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Trial record 1 of 1 for:    H-244-003
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Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults

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: NCT00442169
Recruitment Status : Completed
First Posted : March 1, 2007
Results First Posted : February 14, 2011
Last Update Posted : April 14, 2016
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
Condition West Nile Fever
Interventions Biological: ChimeriVax-WN02 Low Dose
Biological: ChimeriVax-WN02 Medium Dose
Biological: ChimeriVax-WN02 High Dose
Biological: 0.9% Saline solution
Biological: 0.9 % NaCl solution
Enrollment 208
Recruitment Details Participants were enrolled from 09 December 2005 to 27 March 2006 in 5 clinical centers in the US.
Pre-assignment Details A total of 208 participants (Part 1 = 112; Part 2 = 96) who met the inclusion and exclusion criteria were enrolled, randomized, and vaccinated in the study. Report on Part 1 and Part 2 participants with valid data are presented in this report.
Arm/Group Title Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2)
Hide Arm/Group Description Participants in Part 1 of the study who received a single dose of saline on Day 0 Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0 Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0 Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0 Participants in Part 2 of the study who received a placebo vaccine on Day 0 Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Period Title: Part 1
Started 17 24 40 31 0 [1] 0 [1]
Completed 17 24 40 31 0 0
Not Completed 0 0 0 0 0 0
[1]
Participants in Part 2 are not the same as those in Part 1
Period Title: Part 2
Started 0 [1] 0 [1] 0 [1] 0 [1] 25 57
Completed 0 0 0 0 25 57
Not Completed 0 0 0 0 0 0
[1]
Participants in Part 1 are not the same as those in Part 2
Arm/Group Title Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2) Total
Hide Arm/Group Description Participants in Part 1 of the study who received a single dose of saline on Day 0 Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0 Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0 Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0 Participants in Part 2 of the study who received a placebo vaccine on Day 0 Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0 Total of all reporting groups
Overall Number of Baseline Participants 17 24 40 31 25 57 194
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 24 participants 40 participants 31 participants 25 participants 57 participants 194 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
24
 100.0%
40
 100.0%
31
 100.0%
11
  44.0%
29
  50.9%
152
  78.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
14
  56.0%
28
  49.1%
42
  21.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 24 participants 40 participants 31 participants 25 participants 57 participants 194 participants
26.6  (6.41) 25.4  (5.62) 25  (5.43) 25.1  (6.47) 61.4  (11.8) 61.0  (11.3) 25.7  (6.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 24 participants 40 participants 31 participants 25 participants 57 participants 194 participants
Female
8
  47.1%
12
  50.0%
19
  47.5%
13
  41.9%
22
  88.0%
40
  70.2%
114
  58.8%
Male
9
  52.9%
12
  50.0%
21
  52.5%
18
  58.1%
3
  12.0%
17
  29.8%
80
  41.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 24 participants 40 participants 31 participants 25 participants 57 participants 194 participants
17 24 40 31 25 57 194
1.Primary Outcome
Title Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion).
Hide Description Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population
Arm/Group Title Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2)
Hide Arm/Group Description:
Participants in Part 1 of the study who received a single dose of saline on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Participants in Part 2 of the study who received a placebo vaccine on Day 0
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Overall Number of Participants Analyzed 17 21 37 28 25 55
Measure Type: Number
Unit of Measure: Participants
0 21 36 27 0 53
2.Primary Outcome
Title Number of Viremic Participants Post-vaccination
Hide Description Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Viremia was assessed in all participants in the safety population according to the vaccine actually received.
Arm/Group Title Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2)
Hide Arm/Group Description:
Participants in Part 1 of the study who received a single dose of saline on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Participants in Part 2 of the study who received a placebo vaccine on Day 0
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Overall Number of Participants Analyzed 17 24 40 31 32 64
Measure Type: Number
Unit of Measure: Participants
2 22 36 29 1 55
3.Primary Outcome
Title Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Hide Description [Not Specified]
Time Frame Days 0 to 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants according to the vaccine actually received, safety population.
Arm/Group Title Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2)
Hide Arm/Group Description:
Participants in Part 1 of the study who received a single dose of saline on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Participants in Part 2 of the study who received a placebo vaccine on Day 0
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Overall Number of Participants Analyzed 17 24 40 31 32 64
Measure Type: Number
Unit of Measure: Participants
Fatigue 4 1 8 2 5 11
Headache 5 4 5 2 5 11
Malaise 2 1 3 2 3 10
Feeling Hot 0 1 1 2 5 11
Myalgia 3 1 3 1 5 13
Arthralgia 0 1 1 0 3 8
Nausea 1 1 2 1 2 5
Somnolence 1 1 2 1 0 5
Diarrhoea 0 1 1 0 1 3
Chills 1 1 1 1 0 4
Dizziness 0 0 1 0 1 2
Musculoskeletal stiffness 0 1 1 0 5 4
Injection site pain 2 0 1 0 5 4
Pharyngolaryngeal pain 2 0 2 1 2 4
Injection site erythema NA [1]  NA [1]  NA [1]  NA [1]  6 9
Injection site induration NA [1]  NA [1]  NA [1]  NA [1]  6 4
[1]
Not collected in Part 1
4.Secondary Outcome
Title Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.
