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Trial record 1 of 1 for:    GRC41
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A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

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ClinicalTrials.gov Identifier: NCT00743275
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : February 23, 2010
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
Enrollment 120
Recruitment Details Participants were enrolled from 26 August to 03 September 2008 at one US clinical center.
Pre-assignment Details A total of 122 participants who met the inclusion and exclusion criteria were enrolled. Of these, 120 participants were vaccinated.
Arm/Group Title Age 18-60 Years Age 61 Years and Older
Hide Arm/Group Description Participants received one dose of Fluzone® vaccine on Day 0. Participants received one dose of Fluzone® vaccine on Day 0.
Period Title: Overall Study
Started 59 61
Completed 59 60
Not Completed 0 1
Reason Not Completed
Protocol Violation             0             1
Arm/Group Title Age 18-60 Years Age 61 Years and Older Total
Hide Arm/Group Description Participants received one dose of Fluzone® vaccine on Day 0. Participants received one dose of Fluzone® vaccine on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 59 61 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 61 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
59
 100.0%
8
  13.1%
67
  55.8%
>=65 years
0
   0.0%
53
  86.9%
53
  44.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 61 participants 120 participants
43.2  (12.14) 74.7  (7.67) 59.2  (18.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 61 participants 120 participants
Female
45
  76.3%
38
  62.3%
83
  69.2%
Male
14
  23.7%
23
  37.7%
37
  30.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants 61 participants 120 participants
59 61 120
1.Primary Outcome
Title Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Hide Description Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering
Time Frame Days 0-3 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety profile was assessed in the intent-to-treat (ITT) population
Arm/Group Title Age 18-60 Years Age 61 Years and Older
Hide Arm/Group Description:
Participants received one dose of Fluzone® vaccine on Day 0.
Participants received one dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 59 61
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 35 18
Any Pain 34 16
Grade 3 Pain (Incapacitating) 0 1
Any Erythema (Redness) 7 2
Grade 3 Erythema (Redness) 0 0
Any Swelling 4 1
Grade 3 Swelling (≥ 5 cm) 0 1
Any Induration 5 1
Grade 3 Induration (≥ 5 cm) 0 0
Any Ecchymosis 2 1
Grade 3 Ecchymosis (≥ 5 cm) 0 0
Any Solicited Systemic Reaction 25 14
Any Fever 1 0
Grade 3 Fever (> 102.2 ºF) 0 0
Any Headache 17 6
Grade 3 Headache 1 0
Any Malaise 9 2
Grade 3 Malaise (Prevents daily activities) 1 0
Any Myalgia 19 10
Grade 3 Myalgia (Prevents daily activities) 1 1
Any Shivering 4 0
Grade 3 Shivering (Prevents daily activities) 0 0
2.Primary Outcome
Title Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
Hide Description [Not Specified]
Time Frame Day 0 and 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of Geometric Mean Titers was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)
Arm/Group Title Age 18-60 Years Age 61 Years and Older
Hide Arm/Group Description:
Participants received one dose of Fluzone® vaccine on Day 0.
Participants received one dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 50 49
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Brisbane/59/2007 (H1N1) IVR-148 Pre-dose
26.9
(18.8 to 38.6)
16.9
(13.3 to 21.4)
A/Uruguay (H3N2) X-175-C Pre-dose
34.9
(22.5 to 54.2)
31.5
(21.5 to 46.0)
B/Florida/04/2006 Pre-dose
28.5
(21.0 to 38.6)
21.6
(16.6 to 28.1)
A/Brisbane/59/2007 (H1N1) IVR-148 Post-dose
130.9
(91.1 to 188.1)
46.1
(35.0 to 60.7)
A/Uruguay (H3N2) X-175-C Post-dose
528.7
(351.1 to 796.3)
300.3
(217.9 to 413.7)
B/Florida/04/2006 Post-dose
84.0
(64.9 to 108.6)
56.2
(40.9 to 77.2)
3.Primary Outcome
Title Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
Hide Description Seroprotection was defined as post-vaccination titer value of ≥ 1:40.
Time Frame 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of seroprotection was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)
Arm/Group Title Age 18-60 Years Age 61 Years and Older
Hide Arm/Group Description:
Participants received one dose of Fluzone® vaccine on Day 0.
Participants received one dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 50 49
Measure Type: Number
Unit of Measure: Percentage of Participants
A/Brisbane/59/2007 (H1N1) IVR-148 88 63
A/Uruguay (H3N2) X-175-C 98 98
B/Florida/04/2006 82 67
4.Primary Outcome
Title Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
Hide Description Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation
Time Frame 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of seroconversion was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)
Arm/Group Title Age 18-60 Years Age 61 Years and Older
Hide Arm/Group Description:
Participants received one dose of Fluzone® vaccine on Day 0.
Participants received one dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 50 49
Measure Type: Number
Unit of Measure: Percentage of Participants
A/Brisbane/59/2007 (H1N1) IVR-148 42 33
A/Uruguay (H3N2) X 175-C 77 84
B/Florida/04/2006 36 31
Time Frame Adverse events data were collected throughout the study from Day 0 to Day 21.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Age 18-60 Years Age 61 Years and Older
Hide Arm/Group Description Participants received one dose of Fluzone® vaccine on Day 0. Participants received one dose of Fluzone® vaccine on Day 0.
All-Cause Mortality
Age 18-60 Years Age 61 Years and Older
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Age 18-60 Years Age 61 Years and Older
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/59 (0.00%)      0/61 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Age 18-60 Years Age 61 Years and Older
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/59 (57.63%)      16/61 (26.23%)    
General disorders     
Injection site pain  1  34/59 (57.63%)  34 16/61 (26.23%)  16
Injection site erythema  1  7/59 (11.86%)  7 2/61 (3.28%)  2
Injection site swelling  1  4/59 (6.78%)  4 1/61 (1.64%)  1
Injection site induration  1  5/59 (8.47%)  5 1/61 (1.64%)  1
Malaise  1  9/59 (15.25%)  9 2/61 (3.28%)  2
Chills  1  4/59 (6.78%)  4 0/61 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myalgia  1  19/59 (32.20%)  19 10/61 (16.39%)  10
Nervous system disorders     
Headache  1  17/59 (28.81%)  17 6/61 (9.84%)  6
Respiratory, thoracic and mediastinal disorders     
Cough * 1  5/59 (8.47%)  5 0/61 (0.00%)  0
Nasal congestion * 1  4/59 (6.78%)  4 0/61 (0.00%)  0
Pharyngolaryngeal pain * 1  6/59 (10.17%)  6 1/61 (1.64%)  1
Rhinorrhoea * 1  3/59 (5.08%)  3 1/61 (1.64%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00743275     History of Changes
Other Study ID Numbers: GRC41
First Submitted: August 27, 2008
First Posted: August 28, 2008
Results First Submitted: February 1, 2010
Results First Posted: February 23, 2010
Last Update Posted: May 16, 2016