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Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

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ClinicalTrials.gov Identifier: NCT00258830
Recruitment Status : Completed
First Posted : November 28, 2005
Results First Posted : June 3, 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: Fluzone®: Influenza Virus Vaccine
Enrollment 120
Recruitment Details Study participants were enrolled from 09 September to 18 October 2005 in one medical clinic in the US
Pre-assignment Details A total of 120 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Age 18 to 59 Years Age 60 Years and Older
Hide Arm/Group Description Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly. Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
Period Title: Overall Study
Started 60 60
Completed 60 60
Not Completed 0 0
Arm/Group Title Age 18 to 59 Years Age 60 Years and Older Total
Hide Arm/Group Description Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly. Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly. Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
<=18 years
1
   1.7%
0
   0.0%
1
   0.8%
Between 18 and 65 years
59
  98.3%
2
   3.3%
61
  50.8%
>=65 years
0
   0.0%
58
  96.7%
58
  48.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
42.8  (11.25) 75.7  (6.24) 59.3  (18.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
49
  81.7%
39
  65.0%
88
  73.3%
Male
11
  18.3%
21
  35.0%
32
  26.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Hide Description [Not Specified]
Time Frame Day 0 to 3 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated subjects intent-to-treat safety population with available reaction data.
Arm/Group Title Age 18 to 59 Years Age 60 Years and Older
Hide Arm/Group Description:
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 40 10
Any Erythema 4 6
Grade 3 Erythema (≥ 5.0 cm) 1 1
Any Swelling 3 3
Grade 3 Swelling (≥ 5.0 cm) 1 0
Any Pain 39 8
Grade 3 Pain (Unable to perform usual activities) 0 0
Any Solicited Systemic Reaction 25 9
Any Fever 0 2
Grade 3 Fever (≥ 102.3°F) 0 0
Any Headache 12 3
Grade 3 Headache (Prevents daily activity) 1 0
Any Malaise 7 4
Grade 3 Malaise (Prevents daily activity) 0 0
Any Myalgia 13 3
Grade 3 Myalgia (Prevents daily activity) 0 0
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
Hide Description GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005–2006 Formulation)
Time Frame 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMT results were assessed on the per-protocol population.
Arm/Group Title Age 18 to 59 Years Age 60 Years and Older
Hide Arm/Group Description:
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
Overall Number of Participants Analyzed 60 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/New Caledonia/20/99 (H1N1), Pre
51.8
(35.9 to 74.8)
34.8
(27.7 to 43.8)
A/New Caledonia/20/99 (H1N1), Post
153.6
(113.8 to 207.2)
59.3
(45.9 to 76.6)
A/New York/55/2004 (H3N2), Pre
23.9
(18.2 to 31.5)
23.1
(16.8 to 31.9)
A/New York/55/2004 (H3N2), Post
341.0
(241.0 to 482.5)
174.5
(116.8 to 260.7)
B/Jiangsu/10/2003, Pre
25.9
(19.4 to 34.6)
42.6
(33.3 to 54.6)
B/Jiangsu/10/2003, Post
126.5
(93.0 to 172.1)
104.8
(78.3 to 140.4)
3.Other Pre-specified Outcome
Title Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination.
Hide Description Seroprotection: Percentage of participants with ≥ 40 serum hemagglutination inhibition antibody titers 21 days post-vaccination.
Time Frame 21 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in the per-protocol population
Arm/Group Title Age 18 to 59 Years Age 60 Years and Older
Hide Arm/Group Description:
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Percentage of participants
A/New Caledonia/20/99 (H1N1) ≥ 40 90 71
A/New York/55/2004 (H3N2) ≥ 40 95 83
B/Jiangsu/10/2003 ≥ 40 86 83
4.Other Pre-specified Outcome
Title Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination
Hide Description Seroconversion: percentage of participants with at least a 4-fold increase in serum hemagglutination inhibition antibody titers at 21 days post-vaccination.
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in the per-protocol population.
Arm/Group Title Age 18 to 59 Years Age 60 Years and Older
Hide Arm/Group Description:
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Percentage of participants
A/New Caledonia/20/99 (H1N1) ≥ 4 fold-rise 29 9
A/New York/55/2004 (H3N2) ≥ 4 fold-rise 93 67
B/Jiangsu/10/2003 ≥ 4 fold-rise 54 27
Time Frame Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Age 18 to 59 Years Age 60 Years and Older
Hide Arm/Group Description Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly. Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
All-Cause Mortality
Age 18 to 59 Years Age 60 Years and Older
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Age 18 to 59 Years Age 60 Years and Older
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (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%
Age 18 to 59 Years Age 60 Years and Older
Affected / at Risk (%) Affected / at Risk (%)
Total   15/60 (25.00%)   5/60 (8.33%) 
Infections and infestations     
Nasopharyngitis * 1  0/60 (0.00%)  4/60 (6.67%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  4/60 (6.67%)  1/60 (1.67%) 
Myalgia * 1  3/60 (5.00%)  0/60 (0.00%) 
Nervous system disorders     
Headache * 1  12/60 (20.00%)  0/60 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
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: NCT00258830     History of Changes
Other Study ID Numbers: GRC25
First Submitted: November 24, 2005
First Posted: November 28, 2005
Results First Submitted: March 5, 2009
Results First Posted: June 3, 2009
Last Update Posted: April 14, 2016