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Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

Sponsor
Sanofi (Industry)
Overall Status
Terminated
CT.gov ID
NCT00976027
Collaborator
(none)
9,172
Enrollment
98
Locations
2
Arms
31
Duration (Months)
93.6
Patients Per Site
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly.

Primary objective:

To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations.

Secondary objectives:

  • To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus.

  • To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.

Condition or Disease Intervention/Treatment Phase
  • Biological: Trivalent inactivated influenza vaccine High Dose
  • Biological: Trivalent inactivated influenza vaccine
 Phase 3

Detailed Description

The occurrence of influenza-like illness (ILI) will be determined in elderly participants vaccinated with either Fluzone High Dose or Fluzone® vaccine.

The presence of influenza virus in the respiratory tract of vaccinated individuals with ILI will be confirmed by two methods.

Study Design

Study Type:
Interventional
Actual Enrollment :
9172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fluzone® High Dose Group

Biological: Trivalent inactivated influenza vaccine High Dose
0.5 mL, Intramuscular
Other Names:
  • Fluzone® High Dose

    		•
    Active Comparator: Fluzone® Group

    Biological: Trivalent inactivated influenza vaccine
    0.5 mL, Intramuscular
    Other Names:
  • Fluzone®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations. [Day 0 (pre-vaccination) up to Year 1 post-vaccination]

      The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.

    Other Outcome Measures

    1. Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) [Day 0 (pre-vaccination) up to the end of the influenza season]

      Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).

    2. Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) [Day 14 (post-vaccination) up to 12 Months post-vaccination]

      Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).

    3. Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone [Day 0 before vaccination to Day 180 after vaccination]

      Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria :

    • Aged ≥ 65 years on the day of vaccination

    • Informed consent form signed and dated.

    • Able to attend all scheduled visits and to comply with all trial procedures.

    Exclusion Criteria :

    • Participation in another interventional clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure in the 4 weeks preceding the trial vaccination or planned participation in another clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure during each year of participation in the study trial.

    • Vaccination against influenza in the 6 months preceding the trial vaccination.

    • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or to a vaccine containing any of the same substances.

    • Personal history of Guillain-Barré syndrome.

    • Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures.

    • Thrombocytopenia, bleeding disorder, or anticoagulation therapy contraindicating intramuscular (IM) vaccination.

    • Known or suspected human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C seropositivity.

    • Alcohol abuse or drug addiction that could interfere with the subject's ability to comply with trial procedures.

    • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

    • Bedridden subjects.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35209
    2 Glendale Arizona United States 85308
    3 Mesa Arizona United States 85203
    4 Phoenix Arizona United States 85028
    5 Phoenix Arizona United States 85050
    6 Scottsdale Arizona United States 85251
    7 Tempe Arizona United States 85283
    8 Fountain Valley California United States 92708
    9 Los Angeles California United States 90057
    10 Oceanside California United States 92056
    11 Sacramento California United States 95831
    12 Santa Rosa California United States 95405
    13 Aurora Colorado United States 80045
    14 Colorado Springs Colorado United States 80907
    15 Colorado Springs Colorado United States 80909
    16 Milford Connecticut United States 06460
    17 Ridgefield Connecticut United States 06877
    18 Celebration Florida United States 34747
    19 Clearwater Florida United States 33756
    20 Clearwater Florida United States 33761
    21 Coral Gables Florida United States 33134
    22 Crystal River Florida United States 34429
    23 Cutler Bay Florida United States 33189
    24 Deerfield Beach Florida United States 33442
    25 Inverness Florida United States 34452
    26 Jacksonville Florida United States 32205
    27 Jacksonville Florida United States 32216
    28 Melbourne Florida United States 32935
    29 Miami Florida United States 33126
    30 Pembroke Pines Florida United States 33026
    31 Pinellas Park Florida United States 33781
    32 Sarasota Florida United States 34239
    33 South Miami Florida United States 33143
    34 Stockbridge Georgia United States 30281
    35 Chicago Illinois United States 60637
    36 Peoria Illinois United States 61602
    37 South Bend Indiana United States 46601
    38 Dubuque Iowa United States 52002
    39 Arkansas City Kansas United States 67005
    40 Lenexa Kansas United States 66219
    41 Lexena Kansas United States 66215
    42 Newton Kansas United States 67114
    43 Overland Park Kansas United States 66212
    44 Prairie Village Kansas United States 66206
    45 Wichita Kansas United States 67205
    46 Metairie Louisiana United States 70006
    47 Columbia Maryland United States 21042
    48 Elkridge Maryland United States 21075
    49 Greenbelt Maryland United States 20770
    50 Brockton Massachusetts United States 02301
    51 Haverhill Massachusetts United States 01830
    52 Chaska Minnesota United States 55318
    53 Edina Minnesota United States 55435
    54 St. Louis Missouri United States 63141
    55 Missoula Montana United States 59808
    56 Omaha Nebraska United States 68134
    57 Las Vegas Nevada United States 89104
    58 Rochester New York United States 14642
    59 Cary North Carolina United States 27518
    60 Charlotte North Carolina United States 28209
    61 Hickory North Carolina United States 28601
    62 High Point North Carolina United States 27262
    63 Raleigh North Carolina United States 27607
    64 Raleigh North Carolina United States 27612
    65 Salisbury North Carolina United States 28144
    66 Winston Salem North Carolina United States 27103
    67 Fargo North Dakota United States 58104
    68 Akron Ohio United States 44311
    69 Cleveland Ohio United States 44122
    70 Columbus Ohio United States 43201
    71 Columbus Ohio United States 43210
    72 Columbus Ohio United States 43213
    73 Norman Oklahoma United States 73069
    74 Corvallis Oregon United States 97330
    75 Portland Oregon United States 97203
    76 Downingtown Pennsylvania United States 19335
    77 Erie Pennsylvania United States 16506
    78 Jefferson Hills Pennsylvania United States 15025
    79 Penndel Pennsylvania United States 19047
    80 Pittsburgh Pennsylvania United States 15241
    81 Upper St Clair Pennsylvania United States 15241
    82 Anderson South Carolina United States 29621
    83 Clinton South Carolina United States 29325
    84 Goose Creek South Carolina United States 29445
    85 Greer South Carolina United States 29651
    86 Bristol Tennessee United States 37620
    87 Nashville Tennessee United States 37212
    88 Fort Worth Texas United States 76107
    89 Galveston Texas United States 77555
    90 Houston Texas United States 77074
    91 San Antonio Texas United States 78229
    92 Salt Lake City Utah United States 84124
    93 Fredericksburg Virginia United States 22401
    94 Williamsburg Virginia United States 23185
    95 Lakewood Washington United States 98499
    96 Marshfield Wisconsin United States 54449
    97 San Juan Puerto Rico 00918
    98 Toa Baja Puerto Rico 00949

