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Trial record 92 of 597 for:    Fluzone® | Studies With Results

Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

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: NCT00775450
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : August 11, 2011
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Influenza
Orthomyxovirus Infection
Myxovirus Infection
Intervention Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Enrollment 807

Recruitment Details Participants were enrolled from 14 October to 20 November 2008 in 27 medical centers in the US.
Pre-assignment Details A total of 807 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Group 1a: Fluzone ID After Fluzone ID Group 1b: Fluzone IM After Fluzone ID Group 2a: Fluzone IM After Fluzone IM Group 2b: Fluzone ID After Fluzone IM Group 3: Fluzone HD After Fluzone HD
Hide Arm/Group Description Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
Period Title: Overall Study
Started 295 98 105 108 201
Completed 292 98 105 108 199
Not Completed 3 0 0 0 2
Reason Not Completed
Serious Adverse Event             2             0             0             0             0
Protocol Violation             0             0             0             0             1
Withdrawal by Subject             1             0             0             0             1
Arm/Group Title Group 1a: Fluzone ID After Fluzone ID Group 1b: Fluzone IM After Fluzone ID Group 2a: Fluzone IM After Fluzone IM Group 2b: Fluzone ID After Fluzone IM Group 3: Fluzone HD After Fluzone HD Total
Hide Arm/Group Description Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) Total of all reporting groups
Overall Number of Baseline Participants 295 98 105 108 201 807
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 98 participants 105 participants 108 participants 201 participants 807 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%
0
   0.0%
0
   0.0%
>=65 years
295
 100.0%
98
 100.0%
105
 100.0%
108
 100.0%
201
 100.0%
807
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 295 participants 98 participants 105 participants 108 participants 201 participants 807 participants
73.9  (5.99) 74.2  (5.97) 73.0  (5.37) 74.3  (5.11) 73.5  (5.74) 73.8  (5.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 98 participants 105 participants 108 participants 201 participants 807 participants
Female
169
  57.3%
54
  55.1%
58
  55.2%
61
  56.5%
117
  58.2%
459
  56.9%
Male
126
  42.7%
44
  44.9%
47
  44.8%
47
  43.5%
84
  41.8%
348
  43.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 295 participants 98 participants 105 participants 108 participants 201 participants 807 participants
295 98 105 108 201 807
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Hide Description Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
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 Group 1a: Fluzone ID After Fluzone ID Group 1b: Fluzone IM After Fluzone ID Group 2a: Fluzone IM After Fluzone IM Group 2b: Fluzone ID After Fluzone IM Group 3: Fluzone HD After Fluzone HD
Hide Arm/Group Description:
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
Overall Number of Participants Analyzed 292 98 105 107 200
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection site Pain 68 18 23 31 91
Grade 3 Pain (Incapacitating) 2 0 0 2 1
Any Solicited Injection site Erythema 207 18 9 71 34
Grade 3 Erythema (≥ 5 cm) 34 1 0 7 7
Any Solicited Injection site Swelling 127 4 3 44 23
Grade 3 Swelling (≥ 5 cm) 9 0 0 3 5
Any Solicited Injection site Induration 133 6 6 50 18
Grade 3 Induration (≥ 5 cm) 5 0 0 1 1
Any Solicited Injection site Ecchymosis 27 2 5 11 6
Grade 3 Ecchymosis (≥ 5 cm) 1 0 0 0 0
Any Solicited Injection site Pruritus 99 3 6 38 20
Grade 3 Pruritus (Incapacitating) 6 0 0 1 0
Any Fever 9 1 1 4 7
Grade 3 Fever (>102.2 ºF) 0 0 0 0 0
Any Headache 39 14 15 17 45
Grade 3 Headache (Prevents daily activities) 1 0 0 2 1
Any Malaise 31 7 18 16 36
Grade 3 Malaise (Prevents daily activities) 1 0 0 1 2
Any Myalgia 35 18 25 22 48
Grade 3 Myalgia (Prevents daily activities) 0 0 0 1 2
Any Shivering 12 2 5 7 9
Grade 3 Shivering (Prevents daily activities) 0 0 0 0 0
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Hide Description Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the 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 were assessed in the per-protocol population.
