TerminatedNCT00613509Updated Apr 14, 2016Results posted

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

A Phase 2 interventional study of ALVAC(2) Melanoma multi-antigen therapeutic vaccine and Intron A, Interferon alpha -2b in Melanoma and Cancer, sponsored by Sanofi Pasteur, a Sanofi Company. Terminated at 19 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-14.

Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 2, Interventional, and Treatment

Why this study was terminated

No safety concerns, the study was terminated due to slow enrollment. All enrolled patients were followed per protocol.

Phase: Phase 2
Study type: Interventional
Enrollment: 23
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Primary objective:

To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment.

Secondary objectives:

Safety: To describe the safety profile in both treatment groups.

Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response.

Read the detailed description

Eligible participants will be randomized to receive either a vaccine treatment consisting of a series of multi-antigen melanoma vaccine and GM-CSF injections, followed by high-dose IFN-α2b or only the high-dose IFN-α2b.

Conditions studied

Melanoma
Cancer

Browse trials for

Keywords

Melanoma, Cancer

In context

Melanoma

3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.

This study's enrollment of 23 is below the median of 38 across 2,400 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

First submitted after Sanofi Pasteur became part of Sanofi.

Browse Sanofi Pasteur studies →All Sanofi studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

A pathologically confirmed diagnosis of malignant melanoma with at least one measurable metastatic lesion with a minimum lesion size of 20 mm, based on radiological assessment (or 10 mm if assessed by spiral computed tomography [CT] scan ) as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Stages IIIc, IVa, or IVb only, according to the American Joint Committee on Cancer (AJCC) staging system for melanoma). Cutaneous metastasis (assessed by physical examination) must be at least 10 mm. CT scan or magnetic resonance imaging (MRI) is required to rule out brain metastases.
Patients who received prior treatment for their metastatic disease must have objective evidence of disease progression.
Aged ≥ 18 years on the day of inclusion
IRB-approved informed consent form signed
Able to attend all scheduled visits and to comply with all trial procedures
For a woman, inability to bear a child or negative serum pregnancy test
For a woman of child-bearing potential, using an effective method of contraception or abstinence during the study and at least 4 weeks after the last study treatment
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
Adequate hematologic, hepatic, and renal function (at pre-defined laboratory values).
Fully recovered from surgery, if applicable.

Exclusion criteria

Exclusion Criteria :

Receipt of two or more previous therapies for metastatic melanoma.
Receipt of chemotherapy or another therapy for metastatic melanoma within the last four weeks
Receipt of adjuvant interferon therapy within the last six months
Concurrent receipt of radiotherapy for the metastatic disease, unless for palliative purposes
Participation in another clinical trial within the four weeks preceding the first trial treatment
Planned participation in another clinical trial during the present trial period
Known Human Immunodeficiency Virus (HIV) infection or hepatitis B (Ag HBs) or hepatitis C seropositivity
Presence of active autoimmune disease (excluding vitiligo)
Systemic hypersensitivity to bovine products or to any of the vaccine components, including egg products or Neomycin (used to prepare the vaccine), or history of a life-threatening reaction to granulocyte-macrophage colony stimulating factor (GM-CSF) or interferon (IFN)-α2b
Current alcohol or drug addiction that may interfere with the ability to comply with trial procedures
Significant co-morbid medical conditions, including pre-existing renal disease, cirrhosis, or major depression, which in the estimation of the investigator would preclude safe participation in the study or the accurate interpretation of data.
A calculated glomerular filtration rate (GFR) \<60 mL/min (based on the Cockroft-Gault formula).
Previous receipt of a modified canarypox virus (ALVAC)-based vaccine.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 23 participants (actual)

Study arms

Experimental
Study Group 1: ALVAC melanoma vaccine
Participants will receive a multi-antigen of modified canarypox virus (ALVAC\[2\]) melanoma vaccine and granulocyte macrophage colony stimulating factor (GM-CSF) every 3 weeks, followed by 4 weeks of high-dose interferon alpha-2b 5 times per week.
Biological: ALVAC(2) Melanoma multi-antigen therapeutic vaccine
Active comparator
Study Group 2: Interferon alpha-2b
Participants on 4 weeks of high-dose interferon alpha-2b 5 times per week. Participants who showed disease progression after Cycle 1 will be permitted to cross over to Group 1 treatment.
Biological: Intron A, Interferon alpha -2b

Interventions

BiologicalALVAC(2) Melanoma multi-antigen therapeutic vaccine
0.5 mL, 2 cycles
BiologicalIntron A, Interferon alpha -2b
0.5 mL, 5 times per week for 4 weeks
Also known as: Intron-A®: IFN-α2b

What researchers measure

Primary outcomes

Summary of Disease Progression in Study Participants, Intent-to-treat Population
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
Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population
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

Secondary outcomes

Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
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
Best Overall Objective Response in the Intent-to-treat Population
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
Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population
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
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
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

Other outcomes

Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
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
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
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
Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)
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

Results

Posted Dec 17, 2010

Participant flow

Participants were enrolled from 20 May 2008 to 31 March 2009 at 8 medical centers in the US and 3 medical centers in Canada.

