Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    MEL11
Previous Study | Return to List | Next Study

Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma

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: NCT00613509
Recruitment Status : Terminated (No safety concerns, the study was terminated due to slow enrollment. All enrolled patients were followed per protocol.)
First Posted : February 13, 2008
Results First Posted : December 17, 2010
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: None (Open Label);   Primary Purpose: Treatment
Conditions Melanoma
Cancer
Interventions Biological: ALVAC(2) Melanoma multi-antigen therapeutic vaccine
Biological: Intron A, Interferon alpha -2b
Enrollment 23
Recruitment Details Participants were enrolled from 20 May 2008 to 31 March 2009 at 8 medical centers in the US and 3 medical centers in Canada.
Pre-assignment Details A total of 23 participants who met the inclusion and exclusion criteria were enrolled and treated.
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment) Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
Period Title: Cycle 1
Started 11 12
Completed 6 [1] 4 [2]
Not Completed 5 8
Reason Not Completed
Adverse Event             2             1
Disease Progression             2             6
Unacceptable Toxicity             1             0
Other administrative reason             0             1
[1]
Completion of Cycle 1. 9 participants were deemed evaluable
[2]
Completion of Cycle 1. 12 participants were deemed evaluable
Period Title: Cycle 2 (Group 2 = Crossover)
Started 11 4
Completed 11 4
Not Completed 0 0
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b Total
Hide Arm/Group Description Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment) Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment) Total of all reporting groups
Overall Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  81.8%
10
  83.3%
19
  82.6%
>=65 years
2
  18.2%
2
  16.7%
4
  17.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 23 participants
52.6  (14.23) 52.9  (14.34) 52.8  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Female
6
  54.5%
5
  41.7%
11
  47.8%
Male
5
  45.5%
7
  58.3%
12
  52.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
United States 9 10 19
Canada 2 2 4
1.Primary Outcome
Title Summary of Disease Progression in Study Participants, Intent-to-treat Population
Hide Description Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination).
Time Frame Day 0 up to 35 weeks post 1st vaccination or treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description:
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
Overall Number of Participants Analyzed 11 12
Measure Type: Number
Unit of Measure: Participants
Progressed or died due to any cause 7 6
Did not progress or die due to any cause 4 6
2.Primary Outcome
Title Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population
Hide Description Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol
Time Frame Day 0 - up to 35 weeks post 1st vaccination or treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description:
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
Overall Number of Participants Analyzed 11 12
Median (Inter-Quartile Range)
Unit of Measure: Weeks
15.9 [1] 
(8.0 to NA)
8.9 [1] 
(8.3 to NA)
[1]
NA: Upper limit not estimated because of insufficient observations above the median
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group 1: ALVAC Melanoma Vaccine, Study Group 2: Interferon Alpha-2b
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9406
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Study Group 1: ALVAC Melanoma Vaccine, Study Group 2: Interferon Alpha-2b
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9179
Comments [Not Specified]
Method Likelihood ratio test
Comments [Not Specified]
3.Secondary Outcome
Title Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
Hide Description Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Time Frame Day 0 to 32 weeks post 1st vaccination or treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The best overall objective response as number of participants responding was assessed in the intent-to-treat (ITT) evaluable population.
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description:
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
Overall Number of Participants Analyzed 11 12
Measure Type: Number
Unit of Measure: Particpants
Participants with measurable disease at baseline 11 11
Complete Response (CR) 0 0
Partial Response (PR) 2 1
Stable Disease (SD) 3 3
Not Evaluable (NE) 0 1
Progression (PD) 6 6
4.Secondary Outcome
Title Best Overall Objective Response in the Intent-to-treat Population
Hide Description Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Time Frame Day 0 to 32 weeks post 1st vaccination or treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The best overall objective response were assessed in the intent-to-treat (ITT) evaluable population.
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description:
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
Overall Number of Participants Analyzed 11 12
Measure Type: Number
Unit of Measure: Percentage of participants
18.2 9.1
5.Secondary Outcome
Title Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population
Hide Description Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Time Frame Day 0 to 32 weeks post 1st vaccination or treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The best overall objective response as mean duration of response were assessed in the intent-to-treat (ITT) evaluable population.
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description:
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
Overall Number of Participants Analyzed 11 12
Mean (Full Range)
Unit of Measure: Weeks
16.3
(6.4 to 26.1)
18.3
(18.3 to 18.3)
6.Secondary Outcome
Title Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Hide Description

Common Terminology Criteria for Adverse Events (CTCAE) definitions:

Grade 3 is a severe adverse event; Grade 4 is a life-threatening or disabling adverse event.

