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Trial record 18 of 40 for:    "Yellow fever"

Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)

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ClinicalTrials.gov Identifier: NCT00982137
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : September 20, 2012
Last Update Posted : September 20, 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 Japanese Encephalitis
Yellow Fever
Interventions Biological: Live attenuated Japanese encephalitis virus; Yellow fever virus
Biological: Yellow fever virus; Live attenuated Japanese encephalitis virus
Enrollment 108
Recruitment Details Participants were screened and enrolled from 27 July 2004 to 27 September 2004 at 1 clinical center in Australia.
Pre-assignment Details A total of 108 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Hide Arm/Group Description All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30. All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30. All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
Period Title: Overall Study
Started 36 36 18 18
Completed 36 35 18 17
Not Completed 0 1 0 1
Reason Not Completed
Lost to Follow-up             0             0             0             1
Withdrawal by Subject             0             1             0             0
Arm/Group Title ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® Total
Hide Arm/Group Description All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30. All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30. All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30. Total of all reporting groups
Overall Number of Baseline Participants 36 36 18 18 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 18 participants 18 participants 108 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
36
 100.0%
36
 100.0%
18
 100.0%
18
 100.0%
108
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 18 participants 18 participants 108 participants
27.2  (9.71) 23.4  (6.95) 27.5  (10.19) 25.8  (8.26) 25.8  (8.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 18 participants 18 participants 108 participants
Female
16
  44.4%
13
  36.1%
10
  55.6%
7
  38.9%
46
  42.6%
Male
20
  55.6%
23
  63.9%
8
  44.4%
11
  61.1%
62
  57.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 36 participants 36 participants 18 participants 18 participants 108 participants
36 36 18 18 108
1.Primary Outcome
Title Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.
Hide Description

Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples.

The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

Time Frame Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
Hide Outcome Measure Data
Hide Analysis Population Description
Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).
Arm/Group Title ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL
Hide Arm/Group Description:
Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
Overall Number of Participants Analyzed 17 23 13 10
Measure Type: Number
Unit of Measure: Participants
Day 30 (N = 17, 23, 13, 10) 17 2 12 0
Day 60 (N = 17, 23, 13, 10) 17 21 12 10
30 Days Post-JE Seroconversion (N = 17, 23, 23, 0) 17 21 22 NA [1] 
[1]
Data for the participants in Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL®, then Diluent) and Group 4, (Diluent then co-administration with ChimeriVax™-JE and STAMARIL) were pooled and presented in Group 3 column.
2.Primary Outcome
Title Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.
Hide Description

Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples.

The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

Time Frame Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
Hide Outcome Measure Data
Hide Analysis Population Description
Yellow fever seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).
Arm/Group Title ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Hide Arm/Group Description:
Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
Overall Number of Participants Analyzed 17 23 13 10
Measure Type: Number
Unit of Measure: Participants
Day 30 (N = 17, 23, 13, 10) 0 23 13 1
Day 60 (N = 17, 23, 13, 10) 17 23 13 10
Day 30 Post-JE Seroconversion (N = 17, 23, 23, 0) 17 23 23 NA [1] 
[1]
Data for the participants in Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent) and Group 4, (Diluent then co-administration with ChimeriVax™-JE and STAMARIL) were pooled and presented in Group 3 column.
3.Primary Outcome
Title Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination
Hide Description Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.
Time Frame Day 0 (Pre-vaccination) through Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).
Arm/Group Title ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Hide Arm/Group Description:
Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-JE on Day 30.
Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
Overall Number of Participants Analyzed 17 23 13 10
Measure Type: Number
Unit of Measure: Participants
JE Homologous Virus 17 21 12 10
Genotype I 17 21 13 10
Genotype II 15 16 9 9
Genotype III 16 20 9 10
Genotype IV 15 15 5 9
4.Primary Outcome
Title Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo
Hide Description

Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain.

All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups.

Time Frame Day 0 up to Day 60 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analyses were performed on data from all randomized subjects who received at least one dose of study medication: ChimeriVax JE, STAMARIL, or Diluent (Safety Population).
Arm/Group Title ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Hide Arm/Group Description:
All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
Overall Number of Participants Analyzed 71 72 36 36
Measure Type: Number
Unit of Measure: Participants
Injection Site Pain (N = 71, 72, 36, 36) 13 13 6 4
Injection Site Erythema (N = 71, 72, 36, 36) 6 9 3 1
Injection Site Swelling (N = 71, 72, 36, 36) 4 0 3 1
Injection Site Hemorrhage (N = 71, 72, 36, 36) 1 2 1 0
Venipuncture Site Hemorrhage (N = 71, 72, 36, 36) 0 2 0 0
Fatigue (N = 36, 36, 18, 18) 16 15 3 10
Malaise (N = 36, 36, 18, 18) 10 12 2 6
Pyrexia (N = 36, 36, 18, 18) 3 4 0 3
Chills (N = 36, 36, 18, 18) 1 4 1 2
Headache (N = 36, 36, 18, 18) 18 20 6 8
Dizziness (N = 36, 36, 18, 18) 0 2 0 0
Myalgia (N = 36, 36, 18, 18) 7 12 3 4
Abdominal Pain (N = 36, 36, 18, 18) 5 4 2 3
Diarrhea (N = 36, 36, 18, 18) 7 2 2 3
Nausea (N = 36, 36, 18, 18) 3 1 1 2
Pharyngolaryngeal Pain (N = 36, 36, 18, 18) 0 2 0 1
5.Secondary Outcome
Title Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.
Hide Description

Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test.

Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)

Time Frame Day 0 through 6 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-protocol Population).
Arm/Group Title ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Hide Arm/Group Description:
All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
Overall Number of Participants Analyzed 17 23 13 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
15 Days Post-vaccination (N = 17, 23, 13, 10)
282.1
(130.8 to 608.3)
140.2
(50.9 to 386.3)
119.9
(53.6 to 267.9)
386.5
(135.1 to 1106.4)
30 Days Post-vaccination (N = 17, 23, 13, 10)
1461.6
(632.8 to 3375.8)
426.4
(172.3 to 1055.1)
221.2
(94.9 to 515.3)
611.6
(188.4 to 1986.0)
45 Days Post-vaccination (N = 17, 0, 13, 0)
1099.3
(465.9 to 2593.6)
NA [1] 
(NA to NA)
146.3
(58.3 to 367.2)
NA [1] 
(NA to NA)
60 Days Post-vaccination (N = 17, 0, 13, 0)
687.8
(315.4 to 1499.8)
NA [1] 
(NA to NA)
103.1
(43.9 to 242.1)
NA [1] 
(NA to NA)
6 Months Post-vaccination (N = 16, 22, 13, 10)
267.5
(122.4 to 584.4)
134.0
(59.2 to 303.4)
94.6
(37.8 to 236.9)
99.9
(56.8 to 175.7)
[1]
Data were not assessed at this time point for this group.
6.Secondary Outcome
Title Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo
Hide Description

Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test.

Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

Time Frame Day 0 through 6 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).
Arm/Group Title ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Hide Arm/Group Description:
All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
Overall Number of Participants Analyzed 17 23 13 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 15 Post-vaccination (N = 17, 23, 13, 10)
463.1
(156.2 to 1372.8)
1080.7
(606.3 to 1926.2)
1150.0
(527.3 to 2507.8)
2044.1
(768.7 to 5435.2)
Day 30 Post-vaccination (N = 17, 23, 13, 10)
3288.5
(1415.4 to 7640.4)
3704.6
(2271.4 to 6042.0)
1565.6
(897.9 to 2729.9)
3054.9
(1230.2 to 7586.3)
Day 45 Post-vaccination (N = 0, 23, 13, 0)
NA [1] 
(NA to NA)
2442.5
(1450.5 to 4112.8)
974.6
(572.3 to 1659.8)
NA [1] 
(NA to NA)
Day 60 Post-vaccination (N = 0, 23, 13, 0)
NA [1] 
(NA to NA)
2175.1
(1223.9 to 3865.4)
653.1
(277.2 to 1539.0)
NA [1] 
(NA to NA)
6 Months Post-vaccination (N = 16, 22, 13, 10)
2017.5
(842.0 to 4834.3)
2058.7
(1302.5 to 3253.8)
947.4
(431.3 to 2081.3)
1351.8
(534.9 to 3416.4)
[1]
Data were not assessed at this time point for this group.
Time Frame Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination.
Adverse Event Reporting Description Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
 
Arm/Group Title ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Hide Arm/Group Description All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30. All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30. All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
All-Cause Mortality
ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
ChimeriVax™-JE Then STAMARIL® STAMARIL® Then ChimeriVax™-JE Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/71 (25.35%)   20/72 (27.78%)   6/36 (16.67%)   10/36 (27.78%) 
Gastrointestinal disorders         
Abdominal Pain  1  5/36 (13.89%)  4/36 (11.11%)  2/18 (11.11%)  3/18 (16.67%) 
Diarrhea  1  7/36 (19.44%)  2/36 (5.56%)  2/18 (11.11%)  3/18 (16.67%) 
Nausea  1  3/36 (8.33%)  1/36 (2.78%)  1/18 (5.56%)  2/18 (11.11%) 
General disorders         
Fatigue  1  16/36 (44.44%)  15/36 (41.67%)  3/18 (16.67%)  10/18 (55.56%) 
Injection Site Pain  1  13/71 (18.31%)  13/72 (18.06%)  6/36 (16.67%)  4/36 (11.11%) 
Injection Site Erythema  1  6/71 (8.45%)  9/72 (12.50%)  3/36 (8.33%)  1/36 (2.78%) 
Injection Site Swelling  1  4/71 (5.63%)  0/72 (0.00%)  3/36 (8.33%)  1/36 (2.78%) 
Malaise  1  10/36 (27.78%)  12/36 (33.33%)  2/18 (11.11%)  6/18 (33.33%) 
Pyrexia  1  3/36 (8.33%)  4/36 (11.11%)  0/18 (0.00%)  3/18 (16.67%) 
Chills  1  1/36 (2.78%)  4/36 (11.11%)  1/18 (5.56%)  2/18 (11.11%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  7/36 (19.44%)  12/36 (33.33%)  3/18 (16.67%)  4/18 (22.22%) 
Nervous system disorders         
Headache  1  18/36 (50.00%)  20/36 (55.56%)  6/18 (33.33%)  8/18 (44.44%) 
Dizziness  1  0/36 (0.00%)  2/36 (5.56%)  0/18 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pharyngolaryngeal Pain  1  0/36 (0.00%)  2/36 (5.56%)  0/18 (0.00%)  1/18 (5.56%) 
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: NCT00982137     History of Changes
Other Study ID Numbers: H-040-006
First Submitted: September 21, 2009
First Posted: September 22, 2009
Results First Submitted: July 11, 2012
Results First Posted: September 20, 2012
Last Update Posted: September 20, 2012