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Trial record 1 of 1 for:    FIM07
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Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

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ClinicalTrials.gov Identifier: NCT00976027
Recruitment Status : Terminated (No safety concerns, study terminated due to lack of primary endpoint cases in 2009-2010 Flu season (coincided with H1N1 Pandemic) Subjects followed per-protocol)
First Posted : September 14, 2009
Results First Posted : July 25, 2012
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Trivalent inactivated influenza vaccine High Dose
Biological: Trivalent inactivated influenza vaccine
Enrollment 9172
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 Details 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®
Hide 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
Reason Not Completed
Serious Adverse Event             36             17
Adverse Event             0             2
Protocol Violation             60             27
Lost to Follow-up             208             103
Withdrawal by Subject             107             66
Arm/Group Title Fluzone® High Dose Fluzone® Total
Hide 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 Number of Baseline Participants 6108 3050 9158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6108 participants 3050 participants 9158 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
6108
 100.0%
3050
 100.0%
9158
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6108 participants 3050 participants 9158 participants
72.8  (6.0) 72.8  (5.9) 72.8  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6108 participants 3050 participants 9158 participants
Female
3268
  53.5%
1647
  54.0%
4915
  53.7%
Male
2840
  46.5%
1403
  46.0%
4243
  46.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6108 participants 3050 participants 9158 participants
6108 3050 9158
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.
Hide 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
Hide Outcome Measure Data
Hide 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®
Hide 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.
Overall Number of Participants Analyzed 6013 3008
Measure Type: Number
Unit of Measure: Participants
Laboratory Confirmed Cases of ILI 14 8
Culture Confirmed Cases of ILI 13 7
PCR Confirmed Cases of ILI 14 8
2.Other Pre-specified Outcome
Title Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)
Hide 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
Hide Outcome Measure Data
Hide 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®
Hide 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.
Overall Number of Participants Analyzed 6013 3008
Measure Type: Number
Unit of Measure: Participants
Pneumonia 28 14
Cardio Respiratory Conditions 10 6
Any Health Care Visit 478 245
Hospitalization 31 18
Emergency Room Visit 40 19
Non Routine Medical Office Visits 439 226
Any Medication Use (Taken or Prescribed) 781 402
Antipyretics, NSAIDs, Analgesics Use 552 289
Antiviral Use 37 12
Antibiotic Use 374 194
3.Other Pre-specified Outcome
Title Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI)
Hide 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
Hide Outcome Measure Data
Hide 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®
Hide 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.
Overall Number of Participants Analyzed 6013 3008
Measure Type: Number
Unit of Measure: Participants
Pneumonia 13 7
New Onset or Exacerbation of Cardio Respiratory 3 1
Any Health Care Visit 145 82
Hospitalization 12 6
Emergency Room Visit 14 9
Non Routine Medical Office Visits 129 76
Any Medication Use (Taken or Prescribed) 220 132
Antipyretics, NSAIDs, Analgesics Use 153 94
Antiviral Use 17 6
Antibiotic Use 123 67
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
Hide 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
Hide Outcome Measure Data
Hide 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®
Hide 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.