Time Frame Day 0 to 12 months post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety assessments were conducted in the As-treated safety population.
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description:
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
Overall Number of Participants Analyzed 11 12
Measure Type: Number
Unit of Measure: Participants
Anemia 0 1
Leukocytosis 1 0
Abdominal Pain Upper 1 0
Axillary Pain 1 0
Chest Discomfort 1 0
Chest Pain 1 0
Inflammation 1 0
Pyrexia 0 1
Sepsis 1 0
Septic Shock 0 1
Staphylococcal Bacteremia 0 1
Alanine Aminotransferase (ALT) Increased 0 3
Aspartate Aminotransferase (AST) Increased 0 1
Gamma-Glutamyl Transferase (GGT) Increased 1 1
Neutrophil Count Decreased 1 0
White Blood Cell Count Decreased 1 0
Hypernatremia 1 0
Hypoalbuminemia 0 1
Hypocalcemia 0 1
Hyponatremia 0 1
Joint Range of Motion Decreased 1 0
Metastatic Malignant Melanoma 0 1
Brain Edema 1 0
Cerebral Hemorrhage 1 0
Encephalopathy 1 0
Headache 1 0
Hemiplegia 1 0
Paraesthesia 0 1
Peripheral Sensory Neuropathy 0 1
Syncope Vasovagal 0 1
Polyuria 1 0
Hypotension 1 0
7.Other Pre-specified Outcome
Title Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Hide Description The vaccine-induced increase of CD8 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.
Time Frame Day 0 to 32 weeks post 1st vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunologic responses were assessed in the Per-protocol evaluable population.
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description:
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
Overall Number of Participants Analyzed 9 12
Measure Type: Number
Unit of Measure: Participants
Screening: gp100 pool1 0 0
Screening: gp100 pool2 0 0
Screening: gp100 pool3 0 0
Screening: gp100 pool4 0 0
Screening: gp100 pool5 0 0
Screening: gp100 pool6 0 0
Screening: NYESO-1 pool 1 0 0
Screening: NYESO-1 pool 2 0 0
Screening: Mart1 pool 0 0
Screening: Native 15mer pool 0 0
Screening: 9mer pool 0 0
7 Weeks post 1st Vaccination: gp100 pool1 0 0
7 Weeks post 1st Vaccination: gp100 pool2 0 0
7 Weeks post 1st Vaccination: gp100 pool3 0 0
7 Weeks post 1st Vaccination: gp100 pool4 0 0
7 Weeks post 1st Vaccination: gp100 pool5 1 0
7 Weeks post 1st Vaccination: gp100 pool6 0 0
7 Weeks post 1st Vaccination: NYESO-1 pool 1 0 0
7 Weeks post 1st Vaccination: NYESO-1 pool 2 0 0
7 Weeks post 1st Vaccination: Mart1 pool 0 0
7 Weeks post 1st Vaccination: Native 15mer pool 0 0
7 Weeks post 1st Vaccination: 9mer pool 0 0
8.Other Pre-specified Outcome
Title Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Hide Description The Vaccine-induced increase of CD4 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.
Time Frame Day 0 to 32 weeks post 1st vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunologic responses were assessed in the Per-protocol evaluable population.
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description:
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
Overall Number of Participants Analyzed 9 12
Measure Type: Number
Unit of Measure: Participants
Screening: gp100 pool1 0 0
Screening: gp100 pool2 0 0
Screening: gp100 pool3 0 0
Screening: gp100 pool4 0 0
Screening: gp100 pool5 0 0
Screening: gp100 pool6 0 0
Screening: NYESO-1 pool 1 0 0
Screening: NYESO-1 pool 2 0 0
Screening: Mart1 pool 0 0
Screening: Native 15mer pool 0 0
Screening: 9mer pool 0 0
7 Weeks post 1st Vaccination: gp100 pool1 0 1
7 Weeks post 1st Vaccination: gp100 pool2 0 0
7 Weeks post 1st Vaccination: gp100 pool3 0 0
7 Weeks post 1st Vaccination: gp100 pool4 0 0
7 Weeks post 1st Vaccination: gp100 pool5 1 0
7 Weeks post 1st Vaccination: gp100 pool6 0 0
7 Weeks post 1st Vaccination: NYESO-1 pool 1 0 0
7 Weeks post 1st Vaccination: NYESO-1 pool 2 0 0
7 Weeks post 1st Vaccination: Mart1 pool 0 0
7 Weeks post 1st Vaccination: Native 15mer pool 0 0
7 Weeks post 1st Vaccination: 9mer pool 0 0
9.Other Pre-specified Outcome
Title Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)
Hide Description The immunogenicity of the treatment regimens was assessed by regulatory T-cell responses as assessed primarily by the multi-parametric intracellular cytokine staining (ICS) assay.
Time Frame Day 0 to 32 weeks post 1st vaccination or treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Immunologic responses were assessed in the per-protocol evaluable population.
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description:
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
Overall Number of Participants Analyzed 9 12
Mean (Standard Deviation)
Unit of Measure: Percent Cell Count
Screening 2.7  (1.02) 3.4  (1.24)
Cycle 1 Week 1 3.3  (1.42) 2.3  (0.65)
Cycle 1 Week 7 2.9  (0.83) 3.1  (1.13)
Cycle 2 Week 23 3.3  (0.90) 3.8  (0.51)
Cycle 2 Week 32 4.0  (0.48) 2.6  (0.07)
Time Frame Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Adverse Event Reporting Description Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
 