Arm/Group Title Group 1a: Fluzone ID After Fluzone ID Group 1b: Fluzone IM After Fluzone ID Group 2a: Fluzone IM After Fluzone IM Group 2b: Fluzone ID After Fluzone IM Group 3: Fluzone HD After Fluzone HD
Hide Arm/Group Description:
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
Overall Number of Participants Analyzed 273 94 100 102 187
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 Pre-dose (Day 0,N = 273, 94, 100, 102, 186)
28.7
(25.3 to 32.5)
23.5
(19.3 to 28.6)
27.3
(22.0 to 33.9)
20.8
(17.1 to 25.2)
28.7
(24.5 to 33.6)
A/H1N1 Post -dose (Day 0 = 273, 94, 100, 102, 185)
75.0
(66.4 to 84.7)
59.6
(48.4 to 73.2)
72.4
(58.7 to 89.2)
73.5
(60.4 to 89.5)
113
(96.2 to 133)
A/H2N3 Pre-dose (Day 0, N= 273, 94, 100, 102, 186)
30.8
(26.3 to 36.2)
28.7
(22.1 to 37.3)
24.5
(19.6 to 30.7)
28.1
(21.8 to 36.2)
36.6
(30.2 to 44.4)
A/H2N3 Post Dose (n = 273, 94, 100, 102, 187)
244
(205 to 289)
212
(156 to 288)
257
(197 to 336)
273
(208 to 358)
454
(380 to 543)
B Pre Dose (n = 273, 94, 100, 102, 186
22.8
(20.2 to 25.6)
18.9
(15.5 to 22.9)
21.8
(18.0 to 26.5)
21.9
(17.9 to 26.8)
22.3
(19.6 to 25.4)
B Post Dose (n = 273, 94, 100, 102, 185)
54.3
(48.3 to 61.0)
51.4
(42.4 to 62.3)
60.4
(49.6 to 73.6)
51.1
(42.9 to 60.9)
78.2
(68.5 to 89.3)
3.Secondary Outcome
Title Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
Hide Description Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.
Time Frame Days 0 and 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 Group 1a: Fluzone ID After Fluzone ID Group 1b: Fluzone IM After Fluzone ID Group 2a: Fluzone IM After Fluzone IM Group 2b: Fluzone ID After Fluzone IM Group 3: Fluzone HD After Fluzone HD
Hide Arm/Group Description:
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
Overall Number of Participants Analyzed 273 94 100 102 187
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1 Serogroup - (Day 0, Pre-dose) 40 36 39 26 41
A/H1N1 Serogroup - (Day 28, Post-dose) 80 72 80 81 88
A/H3N2 Serogroup - (Day 0, Pre-dose) 49 40 38 48 50
A/H3N2 Serogroup - (Day 28, Post-dose) 93 86 94 91 98
B Serogroup - (Day 0, Pre-dose) 36 29 32 32 36
B Serogroup - (Day 28, Post-dose) 73 69 75 66 83
4.Secondary Outcome
Title Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
Hide Description Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days 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 Group 1a: Fluzone ID After Fluzone ID Group 1b: Fluzone IM After Fluzone ID Group 2a: Fluzone IM After Fluzone IM Group 2b: Fluzone ID After Fluzone IM Group 3: Fluzone HD After Fluzone HD
Hide Arm/Group Description:
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
Overall Number of Participants Analyzed 273 94 100 102 186
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1 (N = 273, 94, 100, 102, 185) 31 28 31 44 47
A/H2N3 (N = 273, 94, 100, 102, 186) 73 64 76 75 84
B (N = 273, 94, 100, 102, 185) 24 31 33 26 41
Time Frame Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1a: Fluzone ID After Fluzone ID Group 1b: Fluzone IM After Fluzone ID Group 2a: Fluzone IM After Fluzone IM Group 2b: Fluzone ID After Fluzone IM Group 3: Fluzone HD After Fluzone HD
Hide Arm/Group Description Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
All-Cause Mortality
Group 1a: Fluzone ID After Fluzone ID Group 1b: Fluzone IM After Fluzone ID Group 2a: Fluzone IM After Fluzone IM Group 2b: Fluzone ID After Fluzone IM Group 3: Fluzone HD After Fluzone HD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1a: Fluzone ID After Fluzone ID Group 1b: Fluzone IM After Fluzone ID Group 2a: Fluzone IM After Fluzone IM Group 2b: Fluzone ID After Fluzone IM Group 3: Fluzone HD After Fluzone HD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/295 (3.39%)      3/98 (3.06%)      6/105 (5.71%)      3/108 (2.78%)      10/201 (4.98%)    
Cardiac disorders           
Acute Myocardial Infarction * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 3/105 (2.86%)  3 0/108 (0.00%)  0 0/201 (0.00%)  0
Myocardial Infarction * 1  0/295 (0.00%)  0 1/98 (1.02%)  1 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
Gastrointestinal disorders           
Retroperitoneal Haematoma * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Small Intestinal Obstruction * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 1/105 (0.95%)  1 0/108 (0.00%)  0 0/201 (0.00%)  0
Umbilical Hernia * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Umbilical Hernia, Obstructive * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
General disorders           
Chest Pain * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 1/105 (0.95%)  1 0/108 (0.00%)  0 0/201 (0.00%)  0
Non Cardiac Chest Pain * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
Hepatobiliary disorders           