Overall Number of Participants Analyzed 6108 3008
Measure Type: Number
Unit of Measure: Participants
Serious Adverse Events (SAE) 493 236
Death 31 12
Guillain Barre Syndrome 0 0
Bell's Palsy 3 2
Encephalitis or Myelitis 1 0
Optic Neuritis 0 0
Stevens Johnson Syndrome 0 0
Toxic Epidermal Necrolysis 0 0
SAE Leading to Study Discontinuation 36 17
Related SAE 2 2
Related SAE Leading to Study Discontinuation 0 0
Time Frame Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluzone® High Dose Fluzone®
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone® High Dose Fluzone®
Affected / at Risk (%) Affected / at Risk (%)
Total   493/6108 (8.07%)   236/3050 (7.74%) 
Blood and lymphatic system disorders     
Anaemia * 1  5/6108 (0.08%)  1/3050 (0.03%) 
Coagulopathy * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Iron Deficiency Anaemia * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Splenomegaly * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Thrombocytopenia * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Cardiac disorders     
Acute Coronary Syndrome * 1  0/6108 (0.00%)  2/3050 (0.07%) 
Acute Myocardial Infarction * 1  3/6108 (0.05%)  4/3050 (0.13%) 
Angina Pectoris * 1  3/6108 (0.05%)  5/3050 (0.16%) 
Angina Unstable * 1  7/6108 (0.11%)  3/3050 (0.10%) 
Aortic Valve Incompetence * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Arrhythmia * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Atrial Fibrillation * 1  16/6108 (0.26%)  7/3050 (0.23%) 
Atrioventricular Block Complete * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Atrioventricular Block First Degree * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Atrioventricular Block Second Degree * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Bradyarrhythmia * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Bradycardia * 1  5/6108 (0.08%)  0/3050 (0.00%) 
Cardiac Arrest * 1  1/6108 (0.02%)  3/3050 (0.10%) 
Cardiac Failure * 1  0/6108 (0.00%)  2/3050 (0.07%) 
Cardiac Failure Acute * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Cardiac Failure Chronic * 1  1/6108 (0.02%)  2/3050 (0.07%) 
Cardiac Failure Congestive * 1  20/6108 (0.33%)  11/3050 (0.36%) 
Cardiac Valve Disease * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Cardiomegaly * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Cardiomyopathy * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Coronary Artery Disease * 1  11/6108 (0.18%)  4/3050 (0.13%) 
Coronary Artery Occlusion * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Coronary Artery Stenosis * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Ischaemic Cardiomyopathy * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Mitral Valve Incompetence * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Myocardial Infarction * 1  6/6108 (0.10%)  8/3050 (0.26%) 
Myocardial Ischaemia * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Pericardial Effusion * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Pericarditis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Sick Sinus Syndrome * 1  4/6108 (0.07%)  0/3050 (0.00%) 
Sinus Bradycardia * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Congenital, familial and genetic disorders     
Arteriovenous Malformation * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Atrial Septal Defect * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  0/6108 (0.00%)  3/3050 (0.10%) 
Eye disorders     
Retinal Artery Occlusion * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Gastrointestinal disorders     
Abdominal Hernia * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Abdominal Pain * 1  3/6108 (0.05%)  0/3050 (0.00%) 
Abdominal Pain Upper * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Colitis * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Colitis Ischaemic * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Colitis Ulcerative * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Constipation * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Diarrhoea * 1  6/6108 (0.10%)  1/3050 (0.03%) 
Diverticular Perforation * 1  3/6108 (0.05%)  0/3050 (0.00%) 
Diverticulitis Intestinal Haemorrhagic * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Diverticulum Intestinal Haemorrhagic * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Duodenal Ulcer Haemorrhagic * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Duodenal Ulcer Perforation * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Dyspepsia * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Faecaloma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Faeces Discolored * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Food Poisoning * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Gastric Ulcer * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Gastric Ulcer Haemorrhage * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Gastritis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Gastrointestinal Haemorrhage * 1  5/6108 (0.08%)  3/3050 (0.10%) 
Gastrooesophageal Reflux Disease * 1  2/6108 (0.03%)  2/3050 (0.07%) 
Haemorrhoids * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Hiatus Hernia * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Ileus Paralytic * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Inguinal Hernia * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Intestinal Ischaemia * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Intestinal Obstruction * 1  2/6108 (0.03%)  2/3050 (0.07%) 
Intestinal Ulcer * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Intra Abdominal Haematoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Large Intestine Perforation * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Melaena * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Obstruction Gastric * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Oesophageal Ulcer * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Oesophageal Ulcer Hemorrhage * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Pancreatitis * 1  7/6108 (0.11%)  0/3050 (0.00%) 
Pancreatitis Acute * 1  4/6108 (0.07%)  1/3050 (0.03%) 
Pancreatitis Relapsing * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Peptic Ulcer * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Rectal Haemorrhage * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Reflux Oesophagitis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Small Intestinal Obstruction * 1  5/6108 (0.08%)  5/3050 (0.16%) 
Spigelian Hernia * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Swollen Tongue * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Umbilical Hernia Obstructive * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Upper Gastrointestinal Haemorrhage * 1  1/6108 (0.02%)  0/3050 (0.00%) 