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT00976027
    Other Study ID Numbers:
    • FIM07
    • UTN: U1111-1111-4478
    First Posted:
    Sep 14, 2009
    Last Update Posted:
    Aug 1, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by Sanofi
    Influenza
    Respiratory Tract Infections
    Influenza-like illness
    Elderly
    Fluzone®
    Efficacy
    Additional relevant MeSH terms:
    Influenza, Human
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled in the study from 22 September 2009 to 07 November 2009 at 99 clinical centers in the US.
    Pre-assignment Detail A total of 9158 of the 9172 participants that were randomized were vaccinated, evaluated, and reported in this report.
    Arm/Group Title Fluzone® High Dose Fluzone®
    Arm/Group Description All participants received a single dose of Fluzone High Dose vaccine on Day 0. All subjects received a single dose of Fluzone vaccine on Day 0.
    Period Title: Overall Study
    STARTED 6108 3050
    COMPLETED 5697 2835
    NOT COMPLETED 411 215

    Baseline Characteristics

    Arm/Group Title Fluzone® High Dose Fluzone® Total
    Arm/Group Description All participants received a single dose of Fluzone High Dose vaccine on Day 0. All subjects received a single dose of Fluzone vaccine on Day 0. Total of all reporting groups
    Overall Participants 6108 3050 9158
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    6108
    100%
    3050
    100%
    9158
    100%
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    72.8
    (6.0)
    72.8
    (5.9)
    72.8
    (6.0)
    Sex: Female, Male (Count of Participants)
    Female
    3268
    53.5%
    1647
    54%
    4915
    53.7%
    Male
    2840
    46.5%
    1403
    46%
    4243
    46.3%
    Region of Enrollment (Number) [Number]
    United States
    6108
    100%
    3050
    100%
    9158
    100%

    Outcome Measures

    1. Primary Outcome
    Title Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.
    Description The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.
    Time Frame Day 0 (pre-vaccination) up to Year 1 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Efficacy was assessed in all participants who met all study inclusion criteria and none of the exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per Protocol Analysis Set).
    Arm/Group Title Fluzone® High Dose Fluzone®
    Arm/Group Description All participants received a single dose of Fluzone High Dose vaccine on Day 0. All subjects received a single dose of Fluzone vaccine on Day 0.
    Measure Participants 6013 3008
    Laboratory Confirmed Cases of ILI
    14
    0.2%
    8
    0.3%
    Culture Confirmed Cases of ILI
    13
    0.2%
    7
    0.2%
    PCR Confirmed Cases of ILI
    14
    0.2%
    8
    0.3%
    2. Other Pre-specified Outcome
    Title Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)
    Description Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).
    Time Frame Day 0 (pre-vaccination) up to the end of the influenza season

    Outcome Measure Data

    Analysis Population Description
    The occurrence of events associated with ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).
    Arm/Group Title Fluzone® High Dose Fluzone®
    Arm/Group Description All participants received a single dose of Fluzone High Dose vaccine on Day 0. All subjects received a single dose of Fluzone vaccine on Day 0.
    Measure Participants 6013 3008
    Pneumonia
    28
    0.5%
    14
    0.5%
    Cardio Respiratory Conditions
    10
    0.2%
    6
    0.2%
    Any Health Care Visit
    478
    7.8%
    245
    8%
    Hospitalization
    31
    0.5%
    18
    0.6%
    Emergency Room Visit
    40
    0.7%
    19
    0.6%
    Non Routine Medical Office Visits
    439
    7.2%
    226
    7.4%
    Any Medication Use (Taken or Prescribed)
    781
    12.8%
    402
    13.2%
    Antipyretics, NSAIDs, Analgesics Use
    552
    9%
    289
    9.5%
    Antiviral Use
    37
    0.6%
    12
    0.4%
    Antibiotic Use
    374
    6.1%
    194
    6.4%
    3. Other Pre-specified Outcome
    Title Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI)
    Description Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).
    Time Frame Day 14 (post-vaccination) up to 12 Months post-vaccination

