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Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

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ClinicalTrials.gov Identifier: NCT00831987
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : August 27, 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 2004-2005 formulation
Enrollment 120
Recruitment Details The study participants were enrolled from 06 through 16 August 2004 in 1 US site.
Pre-assignment Details A total of 120 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Fluzone® Vaccine Group - Age 18-59 Years Fluzone® Vaccine Group - Age ≥ 60 Years
Hide Arm/Group Description Participants received 1 dose of Fluzone® vaccine on Day 0. Participants received 1 dose of Fluzone® vaccine on Day 0.
Period Title: Overall Study
Started 60 60
Completed 60 60
Not Completed 0 0
Arm/Group Title Fluzone® Vaccine Group - Age 18-59 Years Fluzone® Vaccine Group - Age ≥ 60 Years Total
Hide Arm/Group Description Participants received 1 dose of Fluzone® vaccine on Day 0. Participants received 1 dose of Fluzone® vaccine on Day 0. 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
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
 100.0%
4
   6.7%
64
  53.3%
>=65 years
0
   0.0%
56
  93.3%
56
  46.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
41.3  (11.1) 74  (5.9) 57.7  (18.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
44
  73.3%
38
  63.3%
82
  68.3%
Male
16
  26.7%
22
  36.7%
38
  31.7%
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 Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Hide Description

Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site.

Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia

Time Frame 0 to 3 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluzone® Vaccine Group - Age 18-59 Years Fluzone® Vaccine Group - Age ≥ 60 Years
Hide Arm/Group Description:
Participants received 1 dose of Fluzone® vaccine on Day 0.
Participants received 1 dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Local (Injection Site) Reaction 60 23
Any Erythema (> 0.5 cm) 8 5
Grade 3 Erythema (≥ 5.0 cm) 0 2
Any Induration (> 0.5 cm) 7 0
Grade 3 Induration (≥ 5.0 cm) 2 0
Any Bruising (> 0.5 cm) 2 0
Grade 3 Bruising (≥ 5.0 cm) 0 0
Any Pain 60 20
Grade 3 Pain (unable to perform usual activities) 0 0
Any Solicited Systemic Reaction 42 23
Any Fever (≥ 100.4 º F) 0 0
Grade 3 Fever (≥ 104.0 º F) 0 0
Any Headache 23 8
Grade 3 Headache (prevents daily activity) 0 0
Any Chills 2 2
Grade 3 Chills (prevents daily activity) 0 0
Any Cough 7 3
Grade 3 Cough (prevents daily activity) 0 0
Any Runny Nose 8 3
Grade 3 Runny Nose (prevents daily activity) 0 0
Any Rash 0 0
Grade 3 Rash (prevents daily activity) 0 0
Any Malaise 7 2
Grade 3 Malaise (prevents daily activity) 0 0
Any Myalgia 13 8
Grade 3 Myalgia (prevents daily activity) 0 0
Any Arthralgia 7 2
Grade 3 Arthralgia (prevents daily activity) 0 0
Any Nausea 8 2
Grade 3 Nausea (prevents daily activity) 0 0
Any Vomiting 2 0
Grade 3 Vomiting (≥ 3 per day) 0 0
Any Diarrhea 3 5
Grade 3 Diarrhea (≥ 5 episodes per day) 0 0
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
Hide Description GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.
Time Frame Day 0 and Day 21 Post-Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers were assessed in the per-protocol population
Arm/Group Title Fluzone® Vaccine Group - Age 18-59 Years Fluzone® Vaccine Group - Age ≥ 60 Years
Hide Arm/Group Description:
Participants received 1 dose of Fluzone® vaccine on Day 0.
Participants received 1 dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 60 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/NEW CALEDONIA/20/99 (H1N1) Pre-vaccination
21.3
(15.7 to 28.9)
15.6
(13.1 to 18.6)
A/New CALEDONIA/20/99 (H1N1) Post-vaccination
39.3
(29.0 to 53.3)
19.8
(16.0 to 24.3)
A/WYOMING/03/2003 (H3N2) Pre-vaccination
34.2
(24.1 to 48.7)
25.6
(20.1 to 32.6)
A/WYOMING/03/2003 (H3N2) Post-vaccination
85.7
(64.8 to 113.4)
64.2
(46.2 to 89.1)
B/JIANGSU/10/2003 Pre-vaccination
8.5
(7.2 to 10.0)
10.6
(9.1 to 12.4)
B/JIANGSU/10/2003 Pre-vaccination
23.5
(18.3 to 30.2)
21.5
(16.3 to 28.5)
3.Primary Outcome
Title Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
Hide Description [Not Specified]
Time Frame 21 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluzone® Vaccine Group - Age 18-59 Years Fluzone® Vaccine Group - Age ≥ 60 Years
Hide Arm/Group Description:
Participants received 1 dose of Fluzone® vaccine on Day 0.
Participants received 1 dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Percentage of Participants
A/NEW CALEDONIA/20/99 (H1N1) 60 23
A/WYOMING/55/2004 (H3N2) 87 78
B/JIANGSU/10/2003 45 33
4.Primary Outcome
Title Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
Hide Description [Not Specified]
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluzone® Vaccine Group - Age 18-59 Years Fluzone® Vaccine Group - Age ≥ 60 Years
Hide Arm/Group Description:
Participants received 1 dose of Fluzone® vaccine on Day 0.
Participants received 1 dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Percentage of Participants
A/NEW CALEDONIA/20/99 (H1N1) 18 5
A/WYOMING/55/2004 (H3N2) 35 33
B/JIANGSU/10/2003 47 23
Time Frame Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluzone® Vaccine Group - Age 18-59 Years Fluzone® Vaccine Group - Age ≥ 60 Years
Hide Arm/Group Description Participants received 1 dose of Fluzone® vaccine on Day 0. Participants received 1 dose of Fluzone® vaccine on Day 0.
All-Cause Mortality
Fluzone® Vaccine Group - Age 18-59 Years Fluzone® Vaccine Group - Age ≥ 60 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone® Vaccine Group - Age 18-59 Years Fluzone® Vaccine Group - Age ≥ 60 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      1/60 (1.67%)    
Cardiac disorders     
Acute coronary syndrome * 1  0/60 (0.00%)  0 1/60 (1.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
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 - Age 18-59 Years Fluzone® Vaccine Group - Age ≥ 60 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/60 (100.00%)      20/60 (33.33%)    
Gastrointestinal disorders     
Diarrhoea  1  3/60 (5.00%)  5/60 (8.33%) 
Diarrhoea NOS * 1  1/60 (1.67%)  3/60 (5.00%) 
Nausea  1  8/60 (13.33%)  2/60 (3.33%) 
General disorders     
Injection site erythema  1  8/60 (13.33%)  5/60 (8.33%) 
Injection site induration  1  7/60 (11.67%)  0/60 (0.00%) 
Injection site pain  1  60/60 (100.00%)  20/60 (33.33%) 
Malaise  1  7/60 (11.67%)  2/60 (3.33%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  13/60 (21.67%)  8/60 (13.33%) 
Arthralgia  1  7/60 (11.67%)  2/60 (3.33%) 
Nervous system disorders     
Headache  1  23/60 (38.33%)  8/60 (13.33%) 
Headache * 1  10/60 (16.67%)  3/60 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/60 (11.67%)  3/60 (5.00%) 
Rhinorrhoea (Runny nose) * 1  8/60 (13.33%)  3/60 (5.00%) 
Indicates events were collected by systematic assessment
*
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
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: NCT00831987     History of Changes
Other Study ID Numbers: GRC20
First Submitted: January 28, 2009
First Posted: January 29, 2009
Results First Submitted: July 20, 2009
Results First Posted: August 27, 2009
Last Update Posted: April 14, 2016