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Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.

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ClinicalTrials.gov Identifier: NCT00314132
Recruitment Status : Completed
First Posted : April 13, 2006
Results First Posted : December 5, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

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: ChimeriVax-JE, Japanese Encephalitis vaccine
Biological: 0.9% Saline
Enrollment 2004
Recruitment Details Participants were enrolled and vaccinated from 10 October 2005 to 30 March 2006 at 6 clinical centers in Australia and 16 clinical centers in the US.
Pre-assignment Details A total of 2004 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title Placebo ChimeriVax™-JE 4 log10 PFU Vaccine
Hide Arm/Group Description Participants received a single injection of placebo on Day 0. Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
Period Title: Overall Study
Started 403 1601
Completed 395 1583
Not Completed 8 18
Reason Not Completed
Lost to Follow-up             3             13
Withdrawal by Subject             3             5
Adverse Event             1             0
Physician Decision             1             0
Arm/Group Title Placebo ChimeriVax™-JE 4 log10 PFU Vaccine Total
Hide Arm/Group Description Participants received a single injection of placebo on Day 0. Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 403 1601 2004
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 1601 participants 2004 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
403
 100.0%
1601
 100.0%
2004
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 403 participants 1601 participants 2004 participants
34.8  (14.12) 34.6  (14.25) 34.7  (14.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 1601 participants 2004 participants
Female
165
  40.9%
721
  45.0%
886
  44.2%
Male
238
  59.1%
880
  55.0%
1118
  55.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 403 participants 1601 participants 2004 participants
United States 263 1201 1464
Australia 140 400 540
1.Primary Outcome
Title Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Hide Description Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Time Frame Day 0 up to 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment related adverse events were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).
Arm/Group Title Placebo ChimeriVax™-JE 4 log10 PFU Vaccine
Hide Arm/Group Description:
All subjects received a single injection of placebo on Day 0.
All participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
Overall Number of Participants Analyzed 403 1601
Measure Type: Number
Unit of Measure: Participants
Fatigue 90 365
Malaise 69 297
Injection Site Pain 36 199
Feeling Hot 27 152
Chills 17 112
Injection Site Erythema 14 74
Injection Site Pruritus 11 64
Headache 99 417
Myalgia 48 265
Arthralgia 21 119
Diarrhea 25 140
Nausea 26 114
Abdominal Pain 21 89
Pharyngolaryngeal Pain 10 55
Dyspnea 10 53
Nasal Congestion 9 14
Nasopharyngitis 13 10
2.Primary Outcome
Title Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Hide Description

Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.

Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.

Time Frame Day 0 up to 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment emergent local adverse reactions and systemic reactions were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).
Arm/Group Title Placebo ChimeriVax™-JE 4 log10 PFU Vaccine
Hide Arm/Group Description:
Participants received a single injection of placebo on Day 0.
Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
Overall Number of Participants Analyzed 403 1601
Measure Type: Number
Unit of Measure: Participants
Injection Site Pain 36 199
Injection Site Erythema 15 74
Injection Site Pruritus 12 66
Injection Site Hemorrhage 4 21
Injection Site Swelling 4 17
Injection Site Reaction 3 10
Injection Site Rash 3 5
Injection Site Induration 0 1
Injection Site Joint Pain 0 1
Injection Site Paresthesia 1 0
Injection Site Stinging 0 1
Injection Site Warmth 0 1
Fatigue 112 479
Malaise 92 383
Chills 26 147
Pyrexia 7 26
Headache 124 597
Myalgia 67 352
Arthralgia 28 179
Diarrhea 36 183
Nausea 37 164
Vomiting 12 37
Rash 13 34
Time Frame Adverse events data were collected from Day 0 to Month 6 post vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo ChimeriVax™-JE 4 log10 PFU Vaccine
Hide Arm/Group Description Participants received a single injection of placebo on Day 0. Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
All-Cause Mortality
Placebo ChimeriVax™-JE 4 log10 PFU Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo ChimeriVax™-JE 4 log10 PFU Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/403 (0.50%)      5/1601 (0.31%)    
Gastrointestinal disorders     
Inguinal Hernia  1  0/403 (0.00%)  0 1/1601 (0.06%)  1
General disorders     
Pyrexia  1  0/403 (0.00%)  0 1/1601 (0.06%)  1
Infections and infestations     
Streptococcal Sepsis  1  1/403 (0.25%)  1 0/1601 (0.00%)  0
Gastroenteritis Viral  1  0/403 (0.00%)  0 1/1601 (0.06%)  1
Psychiatric disorders     
Anxiety  1  0/403 (0.00%)  0 1/1601 (0.06%)  1
Reproductive system and breast disorders     
Fallopian Tube Cyst  1  0/403 (0.00%)  0 1/1601 (0.06%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/403 (0.25%)  1 0/1601 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Placebo ChimeriVax™-JE 4 log10 PFU Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   124/403 (30.77%)      597/1601 (37.29%)    
Gastrointestinal disorders     
Diarrhea  1  36/403 (8.93%)  42 183/1601 (11.43%)  251
Nausea  1  37/403 (9.18%)  50 164/1601 (10.24%)  228
Abdominal Pain  1  26/403 (6.45%)  33 138/1601 (8.62%)  219
General disorders     
Chills  1  26/403 (6.45%)  38 147/1601 (9.18%)  193
Feeling Hot  1  35/403 (8.68%)  55 193/1601 (12.05%)  281
Injection Site Pain  1  36/403 (8.93%)  51 199/1601 (12.43%)  279
Malaise  1  92/403 (22.83%)  150 383/1601 (23.92%)  664
Fatigue  1  90/403 (22.33%)  141 365/1601 (22.80%)  699
Musculoskeletal and connective tissue disorders     
Myalgia  1  67/403 (16.63%)  104 352/1601 (21.99%)  561
Arthralgia  1  28/403 (6.95%)  44 179/1601 (11.18%)  259
Nervous system disorders     
Headache  1  124/403 (30.77%)  251 597/1601 (37.29%)  1253
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal Pain  1  23/403 (5.71%)  33 89/1601 (5.56%)  122
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
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
ClinicalTrials.gov Identifier: NCT00314132     History of Changes
Other Study ID Numbers: H-040-010
First Submitted: April 11, 2006
First Posted: April 13, 2006
Results First Submitted: November 6, 2012
Results First Posted: December 5, 2012
Last Update Posted: December 6, 2012