    Outcome Measure Data

    Analysis Population Description
    The occurrence of events associated with CDC defined ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).
    Arm/Group Title Fluzone® High Dose Fluzone®
    Arm/Group Description All participants received a single dose of Fluzone High Dose vaccine on Day 0. All subjects received a single dose of Fluzone vaccine on Day 0.
    Measure Participants 6013 3008
    Pneumonia
    13
    0.2%
    7
    0.2%
    New Onset or Exacerbation of Cardio Respiratory
    3
    0%
    1
    0%
    Any Health Care Visit
    145
    2.4%
    82
    2.7%
    Hospitalization
    12
    0.2%
    6
    0.2%
    Emergency Room Visit
    14
    0.2%
    9
    0.3%
    Non Routine Medical Office Visits
    129
    2.1%
    76
    2.5%
    Any Medication Use (Taken or Prescribed)
    220
    3.6%
    132
    4.3%
    Antipyretics, NSAIDs, Analgesics Use
    153
    2.5%
    94
    3.1%
    Antiviral Use
    17
    0.3%
    6
    0.2%
    Antibiotic Use
    123
    2%
    67
    2.2%
    4. Other Pre-specified Outcome
    Title Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone
    Description Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis
    Time Frame Day 0 before vaccination to Day 180 after vaccination

