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Trial record 57 of 597 for:    Fluzone® | Studies With Results

Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects

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ClinicalTrials.gov Identifier: NCT00551031
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : November 24, 2011
Last Update Posted : May 16, 2016
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
Conditions Influenza
Myxovirus Infection
Interventions Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)
Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)
Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
Biological: Split, Inactivated, Trivalent Influenza Vaccine (High-dose)
Enrollment 2098

Recruitment Details Participants were enrolled from 24 October to 31 October 2007 in 31 medical centers in the US.
Pre-assignment Details A total of 2095 of the 2098 enrolled participants who met the inclusion and exclusion criteria were vaccinated.
Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
Hide Arm/Group Description Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Period Title: Overall Study
Started 637 636 319 320 186
Completed 635 625 317 317 185
Not Completed 2 11 2 3 1
Reason Not Completed
Adverse Event             0             1             0             0             0
Protocol Violation             1             1             0             0             0
Lost to Follow-up             0             1             0             1             1
Withdrawal by Subject             0             4             1             2             0
Serious Adverse Event             0             2             1             0             0
Did not receive vaccine             1             2             0             0             0
Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group Total
Hide Arm/Group Description Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM) Total of all reporting groups
Overall Number of Baseline Participants 635 635 319 320 186 2095
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 635 participants 635 participants 319 participants 320 participants 186 participants 2095 participants
<=18 years
0
   0.0%
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%
186
 100.0%
186
   8.9%
>=65 years
635
 100.0%
635
 100.0%
319
 100.0%
320
 100.0%
0
   0.0%
1909
  91.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 635 participants 635 participants 319 participants 320 participants 186 participants 2095 participants
73.1  (6.03) 72.9  (5.86) 73.4  (5.91) 73.0  (6.00) 32.2  (8.49) 64.8  (6.458)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 635 participants 635 participants 319 participants 320 participants 186 participants 2095 participants
Female
363
  57.2%
347
  54.6%
176
  55.2%
183
  57.2%
121
  65.1%
1190
  56.8%
Male
272
  42.8%
288
  45.4%
143
  44.8%
137
  42.8%
65
  34.9%
905
  43.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 635 participants 635 participants 319 participants 320 participants 186 participants 2095 participants
635 635 319 320 186 2095
1.Primary Outcome
Title Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Hide Description Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.
Time Frame Day 0 and Day 28 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers GMTs were assessed in the per-protocol population.
Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
Hide Arm/Group Description:
Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Overall Number of Participants Analyzed 607 608 304 309 179
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 Pre Dose (N=604, 607, 304, 309, 179)
18.3
(16.9 to 19.8)
18.6
(17.1 to 20.2)
17.8
(15.7 to 20.0)
17.3
(15.3 to 19.5)
41.4
(32.6 to 52.7)
A/H1N1 Post Dose (N=605, 607, 304, 309, 179)
165.4
(149.2 to 183.4)
174.1
(157.5 to 192.4)
107.6
(93.2 to 124.3)
236.1
(207.3 to 268.9)
345.8
(294.1 to 406.6)
A/H3N2 Pre Dose (N=606, 608, 304, 309, 179)
103.8
(93.1 to 115.9)
104.7
(93.9 to 116.7)
95.1
(82.1 to 110.3)
99.3
(84.6 to 116.7)
73.0
(58.7 to 90.8)
A/H3N2 Post Dose (N=605, 608, 304, 309, 179)
348.3
(320.2 to 378.9)
378.4
(346.9 to 412.7)
276.9
(245.8 to 311.8)
508.0
(452.6 to 570.1)
398.3
(343.4 to 461.9)
B Pre Dose (N=607, 608, 304, 309, 179)
24.7
(22.9 to 26.6)
25.1
(23.3 to 27.1)
24.7
(22.2 to 27.4)
24.1
(21.7 to 26.8)
15.5
(13.4 to 17.9)
B Post Dose (N=607, 608, 304, 309, 179)
45.3
(42.3 to 48.4)
47.5
(44.3 to 50.9)
43.4
(39.2 to 48.0)
59.9
(54.5 to 65.9)
71.2
(61.7 to 82.3)
2.Primary Outcome
Title Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine
Hide Description Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.
Time Frame Day 28 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers were assessed in the per protocol population.
Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
Hide Arm/Group Description:
Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Overall Number of Participants Analyzed 607 608 304 309 179
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1 (N=604, 607, 304, 309, 179) 73 74 61 82 62
A/H3N2 (N=605, 608, 304, 309, 179) 42 42 37 56 52
B (N=607, 608, 304, 309, 179) 15 15 9 26 44
3.Primary Outcome
Title Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Hide Description Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40
Time Frame Day 0 and Day 28 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers were assessed in the per protocol population.
Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
Hide Arm/Group Description:
Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Overall Number of Participants Analyzed 607 608 304 309 179
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) 27 25 25 23 49
A/H1N1 Post Dose (N=605, 607, 304, 309, 179) 88 90 79 94 97
A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) 78 79 80 78 72
A/H3N2 Post Dose (N=605, 608, 304, 309, 179) 98 98 97 99 99
B Pre Dose (N=607, 608, 304, 309, 179) 38 37 39 37 25
B Post Dose (N=607, 608, 304, 309, 179) 65 67 62 77 79
4.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Hide Description

Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis.

Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills

Time Frame Days 0 through 7 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent to treat population.
Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
Hide Arm/Group Description:
Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Overall Number of Participants Analyzed 635 635 319 320 186
Measure Type: Number
Unit of Measure: Participants
Any Injection Site Pain 174 187 57 117 106
Grade 3 Pain (Prevents daily activities) 0 0 0 0 0
Any Injection Site Pruritus 204 214 27 17 24
Grade 3 Pruritus (Prevents daily activities) 2 3 0 0 0
Any Injection Site Erythema 426 434 48 55 29
Grade 3 Erythema (≥ 5 cm) 109 108 5 12 5
Any Injection Site Swelling 286 286 23 45 14
Grade 3 Swelling (≥ 5 cm) 50 49 6 16 1
Any Injection Site Induration 310 311 33 45 20
Grade 3 Induration (≥ 5 cm) 41 43 5 12 4
Any Injection Site Ecchymosis 38 41 19 17 14
Grade 3 Ecchymosis (≥ 5 cm) 5 9 2 2 2
Any Fever 14 18 5 17 10
Grade 3 Fever (> 102.2 ºF) 0 0 0 0 1
Any Headache 103 89 41 59 61
Grade 3 Headache (Prevents daily activities) 2 6 1 2 2
Any Malaise 76 98 42 50 45
Grade 3 Malaise (Prevents daily activities) 5 3 0 3 6
Any Myalgia 86 106 46 79 68
Grade 3 Myalgia (Prevents daily activities) 2 2 1 3 1
Any Chills 21 32 9 28 17
Grade 3 Chills (Prevents daily activities) 0 3 0 2 2
Time Frame Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
Hide Arm/Group Description Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
All-Cause Mortality
Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/635 (5.35%)      38/635 (5.98%)      21/319 (6.58%)      16/320 (5.00%)      7/186 (3.76%)    
Blood and lymphatic system disorders           
Microcytic anaemia * 1  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Cardiac disorders           
Acute myocardial infarction * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 1/320 (0.31%)  1 0/186 (0.00%)  0
Angina pectoris * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Atrial fibrillation * 2  2/635 (0.31%)  2 1/635 (0.16%)  1 2/319 (0.63%)  2 0/320 (0.00%)  0 0/186 (0.00%)  0
Cardiac arrest * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Cardiac failure * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Cardiac failure congestive * 2  1/635 (0.16%)  1 1/635 (0.16%)  1 1/319 (0.31%)  1 1/320 (0.31%)  1 0/186 (0.00%)  0
Cardiovascular disorder * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Coronary artery disease * 2  1/635 (0.16%)  1 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Ventricular tachycardia * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 1/186 (0.54%)  1
Ear and labyrinth disorders           
Meniere's disease * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Vertigo * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Colitis ulcerative * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 1/319 (0.31%)  1 0/186 (0.00%)  0
Gastric ulcer * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Gasgtrooesophageal reflux disease * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 1/320 (0.31%)  1 0/186 (0.00%)  0
Intestinal perforation * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Large intestine perforation * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Oesophagitis * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Pancreatitis * 2  1/635 (0.16%)  1 2/635 (0.31%)  2 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Pancreatitis acute * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Small intestinal obstruction * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
General disorders           
Chest pain * 2  0/635 (0.00%)  0 2/635 (0.31%)  2 0/319 (0.00%)  0 2/319 (0.63%)  2 1/186 (0.54%)  1
Influenza like illness * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Non cardiac chest pain * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 1/186 (0.54%)  1
Pain * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Hepatobiliary disorders           
Biliary colic * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Gallbladder disorder * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Hepatic failure * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Immune system disorders           
Drug hypersensitivity * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 1/320 (0.31%)  1 0/186 (0.00%)  0
Hypersensitivity * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Infections and infestations           
Bronchitis * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Cellulitis * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Clostridial infection * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Diverticulitis * 2  1/635 (0.16%)  1 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Infection * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Influenza * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 1/320 (0.31%)  1 0/186 (0.00%)  0
Otitis media * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 1/320 (0.31%)  1 0/186 (0.00%)  0
Pneumonia * 2  0/635 (0.00%)  0 2/635 (0.31%)  2 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Viral infection * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Injury, poisoning and procedural complications           
Cardiac pacemaker malfunction * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Dislocation of joint prosthesis * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Head injury * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Hip fracture * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Humerus fracture * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Joint injury * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Procedural pain * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Renal haematoma * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Spinal compression fracture * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Stent graft material failure * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Subdural haematoma * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
