Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    FIM05
Previous Study | Return to List | Next Study

Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00391053
Recruitment Status : Completed
First Posted : October 23, 2006
Results First Posted : April 30, 2010
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Interventions Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
Biological: Inactivated, Split-Virion Influenza Vaccine
Enrollment 3851
Recruitment Details Participants were enrolled from 09 October 2006 to 21 December 2006 at 30 US sites.
Pre-assignment Details A total of 3851 participants who met the inclusion and exclusion criteria were randomized and vaccinated. The vaccine received by 14 participants could not be verified, they were excluded from all analyses except immunogenicity analysis. 4 participants that started the study, but had no post-vaccination assessment were also excluded from analysis.
Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®)
Hide Arm/Group Description Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3 Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Period Title: Overall Study
Started 857 848 870 1262
Completed 848 847 868 1252
Not Completed 9 1 2 10
Reason Not Completed
Serious Adverse Events             1             0             1             4
Protocol Violation             2             0             0             0
Lost to Follow-up             1             0             0             5
Withdrawal by Subject             5             1             1             1
Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®) Total
Hide Arm/Group Description Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3 Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation Total of all reporting groups
Overall Number of Baseline Participants 855 848 870 1260 3833
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 855 participants 848 participants 870 participants 1260 participants 3833 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
855
 100.0%
848
 100.0%
870
 100.0%
1260
 100.0%
3833
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 855 participants 848 participants 870 participants 1260 participants 3833 participants
72.9  (6.15) 72.9  (6.20) 72.9  (6.17) 72.9  (5.99) 72.9  (6.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 855 participants 848 participants 870 participants 1260 participants 3833 participants
Female
437
  51.1%
438
  51.7%
445
  51.1%
688
  54.6%
2008
  52.4%
Male
418
  48.9%
410
  48.3%
425
  48.9%
572
  45.4%
1825
  47.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 855 participants 848 participants 870 participants 1260 participants 3833 participants
855 848 870 1260 3833
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.
Hide Description Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.
Time Frame Day 0 and Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The geometric mean titers was assessed in the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.
Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®)
Hide Arm/Group Description:
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Overall Number of Participants Analyzed 854 861 861 1275
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 New Caledonia Pre-Dose
28.25
(26.37 to 30.26)
29.41
(27.39 to 31.57)
27.86
(25.94 to 29.93)
29.36
(27.72 to 31.11)
A/H1N1 New Caledonia Post-Dose
112.77
(105.64 to 120.37)
114.63
(107.18 to 122.61)
120.02
(112.12 to 128.48)
67.29
(63.65 to 71.13)
A/H3N2 Wisconsin Pre-Dose
74.53
(67.29 to 82.55)
77.3
(69.5 to 85.97)
72.07
(65.12 to 79.77)
74.74
(68.64 to 81.37)
A/H3N2 Wisconsin Post-Dose
595.03
(552.8 to 640.49)
628.54
(583.21 to 677.4)
603.59
(561.33 to 649.03)
332.46
(310.44 to 356.05)
B/Malaysia Pre-Dose
19.24
(17.98 to 20.58)
18.96
(17.71 to 20.29)
19.78
(18.49 to 21.16)
18.96
(17.93 to 20.04)
B/Malaysia Post-Dose
68.98
(64.77 to 73.47)
69.26
(64.99 to 73.81)
68.93
(64.81 to 73.3)
52.34
(49.48 to 55.35)
2.Primary Outcome
Title Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
Hide Description Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer <10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).
Time Frame Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.
Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®)
Hide Arm/Group Description:
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Overall Number of Participants Analyzed 854 861 861 1275
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1 New Caledonia 47 47 52 23
A/H3N2 Wisconsin 70 68 70 51
B/Malaysia 43 41 42 30
3.Secondary Outcome
Title Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
Hide Description Seroprotection was defined as a Hemagglutination Inhibition Titers of at least 40 (≥ 1:40) for each of the Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) pre- or post-vaccination with Fluzone® High-Dose or Standard Fluzone® vaccines.
Time Frame Day 0 and Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.
Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®)
Hide Arm/Group Description:
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Overall Number of Participants Analyzed 854 861 861 1275
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1 New Caledonia Pre-Dose 44 46 42 46
A/H1N1 New Caledonia Post-Dose 91 89 90 77
A/H3N2 Wisconsin Pre-Dose 70 69 68 69
A/H3N2 Wisconsin Post-Dose 99 99 99 97
B/Malaysia Pre-Dose 27 28 30 27
B/Malaysia Post-Dose 80 78 80 68
4.Secondary Outcome
Title Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination
Hide Description The occurrence, time to onset, number of days of occurrence, and severity of solicited injection site reactions: Injection Site Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia were collected.
Time Frame Day 0 to Day 7 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was performed on the Full Analysis Set according to the participants who actually received a vaccine, whether or not the subject received the assigned vaccine. A total of 3,833 participants were included in the analysis set for the evaluation of all safety.
Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®)
Hide Arm/Group Description:
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Overall Number of Participants Analyzed 855 848 870 1260
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Injection Site Reaction 41 42 43 31
Any Swelling 9 9 9 6
Grade 3 Swelling (≥ 5 cm) 1 2 1 1
Any Erythema 16 15 14 11
Grade 3 Erythema (≥ 5 cm) 3 1 2 1
Any Pain 35 34 38 24
Grade 3 Pain (Incapacitating) 1 0 0 0
Any Solicited Systemic Reaction 37 33 33 29
Any Fever 4 3 4 2
Grade 3 Fever (>102.2 ºF or >39.0 ºC) 0 0 0 0
Any Headache 17 16 17 14
Grade 3 Headache (Prevents Daily Activities) 1 2 1 0
Any Malaise 20 18 16 14
Grade 3 Malaise (Prevents Daily Activities) 1 2 2 1
Any Myalgia 23 21 21 18
Grade 3 Myalgia (Prevents Daily Activities) 1 1 2 0
Time Frame Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Standad Dose Inactivated, Split-Virion Influenza Vaccine
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Standad Dose Inactivated, Split-Virion Influenza Vaccine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Standad Dose Inactivated, Split-Virion Influenza Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/855 (6.55%)      56/848 (6.60%)      44/870 (5.06%)      93/1260 (7.38%)    
Blood and lymphatic system disorders         
Anaemia * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Pancytopenia * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Cardiac disorders         
Acute coronary syndrome * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Acute myocardial infarction * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Angina pectoris * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Angina unstable * 1  0/855 (0.00%)  0 2/848 (0.24%)  2 0/870 (0.00%)  0 1/1260 (0.08%)  1
Atrial fibrillation * 1  0/855 (0.00%)  0 2/848 (0.24%)  2 1/870 (0.11%)  1 3/1260 (0.24%)  3
Cardiac arrest * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 1/870 (0.11%)  1 2/1260 (0.16%)  2
Cardiac Failure * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Cardiac failure congestive * 1  4/855 (0.47%)  5 3/848 (0.35%)  3 0/870 (0.00%)  0 2/1260 (0.16%)  2
Cardio-respiratory arrest * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Congestive cardiomyopathy * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Coronary artery disease * 1  2/855 (0.23%)  2 3/848 (0.35%)  3 0/870 (0.00%)  0 4/1260 (0.32%)  4
Coronary artery occlusion * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 1/1260 (0.08%)  1
Myocardial infarction * 1  2/855 (0.23%)  2 1/848 (0.12%)  1 2/870 (0.23%)  2 4/1260 (0.32%)  4
Ventricular fibrillation * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Congenital, familial and genetic disorders         
Atrial septal defect * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Gastrointestinal disorders         
Abdominal mass * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Abdominal pain * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 1/1260 (0.08%)  1
Constipation * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Crohn's disease * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Duodenitis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Enterovesical fistula * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Gastritis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Gastrointestinal haemorrhage * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 1/870 (0.11%)  1 0/1260 (0.00%)  0
Oesophagitis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 2/1260 (0.16%)  2
Small intestinal obstruction * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 3/870 (0.34%)  3 1/1260 (0.08%)  1
Small intestinal perforation * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Umbilical hernia * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Upper gastrointestinal haemorrhage * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
General disorders         
Asthenia * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Chest pain * 1  0/855 (0.00%)  0 2/848 (0.24%)  2 0/870 (0.00%)  0 5/1260 (0.40%)  5
Fatigue * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Hernia * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Malaise * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Non-cardiac chest pain * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 2/1260 (0.16%)  2
Hepatobiliary disorders         
Cholecystitis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 2/1260 (0.16%)  2