    Outcome Measure Data

    Analysis Population Description
    Adverse events of special interest were assessed in all participants who received study vaccine (Full Analysis Set).
    Arm/Group Title Fluzone® High Dose Fluzone®
    Arm/Group Description All participants received a single dose of Fluzone High Dose vaccine on Day 0. All subjects received a single dose of Fluzone vaccine on Day 0.
    Measure Participants 6108 3008
    Serious Adverse Events (SAE)
    493
    8.1%
    236
    7.7%
    Death
    31
    0.5%
    12
    0.4%
    Guillain Barre Syndrome
    0
    0%
    0
    0%
    Bell's Palsy
    3
    0%
    2
    0.1%
    Encephalitis or Myelitis
    1
    0%
    0
    0%
    Optic Neuritis
    0
    0%
    0
    0%
    Stevens Johnson Syndrome
    0
    0%
    0
    0%
    Toxic Epidermal Necrolysis
    0
    0%
    0
    0%
    SAE Leading to Study Discontinuation
    36
    0.6%
    17
    0.6%
    Related SAE
    2
    0%
    2
    0.1%
    Related SAE Leading to Study Discontinuation
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
    Adverse Event Reporting Description
    Arm/Group Title Fluzone® High Dose Fluzone®
    Arm/Group Description All participants received a single dose of Fluzone High Dose vaccine on Day 0. All subjects received a single dose of Fluzone vaccine on Day 0.
    All Cause Mortality
    Fluzone® High Dose Fluzone®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Fluzone® High Dose Fluzone®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 493/6108 (8.1%) 236/3050 (7.7%)
    Blood and lymphatic system disorders
    Anaemia 5/6108 (0.1%) 1/3050 (0%)
    Coagulopathy 1/6108 (0%) 0/3050 (0%)
    Iron Deficiency Anaemia 1/6108 (0%) 0/3050 (0%)
    Splenomegaly 1/6108 (0%) 0/3050 (0%)
    Thrombocytopenia 0/6108 (0%) 1/3050 (0%)
    Cardiac disorders
    Acute Coronary Syndrome 0/6108 (0%) 2/3050 (0.1%)
    Acute Myocardial Infarction 3/6108 (0%) 4/3050 (0.1%)
    Angina Pectoris 3/6108 (0%) 5/3050 (0.2%)
    Angina Unstable 7/6108 (0.1%) 3/3050 (0.1%)
    Aortic Valve Incompetence 1/6108 (0%) 0/3050 (0%)
    Arrhythmia 0/6108 (0%) 1/3050 (0%)
    Atrial Fibrillation 16/6108 (0.3%) 7/3050 (0.2%)
    Atrioventricular Block Complete 2/6108 (0%) 0/3050 (0%)
    Atrioventricular Block First Degree 1/6108 (0%) 0/3050 (0%)
    Atrioventricular Block Second Degree 1/6108 (0%) 0/3050 (0%)
    Bradyarrhythmia 1/6108 (0%) 0/3050 (0%)
    Bradycardia 5/6108 (0.1%) 0/3050 (0%)
    Cardiac Arrest 1/6108 (0%) 3/3050 (0.1%)
    Cardiac Failure 0/6108 (0%) 2/3050 (0.1%)
    Cardiac Failure Acute 1/6108 (0%) 0/3050 (0%)
    Cardiac Failure Chronic 1/6108 (0%) 2/3050 (0.1%)
    Cardiac Failure Congestive 20/6108 (0.3%) 11/3050 (0.4%)
    Cardiac Valve Disease 1/6108 (0%) 0/3050 (0%)
    Cardiomegaly 1/6108 (0%) 0/3050 (0%)
    Cardiomyopathy 1/6108 (0%) 0/3050 (0%)
    Coronary Artery Disease 11/6108 (0.2%) 4/3050 (0.1%)
    Coronary Artery Occlusion 1/6108 (0%) 0/3050 (0%)
    Coronary Artery Stenosis 0/6108 (0%) 1/3050 (0%)
    Ischaemic Cardiomyopathy 0/6108 (0%) 1/3050 (0%)
    Mitral Valve Incompetence 1/6108 (0%) 0/3050 (0%)
    Myocardial Infarction 6/6108 (0.1%) 8/3050 (0.3%)
    Myocardial Ischaemia 2/6108 (0%) 0/3050 (0%)
    Pericardial Effusion 1/6108 (0%) 0/3050 (0%)
    Pericarditis 1/6108 (0%) 0/3050 (0%)
    Sick Sinus Syndrome 4/6108 (0.1%) 0/3050 (0%)
    Sinus Bradycardia 0/6108 (0%) 1/3050 (0%)
    Congenital, familial and genetic disorders
    Arteriovenous Malformation 0/6108 (0%) 1/3050 (0%)
    Atrial Septal Defect 1/6108 (0%) 0/3050 (0%)
    Ear and labyrinth disorders
    Vertigo 0/6108 (0%) 3/3050 (0.1%)
    Eye disorders
    Retinal Artery Occlusion 0/6108 (0%) 1/3050 (0%)
    Gastrointestinal disorders
    Abdominal Hernia 0/6108 (0%) 1/3050 (0%)
    Abdominal Pain 3/6108 (0%) 0/3050 (0%)
    Abdominal Pain Upper 1/6108 (0%) 0/3050 (0%)
    Colitis 1/6108 (0%) 1/3050 (0%)
    Colitis Ischaemic 1/6108 (0%) 0/3050 (0%)
    Colitis Ulcerative 0/6108 (0%) 1/3050 (0%)
    Constipation 1/6108 (0%) 0/3050 (0%)
    Diarrhoea 6/6108 (0.1%) 1/3050 (0%)
    Diverticular Perforation 3/6108 (0%) 0/3050 (0%)
