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Trial record 2 of 2 for:    JEC02

Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

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: NCT00735644
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : August 15, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Japanese Encephalitis
Hepatitis A
Interventions Biological: Japanese encephalitis vaccine
Biological: Japanese encephalitis vaccine (Acambis)
Biological: Hepatitis A vaccine
Enrollment 1200
Recruitment Details The study participants were enrolled from 02 August 2008 through 27 March 2009 at 3 clinic sites in Thailand and 5 clinic sites in the Philippines.
Pre-assignment Details A total of 1200 participants who met all of the inclusion and none of the exclusion criteria were randomized, 1199 were vaccinated in this study.
Arm/Group Title JE-CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A
Hide Arm/Group Description Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1. Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3 Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) Participants 12 to 18 months of age received the Hepatitis A vaccine
Period Title: Overall Study
Started 303 300 296 199 102
Completed 303 298 295 198 102
Not Completed 0 2 1 1 0
Reason Not Completed
Did not receive study vaccine             0             1             0             0             0
Withdrawal by Subject             0             1             1             1             0
Arm/Group Title JE CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A Total
Hide Arm/Group Description Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) Participants 12 to 18 months of age received Hepatitis A vaccine Total of all reporting groups
Overall Number of Baseline Participants 303 299 296 199 102 1199
Hide Baseline Analysis Population Description
The baseline analysis population represents the participants who have received the trial vaccine or control vaccine (safety analysis set). Data on participants were analyzed and presented according to the vaccine they actually received.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 303 participants 299 participants 296 participants 199 participants 102 participants 1199 participants
<=18 years
303
 100.0%
299
 100.0%
296
 100.0%
199
 100.0%
102
 100.0%
1199
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 303 participants 299 participants 296 participants 199 participants 102 participants 1199 participants
14.3  (1.91) 14.5  (1.84) 14.4  (1.88) 14.3  (1.81) 14.3  (1.93) 14.4  (1.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 303 participants 299 participants 296 participants 199 participants 102 participants 1199 participants
Female
155
  51.2%
138
  46.2%
143
  48.3%
94
  47.2%
45
  44.1%
575
  48.0%
Male
148
  48.8%
161
  53.8%
153
  51.7%
105
  52.8%
57
  55.9%
624
  52.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 303 participants 299 participants 296 participants 199 participants 102 participants 1199 participants
Thailand 123 122 121 82 42 490
Philippines 180 177 175 117 60 709
1.Primary Outcome
Title Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots
Hide Description Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to the JE CV vaccine antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.
Arm/Group Title JE CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
Participants 12 to 18 months of age received Hepatitis A vaccine
Overall Number of Participants Analyzed 288 292 286 193 97
Measure Type: Number
Unit of Measure: Participants
JE CV Day 0 (≥10 1/dil; N=288, 290, 285, 192, 0) 0 0 0 0 NA [1] 
JE CV Day 28 (≥10 1/dil; N=288, 284, 283, 192, 0) 282 262 267 185 NA [1] 
[1]
Anti-Japanese encephalitis chimeric virus vaccine antibodies were not assayed in this group
2.Secondary Outcome
Title Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV
Hide Description Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers against the JE CV antigens were assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.
Arm/Group Title JE CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
Participants 12 to 18 months of age received Hepatitis A vaccine
Overall Number of Participants Analyzed 288 292 286 193 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti JE-CV Day 0 (N=288, 290, 285, 192, 0)
5.17
(5.06 to 5.29)
5.08
(4.99 to 5.17)
5.19
(5.02 to 5.37)
5.09
(4.95 to 5.24)
Anti JE CV Day 28 (N=288, 284, 283, 192, 0)
212
(179 to 252)
167
(138 to 202)
188
(156 to 226)
212
(168 to 268)
3.Secondary Outcome
Title Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV
Hide Description Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against JE CV antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.
Arm/Group Title JE-CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
Participants 12 to 18 months of age received Hepatitis A vaccine
Overall Number of Participants Analyzed 288 292 286 193 97
Measure Type: Number
Unit of Measure: Participants
JE CV Day 0 (N=288, 290, 285, 192, 0) 10 4 8 2 NA [1] 
JE CV Day 28 (N=288, 284, 283, 192, 0) 297 269 276 190 NA [1] 
[1]
Japanese encephalitis chimeric virus vaccine antibodies were not measured in this group
4.Secondary Outcome
Title Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine
Hide Description Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers against the JE CV antigens were assessed in the Per Protocol Analysis Set.
