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Trial record 1 of 1 for:    FID04
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Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects

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ClinicalTrials.gov Identifier: NCT00388583
Recruitment Status : Completed
First Posted : October 17, 2006
Results First Posted : September 13, 2011
Last Update Posted : April 18, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Intervention Biological: Split, Inactivated, Trivalent Influenza Vaccine
Enrollment 817
Recruitment Details Participants were enrolled from 28 September 2006 through 30 May 2007 in 16 clinics in the US
Pre-assignment Details A total of 816 of the 817 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on the 807 participants that completed the study are presented.
Arm/Group Title Fluzone Intradermal (ID) Vaccine Group Fluzone Intramuscular (IM) Vaccine Group
Hide Arm/Group Description Participants received a dose of Fluzone Intradermal vaccine on Day 0 Participants received a dose of Fluzone Intramuscular vaccine on Day 0
Period Title: Overall Study
Started 407 410
Completed 401 406
Not Completed 6 4
Reason Not Completed
Protocol Violation             1             0
Withdrawal by Subject             3             3
Serious Adverse Event             2             0
Did not receive vaccine             0             1
Arm/Group Title Fluzone ID Vaccine Group Fluzone IM Vaccine Group Total
Hide Arm/Group Description Participants received a dose (0.1 mL) of Fluzone intradermal vaccine on Day 0. Participants received a dose (0.5 mL) of Fluzone intramuscular vaccine on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 401 406 807
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 401 participants 406 participants 807 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
401
 100.0%
406
 100.0%
807
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 401 participants 406 participants 807 participants
72.8  (6.08) 72.3  (5.83) 72.5  (5.955)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 401 participants 406 participants 807 participants
Female
234
  58.4%
223
  54.9%
457
  56.6%
Male
167
  41.6%
183
  45.1%
350
  43.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 401 participants 406 participants 807 participants
401 406 807
1.Primary Outcome
Title Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Hide Description The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Time Frame Pre-vaccination and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity determination was in all per protocol population
Arm/Group Title Fluzone Intradermal (ID) Vaccine Group Fluzone Intramuscular (IM) Vaccine Group
Hide Arm/Group Description:
Participants received a dose of Fluzone Intradermal vaccine on Day 0
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
Overall Number of Participants Analyzed 401 406
Measure Type: Number
Unit of Measure: Participants
A/H1N1 Serogroup (N = 400, 406) 119 105
A/H3N2 Serogroup (N = 398, 404) 235 222
B Serogroup (N = 400, 405) 105 103
2.Primary Outcome
Title Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Hide Description Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity determination was in all per protocol population
Arm/Group Title Fluzone Intradermal (ID) Vaccine Group Fluzone Intramuscular (IM) Vaccine Group
Hide Arm/Group Description:
Participants received a dose of Fluzone Intradermal vaccine on Day 0
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
Overall Number of Participants Analyzed 401 406
Measure Type: Number
Unit of Measure: Participants
A/H1N1 Serogroup (N = 400, 406) 303 292
A/H3N2 Serogroup (N = 398, 405) 391 389
B Serogroup (N = 400, 406) 200 213
3.Secondary Outcome
Title Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
Hide Description The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Time Frame Pre- and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity determination was in all per protocol population
Arm/Group Title Fluzone Intradermal (ID) Vaccine Group Fluzone Intramuscular (IM) Vaccine Group
Hide Arm/Group Description:
Participants received a dose of Fluzone Intradermal vaccine on Day 0
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
Overall Number of Participants Analyzed 401 406
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 Serogroup (Pre-vaccination)
27.46
(24.81 to 30.40)
24.86
(22.33 to 27.69)
A/H1N1 Serogroup (Post-vaccination)
71.17
(63.93 to 79.22)
59.04
(53.27 to 65.42)
A/H3N2 Serogroup (Pre-vaccination)
75.95
(65.42 to 88.17)
64.95
(55.91 to 75.45)
A/H3N2 Serogroup (Post-vaccination)
500.65
(442.40 to 566.56)
360.42
(317.68 to 408.91)
B Serogroup (Pre-vaccination)
13.11
(12.08 to 14.22)
12.95
(11.93 to 14.05)
B Serogroup (Post-vaccination)
35.06
(31.91 to 38.53)
35.77
(32.44 to 39.44)
4.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Hide Description