    Diverticulitis Intestinal Haemorrhagic 1/6108 (0%) 0/3050 (0%)
    Diverticulum Intestinal Haemorrhagic 1/6108 (0%) 0/3050 (0%)
    Duodenal Ulcer Haemorrhagic 1/6108 (0%) 0/3050 (0%)
    Duodenal Ulcer Perforation 0/6108 (0%) 1/3050 (0%)
    Dyspepsia 2/6108 (0%) 0/3050 (0%)
    Faecaloma 1/6108 (0%) 0/3050 (0%)
    Faeces Discolored 0/6108 (0%) 1/3050 (0%)
    Food Poisoning 1/6108 (0%) 0/3050 (0%)
    Gastric Ulcer 1/6108 (0%) 0/3050 (0%)
    Gastric Ulcer Haemorrhage 0/6108 (0%) 1/3050 (0%)
    Gastritis 1/6108 (0%) 0/3050 (0%)
    Gastrointestinal Haemorrhage 5/6108 (0.1%) 3/3050 (0.1%)
    Gastrooesophageal Reflux Disease 2/6108 (0%) 2/3050 (0.1%)
    Haemorrhoids 1/6108 (0%) 0/3050 (0%)
    Hiatus Hernia 1/6108 (0%) 0/3050 (0%)
    Ileus Paralytic 1/6108 (0%) 0/3050 (0%)
    Inguinal Hernia 0/6108 (0%) 1/3050 (0%)
    Intestinal Ischaemia 0/6108 (0%) 1/3050 (0%)
    Intestinal Obstruction 2/6108 (0%) 2/3050 (0.1%)
    Intestinal Ulcer 1/6108 (0%) 0/3050 (0%)
    Intra Abdominal Haematoma 1/6108 (0%) 0/3050 (0%)
    Large Intestine Perforation 0/6108 (0%) 1/3050 (0%)
    Melaena 0/6108 (0%) 1/3050 (0%)
    Obstruction Gastric 0/6108 (0%) 1/3050 (0%)
    Oesophageal Ulcer 0/6108 (0%) 1/3050 (0%)
    Oesophageal Ulcer Hemorrhage 0/6108 (0%) 1/3050 (0%)
    Pancreatitis 7/6108 (0.1%) 0/3050 (0%)
    Pancreatitis Acute 4/6108 (0.1%) 1/3050 (0%)
    Pancreatitis Relapsing 1/6108 (0%) 0/3050 (0%)
    Peptic Ulcer 1/6108 (0%) 0/3050 (0%)
    Rectal Haemorrhage 0/6108 (0%) 1/3050 (0%)
    Reflux Oesophagitis 1/6108 (0%) 0/3050 (0%)
    Small Intestinal Obstruction 5/6108 (0.1%) 5/3050 (0.2%)
    Spigelian Hernia 1/6108 (0%) 0/3050 (0%)
    Swollen Tongue 1/6108 (0%) 0/3050 (0%)
    Umbilical Hernia Obstructive 1/6108 (0%) 0/3050 (0%)
    Upper Gastrointestinal Haemorrhage 1/6108 (0%) 0/3050 (0%)
    General disorders
    Adverse Drug Reaction 0/6108 (0%) 1/3050 (0%)
    Asthenia 1/6108 (0%) 0/3050 (0%)
    Catheter Site Haematoma 1/6108 (0%) 0/3050 (0%)
    Chest Pain 10/6108 (0.2%) 9/3050 (0.3%)
    Chills 1/6108 (0%) 0/3050 (0%)
    Death 4/6108 (0.1%) 0/3050 (0%)
    Fatigue 0/6108 (0%) 1/3050 (0%)
    Hernia 1/6108 (0%) 0/3050 (0%)
    Hernia Obstructive 1/6108 (0%) 0/3050 (0%)
    Influenza Like Illness 2/6108 (0%) 0/3050 (0%)
    Non Cardiac Chest Pain 3/6108 (0%) 2/3050 (0.1%)
    Oedema Peripheral 0/6108 (0%) 1/3050 (0%)
    Pyrexia 1/6108 (0%) 0/3050 (0%)
    Hepatobiliary disorders
    Cholangitis 1/6108 (0%) 0/3050 (0%)
    Cholecystitis 4/6108 (0.1%) 4/3050 (0.1%)
    Cholecystitis acute 0/6108 (0%) 2/3050 (0.1%)
    Cholelithiasis 4/6108 (0.1%) 1/3050 (0%)
    Portal vein thrombosis 0/6108 (0%) 1/3050 (0%)
    Immune system disorders
    Drug hypersensitivity 2/6108 (0%) 0/3050 (0%)
    Hypersensitivity 0/6108 (0%) 1/3050 (0%)
    Infections and infestations
    Abdominal abscess 2/6108 (0%) 0/3050 (0%)
    Abscess limb 1/6108 (0%) 0/3050 (0%)
    Actinomycotic pulmonary infection 1/6108 (0%) 0/3050 (0%)
    Appendicitis 2/6108 (0%) 0/3050 (0%)
    Application site cellulitis 1/6108 (0%) 0/3050 (0%)
    Arthritis bacterial 0/6108 (0%) 1/3050 (0%)
    Bacterial infection 0/6108 (0%) 1/3050 (0%)
    Biliary sepsis 1/6108 (0%) 0/3050 (0%)
    Bronchitis 2/6108 (0%) 0/3050 (0%)
    Bronchitis viral 0/6108 (0%) 1/3050 (0%)
    Cellulitis 9/6108 (0.1%) 1/3050 (0%)
    Cellulitis staphylococcal 0/6108 (0%) 1/3050 (0%)
    Clostridial infection 2/6108 (0%) 0/3050 (0%)
    Clostridium difficile colitis 2/6108 (0%) 0/3050 (0%)
    Diverticulitis 8/6108 (0.1%) 0/3050 (0%)
    Endocarditis bacterial 1/6108 (0%) 0/3050 (0%)
    Escherichia urinary tract infection 0/6108 (0%) 1/3050 (0%)
    Gangrene 0/6108 (0%) 1/3050 (0%)
    Sepsis syndrome 0/6108 (0%) 1/3050 (0%)
    Septic arthritis staphylococcal 1/6108 (0%) 0/3050 (0%)
    Septic shock 1/6108 (0%) 0/3050 (0%)
    Sialoadenitis 1/6108 (0%) 0/3050 (0%)
    Staphylococcal bacteraemia 1/6108 (0%) 0/3050 (0%)
    Staphylococcal infection 1/6108 (0%) 1/3050 (0%)
    Staphylococcal sepsis 1/6108 (0%) 0/3050 (0%)
    Subcutaneous abscess 1/6108 (0%) 0/3050 (0%)
    Tracheobronchitis 0/6108 (0%) 1/3050 (0%)