Hide Description [Not Specified]
Time Frame Days 0, 14, and 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed according to the vaccine actually received, in the As treat per-protocol population.
Arm/Group Title Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2)
Hide Arm/Group Description:
Participants in Part 1 of the study who received a single dose of saline on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Participants in Part 2 of the study who received a placebo vaccine on Day 0
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Overall Number of Participants Analyzed 17 21 37 28 32 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 0
5.0
(5.0 to 5.0)
5.0
(5.0 to 5.0)
5.0
(5.0 to 5.0)
5.0
(5.0 to 5.0)
5.0
(5.0 to 5.0)
5
(5.0 to 5.0)
Day 14
5.0
(5.0 to 5.0)
16.8
(7.2 to 39.5)
35.7
(18.3 to 69.7)
26.9
(11.8 to 61.5)
5.0
(5.0 to 5.0)
19.2
(11.9 to 31.2)
Day 28
5.0
(5.0 to 5.0)
1367.3
(711.3 to 2628.5)
2331.1
(1193.3 to 4554.3)
3309.3
(1726.9 to 6341.7)
5.0
(5.0 to 5.0)
922.4
(519.2 to 1638.5)
5.Other Pre-specified Outcome
Title Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population
Hide Description [Not Specified]
Time Frame Days 14 and 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunoglobulin M (IgM) response was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population
Arm/Group Title Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2)
Hide Arm/Group Description:
Participants in Part 1 of the study who received a single dose of saline on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Participants in Part 2 of the study who received a placebo vaccine on Day 0
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
Overall Number of Participants Analyzed 17 21 37 28 25 56
Measure Type: Number
Unit of Measure: Participants
IgM Positive at Day 14 0 5 22 10 0 26
IgM Positive at Day 28 0 20 36 27 0 53
Time Frame Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2)
Hide Arm/Group Description Participants in Part 1 of the study who received a single dose of saline on Day 0 Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0 Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0 Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0 Participants in Part 2 of the study who received a placebo vaccine on Day 0 Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
All-Cause Mortality
Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/24 (0.00%)      0/40 (0.00%)      1/31 (3.23%)      0/32 (0.00%)      3/64 (4.69%)    
Gastrointestinal disorders             
Abdominal hernia obstructive * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 1/64 (1.56%)  1
Hepatobiliary disorders             
Cholecystitis acute * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 1/64 (1.56%)  1
Infections and infestations             
Cellulitis * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 1/31 (3.23%)  1 0/32 (0.00%)  0 0/64 (0.00%)  0
Pneumonia primary atypical * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 1/64 (1.56%)  1
Gastroenteritis * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 1/64 (1.56%)  1
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive plumonary disease * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 1/64 (1.56%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Part 1) WN02 Low Dose (Part 1) WN02 Medium Dose (Part 1) WN02 High Dose (Part 1) Placebo (Part 2) WNO2 High Dose (Part 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/17 (82.35%)      16/24 (66.67%)      28/40 (70.00%)      22/31 (70.97%)      25/32 (78.13%)      54/64 (84.38%)    
Gastrointestinal disorders             
Diarrhoea * 1  0/17 (0.00%)  0 4/24 (16.67%)  4 2/40 (5.00%)  2 2/31 (6.45%)  2 3/32 (9.38%)  3 7/64 (10.94%)  7
Nausea * 1  1/17 (5.88%)  1 2/24 (8.33%)  2 4/40 (10.00%)  4 3/31 (9.68%)  3 2/32 (6.25%)  2 7/64 (10.94%)  7
Abdominal pain * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 1/31 (3.23%)  1 0/32 (0.00%)  0 4/64 (6.25%)  4
General disorders             