Cholecystitis acute * 1  2/855 (0.23%)  2 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Cholelithiasis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Chronic hepatic failure * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Infections and infestations         
Bronchitis * 1  2/855 (0.23%)  2 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Cellulitis of male external genital organ * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Clostridium difficile colitis * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 1/1260 (0.08%)  1
Diverticulitis * 1  0/855 (0.00%)  0 2/848 (0.24%)  2 1/870 (0.11%)  1 2/1260 (0.16%)  2
Extradural abscess * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Gastroenteritis * 1  0/855 (0.00%)  0 3/848 (0.35%)  3 1/870 (0.11%)  1 0/1260 (0.00%)  0
Gastroenteritis viral * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Implant site cellulitis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Lung infection * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Osteomyelitis * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Pneumonia * 1  6/855 (0.70%)  6 5/848 (0.59%)  6 6/870 (0.69%)  8 4/1260 (0.32%)  4
Sepsis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 2/1260 (0.16%)  2
Staphylococcal infection * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Urinary tract infection * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Back injury * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Injury, poisoning and procedural complications         
Acetabulum fracture * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Ankle fracture * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Clavicle fracture * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Compression fracture * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Concussion * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Contusion * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Device failure * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Fall * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Femoral neck fracture * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 2/1260 (0.16%)  2
Femur fracture * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Head Injury * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Hip fracture * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 2/870 (0.23%)  2 0/1260 (0.00%)  0
Humerus fracture * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Joint injury * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Pacemaker complication * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Patella fracture * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Perirenal haematoma * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Post procedural haemorrhage * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 1/1260 (0.08%)  1
Postoperative ileus * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Spinal compression fracture * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Subdural haematoma * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Thoracic vertebral fracture * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Tibia fracture * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Upper limb fracture * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 2/1260 (0.16%)  2
Investigations         
Helicobacter pylori identification test positive * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Diabetes mellitus inadequate control * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Diabetic ketoacidosis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Gout * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Arthritis * 1  2/855 (0.23%)  2 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Back pain * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Intervertebral disc protrusion * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 2/1260 (0.16%)  2
Lumbar spinal stenosis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Monarthritis * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Musculoskeletal pain * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Osteoarthritis * 1  1/855 (0.12%)  1 1/848 (0.12%)  1 0/870 (0.00%)  0 1/1260 (0.08%)  1
Spinal column stenosis * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 1/870 (0.11%)  1 1/1260 (0.08%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Brain neoplasm malignant * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 1/1260 (0.08%)  1
Breast cancer * 1  0/855 (0.00%)  0 2/848 (0.24%)  2 2/870 (0.23%)  2 1/1260 (0.08%)  1
Breast cancer metastatic * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Bronchioloalveolar carcinoma * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Cervix carcinoma * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Colon adenoma * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Colon cancer * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Hepatic neoplasm malignant * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Laryngeal cancer * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Lung adenocarcinoma * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Lung neoplasm malignant * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 1/870 (0.11%)  1 1/1260 (0.08%)  1
Non-hodgkin's lymphoma * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Non-small cell lung cancer * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Prostate cancer * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 2/1260 (0.16%)  2