Cholecystitis Acute * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 1/105 (0.95%)  1 0/108 (0.00%)  0 0/201 (0.00%)  0
Cholelithiasis * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 1/108 (0.93%)  1 0/201 (0.00%)  0
Cholecystectomy * 1  0/295 (0.00%)  0 1/98 (1.02%)  1 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Infections and infestations           
Bronchitis * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
Bacterial Sepsis * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Gastroenteritis * 1  0/295 (0.00%)  0 1/98 (1.02%)  1 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Infective Exacerbation of Chronic Obstructive Airways Disease * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
Lobar Pneumonia * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
Otitis Media Chronic * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
Pneumonia * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Injury, poisoning and procedural complications           
Humerus Fracture * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 1/108 (0.93%)  1 0/201 (0.00%)  0
Pelvic Fracture * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Subdural Haematoma * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Tibia Fracture * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthritis * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 1/105 (0.95%)  1 0/108 (0.00%)  0 0/201 (0.00%)  0
Back Pain * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Acute Myeloid Leukemia * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Breast Cancer * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 1/108 (0.93%)  1 1/201 (0.50%)  1
Prostate Cancer * 1  0/295 (0.00%)  0 1/98 (1.02%)  1 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Nervous system disorders           
Cerebral Cyst * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Cerebrovascular Accident * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
Subarachnoid Haemorrhage * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Renal and urinary disorders           
Renal Failure Acute * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Reproductive system and breast disorders           
Endometrial Hyperplasia * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
Respiratory, thoracic and mediastinal disorders           
Asthma * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
Pulmonary Oedema * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 1/105 (0.95%)  1 0/108 (0.00%)  0 0/201 (0.00%)  0
Vascular disorders           
Haemorrhage * 1  1/295 (0.34%)  1 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 0/201 (0.00%)  0
Hypertension * 1  0/295 (0.00%)  0 0/98 (0.00%)  0 0/105 (0.00%)  0 0/108 (0.00%)  0 1/201 (0.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Group 1a: Fluzone ID After Fluzone ID Group 1b: Fluzone IM After Fluzone ID Group 2a: Fluzone IM After Fluzone IM Group 2b: Fluzone ID After Fluzone IM Group 3: Fluzone HD After Fluzone HD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   239/292 (81.85%)      42/98 (42.86%)      54/105 (51.43%)      86/107 (80.37%)      123/200 (61.50%)    
General disorders           
Injection Site Pain  1  68/292 (23.29%)  68 18/98 (18.37%)  18 23/105 (21.90%)  23 31/107 (28.97%)  31 91/200 (45.50%)  91
Injection Site Erythema  1  207/292 (70.89%)  207 18/98 (18.37%)  18 9/105 (8.57%)  9 71/107 (66.36%)  71 34/200 (17.00%)  34
Injection Site Swelling  1  127/292 (43.49%)  127 4/98 (4.08%)  4 3/105 (2.86%)  3 44/107 (41.12%)  44 23/200 (11.50%)  23
Injection Site Induration * 1  133/292 (45.55%)  133 6/98 (6.12%)  6 6/105 (5.71%)  6 50/107 (46.73%)  50 18/200 (9.00%)  18
Malaise  1  31/292 (10.62%)  31 7/98 (7.14%)  7 18/105 (17.14%)  18 16/107 (14.95%)  16 36/200 (18.00%)  36
Shivering  1  12/292 (4.11%)  12 2/98 (2.04%)  2 5/105 (4.76%)  5 7/107 (6.54%)  7 9/200 (4.50%)  9
Musculoskeletal and connective tissue disorders           
Myalgia  1  35/292 (11.99%)  35 18/98 (18.37%)  18 25/105 (23.81%)  25 22/107 (20.56%)  22 48/200 (24.00%)  48
Nervous system disorders           
Headache  1  39/292 (13.36%)  39 14/98 (14.29%)  14 15/105 (14.29%)  15 17/107 (15.89%)  17 45/200 (22.50%)  45
Skin and subcutaneous tissue disorders           
Injection Site Pruritus * 1  99/292 (33.90%)  99 3/98 (3.06%)  3 6/105 (5.71%)  6 38/107 (35.51%)  38 20/200 (10.00%)  20
Vascular disorders           
Injection Site Ecchymosis  1  27/292 (9.25%)  27 2/98 (2.04%)  2 5/105 (4.76%)  5 11/107 (10.28%)  11 6/200 (3.00%)  6
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00775450     History of Changes
Other Study ID Numbers: FID21
First Submitted: October 16, 2008
First Posted: October 20, 2008
Results First Submitted: July 14, 2011
Results First Posted: August 11, 2011
Last Update Posted: December 31, 2013