General disorders     
Adverse Drug Reaction * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Asthenia * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Catheter Site Haematoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Chest Pain * 1  10/6108 (0.16%)  9/3050 (0.30%) 
Chills * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Death * 1  4/6108 (0.07%)  0/3050 (0.00%) 
Fatigue * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Hernia * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Hernia Obstructive * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Influenza Like Illness * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Non Cardiac Chest Pain * 1  3/6108 (0.05%)  2/3050 (0.07%) 
Oedema Peripheral * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Pyrexia * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Hepatobiliary disorders     
Cholangitis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Cholecystitis * 1  4/6108 (0.07%)  4/3050 (0.13%) 
Cholecystitis acute * 1  0/6108 (0.00%)  2/3050 (0.07%) 
Cholelithiasis * 1  4/6108 (0.07%)  1/3050 (0.03%) 
Portal vein thrombosis * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Immune system disorders     
Drug hypersensitivity * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Hypersensitivity * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Infections and infestations     
Abdominal abscess * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Abscess limb * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Actinomycotic pulmonary infection * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Appendicitis * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Application site cellulitis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Arthritis bacterial * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Bacterial infection * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Biliary sepsis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Bronchitis * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Bronchitis viral * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Cellulitis * 1  9/6108 (0.15%)  1/3050 (0.03%) 
Cellulitis staphylococcal * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Clostridial infection * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Clostridium difficile colitis * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Diverticulitis * 1  8/6108 (0.13%)  0/3050 (0.00%) 
Endocarditis bacterial * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Escherichia urinary tract infection * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Gangrene * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Sepsis syndrome * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Septic arthritis staphylococcal * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Septic shock * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Sialoadenitis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Staphylococcal bacteraemia * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Staphylococcal infection * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Staphylococcal sepsis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Subcutaneous abscess * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Tracheobronchitis * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Upper respiratory tract infection * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Urinary tract infection * 1  8/6108 (0.13%)  0/3050 (0.00%) 
Urinary tract infection enterococcal * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Urinary tract infection staphylococcal * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Urosepsis * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Viral infection * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Wound infection * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Gastroenteritis * 1  4/6108 (0.07%)  0/3050 (0.00%) 
Infection * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Influenza * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Kidney infection * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Klebsiella infection * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Lobar pneumonia * 1  3/6108 (0.05%)  1/3050 (0.03%) 
Orchitis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Osteomyelitis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Otitis media * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Perineal abscess * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Pneumonia * 1  16/6108 (0.26%)  13/3050 (0.43%) 
Pneumonia staphylococcal * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Post procedural infection * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Respiratory tract infection * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Sepsis * 1  3/6108 (0.05%)  1/3050 (0.03%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Anaemia postoperative * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Ankle fracture * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Back injury * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Brain contusion * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Burns second degree * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Cervical vertebral fracture * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Compression fracture * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Concussion * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Drug toxicity * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Femoral neck fracture * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Femur fracture * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Fibula fracture * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Fractured sacrum * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Hand fracture * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Head injury * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Hip fracture * 1  4/6108 (0.07%)  3/3050 (0.10%) 
Humerus fracture * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Ilium fracture * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Incisional hernia * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Joint dislocation * 1  3/6108 (0.05%)  1/3050 (0.03%) 
Lower limb fracture * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Medical device complication * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Multiple fractures * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Muscle injury * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Muscle strain * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Pelvic fracture * 1  1/6108 (0.02%)  3/3050 (0.10%) 