Cycle 1

Participant flow — Cycle 1
Milestone	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
Started	11	12
Completed	6	4
Not completed	5	8
Withdrew: Adverse event	2	1
Withdrew: Disease progression	2	6
Withdrew: Unacceptable toxicity	1	0
Withdrew: Other administrative reason	0	1

Cycle 2 (Group 2 = Crossover)

Participant flow — Cycle 2 (Group 2 = Crossover)
Milestone	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
Started	11	4
Completed	11	4
Not completed	0	0

Outcome measures

Other pre-specifiedNumber of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen

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
Reported as:: Number · Participants

Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Participants	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
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

Other pre-specifiedNumber of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen

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
Reported as:: Number · Participants

Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Participants	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
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

SecondaryBest Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population

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
Reported as:: Number · Particpants

Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
Particpants	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
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

SecondaryBest Overall Objective Response in the Intent-to-treat Population

Time frame:: Day 0 to 32 weeks post 1st vaccination or treatment
Reported as:: Number · Percentage of participants

Best Overall Objective Response in the Intent-to-treat Population
Percentage of participants	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
Best Overall Objective Response in the Intent-to-treat Population	18.2	9.1

PrimarySummary of Disease Progression in Study Participants, Intent-to-treat Population

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
Reported as:: Number · Participants

Summary of Disease Progression in Study Participants, Intent-to-treat Population
Participants	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
Progressed or died due to any cause	7	6
Did not progress or die due to any cause	4	6

Other pre-specifiedSummary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)

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
Reported as:: Mean · Percent Cell Count

Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)
Percent Cell Count	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
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

PrimaryProgression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population

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
Reported as:: Median · Weeks

Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population
Weeks	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population	15.9 (8.0 to NA)	8.9 (8.3 to NA)

Statistical analysis

Study Group 1: ALVAC Melanoma Vaccine vs Study Group 2: Interferon Alpha-2b · Log Rank · p = 0.9406
Study Group 1: ALVAC Melanoma Vaccine vs Study Group 2: Interferon Alpha-2b · Likelihood ratio test · p = 0.9179

SecondaryBest Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population

Time frame:: Day 0 to 32 weeks post 1st vaccination or treatment
Reported as:: Mean · Weeks

Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population
Weeks	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population	16.3 (6.4 to 26.1)	18.3 (18.3 to 18.3)

SecondaryNumber of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term

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
Reported as:: Number · Participants

Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Participants	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
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

Adverse events

Collected over Adverse events data were collected from the day of vaccination for 12 months post-vaccination. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Study Group 1: ALVAC Melanoma Vaccine	—	5/11 (45.5%)	5/11 (45.5%)
Study Group 2: Interferon Alpha-2b	—	5/12 (41.7%)	7/12 (58.3%)

Most frequent serious events

Most frequent serious events
Event	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
Disease ProgressionGeneral disorders	2/11	2/12
Metastatic Malignant MelanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/11	0/12
Chest PainGeneral disorders	1/11	1/12
SepsisInfections and infestations	1/11	0/12
Gastrointestinal PerforationGastrointestinal disorders	0/11	1/12
Septic ShockInfections and infestations	0/11	1/12
PneumoniaInfections and infestations	0/11	1/12

Most frequent other events

Showing 10 of 28

Most frequent other events
Event	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b
ALT IncreasedInvestigations	0/11	3/12
LeukocytosisBlood and lymphatic system disorders	1/11	0/12
Abdominal Pain UpperGastrointestinal disorders	1/11	0/12
Axillary PainGeneral disorders	1/11	0/12
Chest DiscomfortGeneral disorders	1/11	0/12
InflammationGeneral disorders	1/11	0/12
GGT IncreasedInvestigations	1/11	1/12
Neutrophil Count DecreasedInvestigations	1/11	0/12
White Blood Cell Count DecreasedInvestigations	1/11	0/12
HypernatremiaMetabolism and nutrition disorders	1/11	0/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b	Total
<=18 years	0	0	0
Between 18 and 65 years	9	10	19
>=65 years	2	2	4

Age, Continuous
Age, Continuous(Years)	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b	Total
Mean	52.6 ± 14.23	52.9 ± 14.34	52.8 ± 14.3

Sex: Female, Male
Sex: Female, Male(Participants)	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b	Total
Female	6	5	11
Male	5	7	12

Region of Enrollment
Region of Enrollment(participants)	Study Group 1: ALVAC Melanoma Vaccine	Study Group 2: Interferon Alpha-2b	Total
United States	9	10	19
Canada	2	2	4

Study locations

19 sites

Tucson, Arizona 85724, United States
Los Angeles, California 90024, United States
Aurora, Colorado 80045, United States
Atlanta, Georgia 30322, United States
Chicago, Illinois 60611, United States
St Louis, Missouri 63110, United States
Omaha, Nebraska 68198, United States
Lebanon, New Hampshire 03756, United States
Portland, Oregon 97213, United States
Bethlehem, Pennsylvania 18015, United States
Pittsburgh, Pennsylvania 15232, United States
Greenville, South Carolina 29605, United States
Dallas, Texas 75246, United States
San Antonio, Texas 78229, United States
Madison, Wisconsin 53792, United States
Hamilton, Ontario L8V 5C2, Canada
London, Ontario, Canada
Toronto, Ontario M4N 3M5, Canada
Montreal, Quebec H3A 1A1, Canada

References and documents

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2008, a primary completion of Apr 2010 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2010, 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 16, 2008
First posted: Feb 13, 2008
Start: Jun 2008
Primary completionActual: Apr 2010
CompletionActual: Jun 2010
Results first posted: Dec 17, 2010
Last update: Apr 14, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00613509
Lead sponsor: Sanofi Pasteur, a Sanofi Company
Responsible party: Sponsor
First posted: Feb 13, 2008
Start date: Jun 2008
Primary completion: Apr 2010
Completion: Jun 2010
Results posted: Dec 17, 2010
Last update: Apr 14, 2016

Study contacts

Medical Director

study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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