Arm/Group Title Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Hide Arm/Group Description Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment) Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
All-Cause Mortality
Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/11 (45.45%)      5/12 (41.67%)    
Gastrointestinal disorders     
Gastrointestinal Perforation * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
General disorders     
Disease Progression * 1  2/11 (18.18%)  2 2/12 (16.67%)  2
Chest Pain * 1  1/11 (9.09%)  1 1/12 (8.33%)  1
Infections and infestations     
Sepsis * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Septic Shock * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Pneumonia * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic Malignant Melanoma * 1  2/11 (18.18%)  2 0/12 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Study Group 1: ALVAC Melanoma Vaccine Study Group 2: Interferon Alpha-2b
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/11 (45.45%)      7/12 (58.33%)    
Blood and lymphatic system disorders     
Anemia * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Leukocytosis * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain Upper * 1  1/11 (9.09%)  2 0/12 (0.00%)  0
General disorders     
Axillary Pain * 1  1/11 (9.09%)  2 0/12 (0.00%)  0
Chest Discomfort * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Inflammation * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Pyrexia * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations     
Staphylococcal Bacteremia * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Investigations     
ALT Increased * 1  0/11 (0.00%)  0 3/12 (25.00%)  3
AST Increased * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
GGT Increased * 1  1/11 (9.09%)  1 1/12 (8.33%)  1
Neutrophil Count Decreased * 1  1/11 (9.09%)  3 0/12 (0.00%)  0
White Blood Cell Count Decreased * 1  1/11 (9.09%)  3 0/12 (0.00%)  0
Metabolism and nutrition disorders     
Hypernatremia * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Hypoalbuminemia * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Hypocalcemia * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Hyponatremia * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders     
Joint Range of Motion Decreased * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Nervous system disorders     
Brain Edema * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Cerebral Hemorrhage * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Encephalopathy * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Headache * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Hemiplegia * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Paraesthesia * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Peripheral Sensory Neuropathy * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Syncope Vasovagal * 1  0/11 (0.00%)  0 1/12 (8.33%)  1
Renal and urinary disorders     
Polyuria * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
Vascular disorders     
Hypotension * 1  1/11 (9.09%)  1 0/12 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
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: NCT00613509     History of Changes
Other Study ID Numbers: MEL11
First Submitted: January 16, 2008
First Posted: February 13, 2008
Results First Submitted: September 14, 2010
Results First Posted: December 17, 2010
Last Update Posted: April 14, 2016