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Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

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ClinicalTrials.gov Identifier: NCT01011049
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : August 11, 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: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Enrollment 1250
Recruitment Details Participants were enrolled and from 23 September 2009 to 16 October 2009 in 46 medical centers in the US.
Pre-assignment Details A total of 1248 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Group 1: Fluzone ID After Fluzone ID Group 2: Fluzone IM After Fluzone ID Group 3: Fluzone IM After Fluzone IM Group 4: Fluzone ID After Fluzone IM
Hide Arm/Group Description Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109) Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109) Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109) Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Period Title: Overall Study
Started 507 252 243 246
Completed 506 250 239 246
Not Completed 1 2 4 0
Reason Not Completed
Protocol Violation             0             0             2             0
Lost to Follow-up             1             2             1             0
Withdrawal by Subject             0             0             1             0
Arm/Group Title Group 1: Fluzone ID After Fluzone ID Group 2: Fluzone IM After Fluzone ID Group 3: Fluzone IM After Fluzone IM Group 4: Fluzone ID After Fluzone IM Total
Hide Arm/Group Description Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109) Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109) Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109) Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109) Total of all reporting groups
Overall Number of Baseline Participants 507 252 243 246 1248
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 507 participants 252 participants 243 participants 246 participants 1248 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
507
 100.0%
252
 100.0%
242
  99.6%
246
 100.0%
1247
  99.9%
>=65 years
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
1
   0.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 507 participants 252 participants 243 participants 246 participants 1248 participants
45.2  (13.10) 44.8  (13.26) 45.8  (12.74) 43.7  (12.78) 45  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 507 participants 252 participants 243 participants 246 participants 1248 participants
Female
324
  63.9%
161
  63.9%
158
  65.0%
155
  63.0%
798
  63.9%
Male
183
  36.1%
91
  36.1%
85
  35.0%
91
  37.0%
450
  36.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 507 participants 252 participants 243 participants 246 participants 1248 participants
507 252 243 246 1248
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
Hide Description Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).
Time Frame Day 0 through Day 7 post-vaccination
Hide 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 1: Fluzone ID After Fluzone ID Group 2: Fluzone IM After Fluzone ID Group 3: Fluzone IM After Fluzone IM Group 4: Fluzone ID After Fluzone IM
Hide Arm/Group Description:
Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Overall Number of Participants Analyzed 505 249 243 245
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Erythema 412 54 27 183
Grade 3 Erythema (≥ 5 cm) 91 2 0 37
Any Solicited Injection Site Swelling 343 45 13 137
Grade 3 Swelling (≥ 5 cm) 40 4 2 14
Any Solicited Injection Site Induration 310 46 27 133
Grade 3 Induration (≥ 5 cm) 24 0 1 11
Any Solicited Injection Site Pain 274 148 147 145
Grade 3 Pain (Incapacitating) 5 4 2 2
Any Solicited Injection Site Pruritus 257 32 20 123
Grade 3 Pruritus (Incapacitating) 10 0 0 1
Any Solicited Injection Site Ecchymosis 53 10 10 25
Grade 3 Ecchymosis (≥ 5 cm) 1 0 1 0
Any Headache 148 65 72 73
Grade 3 Headache (Prevents Daily Activities) 13 4 3 5
Any Myalgia 131 77 75 68
Grade 3 Myalgia (Prevents Daily Activities) 8 5 0 7
Any Malaise 98 55 50 54
Grade 3 Malaise (Prevents Daily Activities) 16 9 4 7
Any Shivering 50 15 19 25
Grade 3 Shivering (Prevents Daily Activities) 8 0 0 5
Any Fever 20 8 9 15
Grade 3 Fever (> 102.2 ºF) 1 0 0 1
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
Hide Description Serum antibody titers for 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
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody geometric mean titers were assessed in the per-protocol population.
