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Trial record 1 of 1 for:    GRC37
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Trial to Describe the Safety and Immunogenicity of Fluzone®

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ClinicalTrials.gov Identifier: NCT00524940
Recruitment Status : Completed
First Posted : September 5, 2007
Results First Posted : March 30, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Inactivated, Split-Virion Influenza Virus
Enrollment 124
Recruitment Details Participants were recruited from 15 August to 24 September 2007 at one US clinic site.
Pre-assignment Details A total of 124 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Study Group
Hide Arm/Group Description All participants enrolled and received Fluzone® Vaccine
Period Title: Overall Study
Started 124
Completed 124
Not Completed 0
Arm/Group Title Study Group
Hide Arm/Group Description All participants enrolled and received Fluzone® Vaccine
Overall Number of Baseline Participants 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
<=18 years
0
   0.0%
Between 18 and 65 years
68
  54.8%
>=65 years
56
  45.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants
59.40  (19.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
Female
80
  64.5%
Male
44
  35.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 124 participants
124
1.Primary Outcome
Title Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Hide Description Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
Time Frame 0-3 days post-vaccination and entire study duration
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants, intend-to-treat Population.
Arm/Group Title Study Group
Hide Arm/Group Description:
All participants enrolled and received Fluzone® Vaccine
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 62
Any Pain 57
Grade 3 Pain (Incapacitating) 0
Any Redness 9
Grade 3 Redness (≥5.0 cm) 0
Any Swelling 7
Grade 3 Swelling (≥ 5.0 cm) 1
Any Induration 8
Grade 3 Induration (≥ 5.0 cm) 0
Any Ecchymosis 5
Grade 3 Ecchymosis (≥ 5.0 cm) 0
Any Solicited Systemic Reaction 40
Any Fever 3
Grade 3 Fever (> 102.2°F) 0
Any Headache 26
Grade 3 Headache (Prevented daily activities) 1
Any Malaise 15
Grade 3 Malaise (Prevented daily activities) 0
Any Myalgia 27
Grade 3 Myalgia (Prevented daily activities) 0
Any Shivering 1
Grade 3 Shivering (Prevented daily activities) 0
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
Hide Description GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.
Time Frame 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The GMT were evaluated in the per-protocol Population
Arm/Group Title Study Group
Hide Arm/Group Description:
All participants enrolled and received Fluzone® Vaccine
Overall Number of Participants Analyzed 112
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
H1N1 A/Solomon Islands/3/2006 - PRE
30.7
(23.4 to 40.2)
H1N1 A/Solomon Islands/3/2006 - POST
234.1
(180.6 to 303.5)
H3N2 A/Wisconsin/67/2005 - PRE
88.1
(66.7 to 116.2)
H3N2 A/Wisconsin/67/2005 - POST
347.9
(281.0 to 430.7)
B/Malaysia/2506/2004 - PRE
13.0
(11.0 to 15.4)
B/Malaysia/2506/2004 - POST
35.9
(29.4 to 43.8)
Time Frame Adverse events data were collected from the day of vaccination to 21 days post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group
Hide Arm/Group Description All participants enrolled and received Fluzone® Vaccine
All-Cause Mortality
Study Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Study Group
Affected / at Risk (%)
Total   0/124 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Study Group
Affected / at Risk (%)
Total   57/124 (45.97%) 
General disorders   
Injection site pain  1  57/124 (45.97%) 
Injection site redness  1  9/124 (7.26%) 
Injection site swelling  1  7/124 (5.65%) 
Injection site induration  1  8/124 (6.45%) 
Malaise  1  15/124 (12.10%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  27/124 (21.77%) 
Nervous system disorders   
Headache  1  26/124 (20.97%) 
Indicates events were collected by 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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00524940     History of Changes
Other Study ID Numbers: GRC37
First Submitted: September 4, 2007
First Posted: September 5, 2007
Results First Submitted: February 24, 2009
Results First Posted: March 30, 2009
Last Update Posted: April 14, 2016