Post procedural complication * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Post procedural haemorrhage * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Rib fracture * 1  3/6108 (0.05%)  0/3050 (0.00%) 
Road traffic accident * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Spinal compression fracture * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Splenic rupture * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Sternal fracture * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Subdural haematoma * 1  1/6108 (0.02%)  2/3050 (0.07%) 
Subdural haemorrhage * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Tendon injury * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Tendon rupture * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Upper limb fracture * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Wrist fracture * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Investigations     
Heart rate irregular * 1  1/6108 (0.02%)  0/3050 (0.00%) 
International normalised ratio increased * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  5/6108 (0.08%)  2/3050 (0.07%) 
Diabetes mellitus inadequate control * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Diabetic foot * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Diabetic ketoacidosis * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Failure to thrive * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Fluid retention * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Hyperglycaemia * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Hyperkalaemia * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Hypoglycaemia * 1  0/6108 (0.00%)  3/3050 (0.10%) 
Hypokalaemia * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Hyponatraemia * 1  3/6108 (0.05%)  0/3050 (0.00%) 
Type 2 diabetes mellitus * 1  0/6108 (0.00%)  2/3050 (0.07%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  4/6108 (0.07%)  2/3050 (0.07%) 
Arthritis * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Back disorder * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Back pain * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Cervical spinal stenosis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Costochondritis * 1  3/6108 (0.05%)  0/3050 (0.00%) 
Intervertebral disc degeneration * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Intervertebral disc disorder * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Intervertebral disc protrusion * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Lumbar spinal stenosis * 1  5/6108 (0.08%)  0/3050 (0.00%) 
Musculoskeletal chest pain * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Osteoarthritis * 1  20/6108 (0.33%)  9/3050 (0.30%) 
Rotator cuff syndrome * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Spinal column stenosis * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Spinal disorder * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Spinal osteoarthritis * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Spondylolisthesis * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Synovial cyst * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma pancreas * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Adenoid cystic carcinoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Bladder cancer * 1  5/6108 (0.08%)  0/3050 (0.00%) 
Bladder cancer recurrent * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Bladder transitional cell carcinoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Breast cancer * 1  6/6108 (0.10%)  2/3050 (0.07%) 
Breast cancer metastatic * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Breast neoplasm * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Colon adenoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Colon cancer * 1  5/6108 (0.08%)  2/3050 (0.07%) 
Colorectal cancer metastatic * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Glioblastoma * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Hodgkin's disease stage IV * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Intraocular melanoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Large cell lung cancer stage II * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Laryngeal cancer stage III * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Leiomyosarcoma * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Lung adenocarcinoma * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Lung neoplasm malignant * 1  4/6108 (0.07%)  0/3050 (0.00%) 
Lung squamous cell carcinoma stage unspecified * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Lymphoma * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Malignant melanoma * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Metastases to liver * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Metastatic neoplasm * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Neoplasm malignant * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Non-small cell lung cancer metastatic * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Oesophageal adenocarcinoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Oesophageal squamous cell carcinoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Ovarian cancer * 1  0/6108 (0.00%)  2/3050 (0.07%) 
Paget's disease of the breast * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Pancreatic carcinoma * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Pancreatic carcinoma metastatic * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Prostate cancer * 1  3/6108 (0.05%)  1/3050 (0.03%) 
Prostate cancer metastatic * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Prostate cancer recurrent * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Rectal cancer * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Renal cancer * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Skin cancer * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Small intestine carcinoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Splenic marginal zone lymphoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Splenic neoplasm malignancy unspecified * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Squamous cell carcinoma * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Testis cancer * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Thymoma * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Thyroid neoplasm * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Uterine cancer * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Nervous system disorders     
Balance disorder * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Carotid artery occlusion * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Carotid artery stenosis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Cerebral haemorrhage * 1  4/6108 (0.07%)  0/3050 (0.00%) 