Arm/Group Title JE-CV GPO MBP (Lot 1) JE-CV MBP (Lot 2) JE-CV MBP (Lot 3) JE-CV WRAIR Hepatitis A
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 2 subcutaneously
Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 3 subcutaneously
Participants 12 to 18 months of age received one dose of JE CV from Acambis at WRAIR subcutaneously
Participants 12 to 18 months of age received the Hepatitis vaccine intramuscularly
Overall Number of Participants Analyzed 288 292 286 193 97
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratio
41.1
(34.6 to 48.7)
32.9
(27.3 to 39.8)
36.6
(30.3 to 44.1)
42.2
(33.3 to 53.3)
NA [1] 
(NA to NA)
[1]
Participants in this group did not receive a Japanese encephalitis chimeric virus vaccine
5.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.
Hide Description Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; 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 Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.
Time Frame Day 0 up to Day 14 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Arm/Group Title JE CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
Participants 12 to 18 months of age received Hepatitis A vaccine
Overall Number of Participants Analyzed 302 299 297 199 102
Measure Type: Number
Unit of Measure: Participants
Injection site Tenderness 58 59 67 59 18
Grade 3 Injection site Tenderness 0 0 0 0 0
Injection site Erythema 64 63 87 54 26
Grade 3 Injection site Erythema 0 0 0 0 0
Injection site Swelling 22 20 21 13 4
Grade 3 Injection site Swelling 0 0 0 0 0
Fever 51 62 64 48 21
Grade 3 Fever 3 5 3 1 0
Vomiting 60 57 53 39 16
Grade 3 Vomiting 3 1 1 1 1
Crying Abnormal 58 54 50 41 21
Grade 3 Crying Abnormal 1 0 1 0 0
Drowsiness 58 53 53 38 20
Grade 3 Drowsiness 0 0 0 0 0
Appetite Lost 82 71 74 57 27
Grade 3 Appetite Lost 3 1 1 2 0
Irritability 91 79 79 65 28
Grade 3 Irritability 2 0 1 1 1
6.Other Pre-specified Outcome
Title Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.
Hide Description Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution.
Time Frame Day 0 (pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Serological status of Flavivirus infection was assessed in the Per-protocol Analysis Set.
Arm/Group Title JE-CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
Participants 12 to 18 months of age received Hepatitis A vaccine
Overall Number of Participants Analyzed 288 292 285 192 97
Measure Type: Number
Unit of Measure: Participants
JE CV/dengue FV positive (N=288,290,285,192,97) 19 23 32 15 13
JE CV/dengue FV negative (N=288,290,285,192,97) 265 266 249 176 84
JE CV (N=288, 290, 285, 192, 97) 0 0 0 0 0
Dengue serotype 1 (N=284, 289, 282, 192, 97) 17 19 28 14 13
Dengue serotype 2 (N=284, 289, 282, 192, 97) 15 18 26 11 12
Dengue serotype 3 (N=284, 289, 282, 192, 97) 16 18 27 12 11
Dengue serotype 4 (N=284, 289, 282, 192, 97) 10 6 13 7 8
Time Frame Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination.
Adverse Event Reporting Description The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
 
Arm/Group Title JE-CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A
Hide Arm/Group Description Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) Participants 12 to 18 months of age received Hepatitis A vaccine
All-Cause Mortality
JE-CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
JE-CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/302 (3.31%)      17/299 (5.69%)      13/297 (4.38%)      7/199 (3.52%)      7/102 (6.86%)    
Infections and infestations           
Bronchiolitis * 1  2/302 (0.66%)  2 0/299 (0.00%)  0 0/297 (0.00%)  0 0/199 (0.00%)  0 0/102 (0.00%)  0
Cellulitis * 1  0/302 (0.00%)  0 0/299 (0.00%)  0 2/297 (0.67%)  2 0/199 (0.00%)  0 0/102 (0.00%)  0
Gastroenteritis * 1  3/302 (0.99%)  3 4/299 (1.34%)  4 4/297 (1.35%)  4 1/199 (0.50%)  1 0/102 (0.00%)  0
Pneumonia * 1  3/302 (0.99%)  3 3/299 (1.00%)  3 3/297 (1.01%)  3 2/199 (1.01%)  2 1/102 (0.98%)  1