Chills * 1  1/17 (5.88%)  1 1/24 (4.17%)  1 3/40 (7.50%)  3 2/31 (6.45%)  2 0/32 (0.00%)  0 5/64 (7.81%)  5
Fatigue * 1  4/17 (23.53%)  4 2/24 (8.33%)  2 11/40 (27.50%)  11 4/31 (12.90%)  4 7/32 (21.88%)  7 14/64 (21.88%)  14
Feeling Hot * 1  0/17 (0.00%)  0 1/24 (4.17%)  1 4/40 (10.00%)  4 3/31 (9.68%)  3 1/32 (3.13%)  1 5/64 (7.81%)  5
Malaise * 1  3/17 (17.65%)  3 1/24 (4.17%)  1 7/40 (17.50%)  7 4/31 (12.90%)  4 6/32 (18.75%)  6 14/64 (21.88%)  14
Injection site erythema * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 0/31 (0.00%)  0 6/32 (18.75%)  6 9/64 (14.06%)  9
Injection site induration * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 0/31 (0.00%)  0 6/32 (18.75%)  6 4/64 (6.25%)  4
Injection site pain * 1  2/17 (11.76%)  2 0/24 (0.00%)  0 1/40 (2.50%)  1 0/31 (0.00%)  0 5/32 (15.63%)  5 4/64 (6.25%)  4
Infections and infestations             
Upper Respiratory Tract Infection * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 4/40 (10.00%)  4 1/31 (3.23%)  1 0/32 (0.00%)  0 1/64 (1.56%)  1
Investigations             
Alanine Aminotransferase Increased * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 3/40 (7.50%)  3 1/31 (3.23%)  1 0/32 (0.00%)  0 2/64 (3.13%)  2
Blood Creatine Phosphokinase Increased * 1  3/17 (17.65%)  3 3/24 (12.50%)  3 0/40 (0.00%)  0 3/31 (9.68%)  3 0/32 (0.00%)  0 1/64 (1.56%)  1
White Blood Cell Count Decreased * 1  1/17 (5.88%)  1 3/24 (12.50%)  3 3/40 (7.50%)  3 4/31 (12.90%)  5 1/32 (3.13%)  1 2/64 (3.13%)  2
White Blood Cell Count Increased * 1  1/17 (5.88%)  1 0/24 (0.00%)  0 3/40 (7.50%)  3 0/31 (0.00%)  0 0/32 (0.00%)  0 2/64 (3.13%)  2
Musculoskeletal and connective tissue disorders             
Arthralgia * 1  0/17 (0.00%)  0 1/24 (4.17%)  1 3/40 (7.50%)  5 1/31 (3.23%)  1 5/32 (15.63%)  5 11/64 (17.19%)  11
Back Pain * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 2/31 (6.45%)  2 4/32 (12.50%)  4 3/64 (4.69%)  3
Musculoskeletal Stiffness * 1  1/17 (5.88%)  1 2/24 (8.33%)  2 2/40 (5.00%)  2 0/31 (0.00%)  0 5/32 (15.63%)  5 8/64 (12.50%)  8
Myalgia * 1  3/17 (17.65%)  3 2/24 (8.33%)  2 6/40 (15.00%)  6 1/31 (3.23%)  1 5/32 (15.63%)  5 19/64 (29.69%)  19
Pain in Extremity * 1  1/17 (5.88%)  1 0/24 (0.00%)  0 2/40 (5.00%)  2 2/31 (6.45%)  2 1/32 (3.13%)  1 1/64 (1.56%)  1
Neck pain * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 1/40 (2.50%)  1 0/31 (0.00%)  0 0/32 (0.00%)  0 4/64 (6.25%)  4
Nervous system disorders             
Dizziness * 1  0/17 (0.00%)  0 2/24 (8.33%)  3 4/40 (10.00%)  4 0/31 (0.00%)  0 1/32 (3.13%)  1 5/64 (7.81%)  5
Headache * 1  7/17 (41.18%)  17 9/24 (37.50%)  9 14/40 (35.00%)  14 8/31 (25.81%)  8 9/32 (28.13%)  9 18/64 (28.13%)  18
Somnolence * 1  1/17 (5.88%)  1 1/24 (4.17%)  1 2/40 (5.00%)  2 3/31 (9.68%)  3 2/32 (6.25%)  2 6/64 (9.38%)  6
Psychiatric disorders             
Anxiety * 1  0/17 (0.00%)  0 1/24 (4.17%)  1 1/40 (2.50%)  1 0/31 (0.00%)  0 1/32 (3.13%)  1 5/64 (7.81%)  5
Insomnia * 1  1/17 (5.88%)  1 0/24 (0.00%)  0 1/40 (2.50%)  1 0/31 (0.00%)  0 1/32 (3.13%)  1 5/64 (7.81%)  5
Respiratory, thoracic and mediastinal disorders             
Dyspnoea * 1  0/17 (0.00%)  0 1/24 (4.17%)  1 0/40 (0.00%)  0 2/31 (6.45%)  2 1/32 (3.13%)  1 2/64 (3.13%)  2
Nasal Congestion * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 1/40 (2.50%)  1 3/31 (9.68%)  3 2/32 (6.25%)  2 1/64 (1.56%)  1
Pharyngolaryngeal Pain * 1  3/17 (17.65%)  3 2/24 (8.33%)  2 4/40 (10.00%)  4 3/31 (9.68%)  3 4/32 (12.50%)  4 5/64 (7.81%)  5
Skin and subcutaneous tissue disorders             
Photosensitivity reaction * 1  0/17 (0.00%)  0 0/24 (0.00%)  0 0/40 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 4/64 (6.25%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.1
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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00442169     History of Changes
Other Study ID Numbers: H-244-003
First Submitted: February 27, 2007
First Posted: March 1, 2007
Results First Submitted: January 21, 2011
Results First Posted: February 14, 2011
Last Update Posted: April 14, 2016