Cerebral ischaemia * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Cerebrovascular accident * 1  11/6108 (0.18%)  6/3050 (0.20%) 
Cervicobrachial syndrome * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Drug withdrawal convulsions * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Epilepsy * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Facial palsy * 1  3/6108 (0.05%)  2/3050 (0.07%) 
Global amnesia * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Haemorrhage intracranial * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Haemorrhagic stroke * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Hypertensive encephalopathy * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Intracranial aneurysm * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Ischaemic stroke * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Lumbar radiculopathy * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Myelitis transverse * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Nerve compression * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Normal pressure hydrocephalus * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Paraesthesia * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Presyncope * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Subarachnoid haemorrhage * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Syncope * 1  15/6108 (0.25%)  4/3050 (0.13%) 
Transient ischaemic attack * 1  5/6108 (0.08%)  5/3050 (0.16%) 
Psychiatric disorders     
Alcohol abuse * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Alcoholism * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Anxiety disorder * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Bipolar disorder * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Completed suicide * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Delusion * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Depressed mood * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Depression * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Disorientation * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Major depression * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Mental disorder * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Mental status changes * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Renal and urinary disorders     
Anuria * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Bladder obstruction * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Calculus bladder * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Calculus ureteric * 1  3/6108 (0.05%)  0/3050 (0.00%) 
Haematuria * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Incontinence * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Nephrolithiasis * 1  4/6108 (0.07%)  0/3050 (0.00%) 
Renal artery stenosis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Renal failure * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Renal failure acute * 1  7/6108 (0.11%)  3/3050 (0.10%) 
Renal failure chronic * 1  1/6108 (0.02%)  2/3050 (0.07%) 
Renal mass * 1  3/6108 (0.05%)  1/3050 (0.03%) 
Urinary incontinence * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Urinary retention * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Cystocele * 1  2/6108 (0.03%)  2/3050 (0.07%) 
Uterine prolapse * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Vaginal haemorrhage * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Acute respiratory failure * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Asthma * 1  6/6108 (0.10%)  3/3050 (0.10%) 
Chronic obstructive pulmonary disease * 1  21/6108 (0.34%)  13/3050 (0.43%) 
Cough * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Dyspnoea * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Dyspnoea exertional * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Haemoptysis * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Hypoxia * 1  3/6108 (0.05%)  0/3050 (0.00%) 
Pleural effusion * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Pneumonia aspiration * 1  1/6108 (0.02%)  2/3050 (0.07%) 
Pneumothorax * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Pulmonary embolism * 1  4/6108 (0.07%)  0/3050 (0.00%) 
Pulmonary fibrosis * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Pulmonary oedema * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Respiratory failure * 1  4/6108 (0.07%)  1/3050 (0.03%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Diabetic ulcer * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Surgical and medical procedures     
Colectomy * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Hospitalisation * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Knee arthroplasty * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Shoulder arthroplasty * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Vascular disorders     
Aneurysm * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Aortic aneurysm * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Arterial occlusive disease * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Arterial thrombosis limb * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Arteriosclerosis * 1  1/6108 (0.02%)  1/3050 (0.03%) 
Deep vein thrombosis * 1  4/6108 (0.07%)  0/3050 (0.00%) 
Embolism * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Femoral artery embolism * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Femoral artery occlusion * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Haematoma * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Hypertension * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Hypertensive crisis * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Hypotension * 1  2/6108 (0.03%)  1/3050 (0.03%) 
Ischaemia * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Ischaemic limb pain * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Orthostatic hypotension * 1  0/6108 (0.00%)  1/3050 (0.03%) 
Peripheral artery aneurysm * 1  1/6108 (0.02%)  0/3050 (0.00%) 
Thrombosis * 1  2/6108 (0.03%)  0/3050 (0.00%) 
Vascular rupture * 1  1/6108 (0.02%)  0/3050 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Fluzone® High Dose Fluzone®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6108 (0.00%)   0/3050 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00976027     History of Changes
Other Study ID Numbers: FIM07
UTN: U1111-1111-4478 ( Other Identifier: WHO )
First Submitted: September 11, 2009
First Posted: September 14, 2009
Results First Submitted: June 19, 2012
Results First Posted: July 25, 2012
Last Update Posted: August 1, 2012