    Upper respiratory tract infection 2/6108 (0%) 0/3050 (0%)
    Urinary tract infection 8/6108 (0.1%) 0/3050 (0%)
    Urinary tract infection enterococcal 2/6108 (0%) 0/3050 (0%)
    Urinary tract infection staphylococcal 1/6108 (0%) 0/3050 (0%)
    Urosepsis 2/6108 (0%) 1/3050 (0%)
    Viral infection 1/6108 (0%) 0/3050 (0%)
    Wound infection 1/6108 (0%) 0/3050 (0%)
    Gastroenteritis 4/6108 (0.1%) 0/3050 (0%)
    Infection 1/6108 (0%) 0/3050 (0%)
    Influenza 1/6108 (0%) 0/3050 (0%)
    Kidney infection 2/6108 (0%) 1/3050 (0%)
    Klebsiella infection 0/6108 (0%) 1/3050 (0%)
    Lobar pneumonia 3/6108 (0%) 1/3050 (0%)
    Orchitis 1/6108 (0%) 0/3050 (0%)
    Osteomyelitis 1/6108 (0%) 0/3050 (0%)
    Otitis media 1/6108 (0%) 0/3050 (0%)
    Perineal abscess 1/6108 (0%) 0/3050 (0%)
    Pneumonia 16/6108 (0.3%) 13/3050 (0.4%)
    Pneumonia staphylococcal 1/6108 (0%) 0/3050 (0%)
    Post procedural infection 1/6108 (0%) 0/3050 (0%)
    Respiratory tract infection 1/6108 (0%) 0/3050 (0%)
    Sepsis 3/6108 (0%) 1/3050 (0%)
    Injury, poisoning and procedural complications
    Accidental overdose 2/6108 (0%) 0/3050 (0%)
    Anaemia postoperative 0/6108 (0%) 1/3050 (0%)
    Ankle fracture 2/6108 (0%) 1/3050 (0%)
    Back injury 1/6108 (0%) 0/3050 (0%)
    Brain contusion 1/6108 (0%) 0/3050 (0%)
    Burns second degree 0/6108 (0%) 1/3050 (0%)
    Cervical vertebral fracture 1/6108 (0%) 0/3050 (0%)
    Compression fracture 1/6108 (0%) 0/3050 (0%)
    Concussion 0/6108 (0%) 1/3050 (0%)
    Drug toxicity 1/6108 (0%) 0/3050 (0%)
    Femoral neck fracture 2/6108 (0%) 0/3050 (0%)
    Femur fracture 0/6108 (0%) 1/3050 (0%)
    Fibula fracture 0/6108 (0%) 1/3050 (0%)
    Fractured sacrum 1/6108 (0%) 0/3050 (0%)
    Hand fracture 1/6108 (0%) 1/3050 (0%)
    Head injury 2/6108 (0%) 0/3050 (0%)
    Hip fracture 4/6108 (0.1%) 3/3050 (0.1%)
    Humerus fracture 2/6108 (0%) 1/3050 (0%)
    Ilium fracture 1/6108 (0%) 0/3050 (0%)
    Incisional hernia 1/6108 (0%) 1/3050 (0%)
    Joint dislocation 3/6108 (0%) 1/3050 (0%)
    Lower limb fracture 1/6108 (0%) 0/3050 (0%)
    Medical device complication 1/6108 (0%) 1/3050 (0%)
    Multiple fractures 1/6108 (0%) 0/3050 (0%)
    Muscle injury 0/6108 (0%) 1/3050 (0%)
    Muscle strain 1/6108 (0%) 0/3050 (0%)
    Pelvic fracture 1/6108 (0%) 3/3050 (0.1%)
    Post procedural complication 1/6108 (0%) 0/3050 (0%)
    Post procedural haemorrhage 0/6108 (0%) 1/3050 (0%)
    Rib fracture 3/6108 (0%) 0/3050 (0%)
    Road traffic accident 1/6108 (0%) 0/3050 (0%)
    Spinal compression fracture 1/6108 (0%) 1/3050 (0%)
    Splenic rupture 1/6108 (0%) 0/3050 (0%)
    Sternal fracture 1/6108 (0%) 1/3050 (0%)
    Subdural haematoma 1/6108 (0%) 2/3050 (0.1%)
    Subdural haemorrhage 1/6108 (0%) 0/3050 (0%)
    Tendon injury 0/6108 (0%) 1/3050 (0%)
    Tendon rupture 1/6108 (0%) 0/3050 (0%)
    Upper limb fracture 1/6108 (0%) 0/3050 (0%)
    Wrist fracture 1/6108 (0%) 0/3050 (0%)
    Investigations
    Heart rate irregular 1/6108 (0%) 0/3050 (0%)
    International normalised ratio increased 1/6108 (0%) 0/3050 (0%)
    Metabolism and nutrition disorders
    Dehydration 5/6108 (0.1%) 2/3050 (0.1%)
    Diabetes mellitus inadequate control 1/6108 (0%) 0/3050 (0%)
    Diabetic foot 0/6108 (0%) 1/3050 (0%)
    Diabetic ketoacidosis 2/6108 (0%) 0/3050 (0%)
    Failure to thrive 1/6108 (0%) 0/3050 (0%)
    Fluid retention 1/6108 (0%) 0/3050 (0%)
    Hyperglycaemia 1/6108 (0%) 1/3050 (0%)
    Hyperkalaemia 1/6108 (0%) 0/3050 (0%)
    Hypoglycaemia 0/6108 (0%) 3/3050 (0.1%)
    Hypokalaemia 1/6108 (0%) 1/3050 (0%)
    Hyponatraemia 3/6108 (0%) 0/3050 (0%)
    Type 2 diabetes mellitus 0/6108 (0%) 2/3050 (0.1%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 4/6108 (0.1%) 2/3050 (0.1%)
    Arthritis 2/6108 (0%) 0/3050 (0%)
    Back disorder 0/6108 (0%) 1/3050 (0%)
    Back pain 1/6108 (0%) 1/3050 (0%)
    Cervical spinal stenosis 1/6108 (0%) 0/3050 (0%)
    Costochondritis 3/6108 (0%) 0/3050 (0%)
    Intervertebral disc degeneration 1/6108 (0%) 1/3050 (0%)
    Intervertebral disc disorder 1/6108 (0%) 0/3050 (0%)
