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Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

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: NCT00772109
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : August 10, 2011
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
Intervention Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Enrollment 4292
Recruitment Details Participants were enrolled from 13 through 30 October 2008 in 50 clinics in the US.
Pre-assignment Details A total of 4276 of the 4292 participants that met the inclusion and exclusion criteria enrolled were vaccinated.
Arm/Group Title Fluzone Intradermal (ID) Vaccine Lot 1 Fluzone Intradermal (ID) Vaccine Lot 2 Fluzone Intradermal (ID) Vaccine Lot 3 Fluzone Intramuscular (IM) Vaccine
Hide Arm/Group Description Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0 Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Period Title: Overall Study
Started 956 953 955 1428
Completed 935 934 936 1397
Not Completed 21 19 19 31
Reason Not Completed
Serious adverse event             1             0             1             0
Protocol Violation             5             8             7             6
Lost to Follow-up             7             3             5             9
Withdrawal by Subject             8             8             6             16
Arm/Group Title Fluzone Intradermal (ID) Vaccine Lot 1 Fluzone Intradermal (ID) Vaccine Lot 2 Fluzone Intradermal (ID) Vaccine Lot 3 Fluzone Intramuscular (IM) Vaccine Total
Hide Arm/Group Description Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0 Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0 Total of all reporting groups
Overall Number of Baseline Participants 956 953 955 1428 4292
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 956 participants 953 participants 955 participants 1428 participants 4292 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
956
 100.0%
953
 100.0%
955
 100.0%
1428
 100.0%
4292
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 956 participants 953 participants 955 participants 1428 participants 4292 participants
42.7  (13.41) 42.8  (13.33) 42.2  (13.78) 42.5  (13.55) 42.5  (13.5175)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 956 participants 953 participants 955 participants 1428 participants 4292 participants
Female
611
  63.9%
619
  65.0%
594
  62.2%
899
  63.0%
2723
  63.4%
Male
345
  36.1%
334
  35.0%
361
  37.8%
529
  37.0%
1569
  36.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 956 participants 953 participants 955 participants 1428 participants 4292 participants
956 953 955 1428 4292
1.Primary Outcome
Title Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines
Hide Description The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
Time Frame Baseline (Day 0) and 28 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers (GMTs) were analyzed in the per-protocol population
Arm/Group Title Fluzone Intradermal (ID) Vaccine Lot 1 Fluzone Intradermal (ID) Vaccine Lot 2 Fluzone Intradermal (ID) Vaccine Lot 3 Fluzone Intramuscular (IM) Vaccine
Hide Arm/Group Description:
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Overall Number of Participants Analyzed 863 856 860 1286
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/H1N1 (Pre-vaccination, N = 863, 856, 860, 1285)
23.50
(21.58 to 25.60)
25.27
(23.16 to 27.58)
25.29
(23.20 to 27.56)
24.84
(23.16 to 26.65)
A/H1N1 (Post-vaccination, N = 863, 855, 861, 1283)
188.56
(172.67 to 205.92)
185.59
(169.81 to 202.83)
206.10
(188.53 to 225.31)
178.30
(166.36 to 191.11)
A/H3N2 (Pre-vaccination, N = 862, 853, 860, 1286)
18.77
(17.29 to 20.38)
20.56
(18.89 to 22.38)
18.37
(16.88 to 19.99)
19.99
(18.65 to 21.43)
A/H3N2 (Post-vaccination, N = 862, 853, 860, 1284)
260.46
(235.49 to 288.09)
234.03
(212.13 to 258.21)
246.06
(222.65 to 271.93)
230.71
(213.75 to 249.03)
B (Pre-vaccination, N = 862, 855, 860, 1286)
23.77
(22.03 to 25.63)
25.59
(23.69 to 27.64)
24.24
(22.51 to 26.10)
25.05
(23.53 to 26.68)
B (Post-vaccination, N = 861, 856, 860, 1285)
103.72
(96.61 to 111.35)
102.91
(95.88 to 110.46)
100.82
(93.95 to 108.20)
126.91
(119.70 to 134.56)
2.Primary Outcome
Title Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Hide Description

The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.

Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.

Time Frame 28 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was analyzed in the per-protocol population
Arm/Group Title Fluzone Intradermal (ID) Vaccine Lot 1 Fluzone Intradermal (ID) Vaccine Lot 2 Fluzone Intradermal (ID) Vaccine Lot 3 Fluzone Intramuscular (IM) Vaccine
Hide Arm/Group Description:
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Overall Number of Participants Analyzed 863 856 860 1286
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1 Serogroup 61 59 63 61
A/H3N2 Serogroup 76 73 77 75
B Serogroup 47 45 47 54
3.Secondary Outcome
Title Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM
Hide Description

The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.