Renal cell carcinoma stage unspecified * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Sinus cancer metastatic * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Uterine cancer * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Nervous system disorders         
Oesophageal carcinoma * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Carotid artery stenosis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Cerebrovascular accident * 1  0/855 (0.00%)  0 5/848 (0.59%)  5 0/870 (0.00%)  0 1/1260 (0.08%)  1
Coordination abnormal * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Dizziness * 1  1/855 (0.12%)  1 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Facial palsy * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Grand mal convulsion * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Guillain-barre syndrome * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Headache * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 1/1260 (0.08%)  1
Hypoaesthesia * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Myasthenia gravis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Normal pressure hydrocephalus * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Parkinson's disease * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Syncope * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 5/1260 (0.40%)  5
Syncope vasovagal * 1  2/855 (0.23%)  2 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Transient ischaemic attack * 1  1/855 (0.12%)  1 1/848 (0.12%)  1 3/870 (0.34%)  4 4/1260 (0.32%)  4
Psychiatric disorders         
Affective disorder * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Anxiety * 1  2/855 (0.23%)  2 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Bipolar I disorder * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Bipolar disorder * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Drug dependence * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Mental status changes * 1  3/855 (0.35%)  3 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Renal and urinary disorders         
Renal failure acute * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 2/1260 (0.16%)  2
Renal failure chronic * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Urinary incontinence * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Urinary retention * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Reproductive system and breast disorders         
Benign prostatic hyperplasia * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Cystocele * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Rectocele * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Respiratory, thoracic and mediastinal disorders         
Bronchial hyperreactivity * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Bronchospasm * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Chronic obstructive pulmonary disease * 1  1/855 (0.12%)  1 2/848 (0.24%)  2 0/870 (0.00%)  0 3/1260 (0.24%)  3
Dyspnoea * 1  2/855 (0.23%)  2 2/848 (0.24%)  2 0/870 (0.00%)  0 0/1260 (0.00%)  0
Epistaxis * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 2/1260 (0.16%)  3
Pleural effusion * 1  0/855 (0.00%)  0 3/848 (0.35%)  4 0/870 (0.00%)  0 2/1260 (0.16%)  2
Pneumonia aspiration * 1  0/855 (0.00%)  0 1/848 (0.12%)  2 0/870 (0.00%)  0 0/1260 (0.00%)  0
Pneumonitis * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Pneumothorax * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 0/1260 (0.00%)  0
Pulmonary embolism * 1  2/855 (0.23%)  2 2/848 (0.24%)  2 3/870 (0.34%)  3 1/1260 (0.08%)  1
Skin and subcutaneous tissue disorders         
Erythema * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Urticaria * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 1/1260 (0.08%)  1
Vascular disorders         
Aortic aneurysm * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 1/870 (0.11%)  1 2/1260 (0.16%)  2
Deep vein thrombosis * 1  1/855 (0.12%)  1 2/848 (0.24%)  2 0/870 (0.00%)  0 1/1260 (0.08%)  1
Haematoma * 1  0/855 (0.00%)  0 1/848 (0.12%)  1 0/870 (0.00%)  0 0/1260 (0.00%)  0
Orthostatic hypotension * 1  1/855 (0.12%)  1 0/848 (0.00%)  0 0/870 (0.00%)  0 0/1260 (0.00%)  0
Peripheral vascular disorder * 1  0/855 (0.00%)  0 0/848 (0.00%)  0 0/870 (0.00%)  0 2/1260 (0.16%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Standad Dose Inactivated, Split-Virion Influenza Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   455/855 (53.22%)      454/848 (53.54%)      449/870 (51.61%)      544/1260 (43.17%)    
General disorders         
Injection site erythema  1  136/855 (15.91%)  136 125/848 (14.74%)  125 123/870 (14.14%)  123 136/1260 (10.79%)  136
Injection site pain  1  295/855 (34.50%)  295 292/848 (34.43%)  292 328/870 (37.70%)  328 306/1260 (24.29%)  306
Injection site swelling  1  79/855 (9.24%)  79 76/848 (8.96%)  76 75/870 (8.62%)  75 73/1260 (5.79%)  73
Malaise  1  173/855 (20.23%)  173 150/848 (17.69%)  150 139/870 (15.98%)  139 176/1260 (13.97%)  176
Musculoskeletal and connective tissue disorders         
Myalgia  1  197/855 (23.04%)  197 175/848 (20.64%)  175 178/870 (20.46%)  178 230/1260 (18.25%)  230
Nervous system disorders         
Headache  1  146/855 (17.08%)  146 138/848 (16.27%)  138 147/870 (16.90%)  147 182/1260 (14.44%)  182
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00391053     History of Changes
Other Study ID Numbers: FIM05
First Submitted: October 20, 2006
First Posted: October 23, 2006
Results First Submitted: January 14, 2010
Results First Posted: April 30, 2010
Last Update Posted: April 14, 2016