    Intervertebral disc protrusion 2/6108 (0%) 1/3050 (0%)
    Lumbar spinal stenosis 5/6108 (0.1%) 0/3050 (0%)
    Musculoskeletal chest pain 1/6108 (0%) 0/3050 (0%)
    Osteoarthritis 20/6108 (0.3%) 9/3050 (0.3%)
    Rotator cuff syndrome 2/6108 (0%) 1/3050 (0%)
    Spinal column stenosis 1/6108 (0%) 1/3050 (0%)
    Spinal disorder 0/6108 (0%) 1/3050 (0%)
    Spinal osteoarthritis 1/6108 (0%) 1/3050 (0%)
    Spondylolisthesis 2/6108 (0%) 0/3050 (0%)
    Synovial cyst 1/6108 (0%) 0/3050 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma pancreas 0/6108 (0%) 1/3050 (0%)
    Adenoid cystic carcinoma 1/6108 (0%) 0/3050 (0%)
    Bladder cancer 5/6108 (0.1%) 0/3050 (0%)
    Bladder cancer recurrent 1/6108 (0%) 0/3050 (0%)
    Bladder transitional cell carcinoma 1/6108 (0%) 0/3050 (0%)
    Breast cancer 6/6108 (0.1%) 2/3050 (0.1%)
    Breast cancer metastatic 0/6108 (0%) 1/3050 (0%)
    Breast neoplasm 0/6108 (0%) 1/3050 (0%)
    Colon adenoma 1/6108 (0%) 0/3050 (0%)
    Colon cancer 5/6108 (0.1%) 2/3050 (0.1%)
    Colorectal cancer metastatic 1/6108 (0%) 0/3050 (0%)
    Glioblastoma 0/6108 (0%) 1/3050 (0%)
    Hodgkin's disease stage IV 0/6108 (0%) 1/3050 (0%)
    Intraocular melanoma 1/6108 (0%) 0/3050 (0%)
    Large cell lung cancer stage II 1/6108 (0%) 0/3050 (0%)
    Laryngeal cancer stage III 1/6108 (0%) 0/3050 (0%)
    Leiomyosarcoma 0/6108 (0%) 1/3050 (0%)
    Lung adenocarcinoma 1/6108 (0%) 1/3050 (0%)
    Lung neoplasm malignant 4/6108 (0.1%) 0/3050 (0%)
    Lung squamous cell carcinoma stage unspecified 0/6108 (0%) 1/3050 (0%)
    Lymphoma 0/6108 (0%) 1/3050 (0%)
    Malignant melanoma 0/6108 (0%) 1/3050 (0%)
    Metastases to liver 1/6108 (0%) 0/3050 (0%)
    Metastatic neoplasm 0/6108 (0%) 1/3050 (0%)
    Neoplasm malignant 1/6108 (0%) 0/3050 (0%)
    Non-small cell lung cancer metastatic 1/6108 (0%) 0/3050 (0%)
    Oesophageal adenocarcinoma 1/6108 (0%) 0/3050 (0%)
    Oesophageal squamous cell carcinoma 1/6108 (0%) 0/3050 (0%)
    Ovarian cancer 0/6108 (0%) 2/3050 (0.1%)
    Paget's disease of the breast 1/6108 (0%) 0/3050 (0%)
    Pancreatic carcinoma 2/6108 (0%) 0/3050 (0%)
    Pancreatic carcinoma metastatic 1/6108 (0%) 0/3050 (0%)
    Prostate cancer 3/6108 (0%) 1/3050 (0%)
    Prostate cancer metastatic 1/6108 (0%) 0/3050 (0%)
    Prostate cancer recurrent 1/6108 (0%) 0/3050 (0%)
    Rectal cancer 1/6108 (0%) 0/3050 (0%)
    Renal cancer 1/6108 (0%) 0/3050 (0%)
    Skin cancer 1/6108 (0%) 1/3050 (0%)
    Small intestine carcinoma 1/6108 (0%) 0/3050 (0%)
    Splenic marginal zone lymphoma 1/6108 (0%) 0/3050 (0%)
    Splenic neoplasm malignancy unspecified 1/6108 (0%) 0/3050 (0%)
    Squamous cell carcinoma 1/6108 (0%) 1/3050 (0%)
    Testis cancer 1/6108 (0%) 0/3050 (0%)
    Thymoma 1/6108 (0%) 0/3050 (0%)
    Thyroid neoplasm 1/6108 (0%) 0/3050 (0%)
    Uterine cancer 1/6108 (0%) 0/3050 (0%)
    Nervous system disorders
    Balance disorder 1/6108 (0%) 0/3050 (0%)
    Carotid artery occlusion 0/6108 (0%) 1/3050 (0%)
    Carotid artery stenosis 1/6108 (0%) 0/3050 (0%)
    Cerebral haemorrhage 4/6108 (0.1%) 0/3050 (0%)
    Cerebral ischaemia 0/6108 (0%) 1/3050 (0%)
    Cerebrovascular accident 11/6108 (0.2%) 6/3050 (0.2%)
    Cervicobrachial syndrome 1/6108 (0%) 0/3050 (0%)
    Drug withdrawal convulsions 0/6108 (0%) 1/3050 (0%)
    Epilepsy 1/6108 (0%) 1/3050 (0%)
    Facial palsy 3/6108 (0%) 2/3050 (0.1%)
    Global amnesia 1/6108 (0%) 1/3050 (0%)
    Haemorrhage intracranial 0/6108 (0%) 1/3050 (0%)
    Haemorrhagic stroke 0/6108 (0%) 1/3050 (0%)
    Hypertensive encephalopathy 1/6108 (0%) 0/3050 (0%)
    Intracranial aneurysm 0/6108 (0%) 1/3050 (0%)
    Ischaemic stroke 1/6108 (0%) 0/3050 (0%)
    Lumbar radiculopathy 1/6108 (0%) 0/3050 (0%)
    Myelitis transverse 1/6108 (0%) 0/3050 (0%)
    Nerve compression 1/6108 (0%) 0/3050 (0%)
    Normal pressure hydrocephalus 0/6108 (0%) 1/3050 (0%)
    Paraesthesia 0/6108 (0%) 1/3050 (0%)
    Presyncope 2/6108 (0%) 0/3050 (0%)
    Subarachnoid haemorrhage 1/6108 (0%) 0/3050 (0%)
    Syncope 15/6108 (0.2%) 4/3050 (0.1%)
    Transient ischaemic attack 5/6108 (0.1%) 5/3050 (0.2%)
    Psychiatric disorders