Arm/Group Title Group 1: Fluzone ID After Fluzone ID Group 2: Fluzone IM After Fluzone ID Group 3: Fluzone IM After Fluzone IM Group 4: Fluzone ID After Fluzone IM
Hide Arm/Group Description:
Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Overall Number of Participants Analyzed 495 242 234 240
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239)
54.5
(48.8 to 60.8)
64.8
(55.5 to 75.7)
51.2
(43.4 to 60.5)
56.3
(48.7 to 65.1)
A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239)
142.8
(129.7 to 157.3)
151.7
(132.1 to 174.3)
126.2
(109.4 to 145.7)
137.4
(119.8 to 157.5)
A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239)
78.8
(69.3 to 89.5)
91.3
(75.2 to 110.8)
69.7
(57.9 to 84.0)
79.7
(66.9 to 94.8)
A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239)
286.7
(260.3 to 315.8)
292.0
(250.9 to 339.8)
268.3
(234.2 to 307.3)
290.8
(252.2 to 335.3)
B Pre-dose (Day 0; N = 495, 242, 234, 240)
20.1
(18.5 to 21.9)
21.0
(18.6 to 23.6)
21.0
(18.4 to 24.0)
21.8
(19.3 to 24.7)
B Post-dose (Day 28; N = 495, 242, 234, 240)
75.0
(68.9 to 81.7)
85.7
(75.5 to 97.3)
73.9
(64.8 to 84.1)
72.2
(63.1 to 82.7)
3.Secondary Outcome
Title Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Hide Description Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers were assessed in the per-protocol population.
Arm/Group Title Group 1: Fluzone ID After Fluzone ID Group 2: Fluzone IM After Fluzone ID Group 3: Fluzone IM After Fluzone IM Group 4: Fluzone ID After Fluzone IM
Hide Arm/Group Description:
Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Overall Number of Participants Analyzed 495 242 234 240
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239) 64 70 60 67
A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239) 92 94 92 90
A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239) 71 76 68 71
A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239) 98 96 98 97
B Pre-dose (Day 0; N = 495, 242, 234, 240) 32 32 32 33
B Post-dose (Day 28; N = 495, 242, 234, 240) 83 84 79 78
4.Secondary Outcome
Title Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular 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
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers were assessed in the per protocol population.
Arm/Group Title Group 1: Fluzone ID After Fluzone ID Group 2: Fluzone IM After Fluzone ID Group 3: Fluzone IM After Fluzone IM Group 4: Fluzone ID After Fluzone IM
Hide Arm/Group Description:
Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Overall Number of Participants Analyzed 495 242 234 240
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1 Serogroup (N = 495, 242, 234, 239) 31 29 26 30
A/H3N2 Serogroup (N = 495, 242, 234, 239) 47 40 42 44
B Serogroup (N = 495, 242, 234, 240) 42 46 42 35
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 Group 1: Fluzone ID After Fluzone ID Group 2: Fluzone IM After Fluzone ID Group 3: Fluzone IM After Fluzone IM Group 4: Fluzone ID After Fluzone IM
Hide Arm/Group Description Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109) Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109) Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109) Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
All-Cause Mortality
Group 1: Fluzone ID After Fluzone ID Group 2: Fluzone IM After Fluzone ID Group 3: Fluzone IM After Fluzone IM Group 4: Fluzone ID After Fluzone IM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Fluzone ID After Fluzone ID Group 2: Fluzone IM After Fluzone ID Group 3: Fluzone IM After Fluzone IM Group 4: Fluzone ID After Fluzone IM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/507 (1.78%)      2/252 (0.79%)      3/243 (1.23%)      5/246 (2.03%)    
Endocrine disorders         
Autoimmune thyroiditis * 1  1/507 (0.20%)  1 0/252 (0.00%)  0 0/243 (0.00%)  0 0/246 (0.00%)  0
Hepatobiliary disorders         
Cholelithiasis * 1  1/507 (0.20%)  1 0/252 (0.00%)  0 0/243 (0.00%)  0 0/246 (0.00%)  0
Infections and infestations         
Appendicitis perforated * 1  1/507 (0.20%)  1 0/252 (0.00%)  0 0/243 (0.00%)  0 0/246 (0.00%)  0