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

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

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 Group Fluzone Intramuscular (IM) Vaccine Group
Hide Arm/Group Description:
Participants received a dose of Fluzone Intradermal vaccine on Day 0
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
Overall Number of Participants Analyzed 407 409
Measure Type: Number
Unit of Measure: Participants
Any Injection Site Pain 105 98
Grade 3 Injection Site Pain (Incapacitating) 0 1
Any Injection Site Erythema 282 49
Grade 3 Injection Site Erythema (≥ 5 cm) 39 0
Any Injection Site Swelling 186 20
Grade 3 Injection Site Swelling (≥ 5 cm) 17 4
Any Injection Site Induration 178 17
Grade 3 Injection Site Induration (≥ 5 cm) 12 0
Any Injection Site Ecchymosis 23 12
Grade 3 Injection Site Ecchymosis (Incapacitating) 1 0
Any Injection Site Pruritus 137 23
Grade 3 Injection Site Pruritus (Incapacitating) 0 0
Any Solicited Fever 10 4
Grade 3 Solicited Fever (>102.2°F) 0 1
Any Solicited Headache 69 63
Gr 3 Solicited Headache- Prevents daily activities 2 1
Any Solicited Malaise 57 41
Grd 3 Solicited Malaise- Prevents daily activities 3 4
Any Solicited Myalgia 68 56
Grd 3 Solicited Myalgia- Prevents daily activities 4 0
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 Fluzone Intradermal (ID) Vaccine Group Fluzone Intramuscular (IM) Vaccine Group
Hide Arm/Group Description Participants received a dose of Fluzone Intradermal vaccine on Day 0 Participants received a dose of Fluzone Intramuscular vaccine on Day 0
All-Cause Mortality
Fluzone Intradermal (ID) Vaccine Group Fluzone Intramuscular (IM) Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone Intradermal (ID) Vaccine Group Fluzone Intramuscular (IM) Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/407 (8.11%)      34/409 (8.31%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/407 (0.25%)  2 0/409 (0.00%)  0
Cardiac disorders     
Coronary artery disease * 1  2/407 (0.49%)  4 2/409 (0.49%)  2
Atrial fibrillation * 1  1/407 (0.25%)  1 1/409 (0.24%)  1
Angina pectoris * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Ischaemic cardiomyopathy * 1  1/407 (0.25%)  3 1/409 (0.24%)  3
Myocardial infarction * 1  0/407 (0.00%)  0 0/0  0
Ischaemic cardiomyopathy * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Pericarditis * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Mitral valve incompetence * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Arrhythmia * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Acute coronary syndrome * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Cardiac failure congestive * 1  0/407 (0.00%)  0 2/409 (0.49%)  2
Atrial tachycardia * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Gastrointestinal disorders     
Enterovesical Fistula * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Chest Pain * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Small intestinal obstruction * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Diverticulum * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Hemorrhoids * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Ileus * 1  0/407 (0.00%)  0 0/409 (0.00%)  0
Colitis * 1  0/407 (0.00%)  0 0/409 (0.00%)  0
Pancreatitis * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Inguinal hernia * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Peptic ulcer * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Small intestine obstruction * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
General disorders     
Chest pain * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Hepatobiliary disorders     
Bile duct stone * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Infections and infestations     
Incision site infection * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Bronchitis acute * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Pneumonia * 1  1/407 (0.25%)  2 0/409 (0.00%)  0
Tracheobronchitis * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Injury, poisoning and procedural complications     
Fall * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Femur fracture * 1  1/407 (0.25%)  1 1/409 (0.24%)  2
Device electric finding * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Metabolism and nutrition disorders     
Hypoglycaemia * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Diabetes mellitus * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Diabetes mellitus non insulin dependent * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Musculoskeletal and connective tissue disorders     
Scoliosis * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Shoulder pain * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Rotator cuff syndrome * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Osteoarthritis * 1  1/407 (0.25%)  1 2/409 (0.49%)  2
Joint instability * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Intervertebral disc protrusion * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Back pain * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma * 1  1/407 (0.25%)  1 1/409 (0.24%)  1
Colon cancer * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Lung neoplasm malignant * 1  1/407 (0.25%)  1 1/409 (0.24%)  2
Benign renal neoplasm * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Uterine cancer * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Squamous cell carcinoma of the skin * 1  0/407 (0.00%)  0 0/0  0
Basal cell carcinoma * 1  0/407 (0.00%)  0 0/409 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident * 1  3/407 (0.74%)  7 1/409 (0.24%)  1
Dizziness * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Transient ischaemic attack * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Renal and urinary disorders     
Nephrolithiasis * 1  2/407 (0.49%)  2 0/409 (0.00%)  0
Renal failure acute * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Bladder prolapse * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Urinary retention * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Reproductive system and breast disorders     
Cystocele * 1  0/407 (0.00%)  0 0/409 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonitis * 1  1/407 (0.25%)  4 0/409 (0.00%)  0
Chronic obstructive pulmonary disease * 1  1/407 (0.25%)  2 1/409 (0.24%)  1
Pulmonary embolism * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Atelectasis * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Surgical and medical procedures     
Transuerethral prostatectomy * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
Vascular disorders     
Leriche syndrome * 1  1/407 (0.25%)  1 0/409 (0.00%)  0
Deep vein thrombosis * 1  0/407 (0.00%)  0 1/409 (0.24%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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 Group Fluzone Intramuscular (IM) Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   282/407 (69.29%)      98/409 (23.96%)    
General disorders     
Vessel puncture site bruise * 1  23/407 (5.65%)  23 15/409 (3.67%)  15
Solicited injection site pain  1  105/402 (26.12%)  105 98/409 (23.96%)  98
Solicited injection site erythema  1  282/402 (70.15%)  282 49/409 (11.98%)  49
Solicited injection site induration  1  178/400 (44.50%)  178 17/409 (4.16%)  17
Solicited injection site ecchymosis  1  23/400 (5.75%)  23 12/409 (2.93%)  12
Solicited injection site pruritus  1  137/402 (34.08%)  137 23/409 (5.62%)  23
Solicited malaise  1  57/402 (14.18%)  57 41/409 (10.02%)  41
Solicited myalgia  1  68/402 (16.92%)  68 56/409 (13.69%)  56
Solicited injection site swelling  1  186/402 (46.27%)  186 20/409 (4.89%)  20
Nervous system disorders     
Solicited headache (Pyrexia)  1  69/402 (17.16%)  69 63/409 (15.40%)  63
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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
ClinicalTrials.gov Identifier: NCT00388583     History of Changes
Other Study ID Numbers: FID04
First Submitted: October 16, 2006
First Posted: October 17, 2006
Results First Submitted: July 14, 2011
Results First Posted: September 13, 2011
Last Update Posted: April 18, 2012