    Alcohol abuse 0/6108 (0%) 1/3050 (0%)
    Alcoholism 1/6108 (0%) 0/3050 (0%)
    Anxiety disorder 0/6108 (0%) 1/3050 (0%)
    Bipolar disorder 0/6108 (0%) 1/3050 (0%)
    Completed suicide 1/6108 (0%) 0/3050 (0%)
    Delusion 0/6108 (0%) 1/3050 (0%)
    Depressed mood 1/6108 (0%) 0/3050 (0%)
    Depression 2/6108 (0%) 0/3050 (0%)
    Disorientation 1/6108 (0%) 0/3050 (0%)
    Major depression 0/6108 (0%) 1/3050 (0%)
    Mental disorder 0/6108 (0%) 1/3050 (0%)
    Mental status changes 1/6108 (0%) 0/3050 (0%)
    Renal and urinary disorders
    Anuria 1/6108 (0%) 0/3050 (0%)
    Bladder obstruction 0/6108 (0%) 1/3050 (0%)
    Calculus bladder 1/6108 (0%) 0/3050 (0%)
    Calculus ureteric 3/6108 (0%) 0/3050 (0%)
    Haematuria 2/6108 (0%) 0/3050 (0%)
    Incontinence 1/6108 (0%) 0/3050 (0%)
    Nephrolithiasis 4/6108 (0.1%) 0/3050 (0%)
    Renal artery stenosis 1/6108 (0%) 0/3050 (0%)
    Renal failure 2/6108 (0%) 0/3050 (0%)
    Renal failure acute 7/6108 (0.1%) 3/3050 (0.1%)
    Renal failure chronic 1/6108 (0%) 2/3050 (0.1%)
    Renal mass 3/6108 (0%) 1/3050 (0%)
    Urinary incontinence 0/6108 (0%) 1/3050 (0%)
    Urinary retention 1/6108 (0%) 0/3050 (0%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 2/6108 (0%) 0/3050 (0%)
    Cystocele 2/6108 (0%) 2/3050 (0.1%)
    Uterine prolapse 1/6108 (0%) 1/3050 (0%)
    Vaginal haemorrhage 0/6108 (0%) 1/3050 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome 0/6108 (0%) 1/3050 (0%)
    Acute respiratory failure 2/6108 (0%) 0/3050 (0%)
    Asthma 6/6108 (0.1%) 3/3050 (0.1%)
    Chronic obstructive pulmonary disease 21/6108 (0.3%) 13/3050 (0.4%)
    Cough 1/6108 (0%) 0/3050 (0%)
    Dyspnoea 2/6108 (0%) 1/3050 (0%)
    Dyspnoea exertional 1/6108 (0%) 0/3050 (0%)
    Haemoptysis 2/6108 (0%) 1/3050 (0%)
    Hypoxia 3/6108 (0%) 0/3050 (0%)
    Pleural effusion 1/6108 (0%) 0/3050 (0%)
    Pneumonia aspiration 1/6108 (0%) 2/3050 (0.1%)
    Pneumothorax 1/6108 (0%) 0/3050 (0%)
    Pulmonary embolism 4/6108 (0.1%) 0/3050 (0%)
    Pulmonary fibrosis 0/6108 (0%) 1/3050 (0%)
    Pulmonary oedema 1/6108 (0%) 0/3050 (0%)
    Respiratory failure 4/6108 (0.1%) 1/3050 (0%)
    Skin and subcutaneous tissue disorders
    Angioedema 1/6108 (0%) 0/3050 (0%)
    Diabetic ulcer 1/6108 (0%) 0/3050 (0%)
    Surgical and medical procedures
    Colectomy 0/6108 (0%) 1/3050 (0%)
    Hospitalisation 1/6108 (0%) 1/3050 (0%)
    Knee arthroplasty 0/6108 (0%) 1/3050 (0%)
    Shoulder arthroplasty 0/6108 (0%) 1/3050 (0%)
    Vascular disorders
    Aneurysm 1/6108 (0%) 0/3050 (0%)
    Aortic aneurysm 2/6108 (0%) 1/3050 (0%)
    Arterial occlusive disease 0/6108 (0%) 1/3050 (0%)
    Arterial thrombosis limb 0/6108 (0%) 1/3050 (0%)
    Arteriosclerosis 1/6108 (0%) 1/3050 (0%)
    Deep vein thrombosis 4/6108 (0.1%) 0/3050 (0%)
    Embolism 1/6108 (0%) 0/3050 (0%)
    Femoral artery embolism 0/6108 (0%) 1/3050 (0%)
    Femoral artery occlusion 2/6108 (0%) 0/3050 (0%)
    Haematoma 2/6108 (0%) 1/3050 (0%)
    Hypertension 2/6108 (0%) 1/3050 (0%)
    Hypertensive crisis 1/6108 (0%) 0/3050 (0%)
    Hypotension 2/6108 (0%) 1/3050 (0%)
    Ischaemia 0/6108 (0%) 1/3050 (0%)
    Ischaemic limb pain 1/6108 (0%) 0/3050 (0%)
    Orthostatic hypotension 0/6108 (0%) 1/3050 (0%)
    Peripheral artery aneurysm 1/6108 (0%) 0/3050 (0%)
    Thrombosis 2/6108 (0%) 0/3050 (0%)
    Vascular rupture 1/6108 (0%) 0/3050 (0%)
    Other (Not Including Serious) Adverse Events
    Fluzone® High Dose Fluzone®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6108 (0%) 0/3050 (0%)

    Limitations/Caveats

    The study was terminated due to lack of primary endpoint cases in 2009-2010 influenza season (coincided with the H1N1 Pandemic). There were no safety concerns; enrolled subjects were followed per-protocol.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.
    Phone
    Email RegistryContactUs@sanofipasteur.com
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT00976027
    Other Study ID Numbers:
    • FIM07
    • UTN: U1111-1111-4478
    First Posted:
    Sep 14, 2009
    Last Update Posted:
    Aug 1, 2012
    Last Verified:
    Jul 1, 2012