Pneumonia bacterial * 1  0/302 (0.00%)  0 0/299 (0.00%)  0 0/297 (0.00%)  0 0/199 (0.00%)  0 2/102 (1.96%)  2
Urinary tract infection * 1  0/302 (0.00%)  0 3/299 (1.00%)  3 0/297 (0.00%)  0 0/199 (0.00%)  0 0/102 (0.00%)  0
Amoebiasis * 1  0/302 (0.00%)  0 0/299 (0.00%)  0 0/297 (0.00%)  0 1/199 (0.50%)  1 0/102 (0.00%)  0
Bronchitis * 1  0/302 (0.00%)  0 2/299 (0.67%)  2 0/297 (0.00%)  0 0/199 (0.00%)  0 0/102 (0.00%)  0
Gastroenteritis viral * 1  1/302 (0.33%)  1 0/299 (0.00%)  0 0/297 (0.00%)  0 0/199 (0.00%)  0 0/102 (0.00%)  0
Influenza * 1  1/302 (0.33%)  1 0/299 (0.00%)  0 0/297 (0.00%)  0 0/199 (0.00%)  0 0/102 (0.00%)  0
Pneumonia viral * 1  0/302 (0.00%)  0 0/299 (0.00%)  0 0/297 (0.00%)  0 1/199 (0.50%)  1 0/102 (0.00%)  0
Varicella * 1  0/302 (0.00%)  0 0/299 (0.00%)  0 0/297 (0.00%)  0 1/199 (0.50%)  1 0/102 (0.00%)  0
Viral infection * 1  0/302 (0.00%)  0 2/299 (0.67%)  2 0/297 (0.00%)  0 0/199 (0.00%)  0 1/102 (0.98%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Testicular yolk sac tumour stage III * 1  0/302 (0.00%)  0 0/299 (0.00%)  0 0/297 (0.00%)  0 1/199 (0.50%)  1 0/102 (0.00%)  0
Nervous system disorders           
Febrile convulsion * 1  2/302 (0.66%)  2 6/299 (2.01%)  6 4/297 (1.35%)  4 1/199 (0.50%)  1 3/102 (2.94%)  4
Respiratory, thoracic and mediastinal disorders           
Asthma * 1  1/302 (0.33%)  1 0/299 (0.00%)  0 0/297 (0.00%)  0 0/199 (0.00%)  0 0/102 (0.00%)  0
*
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 5.00%
JE-CV GPO MBP (Lot 1) JE-CV GPO MBP (Lot 2) JE-CV GPO MBP (Lot 3) JE-CV WRAIR Hepatitis A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   91/302 (30.13%)      99/299 (33.11%)      87/297 (29.29%)      65/199 (32.66%)      36/102 (35.29%)    
Gastrointestinal disorders           
Vomiting  1  60/302 (19.87%)  60 57/299 (19.06%)  57 53/297 (17.85%)  53 39/199 (19.60%)  39 16/102 (15.69%)  16
General disorders           
Pyrexia * 1  2/302 (0.66%)  2 6/299 (2.01%)  6 6/297 (2.02%)  6 10/199 (5.03%)  10 1/102 (0.98%)  1
Injection site tenderness  1  58/302 (19.21%)  58 59/299 (19.73%)  59 67/297 (22.56%)  67 59/199 (29.65%)  59 18/102 (17.65%)  18
Injection site erythema  1  64/302 (21.19%)  64 63/299 (21.07%)  63 87/297 (29.29%)  87 54/199 (27.14%)  54 26/102 (25.49%)  26
Injection site swelling  1  22/302 (7.28%)  22 20/299 (6.69%)  20 21/297 (7.07%)  21 13/199 (6.53%)  13 4/102 (3.92%)  4
Fever  1  51/302 (16.89%)  51 62/299 (20.74%)  62 64/297 (21.55%)  64 48/199 (24.12%)  48 21/102 (20.59%)  21
Infections and infestations           
Gastroenteritis * 1  19/302 (6.29%)  21 18/299 (6.02%)  19 11/297 (3.70%)  11 10/199 (5.03%)  11 5/102 (4.90%)  5
Nasopharyngitis * 1  24/302 (7.95%)  25 18/299 (6.02%)  18 22/297 (7.41%)  22 21/199 (10.55%)  26 5/102 (4.90%)  5
Upper respiratory tract infection * 1  84/302 (27.81%)  99 78/299 (26.09%)  88 72/297 (24.24%)  79 52/199 (26.13%)  58 36/102 (35.29%)  42
Metabolism and nutrition disorders           
Appetite Lost  1  82/302 (27.15%)  82 71/299 (23.75%)  71 74/297 (24.92%)  74 57/199 (28.64%)  57 27/102 (26.47%)  27
Nervous system disorders           
Drowsiness  1  58/302 (19.21%)  58 53/299 (17.73%)  53 53/297 (17.85%)  53 38/199 (19.10%)  38 20/102 (19.61%)  20
Psychiatric disorders           
Crying Abnormal  1  58/302 (19.21%)  58 54/299 (18.06%)  54 50/297 (16.84%)  50 41/199 (20.60%)  41 21/102 (20.59%)  21
Irritability  1  91/302 (30.13%)  91 79/299 (26.42%)  79 79/297 (26.60%)  79 65/199 (32.66%)  65 28/102 (27.45%)  28
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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: NCT00735644     History of Changes
Other Study ID Numbers: JEC02
First Submitted: August 14, 2008
First Posted: August 15, 2008
Results First Submitted: June 25, 2014
Results First Posted: August 15, 2014
Last Update Posted: April 21, 2015