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Trial record 1 of 1 for:    GRC16
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A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

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ClinicalTrials.gov Identifier: NCT00835926
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : October 26, 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: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Influenza virus vaccine
Enrollment 121
Recruitment Details Participants were enrolled and treated from 25 July 2003 to 26 August 2003 at 1 US site.
Pre-assignment Details A total of 121 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Fluzone® Vaccine Group 1 Fluzone® Vaccine Group 2
Hide Arm/Group Description Participants were 18 to 59 years old at enrollment in the study Participants were 60 years or older at enrollment in the study
Period Title: Overall Study
Started 61 60
Completed 61 60
Not Completed 0 0
Arm/Group Title Fluzone® Vaccine Group 1 Fluzone® Vaccine Group 2 Total
Hide Arm/Group Description Participants were 18 to 59 years old at enrollment in the study Participants were 60 years or older at enrollment in the study Total of all reporting groups
Overall Number of Baseline Participants 61 60 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
<=18 years
1
   1.6%
0
   0.0%
1
   0.8%
Between 18 and 65 years
60
  98.4%
5
   8.3%
65
  53.7%
>=65 years
0
   0.0%
55
  91.7%
55
  45.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Continuous Number Analyzed 61 participants 60 participants 121 participants
40.7  (10.43) 73.7  (6.16) 57.1  (18.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
Female
48
  78.7%
39
  65.0%
87
  71.9%
Male
13
  21.3%
21
  35.0%
34
  28.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 61 participants 60 participants 121 participants
61 60 121
1.Primary Outcome
Title Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Hide Description

Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site.

Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia

Time Frame Days 0 to 3 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
Arm/Group Title Fluzone® Vaccine Group 1 Fluzone® Vaccine Group 2
Hide Arm/Group Description:
Participants were 18 to 59 years old at enrollment in the study
Participants were 60 years or older at enrollment in the study
Overall Number of Participants Analyzed 61 60
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Erythema 15 7
Grade 3 Erythema (> 5 cm) 0 2
Any Induration 20 12
Grade 3 Induration (> 5 cm) 2 0
Any Bruising 10 3
Grade 3 Bruising (> 5 cm) 0 2
Any Pain 75 12
Grade 3 Pain (Decreased ability to move arm) 0 0
Any Fever 0 2
Grade 3 Fever (Incapacitating) 0 0
Any Chills 5 2
Grade 3 Chills (Incapacitating) 0 0
Any Rash 0 0
Grade 3 Rash (Incapacitating) 0 0
Any Headache 23 7
Grade 3 Headache (Incapacitating) 2 2
Any Cough 0 2
Grade 3 Cough (Incapacitating) 0 0
Any Runny Nose 5 3
Grade 3 Runny Nose (Incapacitating) 0 0
Any Nausea 7 0
Grade 3 Nausea (Incapacitating) 0 0
Any Vomiting 2 0
Grade 3 Vomiting (Incapacitating) 0 0
Any Diarrhea 3 0
Grade 3 Diarrhea (Incapacitating) 0 0
Any Malaise 10 3
Grade 3 Malaise (Incapacitating) 2 2
Any Myalgia 13 5
Grade 3 Myalgia (Incapacitating) 0 0
Any Arthralgia 5 3
Grade 3 Arthralgia (Incapacitating) 0 0
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
Hide Description Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.
Time Frame Day 0 and Day 21 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Geometric mean titers were analyzed in the per-protocol immunogenicity population.
Arm/Group Title Fluzone® Vaccine Group 1 Fluzone® Vaccine Group 2
Hide Arm/Group Description:
Participants were 18 to 59 years old at enrollment in the study
Participants were 60 years or older at enrollment in the study
Overall Number of Participants Analyzed 61 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Panama/2007/99 Pre-Dose
29.6
(22.6 to 38.7)
20.4
(15.9 to 26.2)
A/Panama/2007/99 Post-Dose
67.1
(50.7 to 88.7)
37.5
(29.5 to 47.7)
A/New Caledonia/20/99 Pre-Dose
18.3
(13.6 to 24.7)
9.5
(7.7 to 11.6)
A/New Caledonia/20/99 Post-Dose
46.3
(34.3 to 62.5)
15.1
(12.1 to 18.9)
B/Hong Kong/1434/2002 Pre-Dose
10.7
(8.6 to 13.3)
8.2
(6.8 to 9.7)
B/Hong Kong/1434/2002 Post-Dose
27.8
(22.1 to 34.9)
15.9
(12.6 to 20.1)
3.Primary Outcome
Title Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®
Hide Description Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.
Time Frame Day 21 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine antibody fold rise analysis was in the per-protocol immunogenicity population.
Arm/Group Title Fluzone® Vaccine Group 1 Fluzone® Vaccine Group 2
Hide Arm/Group Description:
Participants were 18 to 59 years old at enrollment in the study
Participants were 60 years or older at enrollment in the study
Overall Number of Participants Analyzed 61 60
Measure Type: Number
Unit of Measure: Percentage of Participants
A/Panama/2007/99 28 18
A/New Caledonia/20/99 30 8
B/Hong Kong/1434/2002 38 22
4.Primary Outcome
Title Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®
Hide Description Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay
Time Frame Day 21 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Fluzone® antibody titers were analyzed in the per-protocol immunogenicity population.
Arm/Group Title Fluzone® Vaccine Group 1 Fluzone® Vaccine Group 2
Hide Arm/Group Description:
Participants were 18 to 59 years old at enrollment in the study
Participants were 60 years or older at enrollment in the study
Overall Number of Participants Analyzed 61 60
Measure Type: Number
Unit of Measure: Percentage of Participants
A/Panama/2007/99 74 60
A/New Caledonia/20/99 62 25
B/Hong Kong/1434/2002 41 25
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluzone® Vaccine Group 1 Fluzone® Vaccine Group 2
Hide Arm/Group Description Participants were 18 to 59 years old at enrollment in the study Participants were 60 years or older at enrollment in the study
All-Cause Mortality
Fluzone® Vaccine Group 1 Fluzone® Vaccine Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone® Vaccine Group 1 Fluzone® Vaccine Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/61 (0.00%)      0/60 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluzone® Vaccine Group 1 Fluzone® Vaccine Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/61 (13.11%)      2/60 (3.33%)    
Nervous system disorders     
Headache * 1  8/61 (13.11%)  12 2/60 (3.33%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
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: NCT00835926     History of Changes
Other Study ID Numbers: GRC16
First Submitted: January 27, 2009
First Posted: February 4, 2009
Results First Submitted: September 23, 2009
Results First Posted: October 26, 2009
Last Update Posted: April 14, 2016