Seroprotection was defined as a HAI antibody titer ≥ 1:40.

Time Frame Before and 28 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
4-Fold increase in antibody levels were analyzed in h per-protocol population
Arm/Group Title Fluzone Intradermal (ID) Vaccine Lot 1 Fluzone Intradermal (ID) Vaccine Lot 2 Fluzone Intradermal (ID) Vaccine Lot 3 Fluzone Intramuscular (IM) Vaccine
Hide Arm/Group Description:
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Overall Number of Participants Analyzed 863 857 861 1287
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1 Serogroup (Pre-vaccination) 39 40 42 39
A/H1N1 Serogroup (Post-vaccination) 90 90 93 92
A/H3N2 Serogroup (Pre-vaccination) 31 32 30 34
A/H3N2 Serogroup (Post-vaccination) 92 90 91 91
B Serogroup (Pre-vaccination) 38 42 40 41
B Serogroup (Post-vaccination) 88 88 86 89
4.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Hide Description Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Time Frame Day 0 up to 7 Days post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population
Arm/Group Title Fluzone Intradermal (ID) Vaccine Lot 1 Fluzone Intradermal (ID) Vaccine Lot 2 Fluzone Intradermal (ID) Vaccine Lot 3 Fluzone Intramuscular (IM) Vaccine
Hide Arm/Group Description:
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Overall Number of Participants Analyzed 953 951 951 1421
Measure Type: Number
Unit of Measure: Participants
Any Injection Site Ecchymosis 81 82 97 86
Grade 3 Injection Site Ecchymosis (≥ 5 cm) 8 2 2 6
Any Injection Site Erythema 716 698 726 184
Grade 3 Injection Site Erythema (≥ 5 cm) 125 118 120 13
Any Injection Site Induration 554 533 547 139
Grade 3 Injection Site Induration (≥ 5 cm) 36 19 41 7
Any Injection Site Pain 480 449 500 749
Grade 3 Injection Site Pain (Incapacitating) 3 6 9 11
Any Injection Site Pruritus 447 430 438 129
Grade 3 Injection Site Pruritus (Incapacitating) 13 10 7 0
Any Injection Site Swelling 544 525 519 117
Grade 3 Injection Site Swelling (≥ 5 cm) 55 45 52 13
Any Solicited Fever 29 40 40 36
Grade 3 Solicited Fever (> 102.2°F) 2 0 0 3
Any Solicited Headache 282 279 314 422
Gr 3 Solicited Headache- Prevents daily activities 11 16 14 22
Any Solicited Malaise 212 202 239 309
Grd 3 Solicited Malaise- Prevents daily activities 19 26 17 25
Any Solicited Myalgia 252 229 260 430
Grd 3 Solicited Myalgia- Prevents daily activities 13 18 10 19
Any Solicited Shivering 71 56 77 87
Gr 3 Solicited Shivering-Prevents daily activities 7 8 6 9
Time Frame Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluzone Intradermal (ID) Vaccine Lot 1 Fluzone Intradermal (ID) Vaccine Lot 2 Fluzone Intradermal (ID) Vaccine Lot 3 Fluzone Intramuscular (IM) Vaccine
Hide Arm/Group Description Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0 Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
All-Cause Mortality
Fluzone Intradermal (ID) Vaccine Lot 1 Fluzone Intradermal (ID) Vaccine Lot 2 Fluzone Intradermal (ID) Vaccine Lot 3 Fluzone Intramuscular (IM) Vaccine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone Intradermal (ID) Vaccine Lot 1 Fluzone Intradermal (ID) Vaccine Lot 2 Fluzone Intradermal (ID) Vaccine Lot 3 Fluzone Intramuscular (IM) Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/953 (1.78%)      16/951 (1.68%)      14/951 (1.47%)      20/1421 (1.41%)    
Blood and lymphatic system disorders         
Iron deficiency anaemia * 1  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 1/1421 (0.07%)  1
Cardiac disorders         
Atrial fibrillation * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 2/1421 (0.14%)  2
Bradycardia * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Cardiac failure acute * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Cardiac failure congestive * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Myocardial infarction * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Congenital, familial and genetic disorders         
Atrial septal defect * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Endocrine disorders         
Hyperthyroidism * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Gastrointestinal disorders         
Colitis ischaemic * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Gastritis * 2  1/953 (0.10%)  1 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Gastrooesophageal reflux disease * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Intussusception * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
General disorders         
Chest discomfort * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Chest pain * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 3/1421 (0.21%)  3
Non cardiac chest pain * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Hepatobiliary disorders         
Cholelithiasis * 2  1/953 (0.10%)  1 1/951 (0.11%)  1 1/951 (0.11%)  1 1/1421 (0.07%)  1
Immune system disorders         
Anaphylactic reaction * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Infections and infestations         
Abscess limb * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Appendicitis * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 1/1421 (0.07%)  1
Chronic sinusitis * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Diverticulitis * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 1/1421 (0.07%)  1
