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Trial record 1 of 1 for:    JEC07
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A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers

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ClinicalTrials.gov Identifier: NCT01092507
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : December 2, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Encephalitis
Japanese Encephalitis
Interventions Biological: Japanese encephalitis chimeric virus vaccine (JE-CV)
Biological: Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)
Enrollment 300
Recruitment Details Participants were enrolled from 07 March 2010 to 27 April 2011 at 3 clinical centers in Thailand.
Pre-assignment Details A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled; 299 were vaccinated.
Arm/Group Title Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Hide Arm/Group Description Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0. Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Period Title: Overall Study
Started 149 150
Completed 147 150
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2) Total
Hide Arm/Group Description Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0. Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 149 150 299
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 150 participants 299 participants
<=18 years
149
 100.0%
150
 100.0%
299
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 149 participants 150 participants 299 participants
13.1  (2.11) 13.2  (1.89) 13.2  (2.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 150 participants 299 participants
Female
69
  46.3%
75
  50.0%
144
  48.2%
Male
80
  53.7%
75
  50.0%
155
  51.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 149 participants 150 participants 299 participants
149 150 299
1.Primary Outcome
Title Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)
Hide Description

Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50).

Japanese Encephalitis seroconversion was defined as a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination.

Time Frame Day 0 through Day 28 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Japanese encephalitis antibody titers were assessed in all participants with immunogenicity data and who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)
Arm/Group Title Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Hide Arm/Group Description:
Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Overall Number of Participants Analyzed 126 128
Measure Type: Number
Unit of Measure: Participants
125 127
2.Secondary Outcome
Title Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)
Hide Description

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.

Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12.

Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Japanese encephalitis antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)
Arm/Group Title Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Hide Arm/Group Description:
Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Overall Number of Participants Analyzed 127 129
Measure Type: Number
Unit of Measure: Participants
Day 0, JE-CV PRNT50 (N = 127, 129) 0 0
Day 28, JE-CV PRNT50 (N = 125, 128) 125 127
Day 0, SA14-14-2 PRNT50 (N = 125, 128) 0 0
Day 28, SA14-14-2 PRNT50 (N = 125, 126) 122 123
3.Secondary Outcome
Title Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)
Hide Description

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.

Seroconversion was defined as a pre-vaccination titer < 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination.

Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)
Arm/Group Title Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Hide Arm/Group Description:
Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Overall Number of Participants Analyzed 127 129
Measure Type: Number
Unit of Measure: Participants
JE-CV PRNT50 (N = 126, 128) 125 127
SA14-14-2 PRNT50 (N = 124, 125) 121 122
4.Secondary Outcome
Title Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)
Hide Description Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)
Arm/Group Title Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Hide Arm/Group Description:
Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Overall Number of Participants Analyzed 127 129
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 0, JE-CV PRNT50 (N = 127, 129)
5.0
(5.0 to 5.0)
5.0
(5.0 to 5.0)
Day 28, JE-CV PRNT50 (N = 126, 128)
491
(378 to 638)
395
(304 to 514)
Day 0, SA14-14-2 PRNT50 (N = 125, 128)
5.00
(5.00 to 5.00)
5.0
(5.0 to 5.0)
Day 28, SA14-14-2 PRNT50 (N = 125, 126)
205
(162 to 259)
190
(152 to 239)
5.Secondary Outcome
Title Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)
Hide Description

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.

Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12.

Time Frame Day 28 up to 12 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Japanese encephalitis antibody titers were assessed in all vaccinated participants with available immunogenicity data (Full Analysis Set)
Arm/Group Title Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Hide Arm/Group Description:
Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Overall Number of Participants Analyzed 149 150
Measure Type: Number
Unit of Measure: Participants
Day 0, JE-CV PRNT50 (N = 149, 150) 6 5
Day 28, JE-CV PRNT50 (N = 146, 148) 145 147
Month 6, JE-CV PRNT50 (N = 145, 145) 137 141
Month 12, JE-CV PRNT50 (N = 143, 146) 126 142
Day 0, SA14-14-2 PRNT50 (N = 147, 149) 0 0
Day 28, SA14-14-2 PRNT50 (N = 145, 146) 141 142
Month 6, SA14-14-2 PRNT50 (N = 145, 145) 122 129
Month 12, SA14-14-2 PRNT50 (N = 142, 144) 109 126
6.Secondary Outcome
Title Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)
Hide Description Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.
Time Frame Day 0 (pre-vaccination) and up to 12 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Japanese encephalitis antibody titers were assessed in all participants that received a vaccine and with available immunogenicity data (Full Analysis Set)
Arm/Group Title Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Hide Arm/Group Description:
Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Overall Number of Participants Analyzed 149 150
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 0, JE-CV PRNT50 (N = 149, 150)
5.39
(5.05 to 5.74)
5.29
(4.98 to 5.61)
Day 28, JE-CV PRNT50 (N = 146, 148)
507
(395 to 651)
370
(291 to 470)
Month 6, JE-CV PRNT50 (N = 145, 145)
119
(91.7 to 154)
103
(85.6 to 124)
Month 12, JE-CV PRNT50 (N = 143, 146)
97.6
(74.0 to 129)
121
(96.7 to 151)
Day 0, SA14-14-2 PRNT50 (N = 147, 149)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Day 28, SA14-14-2 PRNT50 (N = 145, 146)
198
(158 to 247)
171
(138 to 212)
Month 6, SA14-14-2 PRNT50 (N = 145, 145)
52.7
(41.2 to 67.4)
51.4
(41.6 to 63.6)
Month 12, SA14-14-2 PRNT50 (N = 142, 144)
46.5
(35.8 to 60.4)
54.8
(43.9 to 68.4)
7.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®)
Hide Description

Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.

Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature > 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable.

Time Frame Day 0 through Day 14 post-vaccination
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Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in all participants who received a study vaccination and for whom safety data were available, according to the vaccine actually received (Safety Population).
Arm/Group Title Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Hide Arm/Group Description:
Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Overall Number of Participants Analyzed 147 152
Measure Type: Number
Unit of Measure: Participants
Any injection site Tenderness 44 57
Grade 3 injection site Tenderness 0 1
Any injection site Erythema 26 35
Grade 3 injection site Erythema 0 0
Any injection site Swelling 9 12
Grade 3 injection site Swelling 0 0
Any Fever 24 33
Grade 3 Fever 0 1
Any Vomiting 21 40
Grade 3 Vomiting 1 2
Any Crying Abnormal 28 39
Grade 3 Crying Abnormal 1 2
Any Drowsiness 25 38
Grade 3 Drowsiness 0 0
Any Appetite Loss 32 54
Grade 3 Appetite Loss 0 3
Any Irritability 41 58
Grade 3 Irritability 0 5
Time Frame Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination.
Adverse Event Reporting Description Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
 
Arm/Group Title Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Hide Arm/Group Description Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0. Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
All-Cause Mortality
Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/147 (9.52%)      18/152 (11.84%)    
Gastrointestinal disorders     
Oesophageal Obstruction * 1  0/147 (0.00%)  0 1/152 (0.66%)  1
Infections and infestations     
Anal Abscess * 1  1/147 (0.68%)  1 0/152 (0.00%)  0
Bronchitis * 2  1/147 (0.68%)  1 2/152 (1.32%)  2
Dengue Fever * 2  1/147 (0.68%)  1 1/152 (0.66%)  1
Diarrhoea Infectious * 2  0/147 (0.00%)  0 1/152 (0.66%)  1
Gastroenteritis * 2  6/147 (4.08%)  6 1/152 (0.66%)  1
Gastroenteritis Rotavirus * 2  0/147 (0.00%)  0 3/152 (1.97%)  3
Gastroenteritis Viral * 2  0/147 (0.00%)  0 1/152 (0.66%)  1
Nasopharyngitis * 2  0/147 (0.00%)  0 1/152 (0.66%)  1
Pharyngitis * 2  1/147 (0.68%)  1 0/152 (0.00%)  0
Pneumonia * 2  1/147 (0.68%)  1 0/152 (0.00%)  0
Pneumonia Bacterial * 2  0/147 (0.00%)  0 1/152 (0.66%)  1
Pneumonia Respiratory Syncytial Viral * 2  1/147 (0.68%)  1 1/152 (0.66%)  1
Urinary Tract Infection Enterococcal * 2  1/147 (0.68%)  1 0/152 (0.00%)  0
Viral Infection * 2  2/147 (1.36%)  2 1/152 (0.66%)  1
Nervous system disorders     
Febrile Convulsion * 2  0/147 (0.00%)  0 4/152 (2.63%)  4
Reproductive system and breast disorders     
Balanitis * 2  1/147 (0.68%)  1 0/152 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRA 12.0
2
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Japanese Encephalitis Chimeric Vaccine (JE-CV) Japanese Encephalitis Live Vaccine (SA14-14-2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/147 (44.90%)      88/152 (57.89%)    
Gastrointestinal disorders     
Vomiting  1  21/146 (14.38%)  21 40/152 (26.32%)  40
General disorders     
Crying Abnormal  1  28/146 (19.18%)  28 39/152 (25.66%)  39
Injection Site Erythema  1  26/146 (17.81%)  26 35/152 (23.03%)  35
Injection Site Swelling  1  9/146 (6.16%)  9 12/152 (7.89%)  12
Injection Site Tenderness  1  44/146 (30.14%)  44 57/152 (37.50%)  57
Irritability  1  41/146 (28.08%)  41 58/152 (38.16%)  58
Fever  2  24/147 (16.33%)  24 33/152 (21.71%)  33
Infections and infestations     
Nasopharyngitis * 1  14/147 (9.52%)  14 10/152 (6.58%)  12
Pharyngitis * 1  4/147 (2.72%)  4 9/152 (5.92%)  9
Upper Respiratory Tract Infection * 1  11/147 (7.48%)  12 31/152 (20.39%)  35
Metabolism and nutrition disorders     
Appetite Loss  1  32/146 (21.92%)  32 54/152 (35.53%)  54
Nervous system disorders     
Drowsiness  1  25/146 (17.12%)  25 38/152 (25.00%)  38
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA12.0
2
Term from vocabulary, MedDRA 12.0
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01092507     History of Changes
Other Study ID Numbers: JEC07
UTN: U1111-1112-2269 ( Other Identifier: WHO )
First Submitted: March 23, 2010
First Posted: March 25, 2010
Results First Submitted: September 30, 2013
Results First Posted: December 2, 2013
Last Update Posted: December 25, 2013