
Time Frame 1 month
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Rate of Subjects With Unsolicited AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.
Hide Description [Not Specified]
Time Frame 1 month
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Rate of Subjects With Solicited AEs for up to 7 Days Following the Booster Dose. Severity and Duration.
Hide Description [Not Specified]
Time Frame 7 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Booster Group Non-Booster Group
Hide Arm/Group Description IC51 booster vaccination ~12 months after primary immunization in study IC51-323 No treatment in study IC51-325
All-Cause Mortality
Booster Group Non-Booster Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Booster Group Non-Booster Group
Affected / at Risk (%) Affected / at Risk (%)
Total   7/150 (4.67%)   3/150 (2.00%) 
Infections and infestations     
Abscess  1/150 (0.67%)  0/150 (0.00%) 
Amoebic dysentery  1/150 (0.67%)  0/150 (0.00%) 
Bronchopneumonia  1/150 (0.67%)  0/150 (0.00%) 
Dengue fever  1/150 (0.67%)  0/150 (0.00%) 
Gastroenteritis  1/150 (0.67%)  0/150 (0.00%) 
Urinary tract infection  1/150 (0.67%)  0/150 (0.00%) 
Injury, poisoning and procedural complications     
Concussion  0/150 (0.00%)  1/150 (0.67%) 
Injury  0/150 (0.00%)  1/150 (0.67%) 
Pneumothorax traumatic  0/150 (0.00%)  1/150 (0.67%) 
Nervous system disorders     
Paralysis  0/150 (0.00%)  1/150 (0.67%) 
Surgical and medical procedures     
Finger amputation  1/150 (0.67%)  0/150 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Booster Group Non-Booster Group
Affected / at Risk (%) Affected / at Risk (%)
Total   99/150 (66.00%)   100/150 (66.67%) 
General disorders     
Pyrexia  10/150 (6.67%)  8/150 (5.33%) 
Fever  [1]  12/150 (8.00%)  0/150 (0.00%) 
Infections and infestations     
Upper respiratory tract infection  37/150 (24.67%)  34/150 (22.67%) 
Rhinitis  17/150 (11.33%)  16/150 (10.67%) 
Nasopharyngitis  16/150 (10.67%)  15/150 (10.00%) 
Varicella  9/150 (6.00%)  14/150 (9.33%) 
Gastroenteritis  7/150 (4.67%)  8/150 (5.33%) 
Bronchitis  6/150 (4.00%)  8/150 (5.33%) 
Impetigo  10/150 (6.67%)  4/150 (2.67%) 
Viral infection  9/150 (6.00%)  5/150 (3.33%) 
Indicates events were collected by systematic assessment
[1]
predefined term in subject diary; diary to be completed only by subjects receiving booster vaccination for 7 consecutive days
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Senior Manager Clinical Research
Organization: Valneva Austria GmbH
Phone: +43 1 206 20 ext 1175
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01296360     History of Changes
Other Study ID Numbers: IC51-325
First Submitted: December 28, 2010
First Posted: February 15, 2011
Results First Submitted: December 10, 2014
Results First Posted: December 19, 2014
Last Update Posted: December 19, 2014