Gastroenteritis * 1  0/507 (0.00%)  0 1/252 (0.40%)  1 0/243 (0.00%)  0 0/246 (0.00%)  0
Pneumonia * 1  0/507 (0.00%)  0 0/252 (0.00%)  0 0/243 (0.00%)  0 1/246 (0.41%)  1
Viral infection * 1  1/507 (0.20%)  1 0/252 (0.00%)  0 0/243 (0.00%)  0 0/246 (0.00%)  0
Injury, poisoning and procedural complications         
Incisional hernia * 1  0/507 (0.00%)  0 0/252 (0.00%)  0 0/243 (0.00%)  0 1/246 (0.41%)  1
Post procedural complication * 1  0/507 (0.00%)  0 0/252 (0.00%)  0 0/243 (0.00%)  0 1/246 (0.41%)  1
Upper limb fracture * 1  0/507 (0.00%)  0 0/252 (0.00%)  0 0/243 (0.00%)  0 1/246 (0.41%)  1
Musculoskeletal and connective tissue disorders         
Knee arthroplasty * 1  0/507 (0.00%)  0 0/252 (0.00%)  0 1/243 (0.41%)  1 0/246 (0.00%)  0
Spinal operation * 1  0/507 (0.00%)  0 0/252 (0.00%)  0 0/243 (0.00%)  0 1/246 (0.41%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Pituitary tumor * 1  1/507 (0.20%)  1 0/252 (0.00%)  0 0/243 (0.00%)  0 0/246 (0.00%)  0
Uterine leiomyoma * 1  0/507 (0.00%)  0 0/252 (0.00%)  0 1/243 (0.41%)  1 0/246 (0.00%)  0
Psychiatric disorders         
Affective disorder * 1  1/507 (0.20%)  1 0/252 (0.00%)  0 0/243 (0.00%)  0 0/246 (0.00%)  0
Psychiatric decompensation * 1  0/507 (0.00%)  0 0/252 (0.00%)  0 1/243 (0.41%)  1 0/246 (0.00%)  0
Reproductive system and breast disorders         
Cervix haemorrhage uterine * 1  0/507 (0.00%)  0 0/252 (0.00%)  0 0/243 (0.00%)  0 1/246 (0.41%)  1
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  0/507 (0.00%)  0 0/252 (0.00%)  0 0/243 (0.00%)  0 1/246 (0.41%)  1
Chronic obstructive pulmonary disease * 1  2/507 (0.39%)  2 0/252 (0.00%)  0 0/243 (0.00%)  0 0/246 (0.00%)  0
Vascular disorders         
Arteriovenous fistula * 1  0/507 (0.00%)  0 1/252 (0.40%)  1 0/243 (0.00%)  0 0/246 (0.00%)  0
Embolism venous * 1  1/507 (0.20%)  1 0/252 (0.00%)  0 0/243 (0.00%)  0 0/246 (0.00%)  0
Hypertension * 1  1/507 (0.20%)  1 0/252 (0.00%)  0 0/243 (0.00%)  0 0/246 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Group 1: Fluzone ID After Fluzone ID Group 2: Fluzone IM After Fluzone ID Group 3: Fluzone IM After Fluzone IM Group 4: Fluzone ID After Fluzone IM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   412/507 (81.26%)      148/252 (58.73%)      147/243 (60.49%)      183/246 (74.39%)    
Gastrointestinal disorders         
Injection site pain  1  274/505 (54.26%)  274 148/249 (59.44%)  148 147/240 (61.25%)  147 145/245 (59.18%)  145
General disorders         
Injection site erythema  1  412/505 (81.58%)  412 54/249 (21.69%)  54 27/240 (11.25%)  27 183/245 (74.69%)  183
Injection site swelling  1  343/505 (67.92%)  343 45/249 (18.07%)  45 13/240 (5.42%)  13 137/245 (55.92%)  137
Injection site induration  1  310/505 (61.39%)  310 46/249 (18.47%)  46 27/240 (11.25%)  27 133/245 (54.29%)  133
Malaise  1  98/505 (19.41%)  98 55/249 (22.09%)  55 50/240 (20.83%)  50 54/245 (22.04%)  54
Shivering  1  50/505 (9.90%)  50 15/249 (6.02%)  15 19/240 (7.92%)  19 25/245 (10.20%)  25
Fever  1  20/505 (3.96%)  20 8/249 (3.21%)  8 9/240 (3.75%)  9 15/245 (6.12%)  15
Musculoskeletal and connective tissue disorders         
Myalgia  1  131/505 (25.94%)  131 77/249 (30.92%)  77 75/240 (31.25%)  75 68/245 (27.76%)  245
Nervous system disorders         
Headache  1  148/505 (29.31%)  148 65/249 (26.10%)  65 72/240 (30.00%)  72 73/245 (29.80%)  73
Skin and subcutaneous tissue disorders         
Injection site pruritus  1  257/505 (50.89%)  257 32/249 (12.85%)  32 20/240 (8.33%)  20 123/245 (50.20%)  123
Vascular disorders         
Injection site ecchymosis  1  53/505 (10.50%)  53 10/249 (4.02%)  10 10/240 (4.17%)  10 25/245 (10.20%)  25
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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: NCT01011049     History of Changes
Other Study ID Numbers: FID33
UTN: U1111-1111-5095 ( Other Identifier: WHO )
First Submitted: November 9, 2009
First Posted: November 11, 2009
Results First Submitted: July 14, 2011
Results First Posted: August 11, 2011
Last Update Posted: April 14, 2016