Escherichia sepsis * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Gastroenteritis * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Gastroenteritis viral * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Pneumonia * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Sepsi * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Injury, poisoning and procedural complications         
Ankle fracture * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Femur fracture * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Gun shot wound * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Injury * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Lower limb fracture * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Road traffic accident * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 1/951 (0.11%)  1 0/1421 (0.00%)  0
Stent occlusion * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Therapeutic agent toxicity * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Wrist fracture * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Metabolism and nutrition disorders         
Hypokalaemia * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  2
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion * 2  1/953 (0.10%)  1 1/951 (0.11%)  1 1/951 (0.11%)  1 0/1421 (0.00%)  0
Musculoskeletal chest pain * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Osteoarthritis * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bile duct cancer * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Bladder cancer * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Breast cancer * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Carcinoid tumour of the gastrointestinal tract * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Uterine leiomyoma * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Nervous system disorders         
Headache * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous * 2  2/953 (0.21%)  2 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Psychiatric disorders         
Bipolar disorder * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Renal and urinary disorders         
Renal infarct * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Reproductive system and breast disorders         
Adenomyosis * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 0/951 (0.00%)  0 1/1421 (0.07%)  1
Cystocele * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Uterovaginal prolapse * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Vaginal haemorrhage * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Bronchitis chronic * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Pulmonary embolism * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Skin and subcutaneous tissue disorders         
Rash * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Vascular disorders         
Arteriovenous fistula * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (0.00%)  0
Deep vein thrombosis * 2  0/953 (0.00%)  0 0/951 (0.00%)  0 1/951 (0.11%)  1 0/1421 (0.00%)  0
Haematoma * 2  0/953 (0.00%)  0 1/951 (0.11%)  1 0/951 (0.00%)  0 0/1421 (0.00%)  0
Vascular pseudoaneurysm * 2  1/953 (0.10%)  1 0/951 (0.00%)  0 0/951 (0.00%)  0 0/1421 (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%
Fluzone Intradermal (ID) Vaccine Lot 1 Fluzone Intradermal (ID) Vaccine Lot 2 Fluzone Intradermal (ID) Vaccine Lot 3 Fluzone Intramuscular (IM) Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   716/953 (75.13%)      698/951 (73.40%)      726/951 (76.34%)      749/1421 (52.71%)    
General disorders         
Injection site ecchymosis  1  81/935 (8.66%)  81 82/935 (8.77%)  82 97/929 (10.44%)  97 86/1392 (6.18%)  86
Injection site erythema  1  716/936 (76.50%)  716 698/935 (74.65%)  698 726/930 (78.06%)  726 184/1393 (13.21%)  184
Injection site induration  1  554/934 (59.31%)  554 533/935 (57.01%)  533 547/929 (58.88%)  547 139/1392 (9.99%)  139
Injection site pain  1  480/936 (51.28%)  480 449/935 (48.02%)  449 500/931 (53.71%)  500 749/1394 (53.73%)  749
Injection site pruritus  1  447/936 (47.76%)  447 430/935 (45.99%)  430 438/931 (47.05%)  438 129/1394 (9.25%)  129
Injection site swelling  1  544/934 (58.24%)  544 525/935 (56.15%)  525 519/929 (55.87%)  519 117/1392 (8.41%)  117
Solicited Malaise  1  212/936 (22.65%)  212 202/935 (21.60%)  202 239/930 (25.70%)  239 309/1394 (22.17%)  309
Musculoskeletal and connective tissue disorders         
Solicited Myalgia  1  252/936 (26.92%)  252 229/935 (24.49%)  229 260/930 (27.96%)  260 430/1394 (30.85%)  430
Solicited Shivering  1  71/936 (7.59%)  71 56/935 (5.99%)  56 77/930 (8.28%)  77 87/1394 (6.24%)  87
Nervous system disorders         
Solicited Headache  1  282/936 (30.13%)  282 279/935 (29.84%)  279 314/930 (33.76%)  314 422/1394 (30.27%)  422
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA10.0
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
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: NCT00772109     History of Changes
Other Study ID Numbers: FID31
First Submitted: October 13, 2008
First Posted: October 15, 2008
Results First Submitted: July 16, 2011
Results First Posted: August 10, 2011
Last Update Posted: April 14, 2016