International normalised ratio increased * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Metabolism and nutrition disorders           
Dehydration * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 1/320 (0.31%)  1 1/186 (0.54%)  1
Hypokalaemia * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Hyponatraemia * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Intervertebral disc protrusion * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Muscular weakness * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 1/320 (0.31%)  1 0/186 (0.00%)  0
Neck pain * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Osteoarthritis * 2  2/635 (0.31%)  2 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Rhabdomyolysis * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 1/320 (0.31%)  1 0/186 (0.00%)  0
Rotator cuff syndrome * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Bladder cancer * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Breast cancer * 2  1/635 (0.16%)  1 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Chronic lymphocytic leukaemia * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Colon cancer * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Lung adenocarcinoma * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Lung neoplasm malignant * 2  0/635 (0.00%)  0 2/635 (0.31%)  2 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Pancreatic carcinoma * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Prostate cancer * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 1/320 (0.31%)  1 0/186 (0.00%)  0
Prostate cancer recurrent * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Small cell lung cancer metastatic * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 1/320 (0.31%)  1 0/186 (0.00%)  0
Nervous system disorders           
Carotid artery stenosis * 2  1/635 (0.16%)  1 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Cerebrovascular accident * 2  1/635 (0.16%)  1 1/635 (0.16%)  1 3/319 (0.94%)  3 0/320 (0.00%)  0 0/186 (0.00%)  0
Intracranial aneurysm * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Lumbar radiculopathy * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Presyncope * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Syncope * 2  2/635 (0.31%)  2 0/635 (0.00%)  0 1/319 (0.31%)  1 2/320 (0.63%)  2 1/186 (0.54%)  1
Thrombotic stroke * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 1/320 (0.31%)  1 0/186 (0.00%)  0
Transient ischaemic attack * 2  2/635 (0.31%)  2 2/635 (0.31%)  2 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Psychiatric disorders           
Depression * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Renal and urinary disorders           
Bladder prolapse * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Renal failure acute * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Urinary incontinence * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Asthma * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 1/186 (0.54%)  1
Chronic obstructive pulmonary disease * 2  1/635 (0.16%)  1 2/635 (0.31%)  2 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Hypoxia * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Pharyngeal mass * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Respiratory failure * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 0/186 (0.00%)  0
Status asthmaticus * 2  0/635 (0.00%)  0 0/635 (0.00%)  0 1/319 (0.31%)  1 0/320 (0.00%)  0 1/186 (0.54%)  1
Vascular disorders           
Arteriosclerosis * 2  1/635 (0.16%)  1 0/635 (0.00%)  0 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
Peripheral vascular disorder * 2  0/635 (0.00%)  0 1/635 (0.16%)  1 0/319 (0.00%)  0 0/320 (0.00%)  0 0/186 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA10.0
2
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   426/635 (67.09%)      434/635 (68.35%)      57/319 (17.87%)      117/320 (36.56%)      106/186 (56.99%)    
General disorders           
Injection site pain  1  174/635 (27.40%)  174 187/632 (29.59%)  187 57/319 (17.87%)  57 117/318 (36.79%)  117 106/185 (57.30%)  106
Injection site pruritus  1  204/635 (32.13%)  204 214/632 (33.86%)  214 27/319 (8.46%)  27 17/318 (5.35%)  17 24/185 (12.97%)  24
Injection site erythema  1  426/635 (67.09%)  426 434/632 (68.67%)  434 48/319 (15.05%)  48 55/319 (17.24%)  55 29/185 (15.68%)  29
Injection site swelling  1  286/635 (45.04%)  286 286/631 (45.32%)  286 23/319 (7.21%)  23 45/319 (14.11%)  45 14/185 (7.57%)  14
Injection site induration  1  310/635 (48.82%)  310 311/631 (49.29%)  311 33/319 (10.34%)  33 45/319 (14.11%)  45 20/185 (10.81%)  20
Injection site ecchymosis  1  38/634 (5.99%)  38 41/631 (6.50%)  41 19/319 (5.96%)  19 17/319 (5.33%)  17 14/185 (7.57%)  14
Fever  1  14/630 (2.22%)  14 18/630 (2.86%)  18 5/319 (1.57%)  5 17/318 (5.35%)  17 10/182 (5.49%)  10
Malaise  1  76/634 (11.99%)  76 98/631 (15.53%)  98 42/319 (13.17%)  42 50/319 (15.67%)  50 45/185 (24.32%)  45
Chills  1  21/634 (3.31%)  21 32/632 (5.06%)  32 9/319 (2.82%)  9 28/319 (8.78%)  28 17/185 (9.19%)  17
Musculoskeletal and connective tissue disorders           
Myalgia  1  86/634 (13.56%)  86 106/632 (16.77%)  106 46/319 (14.42%)  46 79/319 (24.76%)  79 68/185 (36.76%)  68
Nervous system disorders           
Headache  1  103/634 (16.25%)  103 89/632 (14.08%)  89 41/319 (12.85%)  41 59/319 (18.50%)  59 61/185 (32.97%)  61
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00551031     History of Changes
Other Study ID Numbers: FID29
First Submitted: October 29, 2007
First Posted: October 30, 2007
Results First Submitted: October 13, 2011
Results First Posted: November 24, 2011
Last Update Posted: May 16, 2016